Statin treatment of healthy people

January 2011

How to cover up the bad news

You have probably read about the new report from the Cochrane Collaboration mentioned in many of the major media recently, for instance The Telegraph, BBC, Boston Globe, CBC News, LA Times, and Reuters. The aim of the Cochrane authors was to assess the effects, both harms and benefits, of statins in people with no history of CVD. For that purpose they had analysed randomised controlled trials of statins with minimum duration of one year and follow-up of six months, a total of 14 including 34272 participants.

The authors concluded that ”although reductions in all-cause mortality, composite endpoints and revascularisations were found with no excess of adverse events, there was evidence of selective reporting of outcomes, failure to report adverse events and inclusion of people with cardiovascular disease. Only limited evidence shed that primary prevention with statins may be cost effective and improve patient quality of life. Caution should be taken in prescribing statins for primary prevention among people at low cardiovascular risk.”

As mentioned in the Cochrane report the low number of side effects is unlikely. To mention only that independent researchers have found that muscular problems are seen, not in less than 1 percent as reported in all statin trials, but in about 25 % of those who exercise regularly.

But it is worse than that. As the authors had included only trials with a length of one year or longer, they have missed the first statin trial, named EXCEL. It included more than 8,000 healthy individuals (named ‘patients’ in the trial reports, because of their moderately elevated cholesterol) who received one of four different doses of lovastatin (Mevacor®) or a placebo. The trial was terminated already after 48 weeks of treatment.

The reason?

Because the authors only wanted to see if the ”patients” tolerated the drug, and they did, at least according to the trial report.

In the abstract you look in vain after the clinical outcome. In the text you can read that total mortality was 0.2 percent in the control group and about 0.5 percent in the four treatment groups. The total number of deaths was 36, but as nothing was said about the exact number of participants in each group (they were ”of similar size”), it is impossible to calculate if the higher number of deaths in the treatment groups was statistically significant or not. However, it would most likely have become significant had the trial continued.

It is also worth mentioning that whereas all statin trials with a positive outcome are freely available on the web, this is not the case with EXCEL.