Daiichi Sankyo has presented the study at the American Society of Hypertension (ASH) annual meeting in New York, also found that at week 12, a greater percentage of patients treated with the investigational triple combination therapy (OM/AML/HCTZ 40/10/25mg) reached blood pressure goal ( < 140/90mmHg or < 130/80mmHg for patients with diabetes, chronic renal disease, or chronic cardiovascular disease), as compared to corresponding dual components (64.3% versus 34.9 to 46.6%; P < 0.0001, all comparisons). The triple therapy was well tolerated with most reported adverse events defined as mild or moderate.
The Trinity study, (Triple Therapy with Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide in Hypertensive Patients Study) is a Phase 3, multicenter, randomised, 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. 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.
In the trial, 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.
After 12 weeks of treatment, the group receiving triple combination (OM/AML/HCTZ 40/10/25mg, n=100) achieved a mean 24-hour ambulatory blood pressure of 117/69mmHg (baseline 24-hour blood pressure, 147/87mmHg) compared to those patients taking dual combination therapy for which ambulatory blood pressure ranged from 126/74mmHg to 128/77mmHg (baseline 24-hour blood pressure 147-149/89mmHg), P < 0.0001, all comparisons.
Suzanne Oparil, professor of medicine and physiology and biophysics for the school of medicine at the University of Alabama, said: “Many patients with hypertension fail to reach recommended blood pressure targets even when taking more than one therapy.
“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.”