Currently under FDA review, CS-8635 combines three powerful blood pressure treatments with different mechanisms of action, Benicar (olmesartan medoxomil), amlodipine and hydrochlorothiazide. Results of a new study found that the investigational triple combination therapy of olmesartan medoxomil (OM), amlodipine besylate (AML), and hydrochlorothiazide (HCTZ) demonstrated significantly greater mean reductions at week 12 in blood pressure (37.1/21.8 mm Hg versus 27.5 to 30.0/15.1-18.0 mm Hg LS Mean Reductions, P< 0.0001), as compared to corresponding dual combination therapy (dual components).
The study, presented at the American Society of Hypertension (ASH) annual meeting in New York, also found that at week 12, a significantly greater percentage of patients treated with the investigational triple combination therapy (OM/AML/HCTZ 40/10/25 mg) reached blood pressure goal (<140/90 mm Hg or <130/80 mm Hg for patients with diabetes, chronic renal disease, or chronic cardiovascular disease), as compared to corresponding dual components (64.3 percent versus 34.9 to 46.6 percent; P<0.0001, all comparisons). The triple therapy was well tolerated with most reported adverse events defined as mild or moderate.
“Many patients with hypertension fail to reach recommended blood pressure targets even when taking more than one therapy,” said Suzanne Oparil, MD, Professor of Medicine and Physiology and Biophysics at the University of Alabama School of Medicine. “This study demonstrated that treating patients with a triple combination therapy regimen, each component which has a different mechanism of action, is more effective at lowering blood pressure than the dual combination of any two individual components and was well tolerated among the patients studied.”
The TRINITY study, (Triple Therapy with Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide in Hypertensive Patients Study) is a Phase 3, multicenter, randomized, parallel-group study, which included 2,492 patients with moderate to severe hypertension. The study consisted of a double-blind 12 week treatment period, followed by a 40 week open-label period.1 The 12 week results have been disclosed today. The study found that blood pressure-lowering and percentage of patients reaching the current recommended blood pressure target was greater with the triple combination therapy versus corresponding dual combination therapy regardless of gender, age, race, and hypertension severity (P<0.0001). Ambulatory blood pressure was measured in a subset of 380 patients at baseline and week 12. Twenty-four hour ambulatory blood pressure monitoring revealed greater effects with the triple combination therapy versus corresponding dual combination therapy (P<0.0001). After 12 weeks of treatment, the group receiving triple combination (OM/AML/HCTZ 40/10/25 mg, n=100) achieved a mean 24-hour ambulatory blood pressure of 117/69 mm Hg (baseline 24-hour blood pressure, 147/87 mm Hg) compared to those patients taking dual combination therapy for which ambulatory blood pressure ranged from 126/74 mm Hg to 128/77 mm Hg (baseline 24-hour blood pressure 147-149/89 mm Hg), P<0.0001, all comparisons.
Date: May 4, 2010
Source: Daiichi Sankyo
Filed Under: Drug Discovery