Efficacy And Safety Of Triple-Combination Therapy With Olmesartan, Amlodipine, And Hydrochlorothiazide In Study Participants With Hypertension And Diabetes: A Subpopulation Analysis Of The Trinity Study (Vol 6, Pg 132, 2012)

Most patients with hypertension and diabetes require two or more antihypertensive agents to achieve the recommended blood pressure (BP) goal of <130/80 mm Hg. This prespecified subgroup analysis from the TRIple Therapy with Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide in HyperteNsIve PatienTs StudY assessed the efficacy and safety of triple-combination treatment (olmesartan medoxomil 40/amlodipine besylate 10/hydrochlorothiazide 25 mg) versus the component dual-combination treatments according to diabetes status (diabetes; non-diabetes).Participants received dual-combination treatment for 4 weeks or placebo for 2 weeks. Participants receiving placebo switched to dual-combination treatment from week 2 to week 4. At week 4, participants switched to triple-combination treatment or continued on dual-combination treatment until week 12.The prespecified changes in BP from baseline for the diabetes subgroup receiving triple-combination treatment were greater than the respective dual-combination treatments (P ≤ .0013). Also, more participants with diabetes receiving triple-combination treatment reached BP goal (<130/80 mm Hg) versus those receiving dual-combination treatments (P ≤ .0092). In a post hoc analysis, significantly greater proportions of study participants with diabetes achieved BP targets with triple-combination treatment compared with each dual-combination treatment. Most treatment-emergent adverse events were mild to moderate in severity.In participants with hypertension and diabetes, triple-combination treatment led to greater BP reductions and enabled greater proportions of participants to reach BP goal versus the dual-combination treatments. Triple-combination treatment was well tolerated in both diabetes and non-diabetes subgroups.