FDA Approves Another Triple-Drug Combination for Resistant Hypertension: Tribenzor

Shelley Wood

July 26, 2010

July 26, 2010 (Parsippany, New Jersey) — The FDA has granted marketing approval to another three-drug combination for the treatment of hypertension in patients unable to get their blood pressure controlled with any two of the three classes of drugs that make up the combination [1]. The new product, Tribenzor (Daiichi Sankyo), combines the angiotensin-receptor blocker olmesartan (40 mg), the calcium-channel blocker amlodipine (10 mg), and the diuretic hydrochlorothiazide (HCTZ) (25 mg).

As previously reported by heartwire , this particular three-drug combo pill was studied in the phase 3 TRINITY trial, and the results were reported in a poster presentation at the American Society of Hypertension 2010 Scientific Meeting. In the study, 2492 patients with moderate to severe hypertension (>140/100 mm Hg; mean BP 168/101 mm Hg) from more than 300 centers were randomized to the triple combination product or one of three dual therapies using the same medications. Those who received the triple combination had greater reductions in both systolic and diastolic blood pressure over the 12 weeks of the study compared with the three dual therapies, and a significantly greater proportion of those receiving the triple therapy reached their goal blood pressure. The findings were consistent across prespecified age, gender, and racial subgroups and were the same regardless of hypertension severity.

In a press release announcing the market approval, the manufacturer notes that the most common adverse reactions seen in clinical trials of the combo drug were dizziness, peripheral edema, headache, fatigue, nasopharyngitis, muscle spasms, nausea, upper-respiratory-tract infection, diarrhea, urinary-tract infection, and joint swelling.

Tribenzor is the second three-drug combination pill approved by the FDA. Exforge HCT (Novartis)--a three-drug combo of amlodipine/valsartan/HCTZ--was approved by the FDA last year.

While many experts believe the advantages of fixed-dose, single-pill combinations will help more patients reach their blood-pressure goals, particularly by increasing patient compliance, a recent American Society of Hypertension position paper [2,3] points out that branded combinations are typically more expensive than combining two or three single-drug pills, particularly if the single medications are available as generics.