Patient Prefer Adherence. 2012;6:1-9. doi: 10.2147/PPA.S27939. Epub 2011 Dec 23.
Incidence of adverse events with telmisartan compared with ACE inhibitors: evidence from a pooled analysis of clinical trials.
Patient preference and adherence
Giuseppe Mancia, Helmut Schumacher
Affiliations
Affiliations
- Universita degli Studi Milano-Bicocca, Ospedale San Gerardo di Monza, Milan, Italy.
PMID: 22272064
PMCID: PMC3262485 DOI: 10.2147/PPA.S27939
Abstract
Telmisartan is indicated for the prevention of cardiovascular events in high-risk patients, based on comparable efficacy to the angiotensin-converting enzyme (ACE) inhibitor, ramipril, in the ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial (ONTARGET(®)) trial. However, tolerability must be considered when selecting treatments. This analysis compared the tolerability of telmisartan and ACE inhibitors using data pooled from 12 comparative, randomized studies involving 2564 telmisartan-treated patients and 2144 receiving ACE inhibitors (enalapril, lisinopril, or ramipril). Incidence rates of adverse events for the combined ACE inhibitor treatments and for telmisartan were similar (42.8% vs 43.9%, respectively) as were the rates of serious adverse events (1.8% vs 1.7% for telmisartan, respectively). Patients receiving ACE inhibitors had more cough (8.6% vs 2.6% with telmisartan, P < 0.0001). Results were similar irrespective of age, gender, or ethnicity. The adverse event of angioedema was observed in four patients (0.2%) receiving ACE inhibitors versus none with telmisartan (P = 0.043). There were small, numerical differences in serious adverse events. A total of 107 patients (5.0%) receiving ACE inhibitors and 93 patients (3.6%) receiving telmisartan discontinued treatment because of adverse events (P = 0.021); of these, 32.7% and 5.4%, respectively, were discontinuations due to cough (relative risk reduction of 88% [P < 0.0001] with telmisartan). Telmisartan and ACE inhibitors produced comparable blood pressure reductions at marketed doses. Telmisartan and ACE inhibitors are suitable for the prevention of cardiovascular events in high-risk patients, but telmisartan is better tolerated, particularly with regard to cough.
Keywords: adverse drug event; angiotensin II type 1 receptor blockers; angiotensin-converting enzyme inhibitors; cough; hypertension
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