Skip to main content

New Data Show Investigational Triple Antihypertensive Combination Therapy Significantly Lowers BP in Hard-to-Treat Patients

News

New Data Show Investigational Triple Antihypertensive Combination Therapy Significantly Lowers BP in Hard-to-Treat Patients

06/28/2010
Efficacy and Safety of the Triple Combination Therapy of Olmesartan Medoxomil / Amlodipine / Hydrochlorothiazide Also Demonstrated in Hispanic/Latino and Obese Patients with High Blood Pressure Parsippany, New Jersey – June 28, 2010 – Preliminary results of a pre-specified subgroup study analysis of patients with diabetes and hypertension demonstrated that the investigational triple combination therapy of olmesartan medoxomil / amlodipine / hydrochlorothiazide (40/10/25 mg) resulted in a statistically significant greater Least Squares (LS) mean reduction in blood pressure from baseline at week 12 (37.9/22.0 mmHg versus 26.4-28.0/14.7-17.6 mm Hg, p ≤ 0.0013) as compared to corresponding dual combination therapy [olmesartan medoxomil (40 mg) / amlodipine (10 mg); olmesartan medoxomil (40 mg) / hydrochlorothiazide (25 mg); or amlodipine (10 mg) and hydrochlorothiazide (25 mg)].[i] Blood pressure is more difficult to control among patients with hypertension and diabetes compared to patients with hypertension alone.[i i] These findings were presented today during a poster presentation at the American Diabetes Association (ADA) 70th Annual Scientific Sessions in Orlando, FL. This analysis of the TRINITY study (Triple Therapy with Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide in Hypertensive Patients Study) also demonstrated that the investigational triple combination therapy (40/10/25 mg) enabled more patients with hypertension and diabetes to achieve blood pressure goal of which puts them at greater risk of developing long-term complications such as cardiovascular and renal disease.2 In order to achieve recommended blood pressure control of Publication-Only Abstract on Ethnicity and BMI Subgroup Analysis Two additional prespecified subgroup analyses of the TRINITY study by ethnicity (Hispanic/Latino or non-Hispanic/Non-Latino) and body mass index (BMI) category of It is estimated that hypertension affects 21 percent of Hispanic adults (18 years or older) in the U.S.[v] Additionally, the majority of patients with high blood pressure are overweight, with the condition being six times more frequent in obese people.[vi] Results for the ethnicity subgroup analysis [Hispanic or Latino (n = 369, 14.8 percent) and non-Hispanic or non-Latino (n = 2,122)] showed that the olmesartan medoxomil / amlodipine / hydrochlorothiazide (40/10/25 mg) triple combination therapy produced a significantly greater mean reduction in seated diastolic blood pressure (p ≤ 0.0236) and a greater reduction in seated systolic blood pressure from baseline to week 12 compared with each dual combination therapy regardless of ethnicity.4 Additionally, in both non-obese patients (n = 937, BMI of TRINITY Study Design At total of 2,492 patients with moderate to severe hypertension were enrolled into the Phase 3, multicenter, randomized, double-blind, parallel-group study, which examined the safety and efficacy of the triple combination of olmesartan medoxomil / amlodipine / hydrochlorothiazide (40/10/25 mg).1,4 Patients were randomized to receive one of three dual combination therapies (n = 2,456) or placebo (n = 36) for the first two weeks of the study: olmesartan medoxomil (40 mg) / amlodipine (10 mg); olmesartan medoxomil (40 mg) / hydrochlorothiazide (25 mg); or, amlodipine (10 mg) / hydrochlorothiazide (25 mg).1,4 After the first 2 weeks, until week four, the 36 patients on placebo were switched to one of the dual combination therapies.1,4 At four weeks, a subset of patients from each of the three dual combination groups were switched to the triple combination therapy of olmesartan (40 mg) / amlodipine (10 mg) / hydrochlorothiazide (25 mg) and continued for 12 weeks (n = 627).1,4 The 12 week double-blind treatment period was followed by a 40 week open-label treatment period.1,4 The 12-week results were presented at the American Society of Hypertension (ASH) annual meeting earlier this year, which found that the blood pressure-lowering and percentage of patients reaching the current recommended blood pressure target was greater with the triple combination therapy (40/10/25 mg) versus corresponding dual combination therapy regardless of gender, age, race, and hypertension severity (P Safety & Tolerability Across all groups, drug-related treatment adverse events (TEAEs) were reported in 25.4% of patients.1 Most TEAEs and drug-related TEAEs were mild or moderate in severity.1 More discontinuations due to TEAEs occurred in the olmesartan medoxomil / amlodipine / hydrochlorothiazide (40/10/25 mg) (4.0 percent) versus the dual combination therapy groups (1.0% to 2.1%) and were due to adverse events such as dizziness and hypotension.1 These discontinuations can potentially be attributed to the more pronounced pharmacodynamic effect of the triple combination therapy.1 Peripheral edema also was a cause for discontinuation.1 In addition, discontinuations for patients on triple combination therapy also included subjects who experienced an adverse event on earlier treatment (i.e. placebo or dual), prior to initiation of the triple combination regimen.1 About The Triple Combination Therapy A fixed-dose, single combination product of olmesartan medoxomil/ amlodipine / hydrochlorothiazide is currently under review for approval with the US Food and Drug Administration (FDA) for the treatment of hypertension. For more information, please visit www.daiichisankyo.com
Back to Top