HoungBeom Ahn, Hyun-Wook Chu, Ae-Young Her, Young-Hoon Jeong, Byeong-Keuk Kim, Hyung Joon Joo, Kiyuk Chang, Yongwhi Park, Sung Gyun Ahn, Sang Yeup Lee, Jung Rae Cho, Hyo-Soo Kim, Moo Hyun Kim, Do-Sun Lim, Eun-Seok Shin, Jung-Won Suh
{"title":"Effect of Calcium Channel Blockers on Antiplatelet Activity of Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention: Insights from the PTRG-DES Consortium.","authors":"HoungBeom Ahn, Hyun-Wook Chu, Ae-Young Her, Young-Hoon Jeong, Byeong-Keuk Kim, Hyung Joon Joo, Kiyuk Chang, Yongwhi Park, Sung Gyun Ahn, Sang Yeup Lee, Jung Rae Cho, Hyo-Soo Kim, Moo Hyun Kim, Do-Sun Lim, Eun-Seok Shin, Jung-Won Suh","doi":"10.1177/10742484241298150","DOIUrl":"10.1177/10742484241298150","url":null,"abstract":"<p><p><b>Aims:</b> Calcium channel blockers (CCBs) are frequently co-administered with clopidogrel in cardiovascular disease. Although an inhibitory drug interaction exists between them, comprehensive large-scale studies for its validation are lacking. We investigated interactions between CCBs and clopidogrel using a large-scale national registry of patients who underwent percutaneous coronary intervention (PCI). <b>Methods and Results:</b> The Platelet function and genoType-Related long-term Prognosis-Platelet Function Test consortium investigates the association between platelet function test and long-term prognosis during dual antiplatelet therapy including clopidogrel in patients using drug-eluting stents. We compared the <i>ex vivo</i> platelet reactivity using the VerifyNow P2Y12 test and clinical outcomes between CCB users and non-users. Between 2003 and 2018, 11 714 patients were enrolled and categorized into two groups according to CCB usage. A composite endpoint encompassing all-cause mortality, myocardial infarction, stent thrombosis, or stroke was defined as a major adverse cardiac and cerebrovascular event (MACCE). During the 5-year follow-up period, no significant differences were observed in P2Y12 reaction units (215.8 ± 84.7 vs 218.4 ± 76.7, <i><u>P</u></i> = .156), MACCEs, major bleeding, or high platelet reactivity rates, even after adjusting for propensity score matching (PSM) and inverse probability of treatment weighting (IPTW). When limited to the high platelet reactivity cohort (≥252 PRU), the results remained consistent for MACCE [PSM-adjusted, HR: 0.923 (0.644-1.323), <i><u>P</u></i>-value .663; IPTW-adjusted, HR: 1.300 (0.822-2.056), <i><u>P</u></i>-value .262]. <b>Conclusions:</b> CCB and clopidogrel co-administration does not appear to significantly impact clopidogrel responsiveness or clinical outcomes. Despite these promising results, further investigation may be warranted. <b>Clinical trial registration:</b> Platelet Function and genoType-Related Long-term progGosis in DES-treated Patients: A Consortium From Multi-centered Registries [PTRG-DES]; NCT04734028.</p>","PeriodicalId":15281,"journal":{"name":"Journal of Cardiovascular Pharmacology and Therapeutics","volume":"29 ","pages":"10742484241298150"},"PeriodicalIF":2.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142648342","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jun Wan, Feng Xu, Heping Zuo, Xin Jiang, Yulin Wang, Yang Jiang, Cai Chen, Chunlin Yin, Jinglin Cheng, He Li
{"title":"Impact of SGLT2 Inhibitors on Left Ventricular Remodeling in Diabetic Patients with Acute Myocardial Infarction.","authors":"Jun Wan, Feng Xu, Heping Zuo, Xin Jiang, Yulin Wang, Yang Jiang, Cai Chen, Chunlin Yin, Jinglin Cheng, He Li","doi":"10.1177/10742484241301191","DOIUrl":"10.1177/10742484241301191","url":null,"abstract":"<p><strong>Objective: </strong>To assess the effect of sodium-glucose cotransporter 2 inhibitors (SGLT2-I) on cardiac remodeling and prognosis in type 2 diabetes mellitus (T2DM) patients presenting with acute myocardial infarction (AMI).</p><p><strong>Methods: </strong>In this single-center retrospective active-comparator study, consecutive diabetic AMI patients undergoing percutaneous coronary intervention (PCI) between 2021 and 2023 were enrolled. Patients were divided into SGLT2-I users and non-SGLT2-I users based on discharge medications. The primary endpoint was the left ventricular remodeling index (LVRI), defined as the relative change in LV end-diastolic volume after six months. The secondary outcomes included major adverse cardiovascular events (MACE), comprising all-cause mortality, hospitalization for heart failure, nonfatal MI, and nonfatal stroke.</p><p><strong>Results: </strong>The study comprised 423 T2DM AMI patients(with or without ST-segment elevation), with 239 SGLT2-I users and 184 non-SGLT2-I users. At six months, LVRI was significantly lower in the SGLT2-I users compared to the non-SGLT2-I users (3.49 ± 19.71 vs 7.06 ± 15.15, <i>P</i> = .042). The non-SGLT2-I users exhibited a higher prevalence of positive LVR (LVRI > 0%) (64.67% vs 50.63%, <i>P</i> = .004) and pathological LVR (LVRI > 20%) (19.57% vs 12.13%, <i>P</i> = .036). Multivariate logistic regression indicated that SGLT2-I was associated with a reduced risk of LVR (OR 0.6; 95%CI 0.38-0.97; <i>P</i> = .035). During a mean follow-up of 25 ± 8 months, Kaplan-Meier analysis demonstrated a lower rate of MACE-free survival in the non-SGLT2-I users (<i>P</i> = .005).</p><p><strong>Conclusions: </strong>SGLT2-I protects against LVR and lowers the risk of adverse cardiovascular outcomes in T2DM AMI patients.</p>","PeriodicalId":15281,"journal":{"name":"Journal of Cardiovascular Pharmacology and Therapeutics","volume":"29 ","pages":"10742484241301191"},"PeriodicalIF":2.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142785788","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Alejandro Quintero-Altare, Catalina Flórez-Navas, Henry Robayo-Amortegui, Maria Rojas-Arrieta, Eduardo Tuta-Quintero, Alirio Bastidas-Goyes, Laura Martínez-Delgado, Julián Orlando Casallas-Barrera, Claudia Poveda-Henao, Ricardo Buitrago-Bernal
{"title":"Boosting the Beat: A Critical Showdown of Levosimendan and Milrinone in Surgical and Non-Surgical Scenarios: A Narrative Review.","authors":"Alejandro Quintero-Altare, Catalina Flórez-Navas, Henry Robayo-Amortegui, Maria Rojas-Arrieta, Eduardo Tuta-Quintero, Alirio Bastidas-Goyes, Laura Martínez-Delgado, Julián Orlando Casallas-Barrera, Claudia Poveda-Henao, Ricardo Buitrago-Bernal","doi":"10.1177/10742484241276431","DOIUrl":"10.1177/10742484241276431","url":null,"abstract":"<p><p>Acute heart failure, advanced cardiac failure, cardiac surgery, and sepsis are conditions that require simultaneous treatment to stimulate contractility and/or reduce systemic vascular resistance, with levosimendan and milrinone being treatment options. This research's aim is to review the current indications and evidence for these medications across various scenarios. Evidence suggests that levosimendan is a non-inferior alternative to dobutamine and superior to milrinone in treating low cardiac output syndrome following cardiac surgery. In cases of septic shock, levosimendan has been linked to lower mortality rates compared to placebo, while milrinone's efficacy remains inconclusive. Furthermore, postoperative patients undergoing correction for congenital heart disease have shown reduced mechanical ventilation time and intensive care unit stays when treated with levosimendan, although differences exist between the populations assigned to each intervention. In conclusion, levosimendan, compared to milrinone, appears to offer better hemodynamic favorability in patients undergoing cardiac surgery. However, additional research is necessary to further understand its impact on hemodynamic outcomes, mortality, intensive care unit, and hospital stays in patients with cardiogenic shock of both ischemic and non-ischemic etiologies, as well as septic shock.</p>","PeriodicalId":15281,"journal":{"name":"Journal of Cardiovascular Pharmacology and Therapeutics","volume":"29 ","pages":"10742484241276431"},"PeriodicalIF":2.5,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142154210","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Thanks to Reviewers.","authors":"","doi":"10.1177/10742484231155320","DOIUrl":"https://doi.org/10.1177/10742484231155320","url":null,"abstract":"","PeriodicalId":15281,"journal":{"name":"Journal of Cardiovascular Pharmacology and Therapeutics","volume":"28 ","pages":"10742484231155320"},"PeriodicalIF":2.6,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9191533","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Cardioprotection and its Translation: A Need for New Paradigms? Or for New Pragmatism? An Opinionated Retro- and Perspective.","authors":"Gerd Heusch","doi":"10.1177/10742484231179613","DOIUrl":"https://doi.org/10.1177/10742484231179613","url":null,"abstract":"<p><p>The dawn of cardioprotection by infarct size reduction originated from the idea to favourably alter the oxygen demand-supply balance of the ischaemic/infarcting myocardium by reducing the contractile determinants of its oxygen consumption. This idea is probably not correct, since the ischaemic/infarcting myocardium does not contract anyway. None of the successful initial preclinical attempts of infarct size reduction translated into clinical practice, except for timely reperfusion which has become and still is the backbone of all clinical infarct therapy up today. The idea of cardioprotection gained momentum again with the recognition of ischaemic conditioning, and a myriad of preclinical studies have identified molecules and mechanisms of such self-defence mechanism. Although there are positive clinical proof-of-concept studies, ischaemic conditioning strategies and drugs related to its signal transduction have not translated into clinical practice. We are currently trying to understand the obstacles to translation from successful preclinical studies on cardioprotection to clinical practice, but are also waiting for an innovative mechanistic breakthrough.</p>","PeriodicalId":15281,"journal":{"name":"Journal of Cardiovascular Pharmacology and Therapeutics","volume":"28 ","pages":"10742484231179613"},"PeriodicalIF":2.6,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9998160","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Qi Lou, Luyifei Li, Guangzhong Liu, Tiankai Li, Li Zhang, Yanxiang Zang, Chengchuang Zhan, Hong Wang, Weimin Li
{"title":"Vericiguat reduces electrical and structural remodeling in a rabbit model of atrial fibrillation.","authors":"Qi Lou, Luyifei Li, Guangzhong Liu, Tiankai Li, Li Zhang, Yanxiang Zang, Chengchuang Zhan, Hong Wang, Weimin Li","doi":"10.1177/10742484231185252","DOIUrl":"https://doi.org/10.1177/10742484231185252","url":null,"abstract":"<p><p><b>Purpose:</b> The molecular etiology of atrial fibrillation (AF) and its treatment are poorly understood. AF involves both electrical and structural features. Vericiguat can ameliorate cardiac remodeling in heart failure. The effects of vericiguat on AF, however, are unclear. Here, the actions of vericiguat on atrial structural and electrical remodeling in AF and its possible mechanisms were investigated. <b>Methods and Results:</b> Thirty-six rabbits were randomly allocated to four groups, namely, sham, RAP (pacing with 600 beats/min over three weeks), vericiguat-treated (three weeks' pacing plus daily oral dose of 1.5 mg/kg of vericiguat), and vericiguat-treated only. HL-1 cells received rapid pacing with or without vericiguat. Parameters including electrophysiology, echocardiography, histology, Ca<sup>2+</sup> levels, and I<sub>CaL</sub> density, as well as levels of TRPC6, CaN, NFAT4, p-NFAT4, Cav1.2, collagen I, collagen III, and ST2 were measured. Significant changes of above proteins expression level, circulating biochemical indices, Ca<sup>2+</sup> concentrations, and I<sub>CaL</sub> density in both animals and cell models, these effects were significantly restored by vericiguat. Vericiguat also reversed the enlarged atrium and significantly reduced myocardial fibrosis, together with preventing reduced atrial effective refractory periods (AERPs) and AF induction rate. <b>Conclusion:</b> Vericiguat thus ameliorated AF-associated structural and electrical remodeling. These findings suggest the potential of vericiguat for treating AF.</p>","PeriodicalId":15281,"journal":{"name":"Journal of Cardiovascular Pharmacology and Therapeutics","volume":"28 ","pages":"10742484231185252"},"PeriodicalIF":2.6,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9857269","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Noor Muhammad Azlan Shah Bin Atan, Mohd Firdaus Bin Hadi, Victoria Wen Yeng Teoh, Mahmoud Danaee, Alexander Loch
{"title":"ARNI Versus Perindopril for Remodeling in HFrEF. A Cohort Study.","authors":"Noor Muhammad Azlan Shah Bin Atan, Mohd Firdaus Bin Hadi, Victoria Wen Yeng Teoh, Mahmoud Danaee, Alexander Loch","doi":"10.1177/10742484231195019","DOIUrl":"10.1177/10742484231195019","url":null,"abstract":"<p><p><b>Introduction:</b> Ventricular remodeling is a mal-adaptive process. Both angiotensin-converting enzyme inhibitors and sacubitril/valsartan have been shown to reverse remodeling in mostly uncontrolled observational studies. There is a lack of head-to-head studies. <b>Methods:</b> This cohort study compares the remodeling effects of angiotensin receptor blockers combined with a neprilysin inhibitor (ARNI) and perindopril in heart failure with reduced ejection fraction (HFrEF) patients between January 2017 and December 2020. Inclusion criteria: (i) age > 18 years, (ii) recent diagnosis of de-novo HFrEF (EF < 40%), (iii) baseline echocardiography performed not more than 2 months prior to treatment onset, and (iv) follow-up echocardiography performed not earlier than 6 months and not later than 18 months posttreatment onset. No prior treatment with renin-angiotensin-aldosterone system inhibitors was permitted in the ARNI group. Left ventricular ejection fraction (LVEF), left ventricular end-diastolic volume (LVEDV), and left ventricular end-systolic volume (LVESV) were analyzed. A two-way repeated measure ANOVA (for normally distributed) and generalized estimating equation test for nonnormally distributed interval dependent variables. Mean comparison between and within groups was performed using the Bonferroni test. <b>Results:</b> Following an average treatment period of 9 months, LVEF improved from 24.9% to 36.4% for ARNI and from 28.7% to 40.5% for perindopril, increments of 11.5% and 11.8% resp. (Bonferroni test [<i>P</i> ≤ .05]). LVEDV was reduced by 8.4 mL and 3.2 mL, and LVESV by 17.9 mL and 10.8 mL for ARNI and perindopril resp. Only the reduction of LVESV for ARNI was statistically significant (<i>P</i> = .007). <b>Conclusion:</b> Both ARNI and perindopril yielded a significant improvement in the LVEF within 9 months. The remodeling effect of ARNI seems stronger because of the greater improvements in left ventricular volumes.</p>","PeriodicalId":15281,"journal":{"name":"Journal of Cardiovascular Pharmacology and Therapeutics","volume":"28 ","pages":"10742484231195019"},"PeriodicalIF":2.6,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10087600","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jia Cheng, Lin Qiu, Zixuan Zhang, Na Li, Hongyang Shu, Zhichao Xiao, Ning Zhou
{"title":"Combination of Nicorandil and Beta-Adrenergic Receptor Blockers in Patients with Coronary Artery Disease: A Real-World Observational Study.","authors":"Jia Cheng, Lin Qiu, Zixuan Zhang, Na Li, Hongyang Shu, Zhichao Xiao, Ning Zhou","doi":"10.1177/10742484231197559","DOIUrl":"10.1177/10742484231197559","url":null,"abstract":"<p><strong>Background: </strong>The effect of combined nicorandil and beta-adrenergic receptor blockers (BBs) compared with that of BBs alone on long-term clinical outcomes in patients with coronary artery disease (CAD) remains undetermined.</p><p><strong>Methods: </strong>A multicenter retrospective cohort study was performed. Adult patients who had been hospitalized for CAD and treated for angina with a combination of nicorandil and BBs or BBs alone were included. The effect of different treatments on the cumulative incidence of major adverse cardiovascular event (MACE) and their components within a follow-up duration of 2.5 years were analyzed using Kaplan-Meier survival curves. An inverse probability of treatment weighting (IPTW) method was used to adjust for the possible effect of confounding factors.</p><p><strong>Results: </strong>A total of 137,714 patients were screened, of whom 16,912 individuals (mean age: 61.5 years, men: 67.1%) were successfully enrolled. Among the enrolled participants, 4669 received the combined treatment of nicorandil and BBs, while 12,243 received BBs alone. After IPTW, the results demonstrated that the combined treatment was associated with a significantly reduced incidence of MACE (hazard ratio [HR] 0.79, 95% conidence interval [CI] 0.72-0.87) and stroke (HR 0.48, 95% CI 0.42-0.54) but not of MI (HR 1.03, 95% CI 0.92-1.15) or all-cause mortality (HR 0.93, 95% CI 0.64-1.37). Sensitivity analyses revealed similar results.</p><p><strong>Conclusions: </strong>A combined antiangina treatment of nicorandil and BBs may be more effective than treatment of BBs alone in reducing the long-term incidence of MACE in patients with CAD.</p>","PeriodicalId":15281,"journal":{"name":"Journal of Cardiovascular Pharmacology and Therapeutics","volume":"28 ","pages":"10742484231197559"},"PeriodicalIF":2.6,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10149408","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Protective Effect of Nicorandil on Contrast-Induced Acute Kidney Injury After Emergency Percutaneous Coronary Intervention.","authors":"Zuo-Zhong Yu, Zheng-Xiong Xu, Yue-Hua Ruan, Long-Long Hu, Ming-Hua Wen, Tie-Qiu Huang, Zhi-Gang You, Yan-Qing Wu, Ren-Qiang Yang","doi":"10.1177/10742484231174296","DOIUrl":"https://doi.org/10.1177/10742484231174296","url":null,"abstract":"<p><p><b>Objective:</b> To investigate the protective effect of nicorandil on contrast-induced acute kidney injury (CIAKI) in patients with acute ST-segment elevation myocardial infarction (STEMI) after emergency percutaneous coronary intervention (PCI). <b>Methods:</b> This is a single-center, retrospective control study. A total of 156 patients with STEMI were divided into the nicorandil group (n = 55) and the control group (n = 101). The incidence of CIAKI, defined as an increase of >25% or absolute values > 44.2 μmol/L in serum creatinine (Scr) from baseline within 72 h of exposure to a contrast agent after exclusion of other causes, was the primary endpoint. The secondary endpoints were: (1) changes of Scr, estimated glomerular filtration rate (eGFR), uric acid, and β2-microglobulin at 24/48/72 h and 5 to 7 days after PCI; (2) the peak value difference of creatine kinase isoenzymes (CK-MB) after PCI; (3) adverse events within 6 months after PCI. <b>Results:</b> The overall incidence of CIAKI was 21.8%; the incidence of CIAKI in the nicorandil group was significantly lower (12.7% [7/55]) than in the control group (26.7% [27/101]) (<i>P</i> = .043). Compared with the control group, Scr, uric acid, and β2-microglobulin levels were lower, and the level of eGFR was higher in nicorandil group (<i>P</i> all < .05). The peak value of CK-MB in the nicorandil group was lower than that in the control group (105.30 [56.61, 232.04] vs 178.00 [77.08, 271.91]U/L, <i>P</i> = .042). There was no significant difference in adverse events between the 2 groups within 6 months after PCI. Moreover, multivariate logistic regression analysis showed that hypertension and diabetes were independent risk factors for CIAKI, while nicorandil treatment was a protective factor. <b>Conclusion:</b> Our data suggest that intravenous nicorandil after emergency PCI has a protective effect on the occurrence of CIAKI in STEMI patients.</p>","PeriodicalId":15281,"journal":{"name":"Journal of Cardiovascular Pharmacology and Therapeutics","volume":"28 ","pages":"10742484231174296"},"PeriodicalIF":2.6,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9626291","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Byung Jin Kim, Kwang Soo Cha, Wook Hyun Cho, Eung Ju Kim, Seung-Hyuk Choi, Moo Hyun Kim, Sang-Hyun Kim, Jun-Bean Park, Seong-Mi Park, Il Suk Sohn, Kyu Hyung Ryu, In-Ho Chae
{"title":"Efficacy and Safety of a Single-Pill Triple Combination of Olmesartan, Amlodipine, and Rosuvastatin in Hypertensive Patients with Low-to-Moderate Cardiovascular Risk: A Multicenter, Randomized, Open-Label, Active-Control, Phase IV Clinical Trial.","authors":"Byung Jin Kim, Kwang Soo Cha, Wook Hyun Cho, Eung Ju Kim, Seung-Hyuk Choi, Moo Hyun Kim, Sang-Hyun Kim, Jun-Bean Park, Seong-Mi Park, Il Suk Sohn, Kyu Hyung Ryu, In-Ho Chae","doi":"10.1177/10742484231205204","DOIUrl":"10.1177/10742484231205204","url":null,"abstract":"<p><strong>Introduction: </strong>This study evaluated the efficacy and safety of a single-pill triple-combination of olmesartan/amlodipine/rosuvastatin (Olme/Amlo/Rosu) in comparison with a single-pill dual-combination of olmesartan/amlodipine (Olme/Amlo) in hypertensive patients with low-to-moderate cardiovascular risk.</p><p><strong>Methods: </strong>This multicenter, active-control, randomized study included 106 hypertensive patients at low-to-moderate cardiovascular risk who were randomly assigned to receive either Olme/Amlo/Rosu 20/5/5 mg (Treatment 1), Olme/Amlo/Rosu 20/5/10 mg (Treatment 2), or Amlo/Olme 20/5 mg (Control) once daily for 8 weeks. The primary endpoint was the difference of the percent change in low-density lipoprotein cholesterol (LDL-C) level at 8 weeks from baseline in the 3 groups.</p><p><strong>Results: </strong>The difference in the least square mean percent change (standard deviation) of LDL-C in the Treatment 1 and 2 groups compared with the Control group at 8 weeks was -32.6 (3.7) % and -45.9 (3.3) %, respectively (<i>P</i> < .001). The achievement rates of LDL-C level <100 mg/dL at 8 weeks were significantly different between the 3 groups (65.8%, 86.7%, and 6.3% for Treatment 1, 2, and Control groups, respectively, <i>P</i> < .001). The results of total cholesterol, triglycerides, high-density lipoprotein cholesterol, apolipoprotein B, and apolipoprotein B/apolipoprotein A1 were superior in the Treatment 1 and 2 groups compared with the Control group. Serious adverse drug reaction did not occur in the 3 groups. Medication adherence rates were excellent in the 3 groups (98.0% for Treatment 1 group, 99.7% for Treatment 2 group, and 96.3% for the Control group, <i>P</i> > .05).</p><p><strong>Conclusion: </strong>Single-pill triple-combination of olmesartan/amlodipine/rosuvastatin was superior to the single-pill dual-combination of amlodipine/olmesartan in LDLC-lowering effects, with excellent safety profiles and adherence rates, in hypertensive patients at low-to-moderate cardiovascular risk.<b>Trial Registration:</b> CLinicalTrials.gov identifier NCT04120753.</p>","PeriodicalId":15281,"journal":{"name":"Journal of Cardiovascular Pharmacology and Therapeutics","volume":"28 ","pages":"10742484231205204"},"PeriodicalIF":2.6,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41182653","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}