Efficacy and safety of two single-pill fixed-dose combinations of angiotensin II receptor blockers/calcium channel blockers in hypertensive patients (EXAMINER study)

Abstract

Background: There is some controversy regarding which single-pill fixed-dose combinations of angiotensin II type 1 receptor blockers (ARBs) and calcium channel blockers (CCBs) are effective at reducing blood pressure (BP). Methods: Sixty hypertensive patients who received a single-pill fixed-dose combination of valsartan 80 mg/day and amlodipine 5 mg/day were enrolled (UMIN Registration 000013460). They were randomly divided into two treatment groups [single-pill fixed-dose combination therapy with valsartan 80 mg/day and amlodipine 5 mg/day (Val/Am group), or irbesartan 100 mg/day and amlodipine 5 mg/day (Irb/Am group)] and treated for 16 weeks. If the patient did not reach the target office BP at 8 weeks, they received double doses of amlodipine (10 mg/day). Results: In the Irb/Am group, systolic BP (SBP) and diastolic BP (DBP) were significantly decreased at 16 weeks. There were no significant changes in SBP or DBP in the Val/Am group. In the Irb/Am group, serum uric acid (UA) was significantly decreased at 8 weeks and patients who had hyperuricemia showed significantly decreased serum UA at 16 weeks. In addition, the levels of triglycerides (TG) were significantly decreased at 16 weeks in the Irb/Am group. Conclusion: A single-pill fixed-dose combination therapy with irbesartan 100 mg/day and amlodipine 5 mg/day was superior to the combination of valsartan 80 mg/day and amlodipine 5 mg/day with respect to significant decreases in BP, serum UA and TG in patients with hypertension.

• Amlodipine
• angiotensin II type 1 receptor blocker
• blood pressure
• irbesartan
• triglycerides
• uric acid

Declaration of interest

K.S. and S.M. have received grants and lecture honoraria from Sumitomo Dainippon Pharma Co. LTD. K.S. is a Chief Director and S.M. is a Director of NPO Clinical and Applied Science, Fukuoka, Japan. K.S. has an Endowed “Department of Molecular Cardiovascular Therapeutics” supported by MSD, Co. LTD. S.M. belongs to the Department of Molecular Cardiovascular Therapeutics, which is supported by MSD, Co. LTD.

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.