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替米沙坦与血管紧张素转换酶抑制剂相比的不良事件发生率:来自临床试验汇总分析的证据。

Incidence of adverse events with telmisartan compared with ACE inhibitors: evidence from a pooled analysis of clinical trials.

作者信息

Mancia Giuseppe, Schumacher Helmut

机构信息

Universita degli Studi Milano-Bicocca, Ospedale San Gerardo di Monza, Milan, Italy.

出版信息

Patient Prefer Adherence. 2012;6:1-9. doi: 10.2147/PPA.S27939. Epub 2011 Dec 23.

DOI:10.2147/PPA.S27939
PMID:22272064
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3262485/
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.

摘要

基于在“替米沙坦单药治疗及与雷米普利联合治疗全球终点试验(ONTARGET®)”中与血管紧张素转换酶(ACE)抑制剂雷米普利具有相当的疗效,替米沙坦被用于预防高危患者的心血管事件。然而,选择治疗方案时必须考虑耐受性。本分析使用了12项比较性随机研究汇总的数据,比较替米沙坦和ACE抑制剂的耐受性,这些研究涉及2564例接受替米沙坦治疗的患者和2144例接受ACE抑制剂(依那普利、赖诺普利或雷米普利)治疗的患者。ACE抑制剂联合治疗组和替米沙坦组的不良事件发生率相似(分别为42.8%和43.9%),严重不良事件发生率也相似(替米沙坦分别为1.8%和1.7%)。接受ACE抑制剂治疗的患者咳嗽更多(8.6%,而替米沙坦组为2.6%,P<0.0001)。无论年龄、性别或种族,结果均相似。在接受ACE抑制剂治疗的4例患者(0.2%)中观察到血管性水肿不良事件,而替米沙坦组未观察到(P=0.043)。严重不良事件存在微小的数值差异。共有107例(5.0%)接受ACE抑制剂治疗的患者和93例(3.6%)接受替米沙坦治疗的患者因不良事件停药(P=0.021);其中,分别有32.7%和5.4%因咳嗽停药(替米沙坦相对风险降低88%[P<0.0001])。替米沙坦和ACE抑制剂在上市剂量下产生的血压降低效果相当。替米沙坦和ACE抑制剂均适用于预防高危患者的心血管事件,但替米沙坦耐受性更好,尤其是在咳嗽方面。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/09be/3262485/d90e6a55cffd/ppa-6-001f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/09be/3262485/aeda7ee65dfb/ppa-6-001f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/09be/3262485/d90e6a55cffd/ppa-6-001f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/09be/3262485/aeda7ee65dfb/ppa-6-001f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/09be/3262485/d90e6a55cffd/ppa-6-001f2.jpg

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