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- Title
Efficacy and Safety of a Fixed Combination of Irbesartan/Hydrochlorothiazide in Chinese Patients with Moderate to Severe Hypertension.
- Authors
Huang, Qi-Fang; Sheng, Chang-Sheng; Li, Yan; Ma, Gen-Shan; Dai, Qiu-Yan; Wang, Ji-Guang
- Abstract
Background and Objectives: In a multi-center, single-arm, prospective study, we investigated the efficacy and safety of the fixed irbesartan/hydrochlorothiazide combination in Chinese patients with moderate to severe hypertension. Methods: Eligible patients were aged 18-75 years, with a blood pressure of 160-199 mmHg systolic or 100-119 mmHg diastolic during a 1-week wash-out phase off antihypertensive medication. The enrolled patients started antihypertensive treatment with irbesartan/hydrochlorothiazide 150 mg/12.5 mg once daily, with the possible addition of irbesartan 150 mg once daily and up-titration to irbesartan/hydrochlorothiazide 300 mg/25 mg once daily at 4 and 8 weeks of follow-up, respectively. The primary efficacy variable was the goal blood pressure-attaining rate at 12 weeks of follow-up (<140/90 mmHg, or <130/80 mmHg in patients with diabetes mellitus). Results: In the intention-to-treat analysis ( n = 501) at 12 weeks of follow-up, the goal blood pressure-attaining rate was 57.3 %, and the mean change in blood pressure from baseline was 27.8 mmHg [95 % confidence interval (CI) 26.4-29.1 mmHg; p < 0.001] systolic and 13.5 mmHg (95 % CI 12.6-14.4 mmHg; p < 0.001) diastolic. Similar findings were observed in the per-protocol analysis ( n = 449). The prevalence of microalbuminuria and left ventricular hypertrophy significantly ( p ≤ 0.01) decreased from 33.4 % (150/449) and 50.4 % (215/427) at baseline to 23.4 % (105/447) and 41.3 % (176/427) at the end of follow-up, respectively. Four patients (2.0 %) reported a serious adverse event. Conclusion: The fixed irbesartan/hydrochlorothiazide combination may control blood pressure to the target level in about 60 % of Chinese patients with moderate to severe hypertension, with an acceptable safety profile.
- Subjects
IRBESARTAN; HYDROCHLOROTHIAZIDE; HYPERTENSION; THERAPEUTICS; HEALTH of Chinese people; BLOOD pressure measurement
- Publication
Drugs in R&D, 2013, Vol 13, Issue 2, p109
- ISSN
1174-5886
- Publication type
Article
- DOI
10.1007/s40268-013-0013-9