Why the study?
Does valsartan/amlodipine single pill combination improve blood pressure lowering and tolerability compared to monotherapy in hypertensive patients?
Does valsartan/amlodipine single pill combination improve blood pressure lowering and tolerability compared to monotherapy in hypertensive patients?
The single pill combination of valsartan and amlodipine offers an effective and well-tolerated option for hypertension management, improving adherence and reducing CCB-induced edema.
Supports valsartan/amlodipine combination for BP lowering and reduced edema; leaves open head-to-head comparisons with other regimens.
Data from numerous hypertension intervention studies show that the majority of hypertensive patients, approximately two-thirds, need at least two antihypertensive agents to reach and to stay at their blood pressure goal. Furthermore, any chronic therapy has to be kept as simple as possible in order to improve long-term adherence to the prescribed therapy. Therefore, guidelines generally recommend providing combination therapy as single pill combinations. The single pill combination of valsartan and amlodipine is the first such combination available containing an angiotensin receptor blocker and a calcium channel blocker (CCB). It combines two agents that have been studied extensively in large morbidity and mortality end point trials. Available evidence demonstrates that the combination of valsartan plus amlodipine lowers blood pressure more effectively than the respective monotherapies. The combination of valsartan and amlodipine has to be viewed on the background of recent data from a large end point trial suggesting that blockade of the renin-angiotensin system plus a CCB may be more beneficial than the combination of a renin-angiotensin system blocker plus a thiazide diuretic. Finally, while angiotensin receptor blockers have been shown to exhibit placebo-like tolerability, dihydropyridine CCBs, such as amlodipine, are capable of exerting a dose-dependent swelling predominantly in the ankle regions of the lower extremities, known as vasodilatory edema. This side effect of amlodipine is reduced markedly with the coadministration of valsartan. In conclusion, the single pill combination of valsartan plus amlodipine represents an effective and tolerable treatment option for patients with the need for combination treatment.
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Rainer Düsing (2010) studied this question.
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