Efficacy and safety of a single-pill combination of amlodipine/valsartan in Asian hypertensive patients inadequately controlled with amlodipine monotherapy.
OBJECTIVE
The antihypertensive efficacy of amlodipine/valsartan combination has not been evaluated in Asian patients as previous large-scale studies enrolled very few patients. This multicentre, randomised, double-blind study assessed the efficacy and safety of a single-pill combination of amlodipine/valsartan versus amlodipine in Asian hypertensive patients.


METHODS
After a 1-4-week washout period, patients (mean sitting diastolic BP [msDBP]: >or=95-<110 mmHg) were treated with amlodipine 5 mg for 4 weeks. Patients inadequately controlled on amlodipine (msDBP >or=90 and <110 mmHg) were randomised to receive amlodipine/valsartan 5/80 mg (n = 349) or amlodipine 5 mg (n = 349) for 8 weeks. Efficacy variables were change in msDBP, mean sitting systolic BP (msSBP) from baseline (at randomisation) to week 8 endpoint, and BP control rate (<140/90 mmHg) at week 8 endpoint. Safety assessments included monitoring and recording of adverse events (AEs).


RESULTS
Baseline characteristics were comparable between the groups. Most patients were Chinese (86.4%), men (65.1%), with a baseline BP 139.5/94.5 mmHg. At week 8 endpoint, the least square mean reduction in BP was significantly greater with amlodipine/valsartan combination than amlodipine monotherapy (-11.4/-9.7 vs. -7.4/-7.1 mmHg; p < 0.0001) with a higher BP control rate (69.2 vs. 57.6%; p = 0.0013). Ambulatory BP monitoring in a subgroup of patients (n = 82), showed a significant 24-h mean BP reduction from baseline with amlodipine/valsartan (-7.3/-6.3 mmHg; p < 0.0001), whereas the reduction was not significant with amlodipine (-0.2/+0.3 mmHg; p > 0.05). The overall incidence of AEs was similar in both groups. Peripheral oedema occurred only in the amlodipine group n = 4 (1.1%) and not in the amlodipine/valsartan combination. Hypotension was reported in only one patient in the amlodipine/valsartan combination. Six patients (0.9%) experienced serious AEs, of which only one SAE, i.e. gastric ulcer, was reported to be related to amlodipine treatment.


CONCLUSIONS
The single-pill combination of amlodipine/valsartan was efficacious and well-tolerated in Asian hypertensive patients who were inadequately controlled on amlodipine alone. As with all clinical trials, the entry criteria may limit the extrapolation of these results to a broader population. ClinicalTrials.gov Identifier: NCT00413049.
Ke
YuanNan
Y
China-Japan Friendship Hospital, Beijing, China.
Zhu
DingLiang
D
Hong
HuaShan
H
Zhu
JunRen
J
Wang
RuoNan
R
Cardenas
Pamela
P
Zhang
Ying
Y
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000465:Algorithms; D017311:Amlodipine / Q000008:administration & dosage* / Q000009:adverse effects; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000009:adverse effects; D044466:Asian People; D004311:Double-Blind Method; D004338:Drug Combinations; D004351:Drug Resistance / Q000187:drug effects; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D013607:Tablets; D013777:Tetrazoles / Q000008:administration & dosage*; D016896:Treatment Outcome; D014633:Valine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000068756:Valsartan; D055815:Young Adult
D000959:Antihypertensive Agents; D004338:Drug Combinations; D013607:Tablets; D013777:Tetrazoles; D017311:Amlodipine; D000068756:Valsartan; D014633:Valine