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


CONCLUSIONS
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.
a Department of Cardiology , Fukuoka University School of Medicine , Fukuoka , Japan .|c Department of Molecular Cardiovascular Therapeutics , Fukuoka University School of Medicine , Fukuoka , Japan .
Kota
K
Motozato
a Department of Cardiology , Fukuoka University School of Medicine , Fukuoka , Japan .|b Izumi General Medical Center , Kagoshima , Japan .
Shin-Ichiro
S
Miura
a Department of Cardiology , Fukuoka University School of Medicine , Fukuoka , Japan .|d Inoue Hospital , Fukuoka , Japan , and.|e Fujisawa Clinic , Fukuoka , Japan.
Yuhei
Y
Shiga
c Department of Molecular Cardiovascular Therapeutics , Fukuoka University School of Medicine , Fukuoka , Japan .
Takaaki
T
Kusumoto
a Department of Cardiology , Fukuoka University School of Medicine , Fukuoka , Japan .
Sen
S
Adachi
d Inoue Hospital , Fukuoka , Japan , and.
Takeshi
T
Inoue
e Fujisawa Clinic , Fukuoka , Japan.
Kazuaki
K
Fujisawa
a Department of Cardiology , Fukuoka University School of Medicine , Fukuoka , Japan .|b Izumi General Medical Center , Kagoshima , Japan .
Keijiro
K
Saku
D000368:Aged; D017311:Amlodipine / Q000008:administration & dosage / Q000009:adverse effects; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000009:adverse effects; D001713:Biphenyl Compounds / Q000008:administration & dosage / Q000009:adverse effects; D001794:Blood Pressure / Q000187:drug effects*; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D016903:Drug Monitoring; D005260:Female; D006801:Humans; D006973:Hypertension / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D000077405:Irbesartan; D008297:Male; D008875:Middle Aged; D013777:Tetrazoles / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood; D014527:Uric Acid / Q000097:blood; D000068756:Valsartan / Q000008:administration & dosage / Q000009:adverse effects
D000959:Antihypertensive Agents; D001713:Biphenyl Compounds; D004338:Drug Combinations; D013777:Tetrazoles; D014280:Triglycerides; D017311:Amlodipine; D014527:Uric Acid; D000068756:Valsartan; D000077405:Irbesartan
Amlodipine; angiotensin II type 1 receptor blocker; blood pressure; irbesartan; triglycerides; uric acid