Abstract
Background and ObjectivesResults of the recently published ONTARGET study (The Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial) showed that telmisartan (80 mg/day) was non-inferior to ramipril (10 mg/day) in reducing cardiovascular events. Clinicians in Asia doubt tolerability of these doses for their patients. We therefore analyzed data from this study and a parallel study TRANSCEND (Telmisartan Randomized Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease). Our objectives were to compare Asians and non-Asians with respect to the following:1) Effectiveness of telmisartan vs. ramipril in reducing cardiovascular events;2) Proportions who reached the full dose of telmisartan, ramipril or placebo; and3) Proportions of overall discontinuations, and discontinuations due to adverse effects.MethodThe ONTARGET study randomized 25,620 patients at risk of cardiovascular events to ramipril, telmisartan, or their combination. The primary composite endpoint was death caused by cardiovascular disease, acute MI, stroke, and hospitalization because of congestive heart failure. TRANSCEND randomized 5926 high-risk patients with a history of intolerance to ACE-inhibitors to telmisartan or placebo. The primary outcome was the same. In this substudy, we compared Asians and non-Asians as to how well they tolerated telmisartan (given in both studies) and ramipril (given in ONTARGET).Results1) Telmisartan was non-inferior to ramipril in lowering the primary endpoint among Asians (RR = 0.92; 95% CI: 0.74, 1.13); 2) more Asians achieved the full dose of either drug; 3) less withdrew (overall); and 4) less withdrew for adverse effects. Furthermore, telmisartan was better tolerated than ramipril. This advantage was greater among Asians.Conclusion and SignificanceAlthough Asians had lower BMI than non-Asians, Asians tolerated both drugs better. Regulatory agencies require reporting of safety and effectiveness data by ethnicity, but few comply with this requirement. This study shows that safety data in ethnic subgroups can help assess applicability of results to specific populations.Trial RegistrationClinicalTrials.gov NCT00153101
Highlights
Angiotensin-converting enzyme (ACE) inhibitors reduce cardiovascular morbidity and mortality among patients at risk for these events [1,2]
1) Telmisartan was non-inferior to ramipril in lowering the primary endpoint among Asians (RR = 0.92; 95% CI: 0.74, 1.13); 2) more Asians achieved the full dose of either drug; 3) less withdrew; and 4) less withdrew for adverse effects
Telmisartan was better tolerated than ramipril
Summary
Angiotensin-converting enzyme (ACE) inhibitors reduce cardiovascular morbidity and mortality among patients at risk for these events [1,2]. Studies show a high residual rate of cardiovascular events despite treatment, and a significant incidence of intolerance to these drugs These problems have led to interest in the role of Angiotensin Receptor Blockers (ARBs), either as supplements to, or replacements for ACE inhibitors [3]. In the ONTARGET study, 25,620 patients at risk of cardiovascular events (but no heart failure) were randomized to receive the ACE-inhibitor ramipril, the ARB telmisartan, or their combination. Results showed that telmisartan was non-inferior to ramipril in reducing these cardiovascular events among patients at risk [4]. Results of the recently published ONTARGET study (The Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial) showed that telmisartan (80 mg/day) was non-inferior to ramipril (10 mg/ day) in reducing cardiovascular events. Our objectives were to compare Asians and non-Asians with respect to the following: 1) Effectiveness of telmisartan vs. ramipril in reducing cardiovascular events; 2) Proportions who reached the full dose of telmisartan, ramipril or placebo; and 3) Proportions of overall discontinuations, and discontinuations due to adverse effects
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