Category Archives: Hypertension

Wally’s High Blood Pressure Tales: Of Dentists, Wrist Cuffs and an Experiment

Today’s post comes from the Wally, the life coach of the skeptical cardiologist,  who (ultimately) relates what happened when he agreed to do a blood pressure experiment in exchange for medical advice.


Blood Pressure Story 1

I used to work for a company that, for a short time, rewarded healthy employees with lower insurance premiums. They based your score on body-mass-index (BMI), cholesterol, and blood pressure (BP). At the time, I was riding a bike a lot so my BMI was acceptable. My cholesterol was also within range since I take a low dose of a statin. But, my blood pressure? I’ve been doing battle with my blood pressure since the 1980s. So, on the morning of the screening, I took precautions: no alcohol the night before and no coffee before the test. Let’s talk about coffee for a moment: I’m an engineer and we use coffee for fuel. Never hire an engineer who doesn’t drink coffee. In fact, here’s how I interview a new engineering candidate:

Me: “Do you like coffee?”
Candidate: “Yes”
Me: “How do you like it?”
Candidate: “Black.”
Me: “Congratulations, you have the job!”

Back to the morning of the screening: I had no coffee and I may have had low blood sugar. I got in my car and started backing out. It’s 6:30AM and dark outside – backing, backing, backing, CRUNCH. In spite of having a backup camera I still somehow managed to hit my daughter’s car. I’m sure that sent my BP up. Fortunately, I had calmed down enough to pass all of my tests by the time I got to the screening center 30 minutes later. 

Blood Pressure Story 2

On another morning I had to go to the dentist – I always go early so that I don’t miss any work. So, with three cups of coffee in me I hit the road. Of course, I didn’t take traffic into consideration and  I was 10 minutes late. The staff at the dentist’s office didn’t mind but I was a little anxious because 1) I hate to be late and 2) I was at the dentist’s office. 

They have me sit in the adjustable padded chair and ask me the usual questions about changes in the meds I’m taking. While that’s going on, I’m trying to remember if this is the visit where they take X-rays or the visit where they use a needle to evaluate the pliability and travel of my gumline. Trust me, the gumline eval is not fun and as I start to think it’s going to happen, the hygienist puts a small integrated blood pressure cuff on my wrist. Really? You’re about to poke sharp things into my mouth and you’re measuring my BP? Of course, it’s terrible. They measure again: not so terrible. And on the 3rd measurement? Back to terrible.

Ever hear anybody say, “The dentist sure was fun today!” No, you haven’t. That sentence has never been spoken – unless the valve on the nitrous tank was leaking. This guy though, he liked to visit his dentist:

Blood Pressure Story 3

The Beginning

I had a semiannual physical coming up and I realized I better follow my doctor’s advice from my last visit and measure my BP first thing in the morning – before the coffee. Now, I have an old blood pressure cuff that I bought at a garage sale about 20 years ago and it still worked. But I started wondering how accurate it was given its age. So I went shopping on Amazon and decided to buy the same wrist cuff that they use at the demented dentist office. The morning after it came, I measured my BP and… well it wasn’t very good. So, I called my good friend The Skeptical Cardiologist and asked for his advice. And he graciously agreed to help – for a price. We made a deal: he would guide me on my journey to a lower BP. In exchange I would collect some data and provide an opinion on the different cuffs.

In other words: I volunteered to be the SC’s Lab Rat. At first I was proud that he was considering me to provide invaluable data. But, as time went on, I started thinking this might have been his revenge for a laboratory mishap that I caused when we were undergrads. Anyway, on to the experiment!

The Equipment

LifeSource UA-767

Your basic brachial BP cuff purchased at a garage sale.

OMRON 3 Series Wrist Blood Pressure Monitor

New. Can save data to your phone via bluetooth. Small.

The Protocol

First thing in the morning:

  1. Take three measurements on the left wrist with the Omron
  2. Take three measurements on the left arm with the LifeSource
  3. Take three measurements on the right wrist with the Omron
  4. Take three measurements on the right arm with the LifeSource

The Data

I’m a lousy scientist. I started off with good intentions but pretty soon, I started forgetting the evening measurements. And then, when I saw that there wasn’t too much deviation between the measurements on my left and right arms, I only made left arm measurements.

Here are the first two days of data:

January 1st:

The BP measured on my right side was lower in the morning and higher with the wrist cuff in the evening.

January 2nd:

On the 2nd day, left and right were more consistent but the wrist cuff was higher in the evening. About this time, I was already getting annoyed with the wrist cuff and decided to return it. My reasons for this are detailed below. 

I continued to measure my BP in the mornings using just the LifeSource cuff:

Other than the data from 1/5/20, there appears to be reasonably good correlation between the left and right arms.

Note the 12 day gap between the last two data sets. That’s because:

Tragedy Strikes

On the morning of January 8th, the LifeSource UA-767 blood pressure cuff crashed and burned on my kitchen table. The root cause of the failure was a small molded rubber doohickey that acted as an attachment point for the air system in the meter. I now had no means of measuring my BP. The experiment was over.

Review and Wrap Up

First of all this was not a very scientific experiment. By changing my meds I was able to get my BP down but I failed to collect all the data that the SC asked for. The reasons for this were 1) I returned the Omron wrist cuff early, 2) I kept forgetting to take my BP in the evening (it was a little crazy at my house over the holidays), and 3) the LifeSource died.  But I had used both instruments long enough to form an opinion:

Omron

I had high hopes for the Omron wrist cuff – it was new, and it was small with none of the awkwardness of the more traditional brachial style cuff. But I quickly started finding flaws:

  1. A wrist cuff has to be carefully positioned to get accurate measurements. While Omron says that the edge of the strap should be 1/2” away from the bottom of your palm, I had better luck just centering the strap over the vein where your radial pulse is measured. And besides, exactly where is the bottom of my palm? I could see where that would confuse some people.
  2. I found that manipulating the strap on the wrist cuff with one hand to be a little more difficult than the brachial cuff. Now maybe if I had kept it longer I would have become more adept but right away I felt that this could also lead to some positioning errors.
  3. To make accurate measurements with the Omron requires that you elevate your wrist to the same height as your heart. You can do this one of two ways: 1) physically hold up your wrist for the duration of the measurement or 2) prop it up with a pillow. This step is not required with an arm cuff because once applied it’s already positioned at roughly the same height as your heart. 
  4. Home blood pressure monitors have small air pumps in them to pressurize the cuff – that’s the buzzing sound you hear when you press the Start button. Since the enclosure for the Omron monitor is smaller than the LifeSource device, it has to use a smaller air pump. And a smaller air pump needs more time to pressurize the cuff. So you have to sit there and hold up your wrist while waiting for the cuff to pressurize – I found this a little tiring.

On the plus side the Omron did come with a small plastic case and didn’t take up too much space. And it had Bluetooth which allowed me to save my measurements on my phone using their app.  

LifeSource

The LifeSource was a boring old fashioned BP Meter that got the job done – until it died. My only complaint about these devices is that they’re awkward to store. There’s the cuff, the base, and the rubber tube connecting the two. Combined these things always get tangled up with other stuff.

Conclusions 

The old fashioned arm cuff is the way to go based on my experience. Yes, they’re awkward but they are solid and less prone to error. Because of this, I replaced the LifeSource with an Omron arm cuff monitor. And for storage I also bought a small enclosure for it.  And as for my BP, I was able to get it down in time for my doctor’s appointment.


When Wally is not creating laboratory mishaps or providing life coach consulting he dabbles in electrical engineering, tells mysteriously hilarious jokes,  and runs a website called Pi-Plates.com.

We met our freshman year at Oklahoma University and Jerry claims my first words to him were “Are you ready for the country?”

Skeptically Yours,

-ACP

The Full Omron HeartGuide Review: Is This Wearable Wristwatch Blood Pressure Monitor Right For You?

The Omron HeartGuide (OHG) is a digital wristwatch that takes oscillometric measurements of blood pressure. Named to TIME Magazine’s Best Inventions of 2019 list, the promise of this device was succinctly summarized by an Omron executive: “Integrating a blood-­pressure monitor into a sleek watch that also measures sleep and activity makes staying on top of cardiovascular health easy and provides a fuller picture of overall wellness.”

Previously on the skeptical cardiologist, I described my excitement at the HeartGuide’s ability to “serve as an accurate and unobtrusive daytime ambulatory blood pressure monitor.” After wearing the HeartGuide for a week and using it in a variety of situations to measure my blood pressure I had begun rethinking my usual recommendation against wrist blood pressure cuffs.

For me, the great attraction of the OHG was and still is the ability to measure your BP “anytime, anywhere.”

Despite my unabashed enthusiasm for the Heart Guide’s ability to provide facile daytime BP monitoring, certain limitations need to be recognized.

Herein is my more detailed, objective and pragmatic review of the device.

What Is In The Cube?

The OHG  is available on the Omron website for $499 but upon checkout currently, Omron is providing a 10% discount along with free economy shipping.

The device is available in medium and large wrist sizes. I sized my wrist as a medium using the measuring tool on their website.

Proper wrist sizing is crucial for accurate BP measurement.

The OHG ships in a black cube.

Inside the cube you will discover:

  • 1 Monitor
  • 1 Paper Sizing Guide
  • 1 Instruction Manual
  • 1 Quick Start Guide
  • 1 Charging Clip
  • 1 AC Adapter
  • 1 Charging Cable
  • 2 Replacement Cuff Sleeves

The OHG is large but stylish in appearance. It weighs 115 grams and the watch dial has a diameter  of 1.9 inches.

I found it took about 2 hours to fully charge the battery and that the device remained charged for about 48 hours.

Preparing For Blood Pressure Measurement

For accurate BP measurement, it is important to follow very closely the directions Omron provides.  The band should be positioned about 1 inch (2 fingers) below “the base of the hand.” The fit should be “snug.” Your index finger should not easily slide between the band the wrist.
The instructions ask you to sit in a chair for measurement and “position at heart level.” However, as I discussed in my previous post I found that I could make BP measurements under a variety of circumstances beyond chair sitting.
The OHG is fairly finicky about stability and positioning.  The directions for positioning state “position HeartGuide at heart level with 2 inches space between wrist and chest.” To ensure accuracy “do not bend your wrist or look at the display during measurement.”
Here’s what Omron says about its “Heart Zone Indicator”:

Your monitor has a built-in heart zone indicator that is used as an aid in determining if your monitor is at the correct height and position. It has been designed to work with most people so that when your wrist is at the correct position relative to your heart, your monitor will vibrate once. If it does not vibrate, your monitor may not be at the correct height and position relative to your heart.

Due to differences in individual size and physique, this feature may not be helpful in all cases and you may wish to turn off this feature. If you feel the position of the wrist, according to the heart zone indicator’s guidance, does NOT match your heart level, please turn off this feature and follow your judgment.

It’s not clear to me how the OHG knows that it is at heart level. I experimented with various positions including lying on my back and standing with my wrist definitely at heart level. Sometimes the OHG agreed, others not.

It is clear, however, that it does not like significant movement. It would not make a measurement if I was walking at any speed or while exercising on an elliptical or stationary bicycle.

Measuring A Blood Pressure

Once positioned properly simply push the top button on the watch and put your wrist in the appropriate position. You will notice a vibration followed by an initial mild inflation of the cuff that lasts about 15 seconds followed by a pause of a few seconds then a full , tight inflation of the cuff.

The entire process takes over a minute and is significantly slower than the upper arm BP cuffs I have been using.

When completed, the cuff deflates and the systolic and diastolic blood pressure along with pulse rate are displayed.

Not infrequently after triggering the device  I received an error message. Most commonly I encountered  Errors 4 or 5 which indicates excessive movement or talking

 

 

Accuracy

Before I could recommend the OHG in particular or wrist BP cuff devices, in general, I needed to know how they compared to the gold standard brachial artery, upper arm BP cuff.

I asked Omron for data supporting the accuracy of the OHG and they provided me with a copy of a 2019 paper entitled “Validation of two watch‐type wearable blood pressure monitors according to the ANSI/AAMI/ISO81060‐2:2013 guidelines: Omron HEM‐6410T‐ZM and HEM‐6410T‐ZL”

The lead author of this study is an MD, PhD working at the Jichi School of Medicine in Japan and his 3 co-authors all work for Omron Healthcare, Kyoto, Japan, which provided funding for the research so this skeptical cardiologist takes this information with a grain of salt.

The introduction to this paper points out that ambulatory blood pressure monitoring is important to help identify individuals who have higher blood pressure outside the clinic. Such individuals have masked hypertension, the opposite of white-coat hypertension.

The researchers concluded that both the large and medium wrist HeartGuide devices were accurate and fulfilled criteria set by the American National Standards Institute, Inc/Association for the Advancement of Medical Instrumentation/International Organization for Standardization.

Here are the Bland-Altman plots from that study

Note that although the average difference between the reference BP and the HeartGuide systolic BP is close to zero there is a significant variation from zero for individual measurements with some 20 mm Hg higher and some 20 mm Hg lower.

My experience confirms this significant individual variation. I took a number of simultaneous measurements using the HeartGuide on one wrist and a brachial BP cuff on the contralateral arm. I did this over multiple days under differing circumstances and with the devices on different arms.

I found that the HeartGuide systolic blood pressure was on average 10 mm Hg lower than the brachial BP when my blood pressure was high (>140 mm Hg).  When my systolic BP was between 120 and 130 mm Hg the HeartGuide was 5 mm Hg lower than the brachial and when my blood pressure was less than 120 mm Hg the Heart Guide and brachial BPs were identical.

I made similar measurements on other volunteers and found some had consistently identical wrist and brachial SBP whereas others had consistently higher blood pressures by wrist compared to brachial techniques.

Because of this individual variation I highly recommend users calibrate the OHG (or any wrist-based BP cuff) versus a standard BP cuff over a series of days with multiple measurements to see how the two measurements compare. If you find a consistent over or underestimate then the device can be used with this known adjustment.

Comfort, Form, Fit

The OHG is big. and it is bulky. The fastening strap is made of thick rubber and underneath that is the inflatable microcuff which works like the larger cuffs designed for brachial/upper arm measurement.

I was always aware of something on my wrist when I was wearing it. The OHG cannot be accessed if you are wearing a coat or any garment with thickish sleeves. Getting most upper garments on and off while wearing the OHG is a chore.

In the picture below you get a feel for how the OHG interacts with long sleeve garments. My shirt sleeve would not slip over it. When I was wearing a coat or sweatshirt I could not access or view the OHG as its large size prevented pulling back the sleeve.

IMG_5214.jpeg

Some Other Things the OHG Does

The OHG measures steps and it tells time. Omron also indicates it can be used to measure sleep quality. Frankly, I  did not test this feature because I felt I would not be able to sleep comfortably with the device on my wrist.

The OHG pairs via Bluetooth with the Omron smartphone app “Heart Advisor.” The app displays imported BP, pulse, activity and sleep data in various graphic formats.

IMG_5458

Data can be exported from the Heart Advisor app by email in either an Excel or PDF file. This feature would allow the user to conveniently send recorded BPs to their physician.

The OHG sends an alert when you receive a text message or phone call but you can’t see the text message or answer the call.

Overall Pros and Cons

I am still a fan of the OHG despite the limitations I have indicated above.

I don’t see most people using the OHG as their every day smartwatch The inconvenience and discomfort factors for most will outweigh the benefits.

However, I do see a very beneficial role in wearing the OHG periodically for targeted purposes. For example, it could be worn to work once per week to determine how one’s blood pressure is reacting to stressful situations or to the gym to assess one’s blood pressure before and after a workout. At least one study suggests that BP obtained at work is superior to 24 hour or sleep BP in predicting end-organ damage (manifested by echocardiographic left ventricular hypertrophy) from hypertension

If Omron can develop a method for the device to automatically trigger during sleep and provide accurate nocturnal BP measurements this would be a huge advance in the management of hypertension.

Skeptically Yours,

-ACP

N.B.Technical Specifications for the OHG

Model: BP8000-M
Display: Transflective memory-in-pixel LCD
Memory: Blood pressure measurement up to 100 times, Activity measurement up to 7 days, Sleep measurement up to 7 times, Event up to 100 items
Transmission method: Bluetooth® low energy technology
Power source: 1 Lithium ion polymer rechargeable battery, AC adapter
Battery lifespan: Will last for approximately 500 cycles, 8 times/day measurements in normal temperatures of 77 °F (25 °C) when new battery fully charged
Battery life: A typical user can expect to charge HeartGuide approximately 2-3 times per week, depending upon the frequency of use of HeartGuide’s features
Weight: Approximately 4.1 oz (115 g)
Dimensions: Diameter approximately 1.89” (48 mm), Case thickness approximately 0.55” (14 mm), Band width approximately 1.18” (30 mm)
Measurable wrist circumference: Medium – 6.3” to 7.5” (160 to 190 mm), Large – 7.1” to 8.5” (180 to 215 mm)

 

This Week’s Most Ridiculous Heart Health Headline: “Running One Marathon Can Make Your Arteries Healthier”

Yes, CNBC went with that silly headline.

ABC went with “Training For Your 1st Marathon May Reverse Aging.”

The usually reliable Allison Aubrey and NPR went with ” Ready For Your First Marathon? Training Can Cut Years Off Your Cardiovascular Age.”

Aaarggh! As the newly-minted wife of the skeptical cardiologist likes to say.

The media threw caution to the wind and went gaga over this study which proves nothing of the sorts of things described above.

They may have been egged on by the authors who were wildly overstating the implications of the study

“What we found in this study is that we’re able to reverse the processes of aging that occur in the [blood] vessels,” says study author Dr. Anish Bhuva, a British Heart Foundation Cardiology Fellow at Barts Heart Centre in the UK..

Allison Aubrey did manage to quote a sensible person in her report to counter the balderdash being thrown around by the study authors:

The heart health benefits documented in the study likely have much less to do with the one-time race event than they do with the fact that the training program got people in the habit of regular, moderately intense exercise, says exercise researcher Dr. Tim Church, an adjunct professor at the Pennington Biomedical Research Center. On average, the participants ran between 6 and 13 miles per week, during their training, so, not super long distances.”The training program was very practical and very doable,” says Church, who was not involved in the study, but who reviewed the training regimen and results for NPR. “It was a slow build up over six months,” Church says.

I know a thing or two about aortic distensibility. In 1992 I described a new noninvasive method for quantification of aortic elastic properties in a paper published in the American Heart Journal entitled “Evaluation of aortic distensibility with transesophageal echocardiography.”

One thing I know for sure is aortic distensibility is highly dependent on systolic blood pressure and any changes that were seen in this study could simply have been related to lower systolic blood pressure.

The authors acknowledge this limitation along with about a million other limitations at the end of their paper. The limitations are legion and I’ve copied them at the end of this post. I’m quite surprised that JACC published it given those limitations and the absence of any important new findings.

Taking up exercise is really good for you but do not be fooled by these ridiculous headlines into thinking running one marathon has any special way to make you younger.

Take up exercise that you can sustain and that won’t leave you injured or frustrated.

Pheidippidesically Yours,

-ACP

Study limitations

This study was conducted in healthy individuals; therefore, our findings may not apply to patients with hypertension who have stiffer arteries that may be less modifiable (40). From these data, however, those with higher SBP at baseline appeared to derive greater benefit. This study was not designed to provide structured training, but rather to observe the effects of real-world preparation for a marathon, which randomized control trials cannot address. Nevertheless, information on the intensity, frequency, and type of exercise training would have been valuable to understand further the beneficial effects on aortic stiffness. The modest change in peak VO2 may be related to exercise training intensity or low adherence, which reflects the real world. Peak VO2 was performed semisupine to allow concurrent echocardiography, and this may also have reduced sensitivity to changes due to running or running efficiency. We assessed only marathon finishers—plausibly, nonfinishers could have had different vascular responsiveness. The causal link of exercise to measured changes is only inferred—marathon training may lead to other lifestyle modifications (dietary, other behavioral factors), or alterations in lipid profiles and glucose metabolism, although these have not been previously associated with changes in aortic stiffness (11). We did not examine the effect of exercise on peripheral arteries or endothelial dysfunction. Although individual participants served as internal controls, there may have been run-in bias for the initial BP measurement. This appears unlikely, as BP changes would not have been age-related nor correlated with the change in separate measures (e.g., aortic stiffness) with training. Estimated aortic ages are approximations and are based on the same dataset at baseline rather than independent observations. The exercise dose-response curve here is not sampled—only training for a first-time marathon with single timepoint assessment. This area warrants further study. We measured distensibility on modulus imaging acquired at 1.5-T rather than steady-state free precession imaging. The free-breathing sequence we used achieved good temporal resolution, but may be susceptible to through-plane motion. However, this and similar sequences correlate well with breath-held cine imaging, and show similar associations with aging (18). If error was introduced into distensibility measurements related to through-plane motion, the resultant noise would minimize the effect size related to exercise training, and therefore would be unlikely to account for our key findings. PP undergoes amplification from central to more peripheral locations, typically being ∼6 mm Hg higher in the descending thoracic than the ascending aorta (20). This PP amplification is not accounted for in our analysis, because it would have involved invasive measures of aortic pressure at each location. A sensitivity analysis suggested that the likely impact of this effect on the observed changes after training would be minimal; however, we cannot completely exclude the possibility that changes in PP amplification contribute to the observed differences. Diaphragmatic descending aortic distensibility data reported here were, however, higher than expected, although there is limited published data for comparison (41). Unlike Voges et al. (41), central rather than brachial PP was used, which would explain greater distensibility, and the use of 1.5-T phase-contrast modulus may accentuate image contrast differences between 3T gradient echo sequences.

 

A Septuagenarian Hockey Player With Subclavian Stenosis Hangs Up His Skates

Three years ago I asked “Is There A Difference in Blood Pressure Between Your Right and Left Arms.?”

In that post I stressed the importance of measuring at least once the “interarm BP difference” (IAD) and I promised to give a second post which would “give my recommendations on how to reliably measure IAD and ….tell the story of a 75 year old competitive ice hockey player with a totally blocked subclavian artery to his right arm.”

I saw that remarkable patient, Alan Gerrard, in follow up recently and the visit reminded me of my promise. After 25 years of playing competitive hockey he had finally decided to hang up his skates and retire from the sport he loves.

Here’s what I initially wrote:


The Ancient Hockey Player

The skeptical cardiologist started thinking about IAD because of Alan Gerrard, a most remarkable 77 year old who is still playing competitive ice hockey. Last year an errant hockey puck shattered his shin bone but after 6 months of recovery he is back on the ice, older by 11 years than his nearest competitor.

Alan has noted since his time in the military that the blood pressure in his right arm is significantly lower than that in the left. In fact, he would routinely ask that his BP be taken in the left arm to avoid being diagnosed with hypertension.

The pulse in his right wrist is much weaker than that in his left.

A few years ago, after identifying this IAD, I had him get an MRA of the arteries coming off his aorta and it  blockage of the right subclavian artery which supplies blood to the right arm.

Subclavian stenosis
MRA from Alan. The brachiocephalic artery is the first great artery to come off the ascending aorta. It bifurcates into the right carotid artery and the right subclavian artery. The short red arrow points to the almost complete narrowing at the origin of the right subclavian artery. The subclavian beyond this blockage fills by collaterals.

Since identifying this IAD we exclusively utilize the left arm BP to guide treatment of his hypertension.

At home he keeps a meticulous journal of his right and left arm BPs and brings them in for me to review at office visits.

In the first column he records his left arm BPgerrard IAD BP

on arising. On April 1 it was 120/64. The IAD was 15 meaning his right arm BP was 105.

Interestingly, there is a marked variation in the IAD, as it ranges from  +7 to minus 31 (averaging 10 mmHg)

The average systolic blood pressure in both the right and left arms was identical at 139.

Alan, also shares with me at our office visits a beautiful color-coded graph of his right and left arm BPs which are recorded daily without fail.

altitude left right bp
Graph of systolic blood pressure in left arm (red) and right arm (black). Note that typically left arm SBP> right arm SBP by >10 mm Hg but there is a marked variation in difference and occasionally the right exceeds the left.

At our most recent visit he pointed out that when he was in Colorado at high altitude his blood pressure significantly increased (which, according to a recent European Society of Cardiology report is common.)


Providing Alan’s story was the easy part of my promise. Providing the best method for determining IAD turns out to be much more complicated and likely explains why I never wrote the follow-up post.

It also likely explains why 71% of patients in my poll have never had the IAD checked by a doctor (see below.)

A 2014 study found 8.6% of diabetics had an IAD >10 mm Hg. These patients were 3.5 times more likely to die from cardiovascular disease. An IAD>15 mm Hg conferred a nine-fold increased risk of cardiovascular mortality.

This is how IAD was assessed in this British study:

Carry out two pairs of simultaneous BP measurements:
Swap cuffs over (do not disconnect cuffs from BP machine) and obtain two further pairs of simultaneous readings

They utilized two automatic Omron BP devices. The authors recognized the difficulty of this technique in routine clinical practice:

Confirmation of an interarm difference requires a method of repeated simultaneous measurement, to avoid overestimation of prevalence  This technique, however, may not be practical in routine clinical care. It adds time to the clinical assessment of subjects in primary care, and we have found it to be a barrier to recruitment in our previous study in diabetes. Initially, a sequentially measured pair of readings may be sufficient to rule subjects out of further assessment for an interarm difference, but this requires further evaluation.. Previous small studies that directly compared sequential and simultaneous measurement techniques have concluded that the reproducibility of an interarm difference measured by different techniques is poor (3 although we have found that repeated sequential measures can predict a systolic interarm difference ≥10 mmHg on repeated simultaneous measurement.

Dr. P’s Recommended Method for Measuring The IAD

Here’s what I will be asking my MAs to do to assess IAD:

Simultaneously measure BP with automatic cuff on one arm and manual cuff on the other. Switch arms and repeat measurements.

This should be done at least once on all patients with hypertension or diabetes.

For those wishing to test at home who only have one cuff I would suggest the following protocol:

Rest for 5 minutes in a chair. Check left arm BP. Switch cuff to right arm and measure twice. Switch cuff to left arm and measure. Perform this set of measurements one first thing in the morning and once after dinner. If a significant IAD difference (>10 mmg Hg) is noted on the averaged readings repeat the whole process two more times and if it persists report this to your doctor.

If you note a significant IAD always utilize the arm with the higher BP for measurement.

Dextrosinistrally Yours,

-ACP

N.B. In 2017 I included a poll. Here are the results.

Omron’s HeartGuide Wristwatch Blood Pressure Monitor Allows BP Monitoring During Daily Activities Unobtrusively: Can It Replace Ambulatory BP Monitors?

I’ve been evaluating a wearable wrist watch blood pressure monitor for the last week.

After a Twitter interaction with Omron stimulated by Dr. Wen Dombrowski, the Omron people loaned me one of their HeartGuide devices.

Omron’s website describes the device as follows:

Engineered to keep you informed, HeartGuide is a wearable blood pressure monitor in the innovative form of a wristwatch. In tandem with its companion app HeartAdvisor, HeartGuide delivers powerful new technology making tracking and managing your blood pressure easier than ever before. Proactively monitor your heart health by turning real-time heart data into heart knowledge and knowledge into action. With HeartGuide wherever you go, you’re in the know.

I and the AHA have  not recommended wrist BP devices.  My decision was based on my personal research in the 1990s on arterial waveforms and the influence of wave reflection.  Studies have clearly shown a change in the arterial wave form as it proceeds from the ascending aorta to the periphery.

Therefore, the skeptical cardiologist was skeptical of the value of the HeartGuide

After wearing the HeartGuide for a week and using it in a variety of situations to measure my blood pressure I am rethinking my recommendation against wrist blood pressure cuffs.

I’ll give my full analysis of the device after more evaluation but what I’ve discovered is that it can serve as an accurate and unobtrusive daytime ambulatory blood pressure monitor.

Ambulatory blood pressure monitoring (ABPM) utilizes a portable BP monitor which includes a brachial BP cuff and a device that inflates the cuff every 20-30 minutes, makes a measurement and stores all the recordings for off-line review. Studies have shown ABPM is a better predictor of CV mortality than either clinic BP or home BP monitoring.

It has not been widely utilized in the US because it is poorly reimbursed.

The HeartGuide sits on my wrist and whenever I feel like it, wherever I am, I can quickly and simply make a recording of my BP.

 

 

With the HeartGuide I have made  BP recordings in a variety of situations which I would never previously have considered.

For example, earlier this week I wore the HeartGuide to work. I measured my BP at home and it was 125/76. After dropping my gear off at my office I walked to the 6th floor of the hospital to see inpatients. This involved going down several flights of stairs, crossing to the hospital via a pedway and climbing several flights of stairs.

When I emerged on the 6th floor I stopped (because the Heart Guide does not like it if you are moving), triggered the Heart Guide and put my right hand over my heart (the Heart Guide likes you to put your hand on your heart). Within 90 seconds I knew my BP (it had increased to 143/81).

In order to do this unobtrusively I wandered into the patient waiting area and pretended to be watching NFL highlights on the TV.  Nobody seemed to notice I was taking my BP!

Subsequently, I was paged to do a transesophageal echo/electrical cardioversion and went downstairs to our “heart station” where a room full of RNs, a sonographer, an anesthetist and a patient awaited me. While talking to the patient about the procedure I triggered the Heart Guide and made another BP recording. Nobody noticed!IMG_5220

The Heart Guide BPs are displayed on the watch face for a few seconds and can be sent via BlueTooth to the OmronAdvisor smartphone app.

The graph above shows my BP was high at 807 AM while I was talking to the patient and still up after the procedure.

One day I wore the HeartGuide to the gym and made BP measurements under a variety of conditions.

HG leg press

The HeartGuide will not activate while walking on the treadmill no matter how hard I try to keep my arm still. It does not like motion of any kind.

But the first reading on the left was immediately after running on the treadmill. I then performed an isometric leg press hold on a weight machine and was able to obtain a recording during this maneuver of 140/88.  Shortly after the leg press I repeated the recording and it had dropped down to 104/69.

I have to say this is an abundance of BP information that is quite interesting and heretofore I had never been aware of. It opens up intriguing clinical possibilities.

I will have to spend more time analyzing the Heart Guide before writing my overall impression and recommendations but thus far I see it expanding our toolkit for understanding hypertension and personalizing cardiovacular medicine.

Try to imagine yourself standing like me outside a restaurant unobtrusively taking your blood pressure and ponder the possibilities!

Soon you may find that wherever you go, you’re in the know. But be aware of the possibility of being arrested for loitering while checking your BP.

ap-HG.jpeg

Omnimanometrically Yours,

-ACP

If you’d like to read a detailed description of the HeartGuide check out this review while eagerly awaiting my more serious and more complete analysis.

Taking Blood Pressure Medication At Bedtime Lowers Risk Of Death, Stroke And Heart Attack

When should you take your once daily BP meds?

Increasingly, the skeptical cardiologist has been recommending to patients that they take BP meds at bedtime as evidence has mounted  that this does a better job of normalizing asleep blood pressure and minimizing daytime side effects.

Now a study published in European Heart Journal in October has demonstrated that routine ingestion of BP meds at bedtime as opposed to waking results in improved 24 hour BP control with enhanced decrease in asleep BP and increased sleep-time relative BP decline (known as BP dipping.)

More importantly, bedtime BP med ingestion in this randomized trial of over 19 thousand hypertensive Spaniards resulted in highly significant reductions in cardiovascular events including death, heart attack, heart failure and stroke over a 6 year median follow-up

The so-called Hygia Chronotherapy Trial was extremely well done and the results are powerful and should modify clinical practice immediately.

This figure demonstrates the dramatic and highly significant 45% reduction in all types of cardiovascular events measured. Note that stroke rate was halved!

Screen Shot 2019-11-05 at 7.56.12 AM

Here are the Kaplan-Meier curves showing early and progressive separation of the treatment curves.

Screen Shot 2019-11-05 at 7.50.10 AM

There was no difference side effects or compliance between the two groups.

The remarkable aspect of this intervention is that it costs nothing, introduces no new medications and has no increased side effects.

This study is practice-changing for me. We will be advising all hypertensive patients to take their once daily BP meds at bedtime.

Chronotherapically Yours,

-ACP

h/t Reader Lee Sacry for bringing this study to my attention

 

 

The Skeptical Cardiologist’s 2019 Guide to Self-Monitoring Hypertension (High Blood Pressure)

Because uncontrolled high blood pressure (hypertension) is a well documented risk factor for stroke, heart attack and heart failure I discuss it a lot on this site and with my patients.

I just updated my page on hypertension which summarizes my thoughts and recommendations on home BP self-monitoring along with the latest on the optimal BP goal.

What To Monitor and How To Measure

I primarily makes decisions on blood pressure treatment these days based on patient self-monitoring. I discuss this in detail in a post entitled  (Why I Encourage Self-Monitoring Of Blood Pressure In My Patients With High Blood Pressure.)

I have found self-monitoring of patient’s BP to substantially enhance patient engagement in the process. Self-monitoring patients are more empowered to understand the lifestyle factors which influence their BP and make positive changes.

Blood pressures are amazingly dynamic and as patient’s gain understanding of what influences their BP they are going to be able to take control of it.

If high readings are obtained in the office I instruct patients to use an automatic BP cuff at home and make a measurement when they first get up and again 12 hours later. After two weeks they report the values to me (preferably through the electronic patient portal or by Kardia Pro.)

I discuss in detail the recommended technique for BP measurementin my 2018 post entitled  “Optimal Home Blood Pressure Monitoring: Must The Legs Be Uncrossed and The Feet Flat?

The 2018 ACC/AHA guidelines on hypertension  specify in detail how to optimally make home BP measurements as follows:

• Remain still:

• Avoid smoking, caffeinated beverages, or exercise within 30 min before BP measurements.

• Ensure ≥5 min of quiet rest before BP measurements.

• Sit with back straight and supported (on a straight-backed dining chair, for example, rather than a sofa).

• Sit with feet flat on the floor and legs uncrossed.

• Keep arm supported on a flat surface (such as a table), with the upper arm at heart level.

• Bottom of the cuff should be placed directly above the antecubital fossa (bend of the elbow).

• Take at least 2 readings 1 min apart in morning before taking medications and in evening before supper. Optimally, measure and record BP daily. Ideally, obtain weekly BP readings beginning 2 weeks after a change in the treatment regimen and during the week before a clinic visit.

• Record all readings accurately:

• Monitors with built-in memory should be brought to all clinic appointments.

And, spoiler alert, it does matter if you cross or uncross your legs.

What Should The BP Goal Be?

For many patients with hypertension, SPRINT trial data published in 2015 suggest that a systolic blood pressure target of <120 mm Hg (intensive therapy) is preferable to a target of <140 mm Hg.

The SPRINT trial found that cardiovascular events like stroke and heart attack and death from these cardiovascular causes was lower by 25% in those patients treated intensively.  Overall death was lower by 27%

Read my post on SPRINT here and have a discussion with your physician about whether these more stringent BP goals are right for you. Keep in mind that the technique used in SPRINT likely gives us lower BP than home self-monitoring.

I discuss recent European and American BP guidelines which came to different BP goals after SPRINT in a post entitled “Becoming Enlightened About More Stringent Blood Pressure Goals: Sapere Aude”.

“As a 64 year old who has emerged from his nonage with hypertension, I have carefully examined the latest American hypertension guidelines especially in light of the SPRINT study and elected to add a third anti-hypertensive agent to get my average BP below 130/80. It’s worked for me with minimal  side effects but I carefully monitor my BP.

If I notice any symptoms (light-headed, fatigued) suggesting hypotension associated with systolic BP <120 mm Hg I tweak my medical regimen to allow a higher BP.

Like all of my patients I would prefer to be on less medications, not more but when it comes to enlightenment about the effects of hypertension, it is now clear that lower is better for most of us in our sixties down to at least 130/80*

Home Blood Pressure Monitoring Devices

You can get a good validated automatic BP monitor at Walgreens or CVS for around 35-40$.

But if you want to spend a little more you can get  BP devices which have added features such as style, portability, BlueTooth communication with smartphone apps and perhaps most importantly connection through the cloud with your physician.

My favorite BP cuff used to be the QardioArm (QardioArm: Stylish, Accurate and Portable. Is It the iPhone of Home Blood Pressure Monitors?)

I still love the QardioArm but lately I’ve been recommending the Omron Evolv for my patients who need monitoring as their recordings can be connected with me through Omron/Alivecor’s smartphone app:

The Omron Evolv One-Piece Blood Pressure Monitor: Accurate, Quick And Connected

For my patients using Omron Bluetooth BP monitors plus Alivecor’s Kardia Mobile ECG and the KardiaPro cloud connection I can view their rhythm and blood pressure at any time and analyze summary data via my patient dashboard as below.Finally, be aware that scam methods of BP measurement are being promoted to the public.

I wrote about one such  smartphone app called “Instant blood pressure”

Sphygmomanometrically Yours,

-ACP

The Omron Evolv One-Piece Blood Pressure Monitor: Accurate, Quick And Connected

When it comes to self-monitoring of blood pressure the best device (assuming equivalent accuracy) is the one that patients are most likely to use.

The Omron Evolv has become that device for the skeptical cardiologist as it combines a unique one-piece design with built in read-out with a quicker, more comfortable  yet highly accurate BP measurement technique.

My previous favorite BP device, the QardioArm remains a close second.

Evolv Form and Function

The Evolv is sleek and stylish in appearance and has no external tubes, wires or connectors. It runs on 4 AAA batteries.

 

 

The  cuff is pre-formed and is incredibly easy to self-administer to the upper arm. Measurement is simple. Press the start button and it immediately starts inflating the cuff.

The results are displayed on an LCD screen on the cuff.

The Omron uses an oscillometric technique to measure the blood pressure as it is inflating. This “inflationary” technique has been shown to be as accurate as measuring during deflation but is much quicker. A study using the recently developed “Universal Standard Protocol” for evaluating the accuracy of BP devices showed that the Omron Evolv was highly accurate compared to gold standard sphygmomanometry.

Omron has come up with some slick marketing terms for the inflationary and pre-formed wrap aspects:

  • Intellisense Technology – Inflates the cuff to the ideal level for each use.
  • Intelli Wrap Cuff – For an easy and accurate reading

With the inflationary technique the cuff knows when to stop inflating, (hence “intellisense”) therefore, there is less tendency to go to higher pressures compared to the deflationary technique and less potential for discomfort from those higher pressures.

Evolv Communication-Sharing Results

The Evolv communicates via Bluetooth with the Omron Wellness (or Connect) smartphone app. Your BP  and heart rate measurements are easily transferred to this app and can be viewed over time.

My blood pressure and heart rate measurements over the last week.

If  one clicks on the little export icon at the upper right had corner of this summary screen you can “export CSV” which creates a file of BP measurements over a defined period that can then be emailed to yourself, your curious friends, or your doctor.

Another option is to export the summary report but this is a premium feature and requires payment.

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Monitoring Heart Rhythm and Blood Pressure-The Omron/Kardia Pro Connection

I’ve discussed in detail how management of my afib patients who have the Kardia mobile ECG device and connect to me via the internet using KardiaPro Remote has tremendously advanced their care.

AliveCor has partnered with Omron and the Omron Connect (or Wellness) app is essentially the Kardia app which my patients utilize to record their ECG recordings and share them with me.

With this app, therefore, patients who have the connection subscription service can utilize the Omron app to share both their ECG and BP recordings with me online. This is really quite an amazing development.

Below are recordings from one of my patients that I took from the patient screen which I view online.

The data can be viewed in various formats including this one which gives a good idea of daytime variation in BP as well as percentage recordings in goal range.

 

For me, this ability to rapidly view patient’s blood pressures over time in meaningful ways greatly facilitates management. If we could find a way to seamlessly import these data directly into our EMR it would an even bigger step forward.

Speaking To Your BP Cuff

I don’t use Alexa but Omron highlights how the Evolv works with Alexa:

 

 

Somehow, this doesn’t seem helpful to me but I tried asking Siri (with both my Apple Watch and iPhone) if she could give me info on my blood pressure and she failed miserably

 

 

 

 

 

 

 

Evolv-The Future of BP Management?

To summarize why I am so enthusiastic about this BP cuff

  • Portability and compactness. One piece design without tubes or wires.
  • Rigorously proven accuracy
  • Esthetically pleasing
  • Quicker and more comfortable than “deflationary” cuffs
  • Read-out on cuff-no separate unit or smartphone required
  • Communicates well with highly functional app for organizing or reporting BP measurements over time
  • Coordination of ECG measurements from Kardia and BP measurements on app through KardiaPro facilitates physician management of patient’s cardiovascular conditions.

Oscillometrically Yours,

-ACP

N.B. In the course of researching the Omron Evolv I looked at multiple home BP monitor review websites online. Almost without exception these were worthless.  I suspect many of these device review sites are funded by companies making the products. Others just aggregate information from company websites and regurgitate it without analysis. Websites with apparent consumer reviews are also suspect as I have found unscrupulous vendors are manipulating the whole review process.

Fortunately, your trusty skeptical cardiologist remains unsullied by any financial connections to corporate America. Or corporate Japan for that matter  (It appears Omron has its headquarters in Kyoto, Japan). However, Omron, if you are listening perhaps you can send me for my review one of your new Complete combined BP and EKG monitoring devices!

 

 

 

 

And one final detail. I checked just now and you can purchase the Evolv at Amazon for $69. Bundles that connect you to your doctor through the cloud and get you an Evolv plus or minus the Kardia ECG device at a reduced price are available through both the Kardia and Omron websites and apps.

 

Why I Encourage Self-Monitoring Of Blood Pressure In My Patients With High Blood Pressure

The skeptical cardiologist primarily makes decisions on blood pressure treatment these days based on patient self-monitoring. If high readings are obtained in the office I instruct patients to use an automatic BP cuff at home and make a measurement when they first get up and again 12 hours later. After two weeks they report the values to me.

I described in detail the recommended technique in my 2018 post entitled “Optimal Home Blood Pressure Monitoring: Must The Legs Be Uncrossed and The Feet Flat?

Although I’ve been recommending self-monitoring to my patients for decades it is only recently that guidelines have endorsed the approach and good scientific studies verified its superiority. I was pleased when the 2017 ACC/AHA guidelines for High Blood Pressure made home self-monitoring of BP a IA recommendation.

And last year a very good study, the TASMNH4 was published which demonstrated the superiority of self-monitoring compared to usual care.

TASMINH4 was a parallel randomised controlled trial done in 142 general practices in the UK, and included hypertensive patients older than 35 years, with blood pressure higher than 140/90 mm Hg, who were willing to self-monitor their blood pressure. Patients were randomly assigned (1:1:1) to self-monitoring blood pressure (self-montoring group), to self-monitoring blood pressure with telemonitoring (telemonitoring group), or to usual care (clinic blood pressure; usual care group).

The home BP goal was 135/85 mm Hg, 5 mm Hg lower than the office BP goal. At one year both home self-monitoring groups had significantly lower systolic blood pressure than the usual care group.

This trial was not powered to detect cardiovascular outcomes, but the differences between the interventions and control in systolic blood pressure would be expected to result in around a 20% reduction in stroke risk and 10% reduction in coronary heart disease risk. Although not significantly different from each other at 12 months, blood pressure in the group using telemonitoring for medication titration became lower more quickly (at 6 months) than those self-monitoring alone, an effect which is likely to further reduce cardiovascular events and might improve longer term control.

Advantages of Home Self-Monitored Blood Pressure-Limitations of Office BPs

I described why I switched to home BPs in a post about the landmark  SPRINT trial in 2015:

Every patient I see in my office gets a BP check. This is typically done by one of the office assistants who is “rooming” the patient using the classic method with , listening with stethoscope for Korotkov sounds. If the BP seems unexpectedly high or low I will recheck it myself.

Often the BP we record is significantly higher than what the patient has been getting at home or at other physician offices.

There are multiple factors that could be raising the office BP: mental stress from driving to the doctor or being hurried or physical stress from walking from the parking lot.

In addition, I feel that multiple assessments of out of office BP over the course of the day and different days are more likely representative of the BP that we are consistently exposed to rather than one reading in the doctor’s office.

Accuracy and technique in the doctor’s office is also an issue.

Interestingly, we have assumed that manual office BP measurement is superior to automatic but this recent paper found the opposite:

Automated office blood pressure readings, only when recorded properly with the patient sitting alone in a quiet place, are more accurate than office BP readings in routine clinical practice and are similar to awake ambulatory BP readings, with mean AOBP being devoid of any white coat effect.

A patient left a comment to that paper which is quite insightful:

I had a high blood pressure event several years ago. Since then I have monitored my BP at home, sitting with both feet flat on the floor, not eating or drinking, not speaking or moving around, on a chair with a back, and without clothes on the arm being used for the measure. My BP remains normal.

I have never had my BP taken correctly in a doctor’s office. They will do it while I am speaking with the doctor, sitting on an exam table with my legs swinging, with the monitor band over my heavy winter sweater, right after I have sat down. They do not ensure that my arm is supported or at the right height. If I recommend that I take off my sweater, or move to a chair with a back, they tell me that is not needed. I have decided to refuse such measurements. How can they possibly be monitoring my health this way?

This patient’s observations are not unique and I suspect the majority of office BPs have most if not all of the limitations she describes.

Self Monitoring Improves Patient Engagement In BP Control

I have found self-monitoring of patient’s BP to substantially enhance patient engagement in the process. Self-monitoring patients are more empowered to understand the lifestyle factors which influence their BP and make positive changes.

Blood pressures are amazingly dynamic and as patient’s gain understanding of what influences their BP they are going to be able to take control of it.

I take my BP almost daily and adjust my BP medications based on the readings. After prolonged work or exercise in heat, for example, BPs will decline to a point where I’m light headed or fatigued. Less BP med at this time is indicated. Conversely, if I’ve been overly stressed BPs increase and upward titration of medication is warranted.

With some of my most engaged and enlightened patients we perform similar titrations depending on their circumstances. Sometimes patients perform these titrations on their own and tell me about them at the next office visit.

What’s The Best Way To Communicate Home BPs?

Many of my patients provide me with a hand-written record of their BPs over two weeks.  Some mail them to me, others bring them in to the office. We scan these into the EMR. I look at these and make an estimate of the average systolic blood pressure, the variation over time and the variation during the day. It’s not feasible for me or my staff to enter the numbers or precisely obtain an average.

Some patients send us the numbers through the internet-based patient portal into the EMR. This is preferable as I can view these and respond quickly and directly back to the patient with recommendations.

More and more patients are utilizing their smart phones to record and aggregate their health data and will bring them in for me to look at during an office visit. I’ve described one stylish and slick BP cuff, the QardioArm which has neither tubes nor wires and works through a smartphone app. Omron , also has multiple cuffs which communicate via BlueTooth to store data in a smartphone app.

Ideally, we would have a way for me to view those digitally recorded BPs with nicely calculated averages online and within the EMR. Unfortunately, such connectivity is not routinely available.

However, for my patients who are already monitoring their heart rhythms with a Kardia mobile ECG and are connected with me online through KardiaPro Remote I can view their BP recordings online.

I’ll discuss in detail in a subsequent post the Omron Evolv home automatic BP cuff (my current favorite) which is wireless and tubeless and connects seamlessly to KardiaPro allowing me to view both BP and heart rhythm (and weight) recordings in my patients

To me, this empowerment of patients to record, monitor and respond to their own physiologic parameters is the future of medicine.

Sphygmomanometrically Yours,

-ACP

From the 2017 ACC/AHA BP guidelines

and the proper technique for office BP measurement

 

 

FDA Recalls More Generic Blood Pressure Meds: Where Are Your Medications Manufactured?

In July of 2018, the FDA made a series of voluntary recalls of several versions of the generic blood pressure medication valsartan which were made in China and were contaminated by the “possible carcinogen,”  N-nitrosodimethylamine (NDMA).

At the time I asked readers the question, “Is your BP med made in china and is it safe?” as it became clear that now in the US users of medications must be very aware of the source and quality of the products they put in their body.

Generic prescription medications and OTC products are highly likely to be manufactured out of the US and with minimal oversight.

Since then the FDA has announced multiple other recalls for companies producing angiotensin II receptor blockers (ARBs) in the same class as valsartan, including products containing losartan and irbesartan,. These drugs have been found to be contaminated contaminated with NDMA or another carcinogen  N-nitrosodiethylamine (NDEA).

The recall now includes irbesartan and losartan plus additional lots of valsartan. Thus, some patients who we switched from valsartan to losartan are now having to switch again.

Click the following links to review updated lists of irbesartan products under recall, losartan medications under recall, valsartan products under recall and valsartan products not under recall.

Here’s  the FDA’s valsartan alert notice from 1/2/19

FDA is alerting patients and health care professionals to Aurobindo Pharma USA’s voluntary recall of two lots of valsartan tablets, 26 lots of amlodipine and valsartan combination tablets, and 52 lots of valsartan and hydrochlorothiazide (HCTZ) combination tablets due to the amount of N-Nitrosodiethylamine (NDEA) in the valsartan active pharmaceutical ingredient. Aurobindo is recalling amlodipine and HCTZ only in combination medications containing valsartan. Neither amlodipine nor HCTZ is currently under recall by itself.

Aurobindo is recalling lots of valsartan-containing medication that tested positive for NDEA above the interim acceptable daily intake level of 0.083 parts per million.

The agency continues to investigate and test all angiotensin II receptor blockers (ARBs) for the presence of NDEA and N-Nitrosodimethylamine (NDMA) and is taking swift action when it identifies these impurities that are above interim acceptable daily intake levels.

FDA also updated the list of valsartan products under recall and the list of valsartan products not under recall.

FDA reminds patients taking any recalled ARB to continue taking their current medicine until their pharmacist provides a replacement or their doctor prescribes a different medication that treats the same condition. Some ARBs contain no NDMA or NDEA.

Fortunately, there are multiple generic  and brand nameARBs we can substitute for the recalled products.

perspective-1

Patients Discover How Hard It Is To Find Non-Chinese Medications

When I tried to find the source of my generic medications, the results were eye-opening:

 my cholesterol drug is made in India by an Indian company and my blood pressure drug is made in Columbus, Ohio, by a Jordanian company.

I had not realized how globalized the pharmaceutical industry had become.

Many readers also researched the source of the pills they were taking and shared their experience through comments on my blog:

“Frustrated” wrote

My cardiologist changed my blood pressure med to irbesartan. Another generic ARB. I went to get it filled today at a local grocery store pharmacy. I asked where it was made and they showed me the bottle. Guess what? It was SOLCO/Prinston as distributor and Zhejiang Huahai Pharmaceuticals LTD – the same manufacturer as the tainted valsartan. Exactly the same. Despite the recent horrible FDA inspection report of that facility which is posted online here: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM621162.pdf

Also, the FDA has found another cancer causing chemical in the drug since I last wrote – now there are two. I checked at [MAJOR CHAIN] pharmacy – they use the SAME CHINESE MANUFACTURER. I checked at [MAJOR CHAIN 2] – yep, they use the SAME CHINESE MANUFACTURER. This is really starting to get scary. I’m trying hard to find a pharmacy that has the non-Chinese version (there are 16 other generic manufacturers of the drug). My insurance company only permits me to use the pharmacies I tried today. Funny how everyone is buying Chinese. Does that validate the claims made in the Epoch article. Is this really that Chinese are undercutting everyone else? I’m just disgusted. I will tell you that if I owned a pharmacy I would not purchase my generics from the same company that just caused one of the largest drug recalls in history. It must be really really cheap. Really really cheap.

Mitch writes:

I have been taking Losartan, but became really concerned with the latest news about carcinogens found in two more BP medications. I called EVERY local pharmacy, including big-box stores, grocery store pharmacies, independent pharmacies, and traditional pharmacies. Not a single one has US-made losartan. Every one of them has stock of meds made in either China or India. One pharmacists told me that he had no control of what he sells; it’s all decided on the corporate level. Another said that he would stock the cheapest generic he could find. Still another pharmacy tried to convince me that Citron, Torrent, and Solco are New Jersey companies selling US-made drugs. It takes only a few minutes of Internet research to prove them wrong. Apparently, there is no incentive to stock US-made drugs. I agree, the consumers have to take action and write to their representatives demanding answers from the FDA.

BIS wrote:

I have just had the same experience. My Indian made Valsartan (Camber) was recalled so my doctor switched me to Irbesartan 150 mg tablets which at my local CVS were also manufactured by Camber. I reluctantly took these while searching for US or European made alternatives. I just went to CVS to get my refill. When I got home instead of the Indian Irbesartan I received a bottle manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd.,(ZHP) Xunqiao, Linhal, Zhejiang China. I am a mechanical engineer not a chemistry major but I believe Irbesartan contains API which is what has been the problem from this company. Looking at the internet I see that the FDA has and import alert for this company. The import alert halts all ZHP-made API and finished drug products using the company’s API from legally entering the United States (https://www.pharmacist.com/article/fda-places-zhejiang-huahai-pharmaceuticals-import-alert). Let’s see- did the Chinese use good API in this batch….I called the CVS and asked for alternatives and was told “good luck”. My doctor said he will work with me if I can find non Chinese or Indian medication. I go out of my way to buy American made goods as I have worked in manufacturing my entire career and have made numerous trips to China and seen what goes on. My Chinese colleagues when they come to the US fill their bags with US made baby formula and vitamins (which probably contain Chinese ingredients). If anyone finds a US or European source of BP medication please post it.

What Can We Do?

One of my readers, Kate, made the following suggestion which made a lot sense:

write to the Senate committee that oversees the FDA. Demand more clarity in labeling of prescription bottles – the country of origin should be CLEAR and CONSPICUOUS – just like that little “Made in China” sticker on the photo above – but on the prescription label itself. Right now only the pharmacist’s supply bottle has the labeling. Write your congressman and to:

U.S. Senate Committee on Health, Education, Labor & Pensions

428 Senate Dirksen Office Building

Washington, DC 20510

I would encourage patients who are taking these recalled ARBS (which are really good blood pressure medications) to check their pill bottles and check with their pharmacists to determine if they have been recalled. If the pharmacist can’t replace your medication with an identical ARB that hasn’t been withdrawn, ask your physician for one of the alternatives listed above.

Find out what country you’re generic drugs in general are made in and let your congressional representatives know you want better FDA oversight of off-shore pharmacuetical manufacturing along with complete transparency with respect to country of origin.

Skeptically Yours,

-ACP