ABSTRACT
O objetivo do estudo é comparar a eficácia e a tolerabilidade da combinação fixa ramipril/anlodipino e do anlodipino em monoterapia para o tratamento de hipertensão arterial. Após um período de duas semanas de retirada de anti-hipertensivos e uso de placebo (washout), 265 pacientes hipertensos com idades entre 40 e 79 anos foram randomizados para iniciar tratamento com 2,5/2,5 mg de ramipril/anlodipino em combinação fixa ou 2,5 mg de anlodipino, que foram titulados para 5/5 mg e 10/10 mg de ramipril/anlodipino, ou 5 e 10 mg de anlodipino, se necessário. No total, 131 pacientes foram randomizados para terapia combinada e 134 para monoterapia sem diferenças significativas entre os grupos nas características basais e nos níveis de pressão arterial (PA) inicial. A redução média da PA sistólica nos períodos do dia (20,36 ± 13,42 versus 15,86 ± 12,71 mmHg; p = 0,003) e da noite (17,6 ± 17,61 versus 14,09 ± 14,32 mmHg; p = 0,051), avaliada pela monitorização ambulatorial de pressão arterial (MAPA), foi significativamente maior no grupo tratamento com combinação fixa. A redução média da PA diastólica durante o dia à MAPA (11,28 ± 8,29 versus 8,96 ± 8,16 versus mmHg; p = 0,009) foi maior no grupo terapia combinada, mas não durante a noite (8,42 ± 11,16 mmHg versus 7,70 ± 8,63; p = 0,567). A redução média da PA sistólica e diastólica em 24 horas à MAPA também foi maior no grupo tratamento combinado. Ambas as opções terapêuticas promoveram redução significativa da PA sistólica e diastólica; porém, os resultados observados foram melhores no grupo de combinação fixa ramipril/anlodipino
This study aims to compare the efficacy and tolerability of a fixed-dose ramipril/amlodipine combination and amlodipine monotherapy for the treatment of hypertension. After a 2-week placebo washout, 265 hypertensive patients aged 40 to 79 years were randomized for 2.5/2.5 mg ramipril/amlodipine or 2.5 mg amlodipine, titrated to ramipril/amlodipine 5/5 mg and 10/10 mg , or amlodipine 5 and 10 mg, if necessary. A total of 131 patients were assigned to combination therapy, and 134 to monotherapy with no significant differences among them in basal characteristics and blood pressure (BP) levels at the ambulatory blood pressure monitoring (ABPM). Mean reduction in daytime (20.36 ± 13.42 versus 15.86 ± 12.71 mmHg; p = 0.003) and night-time systolic BP on ABPM (17.6 ± 17.61 versus 14.09 ± 14.32 mmHg; p = 0.051) were significantly higher in the combination therapy. Mean daytime diastolic BP reduction on ABPM (11.28 ± 8.29 versus 8.96 ± 8.16 versus mmHg; p = 0.009) was greater in the combination group, but not at night-time (8.42 ± 11.16 mmHg versus 7.70 ± 8.63; p = 0.567). Mean change in 24-h systolic and diastolic BP on ABPM were also greater in the combination treatment. Both treatments promoted a marked reduction in systolic and diastolic BP, and the results observed were better in the ramipril/amlodipine combination group.
Subject(s)
Humans , Male , Adult , Middle Aged , Aged , Amlodipine , Amlodipine Besylate, Olmesartan Medoxomil Drug Combination , Blood Pressure Monitoring, Ambulatory , Hypertension , RamiprilABSTRACT
OBJECTIVE: To evaluate the efficacy, safety and tolerability of sildenafil among Brazilian patients with hypertension treated with combinations of anti-hypertensive drugs. MATERIALS AND METHODS: One hundred twenty hypertensive men aged 30 to 81 years old under treatment with 2 or more anti-hypertensive drugs and with erectile dysfunction (ED) lasting for at least 6 months were enrolled at 7 research centers in Brazil. Patients were randomized to receive treatment with either sildenafil or placebo taken 1 hour before sexual intercourse (initial dose of 50 mg, adjusted to 25 mg or 100 mg according to efficacy and toxicity). During the following 8 weeks, patients were evaluated regarding vital signs, adverse events, therapeutic efficacy, satisfaction with treatment and use of concurrent medications. RESULTS: The primary evaluation of efficacy, which was based on responses to questions 3 and 4 of the International Index of Erectile Function, showed significant differences regarding treatment with sildenafil (p = 0.0002 and p < 0.0001, respectively). In the assessment of global efficacy, 87 percent of the patients treated with sildenafil reported improved erections, as compared with 37 percent of patients given placebos (p < 0.0001). The other secondary evaluations supported the results favoring sildenafil. The most frequent adverse events among patients treated with sildenafil were headaches (11.4 percent), vasodilation (11.4 percent) and dyspepsia (6.5 percent). There were no significant changes in blood pressure measurements in both groups. CONCLUSION: Sildenafil is efficacious and safe for the treatment of hypertensive patients with ED who receive concurrent combinations of anti-hypertensive drugs.