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Arterial hypertension: too many disadvantages with fixed-dose drug combinations

When a correctly followed anti-hypertensive treatment with a single drug proves ineffective, the combination of 2 even 3 anti-hypertensive drugs is sometimes successful, but it is better to avoid fixed-dose combinations.

The first-line treatment of arterial hypertension is a diuretic such as chlortalidone or hydrochlorothiazide. If these prove ineffective, a calcium channel blocker such as amlodipine, an angiotensin-converting enzyme inhibitor or an angiotensin II receptor antagonist  or, for patients under 60, a beta-blocker, are effective monotherapy options. If several monotherapies fail, prescribing 2 separate antihypertensives is sometimes the answer, taking adverse effects and drug interactions into account.

Fixed-dose combinations of two or three antihypertensives (amlodipine and valsartan in Exforge°, and now amlodipine, valsartan and hydrochlorothiazide in ExforgeHCT°) do not offer the patient any benefit. On the contrary, they expose patients to a number of problems: the impossibility of varying the dosage of each drug; a potentially more serious risk if the patient forgets to take a pill; and increased risk of adverse effects and drug interactions compared with a mono- or bitherapy; etc. Furthermore, Exforge° and Exforge HCT° come in a range of different dosages having similar packaging, which exposes patients to prescription and dispensing errors. 

The French committee that assesses the medical benefits of new drugs and provides recommendations concerning drug reimbursement (Commission de la transparence) is of the opinion that the drawbacks of a triple combination outweigh the expected benefits, and decided against reimbursement of Exforge HCT° by France’s national health insurance system. Exforge HCT° has no role to play in the treatment of hypertension.

©Prescrire 1 March 2011

"Amlodipine + valsartan + hydrochlorothiazide" Prescrire Int 2011; 20 (114): 67. (Pdf, subscribers only).
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