Ambulatory Blood Pressure Response to Once-Daily Fimasartan: An 8-Week,Multicenter, Randomized,Double-Blind,Active-Comparator,Parallel-Group Study in Korean Patients With Mild To Moderate Essential Hypertension |
| |
| Authors: | Howard Lee Kee Sik Kim Shung Chull Chae Myung Ho Jeong Dong-Soo Kim Byung-Hee Oh |
| |
| Affiliation: | 1 Center for Drug Development Science, Department of Bioengineering and Therapeutic Sciences, School of Pharmacy, University of California San Francisco, San Francisco, California, and University of California Washington Center, Washington, DC;2 Division of Cardiology, Department of Internal Medicine, Daegu Catholic University Medical Center, Daegu, Korea;3 Division of Cardiology, Department of Internal Medicine, Kyungpook National University Hospital, Daegu, Korea;4 The Heart Center of Chonnam National University Hospital, Gwangju, Korea;5 Division of Cardiology, Department of Internal Medicine, Inje University, Paik Hospital, Busan, Korea;6 Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea |
| |
| Abstract: | BackgroundFimasartan, a selective angiotensin II type 1 receptor blocker, was approved in Korea for the treatment of patients with mild to moderate hypertension.ObjectiveThe aim of this study was to evaluate the 24-hour blood pressure (BP) profiles before and after 8-week treatment with fimasartan and to compare them with those of valsartan.MethodsA multicenter, randomized, double-blind, active-controlled, parallel-group study was conducted using ambulatory BP monitoring (ABPM). Korean patients with mild to moderate essential hypertension were enrolled and randomly received once-daily oral fimasartan 60 or 120 mg or valsartan 80 mg for 8 weeks. ABPM was performed before and after 8-week treatment, and clinic BP was also measured. Based on ABPM data, trough-to-peak ratio and smoothness index were derived. Tolerability was monitored throughout the study.ResultsNinety-two patients were enrolled (mean [SD] age, 54.1 [8.2] years; weight, 67.9 [10.2] kg). After 8 weeks, 24-hour, daytime, and nighttime mean ambulatory systolic and diastolic BPs (SBP and DBP, respectively) were significantly decreased in all 3 treatment groups (range: SBP, –9.2 to –15.6 mm Hg; DBP, –5.0 to –10.7 mm Hg; P <0.0001–<0.05). The global trough-to-peak ratios of ambulatory DBP in the fimasartan groups were 0.74 (60 mg/d) and 0.81 (120 mg/d)—45.1% and 58.8% higher, respectively, than the ratio of 0.51 in the valsartan group. Fimasartan 60 mg/d was associated with 53.5% (SBP) and 68.3% (DBP) greater smoothness index scores compared with those with valsartan 80 mg/d (SBP, 1.52 vs. 0.99; DBP, 1.38 vs. 0.82). The decrease in clinic-measured DBP was significantly greater in the fimasartan 60-mg/d group compared with that in the valsartan 80-mg/d group (–14.0 vs –8.7 mm Hg; P = 0.0380). Fimasartan was well tolerated; headache was the most common adverse event.ConclusionOnce-daily fimasartan effectively maintained a BP-reduction profile over the full 24-hour dosing interval; this profile was comparable to or slightly better than that of once-daily valsartan. Fimasartan was well tolerated; headache was the most common adverse event. ClinicalTrials.gov identifier: NCT00922441. |
| |
| Keywords: | 24-hour ambulatory blood pressure monitoring angiotensin receptor blocker essential hypertension fimasartan valsartan |
| 本文献已被 ScienceDirect 等数据库收录！ |
|
