American Journal of Cardiovascular Drugs最新文献

{"title":"Safety of Vericiguat in Patients with Coronary Artery Disease: A Systematic Review and Meta-analysis","authors":"Mohamed Bin Zarti,&nbsp;Amna Tamgheli","doi":"10.1007/s40256-024-00701-0","DOIUrl":"10.1007/s40256-024-00701-0","url":null,"abstract":"<div><h3>Objective</h3><p>This study aimed to investigate the safety of vericiguat in patients with coronary artery disease.</p><h3>Methods</h3><p>We conducted a comprehensive literature review of the PubMed, ClinicalTrials.gov, and Cochrane Library databases up to 27 March 2024. We included studies that compared vericiguat with placebo in patients with coronary artery disease. Clinical data were extracted, and adverse events were analyzed using Review Manager software (version 5.4) after conducting a quality assessment of the enrolled studies.</p><h3>Results</h3><p>Three randomized controlled trials involving 151 patients were included in this meta-analysis. Compared with the placebo group, vericiguat treatment resulted in a decrease in systolic blood pressure by 1.4–10 mmHg and diastolic blood pressure by 0.4–6 mmHg, along with an increase in heart rate by 1.8–7 bpm, all of which are clinically insignificant. Vericiguat treatment demonstrated no significant serious adverse events [odds ratio (OR) = 1.97; 95% confidence interval (CI) = 0.39–9.91; <i>P</i> = 0.41]. However, a significant difference in adverse events between the two groups was noted (OR = 4.04; 95% CI = 2.17–7.52; <i>P</i> &lt; 0.001).</p><h3>Conclusion</h3><p>This meta-analysis suggests that vericiguat is a safe drug for use in patients with coronary artery disease; however, further clinical trials are needed to validate these findings.</p><h3>Registration</h3><p>The study protocol has been prospectively registered in PROSPERO (CRD42024528105).</p></div>","PeriodicalId":7652,"journal":{"name":"American Journal of Cardiovascular Drugs","volume":"25 2","pages":"241 - 248"},"PeriodicalIF":2.8,"publicationDate":"2024-12-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142790941","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":"A Systematic Review and Meta-Analysis of the Safety and Efficacy of SGLT2 Inhibitors in Chronic Heart Failure in ACHD Patients","authors":"Bibhuti B. Das,&nbsp;Jianli Niu","doi":"10.1007/s40256-024-00697-7","DOIUrl":"10.1007/s40256-024-00697-7","url":null,"abstract":"<div><h3>Background</h3><p>Sodium-glucose cotransporter 2 inhibitors (SGLT2is) have become a first-line therapy for heart failure (HF) in adults. However, data on their use in HF associated with adult congenital heart disease (ACHD) are limited. This systematic review and meta-analysis evaluated the safety, tolerability, and efficacy of SGLT2is in ACHD HF patients, supplementing guideline-directed medical therapy.</p><h3>Methods</h3><p>A comprehensive systematic search and meta-analysis were conducted on studies examining SGLT2i use in ACHD HF patients. The primary endpoint was the change in the New York Heart Association (NYHA) functional class (FC), with secondary endpoints including changes in ventricular function and N-terminal pro B-type natriuretic peptide (NT-proBNP) levels. Additionally, the safety and tolerability of SGLT2is were evaluated.</p><h3>Results</h3><p>The meta-analysis included eight studies with 287 patients aged 19–67 years (median age 37.5 years). Adding SGLT2is to combined therapies significantly improved NYHA FC (log odds ratio 1.3, 95% confidence interval [CI] 0.37–2.23, <i>p</i> = 0.01) and reduced NT-proBNP levels (mean difference [MD] −0.43, 95% CI −0.70 to −0.16, <i>p</i> &lt; 0.001). A notable decrease in systolic blood pressure was observed (MD −0.32, 95% CI −0.51 to −0.14, <i>p</i> = 0.00). The adverse effect profile was comparable to that seen in routine HF, with fewer HF hospitalizations post-SGLT2i initiation. Urinary tract infections occurred in 14 patients (5%), with no instances of hypoglycemia or ketoacidosis reported. Medication withdrawal due to adverse effects was noted in 19 patients (7%).</p><h3>Conclusions</h3><p>SGLT2is are well tolerated in ACHD HF patients. Notably, SGLT2is improved NYHA FC and reduced NT-proBNP levels across a diverse ACHD HF patient cohort. However, further prospective, multicenter studies are needed to confirm the safety and efficacy of SGLT2is in this unique patient population.</p></div>","PeriodicalId":7652,"journal":{"name":"American Journal of Cardiovascular Drugs","volume":"25 2","pages":"231 - 240"},"PeriodicalIF":2.8,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s40256-024-00697-7.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142765554","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Role of Incretin Mimetics in Cardiovascular Outcomes and Other Classical Cardiovascular Risk Factors beyond Obesity and Diabetes Mellitus in Nondiabetic Adults with Obesity: a Meta-analysis of Randomized Controlled Trials","authors":"William Kamarullah,&nbsp;Raymond Pranata,&nbsp;Siska Wiramihardja,&nbsp;Badai Bhatara Tiksnadi","doi":"10.1007/s40256-024-00695-9","DOIUrl":"10.1007/s40256-024-00695-9","url":null,"abstract":"<div><h3>Background</h3><p>Emerging data on cardiovascular outcomes, specifically major adverse cardiovascular events (MACE), are being reported from various trials involving incretin mimetics, such as glucagon-like peptide-1 receptor agonists (GLP-1 RA) and glucose-dependent insulinotropic polypeptide (GIP), especially among patients with obesity and diabetes. Our aim was to evaluate this matter, while also involving various traditional cardiovascular risk factors [e.g., several body weight (BW) parameters, blood pressure (BP), lipid profile].</p><h3>Methods</h3><p>A search of PubMed, Europe PMC, ScienceDirect, Cochrane, and ClinicalTrials.gov up to September 2024 was performed to identify GLP-1 RA and GIP trials in MACE risk reduction as a primary endpoint. Our secondary endpoints included a reduction in BW, waist circumference (WC), body mass index (BMI), BP changes, and lipid modifying effects, while also yielding safety concerns surrounding the use of these pharmaceutical agents. Mean differences (MD) and risk ratios (RR) were summarized using random-effects model.</p><h3>Results</h3><p>A total of 11 eligible randomized controlled trials (RCTs) comprising 8 GLP-1 RA trials and 3 dual GLP-1 RA/GIP (tirzepatide) trials were included. Compared with control groups, GLP-1 RA significantly reduced the MACE risk by 32% [RR 0.68 (95% CI 0.53–0.87); <i>P</i> = 0.002; <i>I</i>² = 73%, <i>P</i>-heterogeneity &lt; 0.001] and 59% for tirzepatide [RR 0.41 (95% CI 0.18–0.92); <i>P</i> = 0.03; <i>I</i>² = 0%, <i>P</i>-heterogeneity = 0.96]. Incretin mimetics also substantially reduced BW, BP, and improved lipid panel measures. However, there was an increased risk of adverse events, specifically gastrointestinal disorders within the incretin mimetics subset.</p><h3>Conclusions</h3><p>Incretin mimetics have shown promise in reducing MACE risk while also enhancing cardiovascular risk factors, including blood pressure and lipid profile, in adults with obesity without diabetes.</p></div>","PeriodicalId":7652,"journal":{"name":"American Journal of Cardiovascular Drugs","volume":"25 2","pages":"203 - 229"},"PeriodicalIF":2.8,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142765555","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":"A Meta-analysis of the Regulation of Low-Density Lipoprotein Cholesterol and Proprotein Convertase Subtilisin-Kexin Type 9 with Inclisiran","authors":"Yihan Li,&nbsp;Kefan Xue,&nbsp;Rui Hu,&nbsp;Xiao Hu,&nbsp;Ran Guo,&nbsp;Hongxia Guo,&nbsp;Gang Li","doi":"10.1007/s40256-024-00702-z","DOIUrl":"10.1007/s40256-024-00702-z","url":null,"abstract":"<div><h3>Objective</h3><p>This study aimed to systematically evaluate the regulation of low-density lipoprotein cholesterol (LDL-C) and proprotein convertase subtilisin-kexin type 9 (PCSK9) with inclisiran using a meta-analysis.</p><h3>Methods</h3><p>A comprehensive search of PubMed, Embase, the Cochrane Library, and Web of Science was conducted for randomized controlled trials of inclisiran published up to April 2024. Stata software was used for statistical analysis of outcome indicators from the included studies. Egger’s test was employed to assess the risk of publication bias.</p><h3>Results</h3><p>A total of 10 studies involving 5208 participants were included in this meta-analysis. The results indicated that inclisiran significantly reduced LDL-C levels (weighted mean difference [WMD] − 48.17%; 95% confidence interval [CI] − 51.78 to − 44.56%; <i>P</i> &lt; 0.01) and PCSK9 levels (WMD − 77.91%; 95% CI − 82.99 to − 72.84; <i>P</i> &lt; 0.01) compared with the control group. The incidence of adverse reactions in the inclisiran group did not differ significantly from that in the placebo group (relative risk [RR] 1.03; 95% CI 0.99–1.09; <i>P</i> = 0.15). Similarly, there was no significant difference in the incidence of cardiovascular adverse events between the inclisiran and placebo groups (RR 0.92; 95% CI 0.74–1.16;<i> P</i> = 0.49). Sensitivity analysis showed that the exclusion of any single study did not significantly affect the final results.</p><h3>Conclusion</h3><p>Current evidence suggests that inclisiran significantly lowers LDL-C and PCSK9 levels. The incidence of adverse events and cardiovascular adverse events was not significantly different from that with other drugs.</p></div>","PeriodicalId":7652,"journal":{"name":"American Journal of Cardiovascular Drugs","volume":"25 2","pages":"191 - 201"},"PeriodicalIF":2.8,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142754571","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":"Real-Life Individual Comparison of Sodium-Glucose Cotransporter-2 Inhibitors in Patients with Heart Failure and Diabetes Mellitus","authors":"Mehmet Birhan Yilmaz,&nbsp;Ahmet Celik,&nbsp;Tugce Colluoglu,&nbsp;Anil Sahin,&nbsp;Dilek Ural,&nbsp;Arzu Kanik,&nbsp;Naim Ata,&nbsp;Mustafa Mahir Ulgu,&nbsp;Şuayip Birinci","doi":"10.1007/s40256-024-00698-6","DOIUrl":"10.1007/s40256-024-00698-6","url":null,"abstract":"<div><h3>Background</h3><p>Sodium-glucose cotransporter-2 inhibitors (SGLT2is) are breakthrough agents for the treatment of type 2 diabetes mellitus (T2DM) and heart failure (HF). However, among patients with HF and T2DM, some uncertainty remains about individual comparisons, including dosing.</p><h3>Objectives</h3><p>We aimed to make a real-life individual comparison of SGLT2is among patients with HF and T2DM.</p><h3>Methods</h3><p>This was a subgroup analysis of the Turkish Ministry of Health’s National Electronic Database for adult patients with HF (TRends-HF). All-cause mortality (ACM) data up to 7 years were evaluated. Patients with HF and T2DM who were prescribed an SGLT2i were identified, and individual doses of empagliflozin 25 mg, empagliflozin 10 mg, and dapagliflozin 10 mg were compared. For individual comparisons, propensity score-matching analysis was generated as 1:1:1, and disease-modifying therapies (DMTs) for HF were considered.</p><h3>Results</h3><p>In the triple-matched cohort, 1-, 5-, and 7-year survival rates were 95%, 81%, and 76% versus 94%, 78%, and 72% versus 94%, 80%, and 75% for empagliflozin 25 mg, empagliflozin 10 mg, and dapagliflozin 10 mg, respectively. Among patients who were on triple DMT for HF, 1-, 5-, and 7-year survival rates were 95%, 78%, and 70% for empagliflozin 25 mg, 95%, 74%, and 66% for empagliflozin 10 mg, and 94%, 77%, and 69% for dapagliflozin, respectively. Annual emergency department visits were slightly lower with empagliflozin 10 mg and dapagliflozin 10 mg than with empagliflozin 25 mg. A greater proportion of patients on dapagliflozin 10 mg did not experience hospitalization during the 7-year follow-up compared with both doses of empagliflozin, albeit with a small effect size.</p><h3>Conclusion</h3><p>Among patients with HF and T2DM, SGLT2is are instrumental, and empagliflozin 10 mg remains significantly inferior to dapagliflozin 10 mg and empagliflozin 25 mg in terms of 5- and 7-year ACM.</p></div>","PeriodicalId":7652,"journal":{"name":"American Journal of Cardiovascular Drugs","volume":"25 2","pages":"277 - 286"},"PeriodicalIF":2.8,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142749794","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":"Impact of Renal Function Estimation Formulae on Use and Correct Dosing of NOACs in Patients with Non-valvular Atrial Fibrillation in Real Life in Germany","authors":"Uwe Zeymer,&nbsp;Thomas Riemer,&nbsp;Ulrich Wolf,&nbsp;Steffen Schaefer,&nbsp;Jens Taggeselle,&nbsp;Hans-Joachim Kabitz,&nbsp;Roland Prondzinsky,&nbsp;Tim Süselbeck,&nbsp;Thomas Kleemann,&nbsp;Ralf Zahn,&nbsp;Tobias Heer","doi":"10.1007/s40256-024-00700-1","DOIUrl":"10.1007/s40256-024-00700-1","url":null,"abstract":"","PeriodicalId":7652,"journal":{"name":"American Journal of Cardiovascular Drugs","volume":"25 2","pages":"287 - 291"},"PeriodicalIF":2.8,"publicationDate":"2024-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142715022","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":"Prevention of New-Onset Heart Failure in Atrial Fibrillation: The Role of Pharmacological Management","authors":"Amirreza Zobdeh,&nbsp;Daniel J. Hoyle,&nbsp;Pankti Shastri,&nbsp;Woldesellassie M. Bezabhe,&nbsp;Gregory M. Peterson","doi":"10.1007/s40256-024-00703-y","DOIUrl":"10.1007/s40256-024-00703-y","url":null,"abstract":"<div><p>Atrial fibrillation (AF) is the most common type of chronic arrythmia, with a lifetime prevalence of one in every three to five individuals above the age of 45 years. The higher heart rate, abnormal rhythm and inflammation caused by AF lead to changes in the function and structure of the heart. This, over time, can culminate in heart failure. In patients with AF, the lifetime prevalence of new-onset heart failure is twice that of stroke. The development of new-onset heart failure in AF is associated with high mortality. Despite the emphasis that AF guidelines put on preventing cardiovascular comorbidities, there is limited evidence regarding pharmacological therapies to prevent incident heart failure in individuals with AF. Specifically, the association between the use of rate control agents and incident heart failure in this population is unknown. Whilst rhythm control may reduce the risk of heart failure, the comparative effect of each pharmacological agent is not clear. In select subgroups of patients with AF, the choice of direct-acting oral anticoagulants and their optimal dosing has been attributed to a lower risk of new-onset heart failure. Future research is needed to identify an evidence-based approach to minimizing the development of heart failure in patients with AF.</p></div>","PeriodicalId":7652,"journal":{"name":"American Journal of Cardiovascular Drugs","volume":"25 2","pages":"147 - 155"},"PeriodicalIF":2.8,"publicationDate":"2024-11-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142709000","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":"Cardiovascular Safety of Patisiran Among Transthyretin Cardiac Amyloidosis: A Meta-analysis","authors":"Vikash Jaiswal,&nbsp;Kriti Kalra,&nbsp;Novonil Deb,&nbsp;Jishanth Mattumpuram","doi":"10.1007/s40256-024-00699-5","DOIUrl":"10.1007/s40256-024-00699-5","url":null,"abstract":"","PeriodicalId":7652,"journal":{"name":"American Journal of Cardiovascular Drugs","volume":"25 1","pages":"125 - 127"},"PeriodicalIF":2.8,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142692615","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":"Cost Effectiveness of Catheter Ablation Versus Antiarrhythmic Drugs for Atrial Fibrillation: A Systematic Review and Meta-analysis","authors":"Luxzup Wattanasukchai,&nbsp;Tunlaphat Bubphan,&nbsp;Montarat Thavorncharoensap,&nbsp;Sitaporn Youngkong,&nbsp;Usa Chaikledkaew,&nbsp;Ammarin Thakkinstian","doi":"10.1007/s40256-024-00693-x","DOIUrl":"10.1007/s40256-024-00693-x","url":null,"abstract":"<div><h3>Background</h3><p>Atrial fibrillation (AF) is the most prevalent cardiac arrhythmia and is associated with substantial morbidity and mortality. Current international guidelines recommend antiarrhythmic drugs or catheter ablation (CA) as rhythm-control strategies for AF. This study aimed to comprehensively assess economic evaluations (EEs) of the treatment of AF by country income level.</p><h3>Methods</h3><p>Seven electronic databases were systematically searched for EE literature until March 30, 2024, with no constraints on time or language. Two independent reviewers selected the studies, extracted the data, and assessed the quality of the data. Full EEs comparing CA with antiarrhythmic drugs for rhythm-control treatment were included; surgical or rate-control treatments were excluded. The quality of the included articles was assessed using the ECOBIAS checklist. Costs were converted to purchasing power parity US dollars for 2023. A random-effects meta-analysis was applied to pool incremental net benefit (INB) based on a heterogeneity test and its degree (<i>I</i>² &gt; 25% or Cochran’s <i>Q</i> test &lt; 0.1). We also explored heterogeneity and potential publication bias and conducted sensitivity and subgroup analyses.</p><h3>Results</h3><p>In total, 27 studies across nine countries were eligible, predominantly from high-income countries (<i>n</i> = 25), with a smaller subset from upper-middle-income countries (<i>n</i> = 2). Because of the heterogeneity among the studies, a random-effects model was selected over a fixed-effects model to pool INBs. Most studies (<i>n</i> = 21) favored CA as the cost-effective intervention, yielding an INB of $US23,796 (95% confidence interval [CI] 15,341–32,251) in high-income countries. However, heterogeneity was substantial (<i>I</i>² = 99.67%). In upper-middle-income countries, the estimated INB was $US18,330 (95% CI − 11,900–48,526). The publication bias results showed no evidence of asymmetrical funnel plots.</p><h3>Conclusion</h3><p>In this meta-analysis, CA emerged as a cost-effective rhythm-control treatment for AF when compared with antiarrhythmic drugs, particularly in high-income countries. However, economic evidence for upper-middle-income countries is lacking, and no primary evaluations were found for low-middle-income and low-income countries. Further EEs are necessary to expand the understanding of AF treatment globally.</p></div>","PeriodicalId":7652,"journal":{"name":"American Journal of Cardiovascular Drugs","volume":"25 2","pages":"169 - 189"},"PeriodicalIF":2.8,"publicationDate":"2024-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s40256-024-00693-x.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142680666","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacokinetic Drug–Drug Interaction between Cilostazol and Rosuvastatin in Healthy Participants","authors":"Dong Ho Kim,&nbsp;Jang Hee Hong,&nbsp;Won Tae Jung,&nbsp;Kyu-Yeol Nam,&nbsp;Jae Seok Roh,&nbsp;Hye Jung Lee,&nbsp;JungHa Moon,&nbsp;Kyu Yeon Kim,&nbsp;Jin-Gyu Jung,&nbsp;Jung Sunwoo","doi":"10.1007/s40256-024-00686-w","DOIUrl":"10.1007/s40256-024-00686-w","url":null,"abstract":"<div><h3>Background and Objectives</h3><p>Cilostazol improves ischemic symptoms and prevents recurrence following cerebral infarction, and rosuvastatin reduces cholesterol levels. However, no reports exist on the pharmacokinetic interactions between these two drugs in healthy adults. This study evaluated the pharmacokinetic (PK) interactions and safety of cilostazol and rosuvastatin when co-administered to healthy male participants.</p><h3>Methods</h3><p>A randomized, open-label, multiple-dosing, two-arm, two-period study was conducted. Arm A had 30 participants receiving 200 mg cilostazol daily and arm B had 27 participants receiving 20 mg rosuvastatin daily for 7 days. In period 2, both arms received a combination of 200 mg cilostazol and 20 mg rosuvastatin daily for 7 days following a 7-day washout period. Plasma concentrations of cilostazol, its metabolites, and rosuvastatin were quantified using liquid chromatography–tandem mass spectrometry.</p><h3>Results</h3><p>Fifty-seven participants were randomized, and 44 completed the study. The geometric mean ratio (GMR) and 90% confidence intervals (CI) for maximum plasma concentration at steady state (<i>C</i>_max,ss) and area under the plasma concentration–time curve during the dosing interval at steady state (AUC_tau,ss) indicated no significant interaction between cilostazol and rosuvastatin. Safety assessments showed comparable profiles to individual drug administration, with no significant adverse events.</p><h3>Conclusion</h3><p>The repeated co-administration of cilostazol and rosuvastatin in healthy male participants resulted in minor PK interactions and exhibited a safety and tolerability profile similar to those of the individual drugs. This suggested that the combined regimen is well tolerated and does not necessitate dose adjustments.</p><h3>Registration</h3><p>ClinicalTrials.Gov identifier no. NCT06568133.</p></div>","PeriodicalId":7652,"journal":{"name":"American Journal of Cardiovascular Drugs","volume":"25 2","pages":"267 - 276"},"PeriodicalIF":2.8,"publicationDate":"2024-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142563761","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}