INITIAL COMBINED VALSARTAN/HCTZ THERAPY VS EITHER COMPONENT AS MONOTHERAPY IN ELDERLY INDIVIDUALS WITH SYSTOLIC HYPERTENSION: AGE-STRATIFIED ANALYSIS OF THE VALVET STUDY: PP.27.87

Abstract

Objective: The presence of isolated systolic hypertension and the perception of increased adverse events (AEs) are major barriers to effective blood pressure (BP) control in the elderly. Age-stratified analyses are reported from the VALVET study. Methods: The 16-week study compared efficacy and tolerability of initial combination therapy with valsartan/hydrochlorothiazide (V/HCTZ) vs HCTZ or V monotherapy. Subjects >=70 years old with systolic (S) BP between 150 and =<200 mmHg were randomized to V/HCTZ 160/12.5 mg (n = 128); HCTZ 12.5 mg (n = 128); or V 160 mg (n = 128). At Week 4, subjects not achieving BP goal <140/90 mmHg in any of the 3 arms could receive optional titration up to a maximum of V/HCTZ 320/25 mg for an additional 12 weeks. Results: The mean baseline SBP ± standard deviation (SD) were 164.5 ± 11.9, 164.5 ± 11.8, and 166.2 ± 11.1 mmHg for the V/HCTZ, HCTZ, and V groups, respectively. At Week 4, mean reductions in SBP ± SD were greatest with V/HCTZ (17.3 ± 17.6 mmHg) compared to HCTZ (13.6 ± 16.8 mmHg; p=ns) or V (8.6 ± 19.5 mmHg; p < 0.0001); with differences less pronounced at Week 16 (V/HCTZ[20.9 ± 18.5 mmHg] vs HCTZ[19.7 ± 19.7 mmHg; p=ns] and V[-17.5 ± 19.6 mmHg; p=ns]). Similar BP patterns persisted for each age stratum (70–75 y [n = 126]; 76–80 y [n = 181]; >80 y [n = 77]); however, within these strata, baseline BP influenced treatment responses. Overall BP control rates at Week 4 were 41.7%, 29.3%, and 14.4% and at Week 16 were 52.0%, 49.5%, and 36.6% for subjects in the V/HCTZ, HCTZ, and V groups, respectively, with similar patterns persisting for each age stratum. Dizziness, fatigue, and headache occurred relatively frequently in all 3 treatment groups but serious AEs were rare; 96 subjects (25.0%) discontinued the study prematurely (3/4 of the total discontinuations occurred within first 4 weeks). Age group did not predict discontinuation rates (70–75 y:23.8%, 76–80 y:28.7%, and >80 y:18.2%, respectively). Conclusion: Initial therapy with combination V/HCTZ was more effective and equally well tolerated vs monotherapy in hypertensive individuals > = 70 years of age.