PMID- 21029339 OWN - NLM STAT- MEDLINE DCOM- 20110602 LR - 20211217 IS - 1751-7176 (Electronic) IS - 1524-6175 (Print) IS - 1524-6175 (Linking) VI - 12 IP - 10 DP - 2010 Oct TI - Safety and tolerability of the direct renin inhibitor aliskiren: a pooled analysis of clinical experience in more than 12,000 patients with hypertension. PG - 765-75 LID - 10.1111/j.1751-7176.2010.00352.x [doi] AB - While the safety of renin-angiotensin system (RAS)-blocking drugs such as angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers is well known, less is known about the new direct renin inhibitor aliskiren. The authors pooled data from 12 randomized controlled trials of aliskiren in patients with hypertension and analyzed the incidence and types of adverse events (AEs) and laboratory abnormalities. Studies were characterized as short-term (2 months) active-controlled. Relative risks for AEs of particular interest for RAS blockers were calculated. In short-term studies, AEs occurred in similar proportions of aliskiren 150 mg and 300 mg (33.6% and 31.6%, respectively) and placebo treatment groups (36.8%). In long-term studies, a lower proportion of patients treated with aliskiren 150 mg and 300 mg had AEs (33.7% and 43.2%, respectively) than those treated with ACE inhibitors (60.1%), angiotensin receptor blockers (53.9%), and thiazide diuretics (48.9%). Events of special interest, including angioedema, hyperkalemia, and diarrhea occurred in similar proportions of patients taking aliskiren, placebo, and comparator agents. In studies of up to 36 weeks, patients treated with aliskiren were significantly less likely to develop cough than those treated with ACE inhibitors. At the registered doses of 150 mg and 300 mg daily, aliskiren has safety and tolerability profiles similar to placebo, other RAS blockers, and diuretics. Cough rates are lower with aliskiren compared with ACE inhibitors. CI - (c) 2010 Wiley Periodicals, Inc. FAU - White, William B AU - White WB AD - Calhoun Cardiology Center, University of Connecticut School of Medicine, Farmington, CT 06030-3940, USA. wwhite@nso1.uchc.edu FAU - Bresalier, Robert AU - Bresalier R FAU - Kaplan, Allen P AU - Kaplan AP FAU - Palmer, Biff F AU - Palmer BF FAU - Riddell, Robert H AU - Riddell RH FAU - Lesogor, Anastasia AU - Lesogor A FAU - Chang, William AU - Chang W FAU - Keefe, Deborah L AU - Keefe DL LA - eng GR - R01 DA024667/DA/NIDA NIH HHS/United States PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - United States TA - J Clin Hypertens (Greenwich) JT - Journal of clinical hypertension (Greenwich, Conn.) JID - 100888554 RN - 0 (Amides) RN - 0 (Antihypertensive Agents) RN - 0 (Fumarates) RN - 502FWN4Q32 (aliskiren) RN - EC 3.4.23.15 (Renin) SB - IM MH - Aged MH - Amides/*adverse effects/therapeutic use MH - Antihypertensive Agents/*adverse effects/therapeutic use MH - Female MH - Fumarates/*adverse effects/therapeutic use MH - Humans MH - Hypertension/*drug therapy MH - Incidence MH - Male MH - Middle Aged MH - Renin/*antagonists & inhibitors MH - Renin-Angiotensin System/drug effects MH - Risk PMC - PMC3057428 MID - NIHMS269627 EDAT- 2010/10/30 06:00 MHDA- 2011/06/03 06:00 PMCR- 2010/07/16 CRDT- 2010/10/30 06:00 PHST- 2010/10/30 06:00 [entrez] PHST- 2010/10/30 06:00 [pubmed] PHST- 2011/06/03 06:00 [medline] PHST- 2010/07/16 00:00 [pmc-release] AID - JCH352 [pii] AID - 10.1111/j.1751-7176.2010.00352.x [doi] PST - ppublish SO - J Clin Hypertens (Greenwich). 2010 Oct;12(10):765-75. doi: 10.1111/j.1751-7176.2010.00352.x.