Management of Hypertension in the General Practice Clinic: Post-Marketing Surveillance with a fixed Combination of Perindopril and Indapamide

Abstract

Background and objectives: A fixed-dose combination of perindopril and indapamide (FCPI) is currently used as antihypertensive agent. We studied the short-term efficacy and safety of FCPI in Thai hypertensive patients.

Methods: The study was a post-marketing surveillance and safety monitoring in a prospective, observational, multicenter trial in ambulatory hypertensive patients recruited in daily hypertension and diabetes clinics in 18 hospitals in Thailand. The study assessed the efficacy and tolerability of FCPI (4/1.25 mg) given once daily for 3 months during October 2008 to May 2009.

Results: Of the 476 hypertensive patients, 39.3 % had stage 1 hypertension with mean baseline BP of 145.7/86.1 mmHg and 51.5 % had stage 2 hypertension with mean baseline BP of 167.5/98.7 mmHg and 9.2 % were prehypertensive. In stage 1 hypertension, BP control was achieved in 86.6% of patients by month 3, and BP reduction was significant at month 1 (12.1/5.7 mmHg [p<0.001]) and at month 3 (15.8/7.7 mmHg [p<0.001]), respectively, compared with baseline. In stage 2 hypertension, BP control was achieved in 88.5% patients by month 3 (132.9/78.8 mmHg), and BP reduction was significant at month 1 (25.6/14.1 mmHg [p<0.001]) and at month 3 (34.6/19.9 mmHg [p<0.001]), respectively, compared with baseline. Overall, blood pressure was below 140/90 mmHg in 74% of patients at month 1. Adverse drug reactions reported in about 0.2 % of patients were dry cough, dizziness and hypokalemia.

Conclusion: The fixed-dose combination of perindopril and indapamide (4/1.25 mg) was effective and well tolerated in daily clinical use for BP control in Thai hypertensive patients.

Keywords: Fixed-dose combination of perindopril and indapamide (FCPI); antihypertensive; hypertension; stage 1 hypertension; stage 2 hypertension; type 2 diabetes