EXCEL, the Expanded Clinical Evaluation of Lovastatin
This trial was performed by Dr. Reagan H. Bradford and his team from a large number of American clinics and research institutions, including the Merck Sharp & Dohme Research Laboratories at West Point, NY, where the drug was produced where the drug was produced. More than 8,000 healthy individuals (called “patients” in the trial reports) with cholesterol levels between 240 and 300 mg/dl (6.2-7.7 mmol/l) received one of four different doses of lovastatin (Mevacor®) or a placebo.
With a view to reporting on possible adverse effects of the treatment, preliminary study results were published after only one year of the trial. No significant side effects were reported, but in the fine print the authors were obliged to mention that death due to all causes was 0.5 percent in the four lovastatin groups combined (32 or 33 individuals out of a group of about 6,600—no exact figures were given in the report) compared to 0.2 percent in the placebo group (three or four individuals out of a group of 1,650). By taking all the lovastatin groups together, the difference would have been statistically significant if the number of deaths in the treatment groups were 33, but not if it were 32. Even if the difference wasn’t statistically significant after one year, it would certainly have become significant if the tendency to a higher mortality in the treatment groups had continued throughout the trial. In any case, the aim of the treatment was to lower mortality and most certainly no lowering was achieved.
Today at least 20 reports from the EXCEL trial have been published in various medical journals. These reports tell us how well lovastatin is tolerated and how effective it is in lowering blood cholesterol levels in various populations, but not one of them has reported the final outcome of the trial, although more than ten years have passed since it began. Therefore, we do not know whether the increased mortality, seen after just one year of treatment, has continued throughout the trial.
Why have we never heard about this outcome of the first statin trial, which was one of the largest? I asked that question in a letter to Merck, Sharp & Dohme. They answered that, “the trial was not designed to measure the clinical outcome, only to test whether the drug was tolerable and did not produce any serious side effects.”
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