Fixed-Dose Artesunate-Amodiaquine Combination vs Chloroquine for Treatment of Uncomplicated Blood Stage P. vivax Infection in the Brazilian Amazon: An Open-Label Randomized, Controlled Trial.

BACKGROUND: Despite increasing evidence of the development of Plasmodium vivax chloroquine (CQ) resistance, there have been no trials comparing its efficacy with that of artemisinin-based combination therapies (ACTs) in Latin America. METHODS: This randomized controlled trial compared the antischizontocidal efficacy and safety of a 3-day supervised treatment of the fixed-dose combination artesunate-amodiaquine Winthrop® (ASAQ) versus CQ for treatment of uncomplicated P. vivax infection in Manaus, Brazil. Patients were followed for 42 days. Primary endpoints were adequate clinical and parasitological responses (ACPR) rates at day 28. Genotype-adjustment was performed. RESULTS: From 2012 to 2013, 380 patients were enrolled. In the per-protocol (PP) analysis, adjusted-ACPR was achieved in 100% (165/165) and 93.6% (161/172) of patients in the ASAQ and CQ arm (difference 6.4%, 95% CI 2.7%; 10.1%) at day 28 and in 97.4% (151/155) and 77.7% (129/166), respectively (difference 19.7%, 95% CI 12.9%; 26.5%), at day 42. Apart from ITT D28 assessment, superiority of ASAQ on ACPR was demonstrated. ASAQ presented faster clearance of parasitaemia and fever. Based on CQ blood level measurements, CQ resistance prevalence was estimated at 11.5% (95% CI: 7.5-17.3) up to day 42. At least one emergent adverse event (AE) was recorded for 79/190 (41x6%) in the ASAQ group and for 85/190 (44x7%) in the CQ group. Both treatments had similar safety profiles. CONCLUSIONS: ASAQ exhibited high efficacy against CQ resistant P. vivax and is an adequate alternative in the study area. Studies with an efficacious comparator, longer follow-up and genotype-adjustment can improve CQR characterization. CLINICAL TRIALS REGISTRATION: NCT01378286.

Postexercise hypotension induced by low-intensity resistance exercise in hypertensive women receiving captopril.

OBJECTIVE: The present study investigated the effect of a single bout of low-intensity resistance exercise on recovery blood pressure in hypertensive women receiving captopril. METHODS: Twelve essential hypertensive women, who were receiving captopril, underwent two experimental sessions: control (C - 40 min of seated rest) and low-intensity resistance exercise (E - six resistance exercises, three sets, 20 repetitions, 40% of one repetition maximum). Clinic blood pressure was measured in the laboratory, before and for 120 min after exercise or rest. Moreover, ambulatory blood pressure was also measured for 21 h after exercise or rest. RESULTS: Clinic blood pressures decreased significantly after exercise (systolic blood pressure =-12+ or -3 mmHg and diastolic blood pressure =-6+ or -2 mmHg, P<0.05), but not after rest. Mean awake blood pressures (systolic: C=132+ or -5 mmHg vs. E=125+ or -4 mmHg and diastolic: C=83+ or -3 mmHg vs. E=78+ or -2 mmHg, P<0.05) were significantly lower in the E than in the C session, while 21-h (systolic blood pressures: C=128+ or -5 mmHg vs. E=123+ or -4 mmHg; and diastolic blood pressures: C=80+ or -3 mmHg vs. E=76+ or -2 mmHg) and asleep (systolic blood pressures: C=120+ or -7 mmHg vs. E=118+ or -5 mmHg; and diastolic blood pressures: C=73+ or -4 mmHg vs. E=71+ or -3 mmHg) blood pressures did not differ between the experimental sessions. Moreover, there was a positive correlation between blood pressure measured in the C session and blood pressure reduction observed in the E session, showing that blood pressure decrease was greater when blood pressure level was higher. CONCLUSION: In hypertensive women receiving captopril, a single bout of low-intensity resistance exercise reduces blood pressure. This reduction persists for 10 h, during the awake period, while patients were engaged in their daily living activities. It was greater in patients with higher ambulatory blood pressure.