Efficacy of fimasartan/hydrochlorothiazide combination in hypertensive patients inadequately controlled by fimasartan monotherapy

Moo Yong Rhee, Sang Hong Baek, Weon Kim, Chang Gyu Park, Seung Woo Park, Byung Hee Oh, Sang Hyun Kim, Jae Joong Kim, Joon Han Shin, Byung Su Yoo, Se Joong Rim, Jong Won Ha, Joon Hyung Doh, Youngkeun Ahn, Jei Keon Chae, Jeong Bae Park, Soon Kil Kim, Cheol Ho Kim

Research output: Contribution to journalArticlepeer-review

9 Citations (Scopus)

Abstract

Background: The study reported here compared the blood pressure (BP)-lowering efficacy of fimasartan alone with that of fimasartan/hydrochlorothiazide (HCTZ) combination in patients whose BP goal was not achieved after 4 weeks of treatment with once-daily fimasartan 60 mg. Methods: Patients with sitting diastolic blood pressure (siDBP) ≥90 mmHg with 4 weeks of once-daily fimasartan 60 mg were randomly assigned to receive either once-daily fimasartan 60 mg/HCTZ 12.5 mg or fimasartan 60 mg for 4 weeks. After 4 weeks, the dose was increased from fimasartan 60 mg/HCTZ 12.5 mg to fimasartan 120 mg/HCTZ 12.5 mg or from fimasartan 60 mg to fimasartan 120 mg if siDBP was ≥90 mmHg. Results: Of the 263 randomized patients, 256 patients who had available efficacy data were analyzed. The fimasartan/HCTZ treatment group showed a greater reduction of siDBP compared to the fimasartan treatment group at Week 4 (6.88±8.10 mmHg vs 3.38±7.33, P=0.0008), and the effect persisted at Week 8 (8.67±9.39 mmHg vs 5.02±8.27 mmHg, P=0.0023). Reduction of sitting systolic BP in the fimasartan/HCTZ treatment group was also greater than that in the fimasartan treatment group (at Week 4, 10.50±13.76 mmHg vs 5.75±12.18 mmHg, P=0.0069 and, at Week 8, 13.45±15.15 mmHg vs 6.84±13.57 mmHg, P=0.0007). The proportion of patients who achieved a reduction of siDBP ≥10 mmHg from baseline and/or a mean siDBP <90 mmHg after 4 weeks of treatment was higher in the fimasartan/HCTZ treatment group than in the fimasartan treatment group (53.6% vs 39.8%, P=0.0359). The overall incidence of adverse drug reaction was 11.79% with no significant difference between the treatment groups. Conclusion: The combination treatment of fimasartan and HCTZ achieved better BP control than fimasartan monotherapy, and had comparable safety and tolerance to fimasartan monotherapy.

Original languageEnglish
Pages (from-to)2847-2854
Number of pages8
JournalDrug Design, Development and Therapy
Volume9
DOIs
Publication statusPublished - 2015 Jun 2
Externally publishedYes

Bibliographical note

Publisher Copyright:
© 2015 Rhee et al.

Keywords

  • Angiotensin II type 1 receptor
  • Angiotensin-converting enzyme inhibitor
  • Angiotensin-receptor blocker
  • Antihypertensive
  • Blood pressure
  • Renin–angiotensin–aldosterone system inhibitor

ASJC Scopus subject areas

  • Pharmacology
  • Pharmaceutical Science
  • Drug Discovery

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