IntroductionPatients with hypertension often require a combination of three antihypertensive agents to achieve blood pressure control, but very few single-pill triple combinations are available. The aim of this study was to determine whether a single-pill triple combination of perindopril, indapamide, and amlodipine was as effective as a dual-pill combination of perindopril/indapamide plus separate amlodipine at reducing blood pressure in patients with uncontrolled, essential hypertension.MethodsThis international, multicenter, open-label, randomized controlled trial was conducted in men or women aged ≥18 years old with confirmed essential hypertension (SBP ≥140 and <160 mmHg and DBP ≥90 and <100 mmHg), uncontrolled on maximal dose antihypertensive monotherapy or with a single dose of dual therapy. Patients were randomly assigned to: single-pill triple combination of perindopril 5 mg/indapamide 1.25 mg/amlodipine 5 mg (Per/Ind/Aml) or dual-pill combination perindopril 5 mg/indapamide 1.25 mg + amlodipine 5 mg (Per/Ind + Aml) once daily for 12 weeks. The primary endpoint was change in office supine SBP and DBP from baseline to week 12. The proportion of responders defined as those with normalized BP (SBP <140 mmHg and DBP <90 mmHg), and/or decrease of SBP ≥20 mmHg, and/or decrease of DBP ≥10 mmHg at week 12 (W12) compared with baseline was also assessed. Secondary efficacy endpoints included change in office supine SBP and DBP, response, and BP control at weeks 4 and 8. The tolerability of the treatments was also assessed.ResultsA total of 148 patients were randomized: 75 to Per/Ind/Aml and 73 to Per/Ind + Aml. Mean supine SBP and DBP were 149.1 ± 4.7 and 94.1 ± 3.1 mmHg, respectively, with no relevant between-group difference. At week 12, both triple-therapy regimens were associated with clinically significant reductions in SBP compared with baseline (−21.5 ± 11.7 and −20.0 ± 12.9 mmHg, respectively). Reductions in office supine DBP were also clinically significant (−15.3 ± 7.8 and −14.8 ± 9.0 mmHg, respectively). The proportion of treatment responders was high in both groups: 89.2 and 87.1%, respectively. The reduction in office supine SBP/DBP was already evident at week 4 and maintained for the duration of the study in both groups. The majority of patients were treatment responders at week 4 (89.2 and 82.9%, respectively) and had achieved BP control (87.8 vs. 78.6%, respectively), which was maintained until week 12 in both treatment groups. Both treatments were well tolerated with no between-group differences.ConclusionsIn adult patients with uncontrolled essential hypertension on treatment, single-pill triple-combination therapy with Per/Ind/Aml is as effective as the same dose dual-pill combination of Per/Ind + Aml. Both treatments were associated with clinically significant BP reductions compared with baseline and were well tolerated. Clinical trials number: http://www.controlled-trials.com ISRCTN: 16442558. Funding: Les Laboratoires Servier.Electronic supplementary materialThe online version of this article...
Research on the cardiovascular effects of noise in Serbia started in the year 2002, including experimental studies on humans and epidemiological studies on the adult and children population of Belgrade and Pancevo. Experimental exposure to noise [L eq = 89 dB (A)] had a hypodynamic effect, significantly lowering the cardiac index, cardiac work, and pump performance (P < 0.01). The vasoconstrictive effect of noise was shown through the significant elevation of after-load (P < 0.01). In a cross-sectional population study that was carried out on 2874 residents [1243 males and 1631 females] in Pancevo City, a significant odds ratio (adjusted for age, body mass index (BMI), and smoking habits) was found for self-reported hypertension (OR = 1.8, 95% CI = 1.0 - 2.4, P < 0.01) in men with a high level of noise annoyance compared to those with a low level of noise annoyance. In another study on 2503 residents (995 men and 1508 women) residents of Belgrade, the proportions of men with hypertension in the noisy [(L night , 8h > 45 dB (A)] and quiet areas [(L night , 8h ≤ 45 dB (A)] were 23.6% and 17.5%, respectively. The adjusted odds ratio (OR) for hypertension of the exposed group was 1.58 (95% CI = 1.03 - 2.42, P = 0.038), where men living in quiet streets were taken as a reference category. Associations between road traffic noise and blood pressure were also investigated in 328 preschool children in Belgrade. The systolic blood pressure was significantly higher among children from noisy residences and kindergartens, compared to children from both quiet environments (97.30 ± 8.15 and 92.33 ± 8.64 mmHg, respectively, P < 0.01). As a continuation of the study on preschool children, investigations were also carried out on 856 school children, aged between seven and eleven years, in Belgrade. It was found that systolic pressure was significantly higher among children from noisy schools and quiet residences, compared to children from both quiet environments (102.1 ± 9,3 and 100.4 ± 10.4 mmHg, respectively, P < 0.01).
Analysis of the obtained results suggested the protective effect of moderate alcohol consumption on cardiovascular system.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.