Statin Non-Compliance: The Emperor Needs New Clothes

Compliance with cholesterol-lowering drugs, outside of clinical studies, is terrible. 50% of patients who receive a prescription are not taking the medication within 6 months. This falls to 60% after 12 months and to 80% after 5 years.

There is a belief in medical circles that more education improves compliance. Compliance rates following Acute Coronary Syndromes, Myocardial Infarction, and Invasive Procedures are <40% at 2 years. If hospitalization and invasive procedures are not sufficient instruction on the need for lower cholesterol, then what is?

Statin compliance rates following Acute Coronary events are less than 40% at 2 years. Click To Tweet

There are over 40,000 articles on patient compliance. The vast majority are written from the perspective of the medical establishment critiquing patient behavior, with scant understanding of patient beliefs or recognition of organized medicine’s role in creating the problem. It’s only last year that a paper was published that analyzed anti-vaccine beliefs – the issues identified are lack of trust, no alternatives offered, suspect safety statistics, and fear of outright conspiracy. The issues on statins are similar, strangely enough.

In surveys done by Kaiser of Northern California, the patients’ major concern about statins is side effects, and first among them is muscle aches. This is a major junction where doctors lose patient confidence. As each of the new cholesterol-lowering drugs was licensed, it was added to the “statin” class. They were segregated by how intensely they lowered LDL cholesterol, not by intensity of side effects. Researchers, having the first drug that could directly prevent or reduce the majority of heart disease, followed a centuries-old dictum of medicine – “Desperate disease (heart disease the major cause of death) demands desperate cure.” But they failed to appreciate as they moved from the desperately ill to those less so, that the equation of risk and benefit was shifting.

Statins are ranked by LDL-lowering strength, not by intensity of side effects. Click To Tweet

Cholesterol-lowering medications are not a uniform class of drugs in either risk or benefit. This paper will consider the effects of myalgia. Medical research indicates Crestor has 80% more cholesterol-lowering effect but causes 600% more muscle pain. Not a bad tradeoff to save a life, but not a rational decision for asymptomatic patients. The amateur actors called doctors are not playing to the truth as their patients see it.

The table below is taken from FDA Post-Marketing Adverse Event database.

Brand Name Chemical Name Ratio to Rosuvastatin
Crestor rosuvastatin 1.0
Lescol fluvastatin .74
Lipitor atorvastatin .55
Zocor simvastatin .26
Pravachol pravastatin .17
Mevacor lovastatin. .08

 

The fog of war has descended on both sides. The medical community, still holding fast, has classified many non-compliers as “statin deniers,” who deny the benefits regardless of the evidence, similar to those who deny climate change with a similar psychology. More ominous is the invention of the “nocebo effect,” which is a technical way of suggesting any fault with statins is the patient’s imagination.

The medical echo chamber is so firmly sealed off from the reality of the consuming public that a recent survey asked if patients had ever been given a prescription for a “statin.”  Not to belabor a point, but no patient has ever received a prescription for a drug named “statin” – there is no drug by that name. (This question was followed by a list of both brand name and generic names of all the cholesterol-lowering drugs, which is way above the target reading comprehension level for surveys.)

Patients won't listen to someone they can’t relate to. Try listening to them. Click To Tweet

The accepted solution to remedy noncompliance is patient education. More education isn’t succeeding, however, because patients aren’t listening to someone they can’t relate to. Patients are consumers; they make choices based on options. The determining features in the sale of a car are the color, features, and brand image. The truth is that under the sheet metal, many different automobile brands have components from the same manufacturers. When it comes to medications, patients want to know many things such as cost, frequency of administration, side effects, food interactions, and natural vs synthetic (natural is very popular).

The longest study with the highest compliance rate is the West of Scotland Coronary Prevention Trial (WOSCOPS) using pravastatin. It’s key to compliance was getting patients to come in for several trial visits during the first year and had their compliance assessed by pill count, and had their concerns appreciated.  At the first trial visit, the mean compliance was 85%, and rising to approximately 93% at the end of the first year and remaining stable until the end of the study. Rising compliance over a five-year period. Let’s stick with pravastatin.

The first step is to accept the patient’s perception that statins have side-effects because they do. The reported rates of muscle pain are 10-20% and can last for months. Time to show your patients the myalgia chart. Then show them the side-effects chart from the WOSCOPS trial.

Adverse Effect Withdrawals in WOSCOPS
Body System Placebo Treated Total
Cardiovascular 40 24 64
Dermatological 10 14 24
Drug interactive 1 1 2
Metabolic 22 10 32
Gastrointestinal 67 76 143
General 18 26 44
Haematopoietic 2 2 4
Hepatic/biliary 7 8 15
Immunologic 1 0 1
Musculoskeletal 32 37 69
Nervous system 66 66 132
Renal/urinary 14 11 25
Respiratory 19 23 42
Special senses 1 7 8
Total 300 305 605

 

This illustrates that 40 mg of pravastatin has no more side effects than that of placebo. There are many options for primary prevention, including starting patients at 10 mg, to put dose-response on your side. When the conversation turns to higher intensity statins, pravastatin was used at a 160 mg dose safely in two small studies published in the Journal of the American College of Cardiology. However, because Lipitor, Zocor, and Crestor were introduced about the same time, no testing of pravastatin was done at that dose.

For your patients with recent Acute Coronary Syndromes, pravastatin is not the drug of choice. In the PROVE-IT study, most of the benefit from Lipitor was in the first 30 days. The theory is that plaque stabilization was taking place before significant LDL lowering occurred.

Never let the Perfect be the Enemy of the Good

What if a moderate to high-risk patient chooses Pravastatin over Crestor?  Is a 20% five-year compliance rate with Crestor better than 75% compliance rate with Pravastatin?

 

Reference and Additional Reading:

A Survey of the FDA’s AERS Database Regarding Muscle and Tendon Adverse Events Linked to the Statin Drug Class Keith B. Hoffman1, Christina Kraus1, Mo Dimbil1, Beatrice A. Golomb2,3*

ATP III. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection,

Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002;106:3143-3421.

Simons LA, Levis G, Simons J. Apparent discontinuation rates in patients prescribed lipid-lowering drugs. Med J Aust.1996;164:208-211.

Hughes DA, Walley T. Predicting “real world” effectiveness by integrating adherence with pharmacodynamic modeling. Clin Pharmacol Ther. 2003;74:1-8.

Results of Two Clinical Trials on the Safety and Efficacy of Pravastatin 80 and 160 mg Per Day Robert S. Rosenson, MD, and Harold E. Bays, MD

James Katz MD

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