Thursday, September 3, 2009

Hypertension study named ‘Trial of the Year’

Medical Tribune July 2009 P9
David Brill

The Hypertension in the Very Elderly Trial (HYVET) has been named as 2008’s Trial of the Year, reflecting its potential to change healthcare and “improve the lot of mankind.”

The study found that antihypertensive treatment reduced the risk of cardiovascular events, death from stroke, and death from any cause in over-80s.

The largest clinical trial of its kind, HYVET was carried out against a backdrop of uncertainty about the benefits of blood pressure (BP) lowering in the very elderly.

The award was bestowed recently by the Society for Clinical Trials (SCT) and Project ImpACT (Important Achievements of Clinical Trials). HYVET was also voted Medscape’s most important clinical trial of the year, and named in the American Heart Association’s top 10 advances in stroke and heart disease research for 2008.

“The results of HYVET will have important implications for the generation of future guidelines and mean that very elderly individuals with sustained systolic BPs of 160 mmHg or more should now be appropriately assessed and treated in accordance with these findings,” said trial coordinator Dr. Nigel Beckett, from the Care of the Elderly group at Imperial College London, UK.

Dr. Deepak Bhatt, director of the Integrated Interventional Cardiovascular Program at Brigham and Women’s Hospital, US, added: “HYVET is a landmark study that challenges current paradigms which question the risk to benefit of treating hypertension in patients older than 80 years of age. The results of this study should encourage practitioners to treat elevated systolic BP in the very elderly.”

HYVET involved 3,845 patients from 13 centers in Europe, China, Tunisia and Australasia, who had a sustained systolic BP of 160mmHg or more. They were randomized to placebo or sustained release indapamide (1.5 mg), with perindopril (2 or 4mg) to be added if the BP target of 150/80 mmHg could not be reached. [N Engl J Med 2008 May 1;358(18):1887-98]

After a median of 1.8 years of follow-up, treatment reduced the risk of death from stroke by 39 percent (unadjusted hazard ratio [HR] 0.61; P=0.046), death from any cause by 21 percent (unadjusted HR 0.79; P=0.02), risk of any cardiovascular event by 34 percent (unadjusted HR 0.66; P<0.001)>
There were also non-significant risk reductions for outcomes of any stroke (unadjusted HR 0.70; P=0.06) and death from cardiovascular cause (unadjusted HR 0.77; P=0.06) in the treatment group.
The SCT / Project ImpACT awards are given to trials which are deemed, among other criteria, to “have improved the lot of mankind,” and “provided the basis for a substantial, beneficial change in health care.”

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