Clinical Trial Stopped Because of Strong Success

While news of clinical trials prematurely ending because of disappointing results often finds its way into the popular media, a recent clinical trial in the UK was ended because of the opposite - its overwhelming success.

Called the Hypertension in the Very Elderly Trial, the study looked at the results of treating high blood pressure and reducing stroke risk by using an experimental combination drug that combines an ACE Inhibitor (perindopril) and a diuretic (indapamide). The study, which examined more than 4,000 patients, was the first to test whether patients over 80 respond as positively to reductions in blood pressure as do younger people. Earlier studies had tentatively shown a reduction in stroke risk associated with tight blood pressure control in the elderly (as expected) but seemed to suggest that neither lowering blood pressure nor avoiding stroke had any impact on how many patients actually died. The new trial seems to have demonstrated that tight blood pressure control in the elderly does indeed lower the risk of dying.

During the trial, which was conducted by giving one group of patients the experimental drug and another group of patients a placebo, researchers found that those receiving the real drug had dramatic improvments in their blood pressure profile and experienced other health benefits. Because the benefits were so pronounced, the overseers of the study asked for permission to suspend the trial so that those patients on placebo could be given the real drug. Recently, the board in charge of the study agreed, and the study was suspended.

While the results have yet to be published in a peer reviewed journal, the suspension of a clinical trial is so rare and dramatic that there is not very much debate within the scientific community about whether the new treatment is beneficial or not. Dr. Nigel Beckett, one of the leaders of the clinical trial, commented, "We do not want to put an exact figure on the risk reductions at the moment but it is statistically significant."