Tag Archives: Crestor

Are You Paying More For Rosuvastatin (Generic Crestor) Than Brand Name Crestor?

The skeptical cardiologist was shocked to hear from a patient last week that she would have to pay considerably more for generic rosuvastatin (GR) than Crestor, its brand name equivalent.

Crestor is the most potent statin we have at lowering LDL (bad) cholesterol, raising HDL (good) cholesterol, and  preventing strokes and heart attacks.  It is also the best tolerated statin in my experience; I use it frequently at low or intermittent dosages in patients who have developed muscle aches on other statins.

In comparison to atorvastatin (Lipitor, the most widely prescribed statin), Crestor is less likely to interact with other medications and (very important for a surprising number of my patients), you can consume grapefruit when taking it.

When a generic (rosuvastatin calcium) of Crestor became available last year I rejoiced, believing that the high cost of Crestor would now drop to the levels we have typically seen with other generic statins.

I have been giving Crestor sample packs like these to my patients for years. Alas, they will fade away. One downside to going generic.
I have been giving Crestor sample packs like these to my patients for years. Alas, they will fade away. One downside to going generic.

For example, when Lipitor (atorvastatin, the statin market leader for 20 years) went generic, patients no longer worried about its cost.

Initially it seemed GR was much more affordable for my patients than Crestor, however recently, I have had many of them report a rise in its cost.

Why Would The Generic Cost More Than Crestor?

The reasons for brand name versus generic pricing are many and complex, and they yield insight into the legal machinations that Big Pharma engages in to maintain high patient pharmaceutical costs.

This NY Times piece from July, 2016 reveals  how hard AstraZeneca fought to protect its exclusivity in selling Crestor and to prevent generics from entering the market. AstraZeneca’s last tactic involved a lawsuit claiming that their patent was protected by the orphan drug act. They lost and were heavily criticized:

“This case is not about the medical needs of a small population of pediatric patients with a rare disease,” the F.D.A. and Justice Department said in a brief filed in the lawsuit. “It is about AstraZeneca’s profit-driven desire to substantially extend its virtual monopoly on one of the world’s most popular medicines.”

There are other factors that slow the drop in generic prices. Consumer Reports, writing on the anticipated release of GR in May quoted an expert thusly:

“While some pharmacies drop the price as generics enter the market, others will hold it near the brand-name price as long as possible.” They get away with it, he says, because many customers who have health insurance pay a set co-pay regardless of the retail price. But those consumers who pay the entire cost of the drug themselves because they don’t have insurance or have a high deductible may not see the substantial savings that should come with generic availability.”

What an individual pays for drugs varies wildly depending on their insurance coverage. These costs are extremely hard for a physician to anticipate and rarely reflect the actual cost of drugs. Thus, in America, patients as consumers are often isolated from the true costs of pharmaceuticals to society.

Geo (he who was “on the fence” about taking a statin) asked me the following reasonable question about his GR prescription:

I did not pay anything for the 25 pills, however the paperwork states a cost of $220 if I had to buy this outside of a health insurance plan. Do you know if the health insurance company is being charged the $220, or do they negotiate a lower cost with the manufacturer?
I don’t have that answer, but would love to know it. This kind of information is hard to get at.
Send Me Your Observations On The Cost of Generic Rosuvastatin
I would like to get input from my patients and readers on their experience regarding the cost of GR to them and/or their insurance company.
I’d also appreciate input from those in the pharmaceutical or insurance portion of this equation (I know I have at least one patient who is in the pharmaceutical industry).
Finally, if any of you have experience with purchasing GR online from international pharmacies, please share it below. For example, this site claimed in May, 2016:
Ninety pills of generic rosuvastatin cost a whopping $795 at a Walgreens in Brooklyn, NY, but 90 pills of brand name Crestor is $45.65 at a low-cost international online pharmacy,
Specifically Yours,
-ACP

Donald Trump Has Moderate Plaque Buildup In His Coronary Arteries and his Risk For A Cardiac Event Is Seven Times Hilary Clinton’s Risk

Donald Trump recently appeared on the Dr. Oz show and handed a letter to the celebrity medical charlatan and TV host, Mehmet Oz.

The letter was written by his personal physician , Dr. Harold Bornstein,  screen-shot-2016-10-04-at-3-21-11-pm
and summarized various  laboratory and test  results which led Bornstein to conclude  that Mr. Trump is in excellent health (Bornstein did not repeat his earlier, bizarre statement that “If elected, Mr. Trump, I can state unequivocally, will be the healthiest individual ever elected to the presidency.”)

From a cardiovascular standpoint the following sentence stood out:

“His calcium score in 2013 was 98.”

Regular readers of the skeptical cardiologist should be familiar with the coronary calcium scan or score (CAC) by now.  I’ve written about it a lot (here, here, and here) and use it frequently in my patients, advocating its use to help better assess certain  patient’s risk of sudden death and heart attacks.

coronary calcium
Image from a patient with a large amount of calcium in the widowmaker or LAD coronary artery (LAD CA).

The CAC scan utilizes computed tomography (CT)  X-rays, without the need for intravenous contrast, to generate a three-dimensional picture of the heart. Because calcium is very apparent on CT scans, and because we can visualize the arteries on the surface of the heart that supply blood to the heart (the coronary arteries), the CAC scan can detect and quantify calcium in the coronary arteries with great accuracy and reproducibility.

Calcium only develops in the coronary arteries when there is atherosclerotic plaque. The more plaque in the arteries, the more calcium. Thus, the more calcium, the more plaque and the greater the risk of heart attack and death from heart attack.

What Does Donald’s Trump’s Calcium Score Tell Us About His Risk Of A Major Cardiac Event?

We know that, on average, even if you take a statin drug (Trump is taking rosuvastatin or Crestor), the calcium score goes up at least 10% per year which means that 3 years after that 98 score we would predict Trump’s calcium score to be around 120.

Based on large, observational studies of asymptomatic patients, Calcium scores of 101 to 400 put a patient in the moderately high risk category for cardiovascular events.

When I read a calcium score of 101-400, I make the following statements (based on the most widely utilized reference from Rumberger

This patient has:

-Definite, at least moderate atherosclerotic plaque burden

-Non-obstructive CAD (coronary artery disease) highly likely, although obstructive disease possible

-Implications for cardiovascular risk: Moderately High

Patients in this category have a 7-fold risk of major  cardiac events (heart attack or death from coronary heart disease) compared to an individual with a zero calcium scorescreen-shot-2016-10-04-at-3-16-25-pm

 

 

Clinton versus Trump: Zero is Better

Since we know that Hillary Clinton recently had a calcium scan with a score of zero, we can estimate that Trump’s risk of having a heart attack or dying from a cardiac event is markedly  higher than Clinton’s.

Clinton, born October 26, 1947 is 68 years old and we can enter her calcium score into the MESA calcium calculator to see how she compares to other women her age. A  coronary calcium score of 6 is at the 50th percentile for this group.

Interestingly, Trump’s score of 98 at age 67 years was exactly at the 50th percentile. In other words half of all white men age 67 years are below 98 and half are above 98, creeping into the moderately high risk  category.

(This should not be surprising, I touched on the high estimated cardiovascular risk of all aging men in my post entitled “Should all men over age sixty take a statin drug?”)

So, based on his coronary calcium score from 2013, Donald Trump has a  moderate build up of atherosclerotic plaque in his coronary arteries and is at a seven-fold higher risk of a cardiac event compared to Hilary Clinton.

Let the law suits and tweets begin!

Electorally Yours,

-ACP

 

 

 

 

Should I Take A Statin Drug? Risks, Benefits and the New Guidelines

StatinsThe skeptical cardiologist just returned from Washington, DC where he attended the American College of Cardiology (ACC) annual conference and visited Ford’s Theatre. I was hoping to gather more information on diet and cardiovascular disease but most of the discussions on prevention of heart disease centered around the new ACC/AHA guidelines for treating cholesterol.

A recently published analysis of the impact of these guidelines found that

As compared with the ATP-III guidelines, the new guidelines would increase the number of U.S. adults receiving or eligible for statin therapy from 43.2 million (37.5%) to 56.0 million (48.6%). Most of this increase in numbers (10.4 million of 12.8 million) would occur among adults without cardiovascular disease.

If you are a man over the age of 59 (which I just became), even without any cardiovascular disease or diabetes, there is an 87% chance the guidelines would suggest you take a statin drug.

This is a startling increase and consequently there has been a lot of criticism and questioning of the validity of these recommendations.

More importantly, for an individual patient, should you take a statin drug if your doctor recommends it? This is an especially good question if you have no evidence of any atherosclerotic cardiovascular disease (so-called primary prevention). At a minimum, you should have a very detailed discussion with your doctor about the risk and benefits of taking the medication in your particular situation.

What are statin drugs?

Statins are the most powerful, safe and effective drugs available for lowering LDL or bad cholesterol levels. They inhibit 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, involved in cholesterol biosynthesis. Low density lipoprotein (LDL) cholesterol concentration is lowered by reducing its production in the liver and increasing removal from the circulation. Statins also have anti-inflammatory effects, improve endothelial function, and reduce thrombus formation.

Common examples of statin drugs are Lipitor which is now available as a generic called Atorvastatin , Pravastatin, and Crestor (Rosuvastatin), which is only available in brand name form.

What are the risks of statin drugs?

When large scale randomized trials of statin drug therapy are analyzed, rates of adverse events (17%) or stopping treatment due to adverse events (12%) are similar in the statin compared to placebo/control groups.

The incidence of cancers, liver enzyme elevations, kidney dysfunction or arthritis was the same in the two groups.

There are only two side effects from taking statins I consider significant and mention to my patients:
1. There does appear to be a 9% increase in the risk of developing diabetes. Most of the patients who develop diabetes on statins were at high risk for this to begin with and the overall benefits of lowering CV disease outweighs the development of diabetes in patients who take statins.
2. Statins definitely can cause muscle aches (myalgias) and this seems to happen in about 10% of patients over time. If these develop, we stop the statin and the myalgias go away if they are due to the drug. There are no reliable studies showing any long term residual muscle weakness or ache. A very, very small number of patients develop rhabdomyolysis, in which there is severe muscle damage. These patients are almost always taking multiple medications which interact with the statins and often have kidney failure to begin with.

Some things you don’t need to be concerned with while on statins:

1. That the drug will give you Alzheimer’s or make you stupid. There is much anecdotal misinformation on the web about this, but no solid evidence of any adverse effect on cognition.
2. That the drug will destroy your liver. A small percentage of patients will develop elevations of their liver enzymes (AST or ALT) but this does not lead to liver damage and is considered so insignificant now that the FDA now longer advises checking liver enzymes in patients on statin drugs.

What are the benefits of statins in people without known heart disease?

They lower all-cause mortality by 14%, combined fatal and nonfatal cardiovascular disease by 25%, and stroke by 22%. They lower the chances that you would need a stent or bypass surgery by 38%.
Another way of looking at the benefits of a treatment is the number needed to treat (NNT).
To save one life, you would need to treat 138 patients for 5 years with statin drugs. This means that 137 patients would have done fine without taking the drug.

The higher your risk of developing atherosclerotic cardiovascular disease  (ASCVD (all the disease that occurs as a result of fatty plaque build up in the body, including heart attack and stroke)), the more likely you will benefit from taking a statin drug.
Thus, the new guidelines utilize a risk estimator that takes into account your total and good cholesterol values, your systolic blood pressure, age and whether you smoke, have diabetes or treated hypertension to calculate your risk of developing clinical ASCVD over the next ten years.

If this ten year risk is over 7.5%, statin therapy should be considered.

I’ve looked over the guidelines carefully, read a lot of the original studies and listened to the discussion and I think this is a reasonable approach. I try to present each patient with the risks and benefits and let them make the decision as to whether they want to take the drug.
Each individual has a different perspective, perhaps heavily influenced by their father having died of a heart attack in his fifties or by a close friend who feels that statins ruined his life.

Two important new concepts from the new guidelines

The new guidelines no longer look at the LDL or bad cholesterol level as a goal or as a level for initiating treatment (unless it is super high, above 190). Thus, the only reason to be checking follow up cholesterol panels on patients who are taking good levels of statin drugs is to verify compliance and an effective reduction in LDL from baseline. I will not try to get your LDL below 100 or 70 and you will not have to worry that it is not at that level.

The new guidelines rightly emphasize statin drugs as the only drug therapy that has good outcomes data (meaning they have been show to reduce heart attacks and strokes) supporting their use in primary prevention.
Ezitimibe (Zetia) is a commonly prescribed drug which lowers LDL cholesterol but is expensive and has never been shown to lower heart attack or stroke risk and, in my opinion, should not be prescribed.

Our goal should be prevention of heart disease, not lowering LDL levels or triglyceride levels.

I believe that we can fine tune which patients will and will not benefit from statin therapy by looking for evidence of what is called “subclinical atherosclerosis.” I plan to review this in a future post.
For now, I leave you with the humorous line from the play “Our American Cousin” that caused the distracting laughter during which John Wilkes Booth shot Lincoln in Ford’s Theatre (which is not far from the Washington Convention Center and well worth visiting!)

“Don’t know the manners of good society, eh? Well, I guess I know enough to turn you inside out, old gal — you sockdologizing old man-trap.”

Tell your cardiologist you will sockdologize him if he doesn’t give you a good discussion of the risks and benefits of the statin drug he is recommending.