Safety and tolerability of ramipril 10 mg in patients at high risk of cardiovascular events: an observational study.
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2008-05-26
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OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
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Hathial M. Safety and tolerability of ramipril 10 mg in patients at high risk of cardiovascular events: an observational study. Indian Heart Journal. 2008 May-Jun; 60(3): 200-4