Statins are the new wonder drugs now used to prevent everything from heart disease to Alzheimer's. But new evidence from a Finnish doctor shows that statins don't lower cholesterol which, in any case, isn't the real culprit
In the late 1980s, the pharmaceutical companies introduced a new type of cholesterol lowering drug called the 'statins'. These drugs inhibit the body's production of many important substances, one of which is cholesterol.
Sold as Zocor (Zocord in the US), Mevacor, Pravachol, Lescol and Lipitor, these new drugs have received wide acclaim because of the substantial cholesterol reduction they achieve, without serious side effects. Whereas the earlier drugs could lower cholesterol by 15-20 per cent at most, the statins can lower cholesterol by 30-40 per cent or more.
As of January 2000, the results of five large scale, controlled, randomised, double blind studies involving more than 30,000 study participants and numerous angiographic trials have been published.
The 4S trial
In 1994, the results of a large multicentre trial, The Scandinavian Simvastatin Survival Study (4S) trial, were published (Lancet, 1994; 344: 1383-9). The results were noteworthy indeed. For the first time, a trial had succeeded in significantly lowering the risk of both fatal and non fatal coronary heart disease (CHD), and even total mortality.
The British Medical Journal proclaimed: "Lower patients' cholesterol now! There is no longer any doubt about the benefit and safety of treating hypercholesterolaemia in patients who have had a myocardial infarction" (BMJ, 1995; 310: 1280-1).
The results of the 4S trial were published in The Lancet on November 19 and, on the same day, presented at a press conference arranged by the manufacturer of simvastatin Merck Sharpe & Dohme. In the vigourous marketing that followed, simvastatin was heralded as "the missing link".
The study was performed in cooperation with 94 Scandinavian medical departments. The steering committee and monitoring staff also included employees from Merck, as they were the sponsors of the trial.
Altogether, 4444 men and women who had had a previous heart attack were treated-half with simvastatin and half with
a placebo. After 5.4 years, 8.5
per cent had died from a heart attack in the control group compared with 5 per cent in the treatment group. This improvement included men only; the number of women who had died from a heart attack was the same in both groups.
But there were other benefits. The number of non-fatal heart attacks had been lower-ed even more-from 22.6 per cent in the control group to
15.9 per cent in the simvastatin group, a gain of 6.7 per cent. Futhermore, the number of strokes was reduced significantly-from 4.3 per cent to
2.7 per cent.
The most recent statin trial, cleverly named the Long-term Intervention with Pravastatin in Ischemic Disease study, or LIPID, included patients who had previous CHD with all stages of cholesterol levels. This was a logical approach because, if the statins can prevent cardiovascular disease whether cholesterol is high or low, then there is no reason to look at cholesterol levels at all.
This trial was conducted
by members of the National Health and Medical Research Council Clinical Trials Centre
at the University of Sydney, Australia, along with a team of