Triple antihypertensive combination therapy may be better than dual therapy in diabetic patients with hypertension

Investigational triple antihypertensive combination therapy lowers blood pressure more effectively than dual therapy in diabetic patients with hypertension, according to the results of a subgroup analysis of the TRINITY study.

The data were presented at the American Diabetes Association (ADA) 70th Annual Scientific Sessions in Orlando, in June, during the TRINITY study report on the effectiveness and safety of the investigational triple antihypertensive agent-olmesartan, amlodipine, and hydrochlorothiazide-in difficult-to-treat patients with hypertension and diabetes as well as in Hispanic/Latino and obese patients with high blood pressure.

“Hispanics are the largest ethnic minority group in the United States, and their responsiveness to antihypertensive treatment has received relatively little attention,” said Suzanne Oparil, MD, professor of Medicine and Physiology and Biophysics at the University of Alabama School at Birmingham. “Thus, it is important to know the efficacy and safety of newer treatment options in Hispanic or Latino patients.”

The objective of the TRINITY (Triple Therapy with Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide in Hypertensive Patients Study) pre-specified subgroup analysis in patients with diabetes and hypertension was to compare the effectiveness and safety of the investigational triple combination therapy of olmesartan medoxomil, amlodipine, and hydrochlorothiazide (40/10/25 mg) to those of the constituent dual combination therapies by diabetic status.

“This study is important because it demonstrated that treating patients with a triple combination therapy regimen of olmesartan, amlodipine, and hydrochlorothiazide, each medication with a different mechanism of action, is more effective in lowering blood pressure than any of the component dual combinations,” Dr Oparil told Formulary.

Specifically, results of this pre-specified subgroup analysis of patients with hypertension and diabetes demonstrated that treatment with the investigational triple combination therapy of olmesartan medoxomil, amlodipine, and hydrochlorothiazide (40/10/25 mg) resulted in a significantly greater least squares mean reduction in blood pressure at week 12 (37.9/22.0 mmHg vs 26.4–28.0/14.7–17.6 mmHg, P≤.0013) compared with dual combination therapy with the constituent agents (olmesartan medoxomil (40 mg)/amlodipine (10 mg); olmesartan medoxomil (40 mg)/ hydrochlorothiazide (25 mg); or amlodipine (10 mg) and hydrochlorothiazide (25 mg).

The TRINITY study also demonstrated that the investigational triple combination therapy enabled more patients with hypertension and diabetes to achieve a blood pressure goal of <130/80 mmHg at week 12 compared with constituent dual combination therapies (41.1% in  the triple combination group vs 10.1% and 16.3% in the dual combination groups, respectively, P≤.0002).

Both the American Diabetes Association and the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) recommend that people with diabetes achieve a blood pressure goal of <130/80 mmHg. “Since patients with both diabetes and high blood pressure are more challenging to treat compared to those with hypertension alone, it is important to know the safety and efficacy of treatment options in this patient population,” Dr Oparil said.

“Studies have shown that combination therapy with 2 or more drugs provides better blood pressure control than single therapy alone, which may prevent more cardiovascular events, which in turn would help to reduce costs associated with hospitalizations or the need for specialized medical procedures, as well as fewer office visits to monitor blood pressure and to titrate doses of antihypertensive medication,” she continued.

Additionally, patients have been shown to have better adherence to fixed-dose combinations of medications than to the component medications prescribed separately, she said. “Patients are more likely to follow the prescription of taking one single pill a day, which consists of 3 different medications, than to follow the prescriptions for the 3 separate medications.”