EFFICACY AND SAFETY OF COMBINATION OLMESARTAN MEDOXOMIL (OM)+AMLODIPINE BESYLATE (AML)+HYDROCHLOROTHIAZIDE (HCTZ) BASED ON RACE: THE TRINITY STUDY: PP.5.172:

The efficacy and safety of OM+AML+HCTZ was evaluated in 2492 patients with moderate-severe HTN in a phase 3, multicenter, parallel-group study consisting of a 12-wk double-blind treatment period followed by a 40-wk open-label treatment period. Patients were stratified by age, race, and diabetic status. This prespecified subgroup analysis examined the efficacy and safety in black (B) and non-black (NB) patients following co-administration of OM 40 mg+AML 10 mg+HCTZ 25 mg compared with the corresponding dual combinations: OM/AML, OM/HCTZ, and AML+HCTZ. Patients received dual-combination therapy for 2 wks; a subset of treatment-naive patients received placebo (n=36) prior to switching to dual-combination therapy, which continued for all patients from wks 2-4. OM+AML+HCTZ was initiated in a subset of patients from each dual-combination group at wk 4 and continued until wk 12. The primary endpoint was change from baseline to wk 12 in SeDBP for OM+AML+HCTZ vs the corresponding dual combinations. Secondary efficacy endpoints included change in SeSBP with OM+AML+HCTZ vs the corresponding dual combinations and % of patients achieving BP goal (<140/90 and <130/80 mmHg for patients with diabetes or chronic renal or CV disease) at wk 12. Statistically significant reductions in SeDBP and SeSBP from baseline (P < 0.0001 for both) were observed in both race subgroups for all 4 treatment groups. OM+AML+HCTZ resulted in significantly greater LS mean reductions in SeDBP (P<=0.0001 for B and NB groups) and SeSBP (P < 0.0001 for B and NB groups) vs the dual-combination therapies. OM+AML+HCTZ resulted in a significantly greater % of patients reaching BP goal (P<=0.0009 for B and NB groups) at wk 12. The incidence of treatment-emergent AEs was comparable between groups; most AEs were mild or moderate. OM+AML+HCTZ compared with the dual-combination therapies resulted in greater reductions in BP and enabled more patients to reach BP goal, regardless of race.