Hathial Manish
Aventis House, 54/A, Sir M V Road, Andheri (E), Mumbai.
Indian Heart J. 2008 May-Jun;60(3):200-4.
To assess the safety and tolerability of ramipril 10 mg in patients at high risk of cardiovascular (CV) events by observing the levels of blood pressure (BP) and by recording the incidence of cough in these patients.
Eligible patients in this prospective, observational, longitudinal, multicentre registry included all normotensives-including treated hypertensives-with BP <140/90 mm Hg, a history of coronary artery disease and a history of cerebrovascular disease, peripheral arterial disease or diabetes (with microalbuminuria), or dyslipidaemia, in whom ramipril was indicated for CV risk reduction and had been prescribed by the treating physician. The primary outcome was the effect on BP at 8 weeks, and the secondary outcome was the incidence of cough at 8 weeks. Ramipril was initiated at 2.5 mg once daily (o.d.) for a week, followed by 5 mg o.d. for 3 weeks and was then increased to 10 mg o.d. Data were analyzed using ANOVA and Chi square test.
A total of 1,048 patients participated in this registry; 868 (82.87 percent;) continued with the treatment till the end of the registry (i.e., 8 weeks). At baseline, systolic BP was 130.1 +/- 5.38 mm Hg, while diastolic BP was 81.07 +/- 4.36 mm Hg. At 8 weeks, these values changed non-significantly to 123.41 +/- 6.33 mm Hg and 79.03 +/- 4.84 mm Hg, respectively. At week 1, 7.1% of patients had cough, which increased non-significantly to 10% by week 8. Only 6 patients complained of severe cough at week 8, which did not lead to treatment discontinuation. Tolerability of the treatment was assessed to be "excellent" or "good" by 63.3% patients and 67% physicians.
Treatment with ramipril 10 mg daily in patients with high risk of CV events and normal/controlled BP produced neither a significant fall in BP nor significant adverse events in real-world clinical practice and was well tolerated.
通过观察血压水平并记录心血管（CV）事件高危患者的咳嗽发生率，评估10毫克雷米普利在这些患者中的安全性和耐受性。
该前瞻性、观察性、纵向、多中心登记研究中的合格患者包括所有血压正常者（包括接受治疗的高血压患者），血压<140/90毫米汞柱，有冠状动脉疾病史、脑血管疾病史、外周动脉疾病或糖尿病（伴有微量白蛋白尿）或血脂异常，雷米普利被用于降低CV风险且由治疗医生开具处方。主要结局是8周时对血压产生了何种影响，次要结局是8周时咳嗽的发生率。雷米普利起始剂量为每日2.5毫克，服用一周，随后每日5毫克，服用3周，然后增至每日10毫克。数据采用方差分析和卡方检验进行分析。
共有1048名患者参与了该登记研究；868名（82.87%）患者持续接受治疗直至登记研究结束（即8周）。基线时，收缩压为130.1±5.38毫米汞柱，舒张压为81.07±4.36毫米汞柱。8周时，这些值分别无显著变化，变为123.41±6.33毫米汞柱和79.03±4.84毫米汞柱。第1周时，7.1%的患者出现咳嗽，到第8周时无显著增加，升至10%。第8周时只有6名患者主诉严重咳嗽，但未导致治疗中断。63.3%的患者和67%的医生将治疗耐受性评估为“极佳”或“良好”。
在CV事件高危且血压正常/得到控制的患者中，每日服用10毫克雷米普利在实际临床实践中既未导致血压显著下降，也未引发显著不良事件，且耐受性良好。
