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New Introductions - Internationally

US-FDA Approves a New Double Drug Combination in Hypertension

Fixed-dose combination of a direct renin inhibitor, aliskiren and a calcium-channel blocker, amlodipine , was approved by US-FDA for hypertension management. It is indicated for first-line therapy in patients who need several drugs to achieve their BP goals and for replacement therapy in individuals who do not achieve such goals through a single medication such as aliskiren or amlodipine.

The approval was based on the study carried in 5549 patients with mild to moderate hypertension. Patients receiving the combination drug experienced significantly greater reductions in systolic (14-17 mmHg) and diastolic (9-11 mmHg) BP than those receiving aliskiren (4-9/3-4 mmHg) or amlodipine (9-14/6-8 mmHg) alone. Overall incidence of adverse events with the combination was similar to that of its individual components.

http://www.theheart.org/article/1113465.do .
Last accessed on 03.09.10

http://www.pslgroup.com/
Last accessed on 03.09.10

September 2010

US-FDA approves 2nd triple drug FDC in hypertension

Approximately 56% of patients taking current BP lowering therapies do not reach current recommended BP goal of <140/90 mm Hg or <130/80 mm Hg for patients with diabetes, chronic renal disease, or chronic cardiovascular disease. More than two-thirds of hypertensives require ≥ 2 antihypertensive medications in order to achieve goal BP control. Fixed-dose combination (FDC) treatment simplifies dosing regimens & reduces pill burden. Fixed-dose antihypertensive combination treatments may also improve patient compliance as compared to taking each medication separately.

Taking these benefits in to consideration US FDA has approved a new triple drug combination, Tribenzor , which combines olmesartan medoxomil 40 mg, amlodipine 10 mg , and hydrochlorothiazide 25 mg . It is approved for hypertensives who are not adequately controlled on any 2 of the following antihypertensive drug classes: angiotensin receptor blockers, calcium channel blockers and diuretics. It is not approved for initial therapy.

According to the trial which contributed to the approval of this combination: 2,492 hypertensives who were switched to this combination pill from the dual combination therapies yielded a significantly greater mean reduction after 8 weeks of treatment in both systolic & diastolic BP. The most common adverse reactions seen in clinical trials were dizziness, peripheral oedema, headache, fatigue, nasopharyngitis, muscle spasms, nausea, upper respiratory tract infection, diarrhoea, urinary tract infection, and joint swelling.

This 3-in-1 pill thus offers a simple, convenient, and consistently effective therapy for hypertensive patients and may be effective option to achieve target BP goal.

August 2010