Downsides of statins will outweigh benefits for some

Dr. Janice B. Schwartz Dr. Janice B. Schwartz Photo: Courtesy Dr. Janice B. Schwartz Photo: Courtesy Dr. Janice B. Schwartz Image 1 of / 1 Caption Close Downsides of statins will outweigh benefits for some 1 / 1 Back to Gallery

I recently wrote about new recommendations for managing high cholesterol that focused on the use of statins for treatment and prevention of cardiovascular disease. The column stimulated a number of comments regarding the disadvantages of taking statins. So let's revisit the statin story.

The connection between high cholesterol and heart attacks, strokes and obstruction of arterial blood vessels was clearly demonstrated during the study of families with very high LDL-cholesterol levels who develop cardiovascular disease in middle age and have some narrowing of their arteries as early as childhood.

Their genetic defect is an abnormal LDL-cholesterol receptor that cannot block the production of cholesterol by an enzyme known as HMGCoA reductase. This discovery laid the groundwork for the development of statins, which can inhibit this liver enzyme and decrease the production of cholesterol. Statins not only decreased cholesterol to a greater extent than other available medications, they were far better tolerated.

The next step was to see whether lowering cholesterol with statins helped patients with cardiovascular diseases and high cholesterol levels who did not have the genetic defect. The answer was "yes."

Multiple studies have shown a decrease in subsequent heart attacks and mortality in people who receive a statin after a heart attack compared with those who do not. It is estimated that about 5 out of 100 people treated with statins after a heart attack will be saved from death, another heart attack or a stroke over the five years following the heart attack.

Unfortunately, we cannot currently identify which five individuals will benefit, and the potential for benefit is less in people without established cardiovascular disease. Statin use will prevent cardiovascular events over the ensuing five years in about 2 of 100 people who are treated. In other words, 50 people will need to be treated to prevent one cardiovascular event.

A key consideration is that the intervention with statins be safe, as people will be treated who may never benefit. There is no question that the medications can cause unwanted side effects - both directly from the drugs themselves and indirectly from the behavior of patients when taking them.

Statins cause muscle problems in about 12 to 20 percent of patients, especially older and smaller patients and those taking medications that interfere with their metabolism. The muscle problems include aches, tenderness or weakness. In a small number of patients, the muscles will actually break down, causing abnormal blood tests and kidney problems and, on rare occasion, death.

About 2 percent of patients may develop problems with blood sugar levels or develop diabetes. Patients also report headaches, difficulty sleeping, flushing of the skin, drowsiness, dizziness, nausea and/or vomiting, abdominal cramping, bloating, diarrhea or constipation and, occasionally, a rash.

About 1 or 2 in 1,000 develop inflammation of the liver that usually does not cause symptoms but may be detected on a blood test and resolves when the statin is stopped. There is some limited evidence that some statins may cause memory loss and mental confusion in older patients.

Patients taking statins also appear to adopt less healthy eating habits, with more fat and calories in their diets over time. This is a mistake for two reasons. First, while statins lower total and LDL cholesterol, they do not affect other bad lipids, such as triglycerides, found in fatty and sugary foods. Second, statins do not raise the good cholesterol, HDL, which is cardio-protective.

All cardiovascular treatment guidelines begin with the recommendation for a healthy lifestyle - diet, exercise, sleep, stress reduction, limited alcohol intake and no smoking.

The best results with any interventions come when patients participate in choosing the therapies and are involved in monitoring for both wanted and unwanted effects. When considering statin use to prevent heart disease, decisions must be individualized as unwanted effects occur commonly and may outweigh the potential benefit in any one patient.