Real-world effectiveness and safety of single-pill combination of amlodipine/valsartan or amlodipine/valsartan/hydrochlorothiazide in patients with hypertension from the Philippines

OBJECTIVE: The EXforge Clinical evaluation of amlodlpine and valsarTan in hypErtension (EXCITE) study was designed to evaluate the real-world effectiveness and safety of amlodipine/valsartan (Aml/Val) and amlodipine/valsartan/hydrochlorothiazide (Aml/Val/HCT) single-pill combination (SPC) in patients with hypertension.METHODOLOGY: This 26-week observational, multicenter, prospective, open-label study included patients aged ? 18 years of age with established diagnosis of hypertension. The change in mean sitting systolic BP (msSBP), diastolic BP (msDBP) from baseline to Week 26, proportion of patients achieving BP goal (msSBP/msDBP RESULTS: Of the total 1,054 patients in the full analysis set (Aml/Val, n=928; Aml/Val/HCTZ, n=126), 923 (87.6%) patients completed the study. The baseline BP was 158.5/96.5 and 167.0/99.5 mmHg in the Aml/Val and Aml/Val/HCTZ groups,respectively. Significant reductions in msSBP and msDBP from baseline to week 26 were observed with both Aml/Val (-31.9/-19.2 mmHg). Adverse events were reported by 8.8% of the patients.CONCLUSION: The Aml/Val and Aml/Val/HCTZ SPCs were effective in controlling BP and were generally well tolerated in patients with hypertension from the Philippines.

Análise de eficácia, eventos adversos e desfechos cardiovasculares em estudos relacionados às combinações de nifedipino GITS ou anlodipino com medicamentos que atuam no sistema renina angiotensina aldosterona / Efficacy analysis, adverse events and cardiovascular outcomes in studies related to combinations of nifedipine GITS or amlodipine with drugs acting on the renin angiotensin aldosterone system

Revisamos 17 estudos com o objetivo de avaliar a eficácia anti-hipertensiva da combinação de antagonistas de cálcio com bloqueadores dos receptores de angiotensina na redução da pressão arterial, de desfechos cardiovasculares e na incidência de efeitos adversos. A terapia combinada de bloqueador de canais de cálcio anlodipino ou nifedipino GITS, mais o bloqueador de receptor de angiotensina II valsartana, mostrou-se, na maioria dos estudos, mais eficaz que a monoterapia para redução de pressão arterial, além de mais benéfica quanto à diminuição de eventos cardiovasculares. O perfil de segurança e tolerabilidade das combinações também se revelou bastante aceitável, com o manejo de efeitos adversos favorecido pela maior possibilidade de ajustes de doses de substâncias com diferentes mecanismos de ação, sem comprometimento da eficácia anti-hipertensiva.

We reviewed 17 studies in order to evaluate the antihypertensive efficacy on the combination of calcium antagonists and angiotensin receptor blockers in lowering the blood pressure, cardiovascular outcomes and incidence of side effects. The combination therapy of amlodipine or nifedipine GITS calcium channel blockers, and angiotensin II receptor blocker valsartan showed, in most studies, more effective than monotherapy to lower blood pressure, as well as more beneficial to decrease cardiovascular events. The safety profile and tolerability of the combinations also proved quite acceptable, with side effects management benefited by higher possibility of adjustments on doses of substances with different mechanisms of actions, without affecting the antihypertensive efficacy.