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TRANSCEND(TM) Trial Results Presented at European Society of Cardiology Congress and Published in The Lancet

Sunday, August 31, 2008 General News J E 4
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RIDGEFIELD, Conn., Aug. 31 The primary results of theTRANSCEND(TM)* trial demonstrated that treatment with MICARDIS(R)(telmisartan) 80mg in patients receiving current standard of care resulted inan 8% reduction in the composite endpoint of cardiovascular death, myocardialinfarction, stroke and hospitalization for congestive heart failure. Thisreduction was not statistically significant (p=0.216; HR 0.92) compared topatients receiving placebo in addition to current standard of care.(1)Results of the main secondary endpoint of TRANSCEND as pre-specified in thestatistical plan demonstrated that telmisartan significantly reduced the riskof cardiovascular death, myocardial infarction and stroke in high-riskcardiovascular patients by 13% compared with those patients already receivingcurrent standard of care (p=0.048).(1) This risk reduction was achieveddespite a high proportion of patients receiving proven therapies such asstatins, anti-platelet agents or beta blockers. The main secondary endpoint ofTRANSCEND mirrors the primary endpoint of the landmark HOPE trial.(2) Apost-hoc analysis to adjust for multiplicity and overlap with primary endpointshowed a p-value of 0.068.(1) The results were presented today at the annualmeeting of the European Society of Cardiology in Munich, Germany and publishedonline in The Lancet.

In high-risk patients who cannot tolerate an angiotensin-converting enzyme(ACE) inhibitor, the TRANSCEND trial was designed to investigate potentialcardiovascular risk reduction benefits using the second-generation angiotensinII receptor blocker (ARB) telmisartan. Telmisartan was compared to placebo ontop of standard therapy (including anti-hypertensives, anti-platelet therapyand statins).

The TRANSCEND trial was part of the ONTARGET(TM) Trial Program, thelargest clinical trial ever undertaken with an ARB, involving more than 31,000high-risk cardiovascular patients with either normal or controlled bloodpressure. The ONTARGET Trial Program was based on the design of the landmarkHOPE trial and encompassed two randomized, double-blind, multi-centerinternational outcome trials: ONTARGET**, the main trial with resultsreported in March 2008,(3) and TRANSCEND, the parallel trial.

"Previously, the ONTARGET trial showed that telmisartan was as effectiveas the ACE inhibitor ramipril in reducing the risk of cardio- andcerebrovascular events, but with a lower rate of discontinuations. For high-risk patients who cannot tolerate an ACE inhibitor, the TRANSCEND resultscould represent an important step forward," said Michael Weber, M.D.,professor of medicine at the State University of New York, Downstate Collegeof Medicine.

It was also published that all cardiovascular hospitalizations weresignificantly reduced with telmisartan (894 vs. 980; p=0.025). Therapy withtelmisartan was well tolerated and showed a trend toward a lower rate ofdiscontinuation (640 patients discontinued taking telmisartan vs. 707 takingplacebo, p=0.051). The most frequently reported reasons for discontinuationwere hypotensive symptoms, syncope, cough, diarrhea, angioedema and renalabnormalities.(1)

TRANSCEND included 5,926 patients from 40 countries who were at high riskfor cardiovascular disease (patients older than 55 years, who have hadmyocardial infarction, peripheral arterial occlusive disease, stroke ortransient ischaemic attacks or suffer from diabetes mellitus and additionalrisk factors) and intolerant to widely-prescribed ACE inhibitors. Patients inthe trial were randomized to treatment with telmisartan 80mg/day or placebo.

It has been reported in medical literature that the incidence of patientswith hypertension who are intolerant to ACE inhibitors ranges between10-39%,(4-6) which often leads to discontinuation of treatment leavingpatients unprotected. Side effects associated with ACE inhibitors includeintolerable cough and rare, but poten
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