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.

• Authors: Kota Motozato, Shin-Ichiro Miura, Yuhei Shiga, Takaaki Kusumoto, Sen Adachi, Takeshi Inoue, Kazuaki Fujisawa, Keijiro Saku
• Journal: Clinical and experimental hypertension (New York, N.Y. : 1993) (Clin Exp Hypertens) Vol. 38 Issue 1 Pg. 45-50 ( 2016) ISSN: 1525-6006 [Electronic] England
• PMID: 26268636 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Antihypertensive Agents
• Biphenyl Compounds
• Drug Combinations
• Tetrazoles
• Triglycerides
• Amlodipine
• Uric Acid
• Valsartan
• Irbesartan

Topics

• Aged
• Amlodipine (administration & dosage, adverse effects)
• Antihypertensive Agents (administration & dosage, adverse effects)
• Biphenyl Compounds (administration & dosage, adverse effects)
• Blood Pressure (drug effects)
• Dose-Response Relationship, Drug
• Drug Combinations
• Drug Monitoring
• Female
• Humans
• Hypertension (blood, diagnosis, drug therapy, physiopathology)
• Irbesartan
• Male
• Middle Aged
• Tetrazoles (administration & dosage, adverse effects)
• Treatment Outcome
• Triglycerides (blood)
• Uric Acid (blood)
• Valsartan (administration & dosage, adverse effects)