This reduction was not statistically significant (p=0.216; HR 0.92) compared to patients receiving placebo in addition to current standard of care. Results of the main secondary endpoint of Transcend as pre-specified in the statistical plan demonstrated that telmisartan significantly reduced the risk of cardiovascular death, myocardial infarction and stroke in high-risk cardiovascular patients by 13% compared with those patients already receiving current standard of care (p=0.048).
This risk reduction was achieved despite a high proportion of patients receiving proven therapies such as statins, anti-platelet agents or beta blockers. The main secondary endpoint of Transcend mirrors the primary endpoint of the Hope trial. A post-hoc analysis to adjust for multiplicity and overlap with primary endpoint showed a p-value of 0.068.
In high-risk patients who cannot tolerate an angiotensin-converting enzyme (ACE) inhibitor, the Transcend trial was designed to investigate potential cardiovascular risk reduction benefits using the second-generation angiotensin II receptor blocker (ARB) telmisartan. Telmisartan was compared to placebo on top of standard therapy.
The Transcend trial was part of the Ontarget trial program, the largest clinical trial ever undertaken with an ARB, involving more than 31,000 high-risk cardiovascular patients with either normal or controlled blood pressure.
The Transcend included 5,926 patients from 40 countries who were at high risk for cardiovascular disease and intolerant to widely-prescribed ACE inhibitors. Patients in the trial were randomized to treatment with telmisartan 80mg/day or placebo.