Do statins make you immortal?

My blogs over the past week have been concerned about the screening of asymptomatic patients for coronary artery disease and whether we make a difference in their morbidity and mortality if we find it. 

That’s really all we are concerned with:  Can we, as physicians, change a patient’s outcome by putting in place a medicine or a lifestyle?   What good is it to find a problem if you can’t act on it?

To date, what we do when we find a patient who we believe to be at risk is tell them to stop smoking, control their blood pressure and their diabetes.  And, we put them on statins.  As those that read my blogs know, statins are our first line of defense against progression of coronary artery disease when a patient already has an infarct, angioplasty or coronary artery bypass surgery.

An article was published in Arch Intern Med 2010;170:1024-1031 which addresses this question.  It is titled Statins and All-Cause Mortality in High -Risk Primary Prevention:  A Meta-Analysis of 11 Randomized Controlled Trials involving 65,229 Participants. 

This represents over 244,000 person- years of follow up.  The average LDL cholesterol was 138 mg/dl and the results of giving statins yielded an average LDL of 94 mg/dl.  An average of 3.7 years of follow up occurred in these studies and there was no evidence of benefit in these findings (7 fewer deaths for every 10,000 person years of treatment).

Although compelling, I believe that this study is flawed by the short follow up.  Remember, this is not a randomized clinical trial which is the highest level of significance; it is a Meta-Analysis and only collates the data already collected in like studies.

Statins were approved because they were tested in randomized clinical trials against placebo and there was always a statistically significant reduction in a triple endpoint of unstable angina, myocardial infarction and death.  Death however is usually the least affected because we are much better at preventing it if patients who are affected by an acute event present to hospitals.  Patients who are found to be “at risk” will continue to be offered statins and the data shows that the lower the LDL is driven, the lower the vent rate.  There seems to be no plateau.  Every time a study drives the number lower, the event rate follows and some studies have the LDL as low as 50 mg/dl.  The study known as TNT, or Treating to new targets,
showed this result in a study with over 10,000 patients.

The real study we want to do can not be done because it is not ethical anymore.  Withholding statins from patients would never pass muster.  It could be done in patients who refuse statins but the numbers would never be great enough.  We will just have to accept the premise for the time being until science moves ahead of need.

Tags: Angina, Cholesterol, clinical trial, Coronary artery disease, Myocardial Infarction, Statins
Posted in Cardiac Surgery, Cholesterol, Chronic Angina, Clinical trials, Coronary Artery Disease, Myocardial Infarction | No Comments »