{"title":"新型 FDC 替米沙坦+比索洛尔与对比替米沙坦+琥珀酸美托洛尔 ER 联合疗法治疗 1 期和 2 期高血压的疗效、安全性和耐受性比较：双盲、多中心、III 期临床研究。","authors":"","doi":"10.1016/j.ihj.2024.06.002","DOIUrl":null,"url":null,"abstract":"<div><h3>Aim</h3><p>The present study compared the safety, efficacy, and tolerability of the new fixed-dose combination (FDC) of telmisartan 40 mg + bisoprolol 5 mg (TBP) tablets with the existing comparator FDC telmisartan 40 mg + metoprolol succinate ER 50 mg (TMS) tablets in patients with stage 1 and stage 2 hypertension.</p></div><div><h3>Methodology</h3><p>The multicentric, double-blind, parallel-group, comparative, prospective, phase-III clinical study involved 264 subjects with stage 1 and stage 2 hypertension from 10 centres across India. The selected subjects were randomized into two groups: group A received the TMS and group B received the new FDC TBP. The primary endpoint was the mean change in seated systolic blood pressure (SeSBP) and seated diastolic blood pressure (SeDBP) from baseline to week 12 in both the control and study arms. The secondary endpoint was achieving the target of SeSBP <140 mmHg and SeDBP <90 mmHg from baseline to week 12 in both groups. Safety and tolerability parameters were evaluated in both groups based on adverse effects (AEs) reported by the patients and the physician.</p></div><div><h3>Results</h3><p>Both treatment groups exhibited a reduction in BP after 2 weeks of treatment, which was sustained until 12 weeks. The mean change in SeSBP and SeDBP at weeks 2, 6, and 12 compared to the previous visit showed statistical significance (<em>p</em> < 0.001) in all cases for both groups A and B. The mean changes in SeSBP and SeDBP from baseline to study end were numerically higher in group B than in group A. The mean difference in SeSBP from baseline to study end was significantly higher in group B compared to group A (<em>p</em> = 0.029). By week 12, 88.28 % and 89.84 % of subjects in group B achieved SeSBP <140 mmHg and SeDBP <90 mmHg respectively, while 86.71 % and 91.40 % of subjects in group A achieved the same targets. Reported AEs were mostly mild to moderate in both treatment groups, and no serious AEs or deaths were reported. Tolerability was rated as ‘excellent’ by 93.75 % of subjects in group B and 91.40 % of subjects in group A.</p></div><div><h3>Conclusion</h3><p>Both the new FDC TBP and the existing comparator TMS combination therapy have comparable efficacy, tolerability, and safety for the management of stage 1 and stage 2 hypertension.</p></div><div><h3>Trial registry name</h3><p>Clinical Trials Registry of India (CTRI)</p></div><div><h3>Trial registration no</h3><p>CTRI/2021/11/037,926</p></div><div><h3>Protocol no</h3><p>MLBTL/05/2021</p></div><div><h3>Protocol url</h3><p><span><span>https://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=62069&EncHid=&userName=bisoprolol</span><svg><path></path></svg></span></p></div>","PeriodicalId":13384,"journal":{"name":"Indian heart journal","volume":"76 3","pages":"Pages 159-166"},"PeriodicalIF":1.4000,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0019483224000750/pdfft?md5=ec2c77a9c028415128a47dbccdef593b&pid=1-s2.0-S0019483224000750-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Comparison of the efficacy, safety, and tolerability of the FDC of telmisartan + bisoprolol with telmisartan + metoprolol succinate ER combination therapy for stage 1 and stage 2 hypertension: A double-blind, multicentric, phase-III clinical study\",\"authors\":\"\",\"doi\":\"10.1016/j.ihj.2024.06.002\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Aim</h3><p>The present study compared the safety, efficacy, and tolerability of the new fixed-dose combination (FDC) of telmisartan 40 mg + bisoprolol 5 mg (TBP) tablets with the existing comparator FDC telmisartan 40 mg + metoprolol succinate ER 50 mg (TMS) tablets in patients with stage 1 and stage 2 hypertension.</p></div><div><h3>Methodology</h3><p>The multicentric, double-blind, parallel-group, comparative, prospective, phase-III clinical study involved 264 subjects with stage 1 and stage 2 hypertension from 10 centres across India. The selected subjects were randomized into two groups: group A received the TMS and group B received the new FDC TBP. The primary endpoint was the mean change in seated systolic blood pressure (SeSBP) and seated diastolic blood pressure (SeDBP) from baseline to week 12 in both the control and study arms. The secondary endpoint was achieving the target of SeSBP <140 mmHg and SeDBP <90 mmHg from baseline to week 12 in both groups. Safety and tolerability parameters were evaluated in both groups based on adverse effects (AEs) reported by the patients and the physician.</p></div><div><h3>Results</h3><p>Both treatment groups exhibited a reduction in BP after 2 weeks of treatment, which was sustained until 12 weeks. The mean change in SeSBP and SeDBP at weeks 2, 6, and 12 compared to the previous visit showed statistical significance (<em>p</em> < 0.001) in all cases for both groups A and B. The mean changes in SeSBP and SeDBP from baseline to study end were numerically higher in group B than in group A. The mean difference in SeSBP from baseline to study end was significantly higher in group B compared to group A (<em>p</em> = 0.029). By week 12, 88.28 % and 89.84 % of subjects in group B achieved SeSBP <140 mmHg and SeDBP <90 mmHg respectively, while 86.71 % and 91.40 % of subjects in group A achieved the same targets. Reported AEs were mostly mild to moderate in both treatment groups, and no serious AEs or deaths were reported. Tolerability was rated as ‘excellent’ by 93.75 % of subjects in group B and 91.40 % of subjects in group A.</p></div><div><h3>Conclusion</h3><p>Both the new FDC TBP and the existing comparator TMS combination therapy have comparable efficacy, tolerability, and safety for the management of stage 1 and stage 2 hypertension.</p></div><div><h3>Trial registry name</h3><p>Clinical Trials Registry of India (CTRI)</p></div><div><h3>Trial registration no</h3><p>CTRI/2021/11/037,926</p></div><div><h3>Protocol no</h3><p>MLBTL/05/2021</p></div><div><h3>Protocol url</h3><p><span><span>https://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=62069&EncHid=&userName=bisoprolol</span><svg><path></path></svg></span></p></div>\",\"PeriodicalId\":13384,\"journal\":{\"name\":\"Indian heart journal\",\"volume\":\"76 3\",\"pages\":\"Pages 159-166\"},\"PeriodicalIF\":1.4000,\"publicationDate\":\"2024-05-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S0019483224000750/pdfft?md5=ec2c77a9c028415128a47dbccdef593b&pid=1-s2.0-S0019483224000750-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Indian heart journal\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0019483224000750\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Indian heart journal","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0019483224000750","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
Comparison of the efficacy, safety, and tolerability of the FDC of telmisartan + bisoprolol with telmisartan + metoprolol succinate ER combination therapy for stage 1 and stage 2 hypertension: A double-blind, multicentric, phase-III clinical study
Aim
The present study compared the safety, efficacy, and tolerability of the new fixed-dose combination (FDC) of telmisartan 40 mg + bisoprolol 5 mg (TBP) tablets with the existing comparator FDC telmisartan 40 mg + metoprolol succinate ER 50 mg (TMS) tablets in patients with stage 1 and stage 2 hypertension.
Methodology
The multicentric, double-blind, parallel-group, comparative, prospective, phase-III clinical study involved 264 subjects with stage 1 and stage 2 hypertension from 10 centres across India. The selected subjects were randomized into two groups: group A received the TMS and group B received the new FDC TBP. The primary endpoint was the mean change in seated systolic blood pressure (SeSBP) and seated diastolic blood pressure (SeDBP) from baseline to week 12 in both the control and study arms. The secondary endpoint was achieving the target of SeSBP <140 mmHg and SeDBP <90 mmHg from baseline to week 12 in both groups. Safety and tolerability parameters were evaluated in both groups based on adverse effects (AEs) reported by the patients and the physician.
Results
Both treatment groups exhibited a reduction in BP after 2 weeks of treatment, which was sustained until 12 weeks. The mean change in SeSBP and SeDBP at weeks 2, 6, and 12 compared to the previous visit showed statistical significance (p < 0.001) in all cases for both groups A and B. The mean changes in SeSBP and SeDBP from baseline to study end were numerically higher in group B than in group A. The mean difference in SeSBP from baseline to study end was significantly higher in group B compared to group A (p = 0.029). By week 12, 88.28 % and 89.84 % of subjects in group B achieved SeSBP <140 mmHg and SeDBP <90 mmHg respectively, while 86.71 % and 91.40 % of subjects in group A achieved the same targets. Reported AEs were mostly mild to moderate in both treatment groups, and no serious AEs or deaths were reported. Tolerability was rated as ‘excellent’ by 93.75 % of subjects in group B and 91.40 % of subjects in group A.
Conclusion
Both the new FDC TBP and the existing comparator TMS combination therapy have comparable efficacy, tolerability, and safety for the management of stage 1 and stage 2 hypertension.
期刊介绍：
Indian Heart Journal (IHJ) is the official peer-reviewed open access journal of Cardiological Society of India and accepts articles for publication from across the globe. The journal aims to promote high quality research and serve as a platform for dissemination of scientific information in cardiology with particular focus on South Asia. The journal aims to publish cutting edge research in the field of clinical as well as non-clinical cardiology - including cardiovascular medicine and surgery. Some of the topics covered are Heart Failure, Coronary Artery Disease, Hypertension, Interventional Cardiology, Cardiac Surgery, Valvular Heart Disease, Pulmonary Hypertension and Infective Endocarditis. IHJ open access invites original research articles, research briefs, perspective, case reports, case vignette, cardiovascular images, cardiovascular graphics, research letters, correspondence, reader forum, and interesting photographs, for publication. IHJ open access also publishes theme-based special issues and abstracts of papers presented at the annual conference of the Cardiological Society of India.
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