CHIEVING TARGET BP WITH THE ADDITION OF HCTZ TO AMLODIPINE/VALSARTAN IN HYPERTENSIVE PATIENTS: PP.5.212

Abstract

Objective: To evaluate the efficacy of triple combination therapy with Amlodipine/valsartan/hydrochlorothiazide (A/V/H) in the subgroup of patients who did not achieve BP control with dual A/V therapy in the EX-FAST trial. Methods: This 16-week, randomized, double-blind trial assessed the efficacy of A/V in patients with previously uncontrolled hypertension on monotherapy, i.e. >=140/90 mmHg for non-diabetics or >=130/80 mmHg for diabetics. At baseline, eligible patients discontinued their previous monotherapy and without a washout period, immediately switched to A/V 5/160 mg or A/V 10/160 mg once daily in a 1:1 randomization. At week 8, patients uncontrolled with A/V received additional open label H 12.5 mg and further up-titration to H 25 mg at week 12 if BP control was still not achieved. Patients who did not receive H at week 8 could still receive it for the final 4 weeks of the study if BP was not at goal at week 12. Results: Of 894 patients randomized (mean baseline [BL] BP while on previous monotherapy: 150.1/90.7 mmHg), 443 received A/V 5/160 and 451 received A/V 10/160. More patients on A/V 5/160 (n=110, 24.8%) required addition of H than patients on A/V 10/160 (n=86, 19.1%), and of these patients, a higher percent on A/V 5/160 required maximum uptitration to H 25 mg (n=51, 46.4% vs n=29, 33.7% respectively) (Table). At endpoint (week 16 with last observation carried forward), mean BP reductions from baseline with A/V/H 5/160/12.5–25 mg were 17.9/11.1 mmHg vs 20.6/12.5 mmHg with A/V/H 10/160/12.5–25 mg. Incremental reductions were seen with the addition of H resulting in mean BP <140/90 mmHg at endpoint in all treatment groups (table). Adverse events regardless of study drug relationship were reported by 30.1% patients receiving A/V/H with only 2% discontinuing due to adverse events. Conclusion: Triple combination therapy with A/V/H provided incremental reductions in BP levels in patients not achieving target BP on dual A/V therapy and was well tolerated.