Telmisartan/amlodipine (Twynsta): approved for high blood pressure

New combination: Telmisartan/amlodipine (Twynsta) was approved on October 16, 2009, for high blood pressure.

Telmisartan/amlodipine tablets are indicated for the treatment of hypertension alone or in combination with other anti-hypertensive agents, or as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals. Telmisartan/amlodipine tablets are a fixed dose combination of telmisartan, an ARB, and amlodipine, a dihydropyridine calcium channel blocker (DHP-CCB). Two-thirds of people treated for high blood pressure are not at their target goals.

Efficacy. Base the choice of telmisartan/amlodipine tablets as initial therapy for hypertension on an assessment of potential benefits and risks including whether the patient is likely to tolerate the starting dose of telmisartan/amlodipine tablets. Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. Consider the patient's baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with monotherapy when deciding whether to use telmisartan/amlodipine tablets as initial therapy. Individual blood pressure goals may vary based upon the patient's risk. Data from an 8-week, placebo-controlled, multi-dose, factorial trial in patients with mild to severe hypertension demonstrated that 4 key treatment combinations (including telmisartan 40 mg or 80 mg and amlodipine 5 mg or 10 mg) had statistically significant reduction in in-clinic seated systolic and diastolic blood pressure compared to telmisartan or amlodipine alone.

Safety. Correct any volume or salt depletion before initiating therapy. Observe for signs and symptoms of hypotension. Titrate slowly in patients with hepatic or severe renal impairment. Monitor for worsening heart failure. Avoid concomitant use of an ACE inhibitor and ARB. Uncommonly, initiating a CCB in patients with severe obstructive coronary artery disease may precipitate myocardial infarction or increased angina. In the placebo-controlled factorial design study, the most common reasons for discontinuation of therapy with telmisartan/amlodipine tablets were peripheral edema, dizziness, and hypotension (each <0.5%). Adverse reactions that occurred at a 2% or higher incidence on telmisartan/amlodipine tablets than placebo were peripheral edema (4.8% vs 0%), dizziness (3.0% vs 2.2%), clinically meaningful orthostatic hypotension (6.3% vs 4.3%), and back pain (2.2% vs 0%).