Category Archives: atherosclerotic cardiovascular disease

What Pain Medications Are Safe For My Heart?

The skeptical cardiologist is frequently asked by patients if it is OK to take certain pain medications.

Yesterday, I got a variation on this  when a patient called and indicated that he had been prescribed meloxicam and tramadol by his orthopedic surgeon for arthritic leg joint pain. The orthopedic surgeon said to check with me to see if it was OK to take either of these medications. (Patients, if you want to skip to my answer skip down to the last two sections of the post and avoid the background information.)

What Is The Risk Of Pain Medications?

Cardiologists have been concerned about the increased risk of heart attack and heart failure with non steroidal anti-inflammatory drugs (NSAIDs) since Vioxx was withdrawn from the market in 2004.

NSAIDS have long been known to increase risk of gastrointestinal (GI) bleeding  by up to 4-5 fold, Scientists developed Vioxx, a COX-2 inhibitor, hoping to reduce that risk but Vioxx  turned out to  increase the risk of heart attack.

Since this revelation it has become clear that NSAIDS in general increase the risk of heart problems as well as GI problems

This includes the two over the counter (OTC) NSAIDS:

-ibuprofen (in the US marked most commonly as Motrin or Advil, internationally known as Nurofen). For extensive list of brand names see here.

-naproxen (most commonly sold as Aleve. Per wikipedia “marketed under various brand names, including: Aleve, Accord, Anaprox, Antalgin, Apranax, Feminax Ultra, Flanax, Inza, Maxidol, Midol Extended Relief, Nalgesin, Naposin, Naprelan, Naprogesic, Naprosyn, Narocin, Pronaxen, Proxen, Soproxen, Synflex, MotriMax, and Xenobid. It is also available bundled with esomeprazole magnesium in delayed release tablets under the brand name Vimovo.)

In 2015  the FDA mandated  warning labels on all prescription NSAIDs including

1) a “black box” warning highlighting the potential for increased risk for cardiovascular  (CV) events and serious life-threatening gastrointestinal  bleeding, ulceration, and perforation;

(2) statements indicating patients with, or at risk for, CV disease and the elderly may be at greater risk, and that these reactions may increase with duration of use;

(3) a contraindication for use after coronary artery bypass graft surgery on the basis of reports with valdecoxib/parecoxib;

(4) language that the lowest dose should be used for the shortest duration possible

5) wording in the warning section that there is no evidence that the concomitant use of aspirin with NSAIDs mitigates the CV risk, but that it does increase the GI risk

Since then, hardly a day goes by without me having a discussion with a patient about what drugs they can safely take for their arthritis.

A reasonable approach to using NSAIDS, balancing GI and CV risks, that I have used in the past comes from a 2014 review
This table and many authorities recommend naproxen as the NSAID of choice for patients with high CV risk.

Indeed prior to the publication of the PRECISION study in 2016 I believed that naproxen was the safest NSAID for my cardiac patients. I told them it was OK to use from a CV standpoint but to use the least amount possible for the shortest time in order to minimize side effects.

The PRECISION study compared a COX-2 NSAID (celecoxicib or Celebrex) to ibuprofen and naproxen in patients who required NSAIDS for relief of their joint pain.

The findings:

cardiovascular death (including hemorrhagic death), nonfatal MI, or nonfatal stroke, occurred in 2.3% of celecoxib-treated patients, 2.5% of the naproxen-treated patients, and 2.7% of the ibuprofen group.

There was no placebo in this trial so we can only look at relative CV risk  of the three NSAIDS and it did not significantly differ.

GI bleeding was less with celecoxib than the other two NSAIDS.

Although this study has flaws it throws into question the greater CV safety of naproxen and suggests that all NSAIDS raise CV risk.

My Current Patient Advice on Cardiac Safety of Pain Meds

Here is an infographic I came across from the Arthritis Foundation (complete PDF….here)

It’s a reasonable approach for these OTC drugs and I will start handing this out to my patients.

We should consider that all NSAIDS have the potential for increasing the risk of heart attack and heart failure, raising blood pressure, worsening renal function and causing GI bleeding.

Therefore, if at all possible avoid NSAIDS.

Acetaminophen (Tylenol) is totally safe from a heart standpoint and overall if you don’t have liver disease it is your safest drug for arthritis. However, it provides no anti-inflammatory effects and often is inadequate at pain relief.

Treating The Whole Patient

Meloxicam is an NSAID so my patient should , if at all possible, avoid it.

The other drug he was prescribed, tramadol, is an opiod. Opiods have their own set of problems including, most importantly,  addiction and abuse.

A recent review concluded

 reliable conclusions about the effectiveness of long-term opioid therapy for chronic pain are not possible due to the paucity of research to date. Accumulating evidence supports the increased risk for serious harms associated with long-term opioid therapy, including overdose, opioid abuse, fractures, myocardial infarction, and markers of sexual dysfunction; for some harms, the risk seems to be dose-dependent.

As his cardiologist I am concerned about his heart, of course, but a good cardiologist doesn’t just focus on one organ, he looks at what his recommendations are doing to the whole person.

I certainly don’t want to have him become addicted to narcotics in order to avoid a slightly increased risk of a heart attack. On the other hand, the risks of the NSAIDS involve multiple organs, most of which don’t fall in the domain of the cardiologist.

My patient’s risk of taking either the meloxicam or the tramadol is best assessed by his primary care physician, who has the best understanding of his overall medical condition and the overall risk of dangerous side effects from these drugs.

Ultimately, I think the decision of which pain pill to take for chronic arthritis has to be made by an informed patient in discussion with his  informed (and informative) primary care physician. Only the patient can decide how much pain he is having and how much risk he/she wants to assume in relieving that pain.

Analgesically Yours,

-ACP

Unsure About Taking A Statin For High Cholesterol? Consider A Compromise Approach

In an earlier post the skeptical cardiologist introduced Geo, a 61 year old male with no risk factors for heart attack or stroke other than a high cholesterol. His total cholesterol was 249, LDL (bad) 154, HDL (good) 72 and triglycerides 116.

His doctor had recommended that he take a statin drug but Geo balked at taking one due to concerns about side effects and requested my input. My first steps were to gather more information.

-I calculated his 10 year risk of stroke or heart attack at 8.4% (treatment with statin typically felt to benefit individuals with 10 year risk >7.5%) and as I have previously noted, this is not unusual for a man over age 60.

-I assessed him for any hidden  or subclinical atherosclerosis and found

The vascular ultrasound showed below normal carotid thickness and no plaque and his coronary calcium score was 18,  putting him at the 63rd  percentile. This is slightly higher than average white men his age.

So Geo definitely has atherosclerotic plaque in his coronary arteries. This puts him at risk for heart attack and stroke but not a lot higher risk than most men his age.

Strictly speaking, since he hasn’t already had a heart attack or stroke, treating him with a statin is a form of primary prevention. However, we know that atherosclerotic plaque has already developed in his arteries and at some point, perhaps years from now it will have consequences.

What is the best approach to reduce Geo’s risk?

It’s essential  to look closely at lifestyle changes in everyone to reduce cardiac risk.

The lifestyle components that influence risk are

  1. Cigarette Smoking (by far the strongest)
  2. Diet
  3. Exercise
  4. Obesity (Obviously related to #1 and #2)
  5. Stress
  6. Sleep

Patients who try to change to what they perceive as a heart healthy diet by switching to non-fat dairy and eliminating all red meat will not substantially lower risk (see here.) Even if you are possess the rock-hard discipline to stay on a radically low fat diet like the Esselstyn diet or the Pritikin diet there are no good data supporting their  efficacy in preventing cardiac disease.

Geo was not far from theMediterranean diet I recommend but would probably benefit from increased veggie and nut consumption. He was not overweight and he doesn’t smoke. I encouraged him to engage in 150 minutes of moderate exercise weekly.

Low Dose, Intermittent Rosuvastatin

I engaged in shared decision-making with Geo.  Informing him, as best I could, of the potential side effects and benefits of statin therapy.

After a long discussion we decided to try a compromise between no therapy and the guideline recommended moderate intensive dose statin therapy.

This approach utilizes a low dose of rosuvastatin taken intermittently with the goal of minimizing any statin side effect but obtaining some of the benefits of statin drugs on  cardiovascular risk reduction.

I have many patients who have been unable to tolerate other statin drugs in any dosage due to statin related muscle aches but who tolerate this particular  treatment and I  see substantial reductions in the LDL (bad) cholesterol with this approach.

Studies have shown that rosuvastatin 5–10 mg or atorvastatin 10–20 mg given every other day produce LDL-C reduction of 20–40 %

Studies have also shown that In patients with previous statin intolerance, rosuvastatin administered once or twice weekly (at a mean dose of 10 mg per week) achieved an LDL-C reduction of 23–29% and was well tolerated by 74–80 % of patients.

In a recent report from a specialized lipid clinic, 90 % of patients referred for intolerance to multiple statins were actually able to tolerate statin therapy, although the majority was at a reduced dose and less-than-daily dosing.

Results in Geo

After several months of taking 5 mg rosuvastatin twice weekly Geo felt fine with no discernible side effects. He obtained repeat cholesterol  levels:

His LDL had dropped 52% from 140 to 92.

Hopefully, this LDL reduction plus the non-cholesterol lowering beneficial properties of statins (see here) will substantially lower Geo’s risk of heart attack and stroke.

We need randomized studies testing long-term outcomes using this approach to make it evidence-based. But in medicine we frequently don’t have studies that apply to  specific patient situations. In these cases shared decision-making in order to find solutions that fit the individual patient’s concerns and experience becomes paramount.

Faithfully Yours,

-ACP

 

 

 

What Really Caused Garry Shandling’s Death: The Exploding Heart That Wasn’t

In March , 2016, Garry Shandling died suddenly and unexpectedly. At the time, TMZ reported that  “Sources familiar with the situation tell TMZ Shandling died from a massive heart attack, with no prior warning whatsoever”

This alleged cause of death  was reported widely.

 Radar Online (a site I strongly recommend avoiding) wrote

“According to an insider close to the comedian, “We are hearing that Garry had a massive and sudden heart attack.” and

“The word is that his heart basically exploded.”

LAPD, LAFD, Shandling’s rep, and LA coroner Ed Winter all declined to comment on the specifics of Shandling’s passing.

 

 

 

 

Beware The Insider’s Information

In a post I wrote entitled “Do You Know What is on Garry Shandling’s and Your Parent’s Death certificate?” I pointed out that his cause of death was unknown and that:

Although a heart attack resulting in ventricular fibrillation is the most common cause of a sudden, unexpected death in individuals over the age of 40, it is not the only one.

In fact, People  magazine reported that Sanders experienced shortness of breath and pain in his legs just a day before his death, and that he spoke to a doctor friend about his symptoms, who stopped by that night to check on him,

Shortness of breath and pain in the legs raise the possibility of a clot or DVT in the leg, which can break loose and embolize into the pulmonary arteries. Such a pulmonary embolism, if massive, can result in swift and sudden death.

What Did Shandling Die Of?

In a post dated 12/27/2016 (which I was unaware of until last week) TMZ reported the details of Shandling’s medical examination .

It turns out that Shandling did not die of a massive heart attack or an explosion of his heart.

His autopsy revealed that he  died from a pulmonary embolism, the disease I had raised as a likely  alternative cause of his sudden death in my post in April, 2016. The actual death certificate can be viewed here.

The medical report on his death reveals that Shandling had a prior
history of clots in the leg (s) (DVT) and that previously he had had an IVC filter implanted.

An IVC filter is an umbrella shaped device that is inserted into the major vein draining blood from the the lower half of the body (the inferior vena cava) to physically obstruct the vein and thereby prevent clots from reaching the pulmonary artery. These are used in cases where the normal medical treatment for blood clots (anticoagulants or blood thinners) can’t be utilized due to bleeding risk or have proven ineffective.

Although effective 95% of the time in preventing legs clots from migrating to the pulmonary artery there are reported failures and Shandling was clearly one.

Risk factors for DVT and PE include cancer, surgery and immobility. Shandling, it appears, was recently in Hawaii and long plane flights like the one he must have taken back to LA are notorious causes of immobility that can lead to DVT.

What Can We Learn From Shandling’s Death

Some take home points

-When some one dies suddenly and unexpectedly  it is not automatically due to a massive heart attack. Do not assume your family member or spouse who  was found dead in bed suffered a myocardial infarction.

-Unless the victim was quite old or had advanced cancer consider asking for an autopsy to find out the true cause of death. Whatever disease caused the death could be  inherited by the victim’s offspring.

-Pulmonary embolism can be a rapidly lethal disease. Consider a medical evaluation for it if you are experiencing leg pain/swelling, sudden, unexplained shortness of breath or chest pain which worsens upon taking a breath. If you have risk factors for leg clots or prior leg clots be even more vigilant.

Antithrombotically Yours

-ACP

N.B. Carrie Fisher was also reported to have suffered a “massive heart attack” by Radar Online (a most despicable website) and multiple other media outlets:

The Star Wars star, 60, suffered a massive heart attack on a United Airlines Flight from London on December 2, 2016, and was rushed to the hospital in LA upon landing, where she died four days later. Her death certificate was released by the Los Angeles County Department of Health and her cause of death was listed as “cardiac arrest/deferred,” which means it was likely a heart attack, but the final result is pending investigation.

No Radar Online! Cardiac arrest is the final mechanism of almost all deaths no matter what the cause. It does not mean she had a heart attack.

The CDC does not want cardiac arrest listed as a cause on death certificates:

In Part I, the immediate cause of death is reported on line (a). This is the final disease, injury, or complication directly causing the death. An imme­ diate cause of death must always be reported on line (a). It can be the sole entry in the cause-of-death section if that condition is the only condition causing the death.

The immediate cause does not mean the mechanism of death or terminal event (for example, cardiac arrest or respiratory arrest). The mechanism of death (for example, cardiac or respiratory arrest) should not be reported as the immediate cause of death as it is a statement not specifically related to the disease process, and it merely attests to the fact of death. Therefore, the mechanism of death provides no additional information on the cause of death.

We may never know the cause of carrie Fisher’s death because the autopsy (with accompanying toxicology) may never be released.

More Incredibly Bad Science From Dr. Esselstyn’s Plant-Based (Vegan) Diet Study

A while back the skeptical cardiologist exposed “The incredibly bad science behind Dr. Esselstyn’s plant-based diet.

The diet has the catchy slogan “eat nothing with a face or a mother” and Esselstyn was featured in the vegan propaganda film “Forks Over Knives.”

After detailing the lack of science I concluded:

Any patients who were not intensely motivated to radically change their diet would have avoided this crazy "study" like the plague.

This "study" is merely a collection of 18 anecdotes, none of which would be worthy of publication in any current legitimate medical journal.

Three of the 18 patients have died, one from pulmonary fibrosis, one presumably from a GI bleed, and one from depression. Could these deaths be related to the diet in some way? We can't know because there is no comparison group.

The post garned little attention initially but in the last few months several hundred visitors per day apparently read it and Essesltyn followers have started leaving me testimonials to the diet along with nasty comments.

Here’s are some typical ones (with my comments in red)

“If your (sic) not backed by some meat industry or cardiac bypass group I would be much surprised.”

I am completely free of bias. Nobody is paying me anything to do the research and writing I do. My only purpose is to find the truth about diet in order to educate my patients properly. I have  saved many more patients from bypass surgery than I have referred for the procedure.

“it is so arrogant to think the only science could come from clinical studies which may be funded by an interested party.”

Doctors like randomized (and preferably blinded) clinical studies because they minimize the bias introduced by interested parties like patients and zealous investigators (like Dr. E)  motivated to see positive outcomes. Small, non-randomized studies can only generate ideas and hypotheses which larger, randomized studies can prove with a greater degree of certainty.

“the entire nentire western medical system is skewed due to the big pharma influence…unfortunately western medicine believes the only science is the pen and the scalpel..whereas …history is the best teacher of all…”

By pen I assume you mean medications. If we examine history as  you suggest we see that life expectancy was 50 years in 1945  but today in developed countries it is around 80 years. This advance corresponds to (among other things) advances in vaccines, antibiotics, anti-cancer drugs, cardiac and blood pressure medications and surgery: the pen and the scalpel. It does not correspond to following a vegan diet.

“Your foolishness is the embarrassment.”

Thank you for this insightful comment! I’m considering it as my epitaph.

One man felt that changing to the Esselstyn diet dramatically improved his cardiac situation and commented:

“Nothing like bashing something that works just because you want to eat meat. .”

I do enjoy meat in moderation but I also really enjoy vegetables, nuts, fish, legumes, olive oil and avocados. I looked into Esselstyn’s diet in detail because it stands out as particularly misguided in banning nuts, avocados, fish and olive oil to heart patients.

..”.So sicking (sic) to see people talk trash about something that works so well… It saved my life…”

I’m happy you are doing well with your cardiac condition but it is impossible to know what would have happened to you on a more reasonable diet such as the Mediterranean diet (which actually has legitimate scientific studies supporting it). And again criticizing Esselstyn’s ideas and “study” can hardly be considered trash talk.

“I personally have followed dr. esselstyn’s program for what will be 5 years in 11/17 and have made tremendous gains in my cardio pulmonary function….my cardiologist looks at me in wonder…why are you here? and often says , if everyone did what you have…Id be out of business…so…isnt that telling and sad?”

I’m glad you’re doing well with the program, most patients can’t follow this kind of diet for more than a few months.  But perhaps we shouldn’t judge its effectiveness until  we make sure you don’t suffer a heart attack next week. Your cardiologist is wrong: see what I wrote about “dealing with the cardiovascular cards you’ve been dealt.” Some individuals inherit genes that guarantee progressive and accelerated atherosclerosis that will kill them at an early age despite the best lifestyle.

“…the phrase “follow the money” comes to mind…and since theres no big money to be made….science will attempt to dispell the results and thousands of years of history that proves this dietary system works…”

Using a scientific approach to analyze Esselstyn’s diet (which tries to claim a scientific basis) seemed appropriate to me but I wasn’t motivated by money. I’m looking for what is best for my patients, pure and simple.

The Plural of Anecdote Is Not Data

One man wrote:

“But since this is only anecdotal evidence – it must be junk science…”

Esseslstyn devotees like to post what their personal experience is with the diet but as skeptical medicine has pointed out “the plural of anecdote is not data.” 

One woman described in detail a good response her husband had after starting the diet following a heart attack:

I’m concerned about the skeptical cardiologist going after the person of dr. Esselstyn versus the science, such as quoting how you States dr. Esselstyn came up with the diet. So there may be a personal bias there. I’m sure there are more people out there on the esselstyn diet that are not noted in the study years ago. I hope there is another book coming out

I’ve reviewed in detail my comments about how Esselstyn came up with the diet but I am at a loss to find any ad hominem attack.

This woman went on to say

We will keep you posted, as my husband is willing to get another cardiac Cath and 12 months to visually see the difference after the diet.

I have to point out that if his cardiologist performs a cardiac cath (which carries risks of stroke, heart attack and death) for the sole purpose of checking the effect of the diet he is engaging in unethical medical behavior and likely insurance fraud. By the way, I hope that your husband is on a statin like most of Dr. Esselstyn’s are!:)

and a man wrote

Calling Essylstein ilk shows a little too much biased hatred on your part

Please note the definition of ilk “a type of people or things similar to those already referred to.” No pejorative there. And no ad hominem attack.  I wrote:

 It is possible that the type of vegan/ultra-low fat diets espoused by Esselstyn and his ilk have some beneficial effects on preventing CAD, but there is nothing in the scientific literature which proves it.

I should be able to criticize the methods and ideas of Dr. E without it being considered an attack on his person

Completely wrong. Esselstyn has saved my life. His book explains it all, how the endothelium cells get ruined, inflammation … heart attack proof (his words). One does not continue as head of the Cleveland Wellness Center if one is a quack.

Words are easy to come by on the interweb but Dr. E’s are not supported by science and as for the “Cleveland Wellness Center” it is probably not wise to get me started. Dr. E ‘s program is listed as being part of the Cleveland Clinic Wellness Center which is an attempt to capitalize on the market for pseudoscientific enterprises. He is not the director. The director recently came under intense criticism for promoting anti vaccine quackery. (See here).

The Wellness Center promotes so-called functional, integrative, complementary and alternative approaches. (Functional medicine is fake medicine!) These are approaches that have not been proven to work and could arguably be called quackery. (Let me be clear, however, I am not calling Dr. Esselstyn a quack but the fact that he is part of the Wellness Center does not add any scientific validity to his work.)

“I’m sure there are more people out there on the esselstyn diet that are not noted in the study years ago. I hope there is another book coming out”

Fake News, Fake Science

As a matter of fact, Dr. E has been hard at work over the last 30 years and has added a grand total of 176 patients who are considered “adherent” to the diet: about 6 per year. The “original research” was published in The Journal of Family Practice in 2014. Unfortunately the bad science present in the original publication has only been amplified.

In addition to any randomization or suitable control group for comparison, the data collection techniques are unacceptable:

“In 2011 and 2012 we contacted all participants by telephone to gather data. If a participant had died, we obtained follow-up medical and dietary information from the spouse, sibling, off-spring or responsible representative.”

In other words, there was no actual systematic review of medical records, autopsies or death certificates, just word of mouth from whomever answered the phone.

“Patients who avoided all meat, fish, dairy, and knowingly, any added oils throughout the program were considered adherent.”

Imagine, if you will, that your husband died 10 years ago and you received a call from Dr. E’s office or perhaps Dr. E himself and he asks you if your husband “avoided all meat, fish, dairy and added oils.”  For one thing, it would be very difficult for you to answer that question with any degree of accuracy: was your husband cheating on Dr. E’s diet when you weren’t looking, do you remember his entire diet from 10 years ago?

For another thing, you know that the caller has an agenda. If your husband died of a heart problem the caller is not going to be happy until he/she gets you to admit that your husband had some guacamole on Cinco de Mayo in 2002. If he’s alive and doing well, the caller is likely to be satisfied with a simple answer that , yes, he’s following the diet.

Yes, we have more data from Dr. E but it turns out to be even more incredibly bad than the first lot.

Let the anecdotes and ad hominem attacks begin!

-ACP