Pharmacovigilance study for SGLT 2 inhibitors- Safety review of real-world data & randomized clinical trials.

PURPOSE: Despite effectiveness of sodium-glucose cotransporter 2 (SGLT 2) inhibitors, concerns have been raised about the potential side effects of these drugs. Thus, a pharmaco-vigilance study was designed that aims to identify any discrepancies between the reported adverse events & assess the safety profile of SGLT2 inhibitors. METHODS: We studied diabetic ketoacidosis (DKA), euglycemic DKA, amputation, urinary tract infection (UTI), mycotic genital infection & hypotension associated with empagliflozin, dapagliflozin, canagliflozin & ertugliflozin in RCTs and reporting databases. WHO's VigiBase, FAERS, EMA's EudraVigilance & DAEN were thoroughly studied to obtain spontaneously reported real-world adverse events. RESULTS: Different SGLT2 inhibitors exhibit varied side effect profiles. Additionally, the findings suggest that adverse events may be more likely to occur in a broader population in the real world than in a highly inclusive clinical trial subset CONCLUSION: Our study provides comparison of the real world reported adverse events to adverse events reported in the clinical trials studying the efficacy of SGLT 2 inhibitors.

Immediate Versus Staged Complete Revascularization in Patients With Acute Coronary Syndrome: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

A strategy of complete revascularization (CR) is recommended in patients with acute coronary syndrome (ACS) and multivessel disease (MVD). However, the optimal timing of CR remains equivocal. We searched MEDLINE, Embase, the Cochrane Library, and ClinicalTrials.gov for randomized controlled trials (RCTs) comparing immediate CR (ICR) with staged CR in patients with ACS and MVD. Our primary outcomes were all-cause and cardiovascular mortality. All outcomes were assessed at 3 time points: in-hospital or at 30 days, at 6 months to 1 year, and at >1 year. Data were pooled in RevMan 5.4 using risk ratios as the effect measure. A total of 9 RCTs (7,506 patients) were included in our review. A total of 7 trials enrolled patients with ST-segment elevation myocardial infarction (STEMI), 1 enrolled patients with non-STEMI only, and 1 enrolled patients with all types of ACS. There was no difference between ICR and staged CR regarding all-cause and cardiovascular mortality at any time window. ICR reduced the rate of myocardial infarction and decreased the rate of repeat revascularization at 6 months and beyond. The rates of cerebrovascular events and stent thrombosis were similar between the 2 groups. In conclusion, the present meta-analysis demonstrated a lower rate of myocardial infarction and a reduction in repeat revascularization at and after 6 months with ICR strategy in patients with mainly STEMI and MVD. The 2 groups had no difference in the risk of all-cause and cardiovascular mortality. Further RCTs are needed to provide more definitive conclusions and investigate CR strategies in other ACS.

Catheter ablation versus medical therapy in atrial fibrillation: an umbrella review of meta-analyses of randomized clinical trials.

This umbrella review synthesizes data from 17 meta-analyses investigating the comparative outcomes of catheter ablation (CA) and medical treatment (MT) for atrial fibrillation (AF). Outcomes assessed were mortality, risk of hospitalization, AF recurrence, cardiovascular events, pulmonary vein stenosis, major bleeding, and changes in left ventricular ejection fraction (LVEF) and MLHFQ score. The findings indicate that CA significantly reduces overall mortality and cardiovascular hospitalization with high strength of evidence. The risk of AF recurrence was notably lower with CA, with moderate strength of evidence. Two associations reported an increased risk of pulmonary vein stenosis and major bleeding with CA, supported by high strength of evidence. Improved LVEF and a positive change in MLHFQ were also associated with CA. Among patients with AF and heart failure, CA appears superior to MT for reducing mortality, improving LVEF, and reducing cardiovascular rehospitalizations. In nonspecific populations, CA reduced mortality and improved LVEF but had higher complication rates. Our findings suggest that CA might offer significant benefits in managing AF, particularly in patients with heart failure. However, the risk of complications, including pulmonary vein stenosis and major bleeding, is notable. Further research in understudied populations may help refine these conclusions.

A Sniff Away From Death: A Rare Case of Cocaine-Induced Triple Vessel Coronary Artery Disease in a 41-Year-Old Male Patient.

Cocaine-associated coronary artery disease and ST-segment elevation myocardial infarction (STEMI) have been well described in the literature. However, very few cases of cocaine-induced multivessel coronary artery disease have been reported. We report a very rare case of cocaine-associated triple vessel coronary artery disease in a 41-year-old male patient. The patient underwent urgent catheterization that revealed occlusion of his proximal left anterior descending artery (LAD), mid-circumflex artery, and right coronary artery with angioplasty and stent placement. His hospitalization course was complicated by cardiogenic shock, shock liver, acute renal failure, and sepsis.

Statins for Attenuating Cardiotoxicity in Patients Receiving Anthracyclines: A Systematic Review and Meta-Analysis.

Anthracycline chemotherapy causes cardiotoxicity, and the evidence regarding the benefit of concomitant statin use in reducing it remains uncertain. We conducted a meta-analysis of studies using statins and anthracyclines by searching PubMed, Embase, the Cochrane Library, and ClinicalTrials.gov from inception until April 10, 2023. Our analysis included 3 observational studies and 4 RCTs, including the STOP-CA trial released in ACC23. Statin prescription significantly reduced cardiotoxicity in cancer patients receiving anthracycline chemotherapy (OR 0.46, 95% CI: 0.33-0.63; I2: 0%). However, no significant difference was observed in the decline of left ventricular ejection fraction (LVEF) from baseline (MD 4.15, 95% CI: -0.69 to 8.99, I2: 97%). These findings demonstrate the protective effect of concomitant statin prescription.