NEW YORK—Long-term data show that a three-drug combination is safe and effective for treating hypertension in elderly patients, according to a report at the American Society of Hypertension annual meeting.
The combination, which is marketed as Tribenzor, consists of olmesartan medoxomil (OM), amlodipine (AML), and hydrochlorothiazide (HCTZ). The FDA approved the product in July 2010. Tribenzor is indicated for the treatment of hypertension in patients who are not adequately controlled on any two of the following antihypertensive medication classes: angiotensin receptor blockers, calcium channel blockers, and diuretics.
The three-drug combination was studied in a 12-week pivotal phase 3 trial called TRINITY (Triple Therapy with Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide in Hypertensive Patients Study), which included 2,492 patients with hypertension. At the end of this study, 2,098 patients (19.6% of whom were aged 65 years or older) went on to enroll into a 40-week open-label extension period. Results at 52 weeks showed that the safety and efficacy of the triple combination observed in the pivotal study was maintained.
At the start of the open-label period, mean seated blood pressure (BP) was 134.2/83.3 mm Hg in patients younger than 65 and 137.5/78 mm Hg in older patients. At week 52, patients younger than 65 achieved a mean seated BP ranging from 124.7/78.5 mm Hg in patients taking the OM 40 mg/AML 5 mg/HCTZ 12.5 mg dosing regimen to 136.6/83.8 mm Hg among those taking the OM 40 mg/AML 10 mg/HCTZ 25 mg regimen. The corresponding range for patients aged 65 and older was 126.2/74 to 137.8/77.5 mm Hg.
The incidence of drug-related adverse events (AEs) was 9.9%-19.4% in the patients younger than 65 and 13.3%-21.1% in the older patients. In both age groups, the most common AEs were dizziness, peripheral edema, nasopharygitis, and upper respiratory tract infection.
In subgroup analyses, investigators found that the triple regimen was effective and well tolerated regardless of whether or not patients were obese or had diabetes.