Amlodipine 5 mg/Losartan 50 mg Fixed-Dose Combination VS Amlodipine 10 mg Monotherapy in Hypertensive Patients Responding Poorly to Amlodipine 5 mg Monotherapy: An 8-Week, Multicenter, Randomized, Double-Blind Phase III Noninferiority Study

Posted by: admin on: January 30, 2012

Here is a study proving that Fixed dose combination of Amlodipine/Losartan is not inferior to Amlodepine monotherapy in Hypertensive patients with poor response in monotherapy.


BACKGROUND:  The number of hypertensive patients achieving treatment targets is not ideal with therapies that engage a single mechanism of action, and combination therapies using different mechanisms of action can increase drug efficacy in a synergistic way.

OBJECTIVE:  This noninferiority study compared the clinical efficacy and safety profile of fixed-dose combination of amlodipine/losartan 5/50 mg and amlodipine 10 mg monotherapy in essential hypertensive patients who respond poorly to amlodipine 5 mg monotherapy.

METHODS:, randomized trial of hypertensive patients (N = 185) aged ≥18 years taking amlodipine 5 mg during the run-in treatment period but failed to achieve sitting diastolic blood pressure (DBP)<90 mm Hg. After randomization into the amlodipine/losartan 5/50 mg fixed-dose combination group and the amlodipine 10 mg monotherapy group, treatment was maintained without dose escalation for 8 weeks.. The primary efficacy evaluation was tested using a confidence interval approach using the average difference in DBP measured at baseline and 8 weeks.

RESULTS: After 8 weeks, the DBP of both groups decreased from baseline by 8.9 and 9.4 mm Hg, respectively.  Secondary end points of reductions in DBP after 4 weeks (-and sitting systolic blood pressure after 4 and 8 weeks  were comparable between the 2 treatment groups. There were 38 adverse events in 20 patients (21.7%) in the amlodipine/losartan 5/50 mg fixed-dose combination group and 31 in 24 patients (26.1%) in the amlodipine 10 mg monotherapy group; most were mild. There were 7 adverse events in 6 patients (6.5%) related to treatment in the fixed-dose combination group and 13 in 10 patients (10.9%) in the monotherapy group (P = 0.30).

CONCLUSIONS: Fixed-dose combination amlodipine/losartan 5/50 mg was not inferior in terms of reductions in DBP after 8 weeks of treatment and had comparable safety profile to amlodipine 10 mg in patients who did not respond to amlodipine 5 mg monotherapy.


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