{"title":"Risk of Suicide, Hair Loss, and Aspiration with GLP1-Receptor Agonists and Other Diabetic Agents: A Real-World Pharmacovigilance Study","authors":"Michael Nakhla, Ambica Nair, Prachi Balani, Aditi Ujjawal, Pramukh Arun Kumar, Mahati Dasari, Zeynep Yukselen, Kannu Bansal, Sarju Ganatra, Sourbha S. Dani","doi":"10.1007/s10557-024-07613-w","DOIUrl":"https://doi.org/10.1007/s10557-024-07613-w","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Purpose</h3><p>With the increasing popularity of glucagon-like peptide 1 receptor agonists (GLP1-RAs), numerous safety concerns arose pertaining to suicide, hair loss, and aspiration risks. We attempted to validate these concerns.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>We queried four pharmacovigilance databases to compare GLP1-RAs to sodium-glucose transporter 2 inhibitors (SGLT2is) with respect to these adverse events (AE): the FDA Adverse Event Reporting System (FAERS), the Australian Database of Adverse Event Notifications (DAEN), the European Medicines Agency’s (EudraVigilance), and the World Health Organization-Vigibase. OpenVigil 2.1 was utilized to perform a disproportionality analysis for GLP1-RAs, SGLT2is, dipeptidyl peptidase 4 inhibitors (DPP4is), sulfonylureas, metformin, and insulin. The following indices were extracted from the FAERS database from Q4/2003 until Q3/2023: relative reporting ratio (RRR), proportional reporting ratio (PRR), reporting odds ratio (ROR), and chi-squared (<i>χ</i><sup>2</sup>). A positive signal was detected if PRR > 2 and <i>χ</i><sup>2</sup> > 4 for any drug-event pair.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>No positive signals were observed between GLP1-RAs and either suicide, hair loss, or aspiration risks. Semaglutide [ROR = 0.60 (0.51–0.71)] and liraglutide [ROR = 0.28 (0.23–0.35)] had higher suicidal events than DPP4is and SGLT2is. GLP1-RAs were the most reported class with hair loss [ROR = 0.61 (0.60–0.64)], and semaglutide, liraglutide, and dulaglutide were the three leading medications. GLP1-RAs ranked lower with aspiration events, which were led by sitagliptin and DPP4is as a group.</p><h3 data-test=\"abstract-sub-heading\">Conclusion</h3><p>GLP1-RAs exhibit higher reporting of suicide, hair loss, and aspiration events when compared to several other antidiabetic medications despite not meeting the criteria for positive signals yet. This warrants intensive monitoring and reporting.</p><h3 data-test=\"abstract-sub-heading\">Graphical Abstract</h3>\u0000","PeriodicalId":9557,"journal":{"name":"Cardiovascular Drugs and Therapy","volume":"44 1","pages":""},"PeriodicalIF":3.4,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142182251","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Zeinab M. Elhadad, Amira B. Kassem, Ahmed Mahmoud El Amrawy, Ahmad Salahuddin, Noha A. El-Bassiouny
{"title":"Comparative Study Between the Effects of High Doses of Rosuvastatin and Atorvastatin on Ventricular Remodeling in Patients with ST-Segment Elevation Myocardial Infarction","authors":"Zeinab M. Elhadad, Amira B. Kassem, Ahmed Mahmoud El Amrawy, Ahmad Salahuddin, Noha A. El-Bassiouny","doi":"10.1007/s10557-024-07621-w","DOIUrl":"https://doi.org/10.1007/s10557-024-07621-w","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Background</h3><p>Most studies reported that treating ST-Elevation Myocardial Infarction (STEMI) patients with high doses of rosuvastatin or atorvastatin could improve left ventricular remodeling and cardiac function.</p><h3 data-test=\"abstract-sub-heading\">Purpose</h3><p>The current study compared the impact of high doses of rosuvastatin and atorvastatin on hypertrophy, fibrosis markers, serum inflammatory markers, and left ventricular function in STEMI patients after primary percutaneous coronary intervention (PCI).</p><h3 data-test=\"abstract-sub-heading\">Method</h3><p>After primary PCI, eighty STEMI patients were randomized to receive either 20 mg of rosuvastatin (<i>n</i> = 40) or 40 mg of atorvastatin (<i>n</i> = 40) once daily for 3 months. Soluble Suppression of Tumorigenicity-2 (sST2), Matrix Metalloproteinase-9 (MMP9), C-Reactive Protein (CRP), lipid parameters, liver enzymes, and echocardiographic parameters were assessed for the two groups at baseline and after 3 months.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>After 3 months of treatment, a statistically significant reduction was observed in the rosuvastatin group regarding the levels of CRP (16 ± 6 vs. 20 ± 10 mg/L, <i>P</i> = 0.024) and MMP9 (104 ± 33 vs. 130 ± 42 ng/L, <i>P</i> = 0.003) compared with the atorvastatin group. The median percentage decrease in sST2 level in the rosuvastatin group was higher (6.1%) than in the atorvastatin group (2.3%) after 3 months of treatment. Also, in the rosuvastatin group, LVEF was significantly increased (48.5 ± 9 vs. 43.5 ± 11%, <i>P</i> = 0.029), while LVEDV and LVESV were significantly decreased compared to those of the atorvastatin group (101 [81/135] vs. 134 [100/150] ml, <i>P</i> = 0.041) (53 [37/75] vs. 73 [52/92] ml, <i>P</i> = 0.033), respectively.</p><h3 data-test=\"abstract-sub-heading\">Conclusion</h3><p>High-intensity rosuvastatin was superior to high-intensity atorvastatin in reducing the inflammatory response and myocardial fibrosis, thus improving ventricular remodeling and cardiac function better in STEMI patients.</p><h3 data-test=\"abstract-sub-heading\">Trial Registration</h3><p>This randomized controlled trial was registered on October 11, 2022, on ClinicalTrials.gov under registration number: NCT05895123 “retrospectively registered”.</p>","PeriodicalId":9557,"journal":{"name":"Cardiovascular Drugs and Therapy","volume":"49 1","pages":""},"PeriodicalIF":3.4,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142182321","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Reading Tea Leaves: Epigallocatechin-3-Gallate for Targeting Atrial Fibrosis.","authors":"Adeniyi Gbenga Adeleye, Mihail G Chelu, Na Li","doi":"10.1007/s10557-024-07628-3","DOIUrl":"10.1007/s10557-024-07628-3","url":null,"abstract":"","PeriodicalId":9557,"journal":{"name":"Cardiovascular Drugs and Therapy","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142153181","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Clopidogrel: Drug of the Past or Drug of the Future?","authors":"Stefano De Servi, Antonio Landi","doi":"10.1007/s10557-024-07629-2","DOIUrl":"https://doi.org/10.1007/s10557-024-07629-2","url":null,"abstract":"","PeriodicalId":9557,"journal":{"name":"Cardiovascular Drugs and Therapy","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142153180","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Does One Size Fits All?","authors":"Vanessa Roldan, Juan Jose Badimon","doi":"10.1007/s10557-024-07625-6","DOIUrl":"https://doi.org/10.1007/s10557-024-07625-6","url":null,"abstract":"","PeriodicalId":9557,"journal":{"name":"Cardiovascular Drugs and Therapy","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142131946","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Danwei Shao, Joyce Mosha, Rajiv C Patel, Craig R Lee, George A Stouffer
{"title":"CYP2C19 Genotype-Guided Antiplatelet Therapy in Stroke Patients-Is It Ready for Prime Time?","authors":"Danwei Shao, Joyce Mosha, Rajiv C Patel, Craig R Lee, George A Stouffer","doi":"10.1007/s10557-024-07627-4","DOIUrl":"10.1007/s10557-024-07627-4","url":null,"abstract":"","PeriodicalId":9557,"journal":{"name":"Cardiovascular Drugs and Therapy","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142124916","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jiacheng Fang, Yuxuan Zhang, Yiyue Zheng, Delong Chen, Abuduwufuer Yidilisi, Rui Ji, Jianping Xiang, Xinyi Zhang, Jun Jiang
{"title":"Comparison of Ticagrelor with Clopidogrel on Coronary Microvascular Dysfunction Following Acute Myocardial Infarction Using Angiography-Derived Index of Microcirculatory Resistance.","authors":"Jiacheng Fang, Yuxuan Zhang, Yiyue Zheng, Delong Chen, Abuduwufuer Yidilisi, Rui Ji, Jianping Xiang, Xinyi Zhang, Jun Jiang","doi":"10.1007/s10557-024-07619-4","DOIUrl":"https://doi.org/10.1007/s10557-024-07619-4","url":null,"abstract":"<p><strong>Purpose: </strong>This research aimed to assess the impact of ticagrelor and clopidogrel on coronary microvascular dysfunction (CMD) and prognosis following acute myocardial infarction (AMI), using the angiography-derived index of microcirculatory resistance (angio-IMR) as a non-invasive assessment tool.</p><p><strong>Methods: </strong>In this retrospective study, angio-IMR was performed to evaluate CMD before and after dual antiplatelet therapy (DAPT) with either ticagrelor (90 mg twice daily, n = 184) or clopidogrel (75 mg once daily, n = 72). The primary endpoint is the improvement of CMD evaluated by angio-IMR (delta angio-IMR) following DAPT. Secondary endpoints included myocardial reinfarction and readmission for heart failure during 2-year follow-up.</p><p><strong>Results: </strong>Compared with clopidogrel, ticagrelor exhibited a significantly higher delta angio-IMR [- 3.09 (5.14) versus - 1.99 (1.91), P = 0.008], indicating a superior improvement of CMD with ticagrelor treatment. Multivariate Cox regression indicated that ticagrelor treatment was related to a reduced risk of readmission for heart failure [8 (4.3) versus 9 (12.5), adjusted HR = 0.329; 95% CI = 0.116-0.934; P = 0.018] and myocardial reinfarction [7 (3.8) versus 8 (11.1), adjusted HR = 0.349; 95% CI = 0.125-0.975; P = 0.026]. Furthermore, ticagrelor treatment serves as an independent predictor of readmission for heart failure (HR = 0.322; 95% CI = 0.110-0.943; P = 0.039).</p><p><strong>Conclusion: </strong>The results of this study indicate a potential association between ticagrelor treatment and improved CMD, as well as a reduced risk of cardiovascular events, including myocardial reinfarction and readmission for heart failure in AMI patients. Further randomized controlled trials are necessary to confirm the potential benefits of ticagrelor on CMD and cardiovascular prognosis. This clinical trial was registered in www.</p><p><strong>Clinicaltrials: </strong>gov (NCT05978726).</p>","PeriodicalId":9557,"journal":{"name":"Cardiovascular Drugs and Therapy","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142104707","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Natalia Soares Carvalho Souza, Thais Barenco-Marins, Ana Paula Ferraz, Raiana Andrade Quintanilha Barbosa, Leonardo Maciel, Cristiano Gonçalves Ponte, Fernando Azevedo Cruz Seara, Emerson Lopes Olivares, Jose Hamilton Matheus Nascimento
{"title":"Low Thyroid Hormones Level Attenuates Mitochondrial Dysfunction and Right Ventricular Failure in Pulmonary Hypertensive Rats.","authors":"Natalia Soares Carvalho Souza, Thais Barenco-Marins, Ana Paula Ferraz, Raiana Andrade Quintanilha Barbosa, Leonardo Maciel, Cristiano Gonçalves Ponte, Fernando Azevedo Cruz Seara, Emerson Lopes Olivares, Jose Hamilton Matheus Nascimento","doi":"10.1007/s10557-024-07618-5","DOIUrl":"https://doi.org/10.1007/s10557-024-07618-5","url":null,"abstract":"<p><strong>Purpose: </strong>This study is to investigate the repercussions of hypothyroidism in the pathophysiological progression of pulmonary arterial hypertension (PAH).</p><p><strong>Methods: </strong>While the control (CTL, n = 5) male Wistar rats received vehicle, PAH was induced with monocrotaline (MCT group, n = 15). Hypothyroidism was induced in a subset of rats by methimazole 3 weeks prior to the MCT injection (MMZ + MCT group, n = 15). Plasma thyroid hormones were measured by radioimmunoassay. Electrocardiographic, echocardiographic, and hemodynamic analyses were performed to evaluate the progression of PAH. Gene expression of antioxidant enzymes and cardiac hypertrophy markers were assessed by qPCR. Mitochondrial respiration, ATP levels, and ROS production were measured in right ventricular (RV) samples.</p><p><strong>Results: </strong>Plasma T3 and T4 decreased in both MCT and MMZ + MCT groups (p < 0.05). Right ventricular systolic pressure (RVSP) increased, and RV - dP/dt, + dP/dt, and contractility index decreased in the MCT versus the CTL group and remained within control levels in the MMZ + MCT group (p < 0.05). Relative RV weight, RV wall thickness, RV diastolic area, and relative lung weight were augmented in the MCT versus the CTL group, whereas all parameters were improved to the CTL levels in the MMZ + MCT group (p < 0.05). Only the MCT group exhibited an increased duration of QTc interval compared to the baseline period (p < 0.05). ADP-induced mitochondrial respiration and ATP levels were decreased, and ROS production was increased in MCT versus the CTL group (p < 0.05), while the MMZ + MCT group exhibited increased mitochondrial respiration versus the MCT group (p < 0.05).</p><p><strong>Conclusion: </strong>Hypothyroidism attenuated the RV mitochondrial dysfunction and the pathophysiological progression of MCT-induced PAH.</p>","PeriodicalId":9557,"journal":{"name":"Cardiovascular Drugs and Therapy","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142104708","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Zhenhong Ou, Fangchao Wang, Yunlin Chen, Xueyuan Liu, Boli Ran, Yuehui Yin, Kun Cui
{"title":"Comparative Efficacy of Colchicine and Intensive Low-density Lipoprotein Cholesterol Lowering in Patients with Atherosclerotic Diseases receiving Statins: A Network Meta-analysis of Randomized Controlled Trials.","authors":"Zhenhong Ou, Fangchao Wang, Yunlin Chen, Xueyuan Liu, Boli Ran, Yuehui Yin, Kun Cui","doi":"10.1007/s10557-024-07622-9","DOIUrl":"https://doi.org/10.1007/s10557-024-07622-9","url":null,"abstract":"<p><strong>Aims: </strong>Adding intensive low-density lipoprotein cholesterol (LDL-C)-lowering agents or colchicine to statin has been shown to result in additional cardiovascular benefits for patients with atherosclerotic cardiovascular diseases (ASCVD). We aimed to compare the efficacy and safety of these supplementary agents in patients with ASCVD receiving statin.</p><p><strong>Methods: </strong>We performed a systematic review and frequentist network meta-analysis of randomized controlled trials. The primary efficacy endpoint was the main adverse cardiovascular event (MACE), and the secondary efficacy endpoints were myocardial infarct, stroke, coronary revascularization, cardiovascular death, and all-cause mortality, respectively. The safety endpoints were treatment discontinuation and non-cardiovascular death. We obtained estimates for efficacy outcomes and safety endpoints and presented these estimates as risk ratio (RR) with 95% confidence intervals. We ranked the comparative efficacy and safety of all drugs with P-scores.</p><p><strong>Results: </strong>Seventeen trials totaling 85,823 participants treated with colchicine (5926 participants), intensive LDL-C lowering (37,854 participants) via proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, Niemann-Pick C1-like 1 protein (NPC1L1) inhibitor or ATP citrate lyase (ACL) inhibitor, or statin alone (42,043 participants) were included. Colchicine was associated with a greater reduction in the risk of MACE (RR 0.72, 0.69-0.91), stroke (RR 0.55, 0.33-0.92), and coronary revascularization (RR 0.73, 0.60-0.90) compared with NPC1L1 inhibitor, and it provided a larger reduction in the risk of MACE (RR 0.79, 0.69-0.91) compared to PCSK9 inhibitor. However, colchicine was associated with increased risk of non-cardiovascular death compared with NPC1L1 inhibitor (RR 1.48, 1.04-2.10) and PCSK9 inhibitor (RR 1.57, 1.08-2.27). Although no regimen prolonged survival, colchicine had worse performance on non-cardiovascular death and all-cause mortality.</p><p><strong>Conclusions: </strong>In patients with ASCVD receiving statin, colchicine seems to be more effective than intensive LDL-C-lowering therapy with PCSK9 inhibitor or NPC1L1 inhibitor for cardiovascular prevention. However, using colchicine as an alternative to intensive LDL-C-lowering therapy may need to be weighed against the cardiovascular benefits and the potential harms of higher non-cardiovascular death.</p><p><strong>Trial registration: </strong>PROSPERO Identifier: CRD42023441385.</p>","PeriodicalId":9557,"journal":{"name":"Cardiovascular Drugs and Therapy","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142104706","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Can We Leave No Metal Behind? DCB vs. DES in Large Coronary Arteries.","authors":"Grace Lian, Spencer Ng, George A Stouffer","doi":"10.1007/s10557-024-07623-8","DOIUrl":"https://doi.org/10.1007/s10557-024-07623-8","url":null,"abstract":"","PeriodicalId":9557,"journal":{"name":"Cardiovascular Drugs and Therapy","volume":" ","pages":""},"PeriodicalIF":3.1,"publicationDate":"2024-08-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142035277","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}