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The latest medical research on Peripheral Vascular Disease

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Pharmacokinetic Drug-Drug Interaction between Cilostazol and Rosuvastatin in Healthy Participants.

Cardiovascular Drugs

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.

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.

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 (Cmax,ss) and area under the plasma concentration-time curve during the dosing interval at steady state (AUCtau,ss) indicated no significant interaction between cilostazol and rosuvastatin. Safety assessments showed comparable profiles to individual drug administration, with no significant adverse events.

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.

ClinicalTrials.Gov identifier no. NCT06568133.

Use of Direct Anticoagulants in Kidney Transplant Recipients: Review of the Current Evidence and Emerging Perspectives.

Cardiovascular Drugs

Thromboembolic events and atrial fibrillation are common among kidney transplant recipients (KTRs), and these conditions typically require anticoag...

Impact of Antibacterials on the Quality of Anticoagulation Control in Patients Initiating Warfarin Therapy.

Cardiovascular Drugs

Warfarin interacts with antibacterials to prolong the prothrombin time international normalized ratio (PT-INR) and increase the risk of bleeding. Patients initiating warfarin therapy often undergo precise dosage adjustments; however, the clinical implications of these interactions with antibacterials remain unclear. This study aimed to clarify the effect of antibacterials on PT-INR during the warfarin induction phase.

This was a retrospective, observational study. Patients who were newly treated with warfarin after cardiovascular surgery were included. The primary endpoint was the comparison of the maximum PT-INR and time in therapeutic range (TTR) after warfarin initiation between the antibacterial-treated (ABx) and non-treated (non-ABx) groups.

The maximum PT-INR was significantly higher in the ABx group (which included β-lactams, glycopeptides, quinolones, tetracyclines, and aminoglycosides) than in the non-ABx group (median [interquartile range] 2.37 [2.03-2.71] vs. 2.08 [1.93-2.33]; P = 0.005); however, the TTR did not differ significantly (65% [44-76] vs. 71% [43-85]; P = 0.150). The odds ratio for maximum PT-INR > 2.6 with antimicrobial therapy was 2.51 (95% confidence interval 1.21-5.21).

Antibacterials have been suggested to increase PT-INR during the induction phase of warfarin. However, with strict dose adjustments, the clinical impact on the PT-INR and TTR is likely limited.

Sacubitril-Valsartan Lowers Atrial Fibrillation Recurrence and Left Atrial Volume Post-catheter Ablation: Systematic Review and Meta-Analysis.

Cardiovascular Drugs

PROSPERO identifier number CRD42024497958.

This study systematically reviewed PubMed, Embase, and the Cochrane Library for randomized controlled trials (RCTs) and propensity-matched cohorts (PMC), evaluating SV's efficacy in preventing AF recurrence after catheter ablation. Outcomes included AF recurrence and structural remodeling assessed via left ventricular ejection fraction (LVEF) and left atrial volume index (LAVi), with statistical analyses performed using Review Manager 5.1.7 and heterogeneity assessed via I2 statistics.

The analysis comprised 642 patients from three RCTs and one PMC (319 SV-treated). SV significantly reduced AF recurrence [risk ratios (RR) 0.54; 95% confidence intervals (CI) 0.41-0.70; p < 0.00001; I2 = 0%), a trend also observed when considering RCTs exclusively (RR 0.58; 95% CI 0.41-0.84; p = 0.004; I2 = 0%). Moreover, SV demonstrated a notable reduction in LAVi [mean deviation (MD) -5.34 mL/m2; 95% CI -8.77 to -1.91; p = 0.002; I2 = 57%] compared with ARB, alongside a significant improvement in LVEF (MD 1.83%; 95% CI 1.35-2.32; p < 0.00001; I2 = 0%). Subgroup analyses among patients with hypertension and LVEF < 50% also indicated lower AF recurrence with SV.

SV therapy exhibited superior efficacy in reducing AF recurrence compared with ACEi or ARB and demonstrated superior outcomes in attenuating atrial structural remodeling after catheter ablation. These findings underscore the potential of SV as a therapeutic option for patients with AF undergoing catheter ablation, highlighting its efficacy in mitigating AF recurrence and structural remodeling.

Sotatercept: The First FDA-Approved Activin A Receptor IIA Inhibitor Used in the Management of Pulmonary Arterial Hypertension.

Cardiovascular Drugs

This report illustrates the Food and Drug Administration (FDA) approval of first-in-its-class activin A receptor IIA inhibitor, sotatercept (Winrev...

Efficacy of Colchicine for Prevention of Stroke and Adverse Cardiovascular Events: A Meta-analysis of 16 Randomized Controlled Trials.

Cardiovascular Drugs

Colchicine has been shown to reduce adverse cardiovascular events (ACE) and stroke among patients with coronary artery disease. However, its efficacy with short- and long-term use and risk of stroke has not been well studied, with conflicting results to date.

We sought to evaluate the efficacy of colchicine for the prevention of stroke and other cardiovascular outcomes and to evaluate the effect of short- and long-term use.

We performed a systematic literature search on PubMed, EMBASE, and Clinicaltrial.gov for relevant randomized controlled trials (RCTs) from inception until July 20th, 2024. Odds ratios (ORs) were pooled using a random-effect model, and a p value of < 0.05 was considered statistically significant.

A total of 16 RCTs with 24,967 patients were included (12,538 in colchicine group and 12,429 in the control group) in the analysis. Pooled analysis of primary outcomes showed that risk of incidence of stroke was comparable between colchicine and placebo groups (OR 0.78, 95% confidence interval [CI] 0.59-1.02, p = 0.07). Pooled analysis of secondary outcomes showed that colchicine significantly reduced the risk of incidence of ACE by 33% (OR 0.67, 95% CI 0.54-0.82, p < 0.001), and myocardial infarction by 21% (OR 0.79, 95% CI 0.65-0.95, p = 0.01) compared with placebo. However, the risk of all-cause mortality (OR 0.98, 95% CI 0.79-1.21, p = 0.83) and cardiovascular mortality (OR 0.78, 95% CI 0.56-1.08, p = 0.14) were comparable between both groups of patients.

Colchicine was associated with an overall reduction in the risk of incidence of ACE and MI; however, no such effect was observed with mortality and stroke.

Levosimendan in Patients with Cardiogenic Shock Refractory to Dobutamine Weaning.

Cardiovascular Drugs

This study examines the effects of levosimendan in patients refractory to dobutamine weaning.

This retrospective study included patients with cardiogenic shock refractory to dobutamine weaning failure admitted between 2010 and 2022. Patients treated with another type of dobutamine alone were compared with those treated with levosimendan in combination with dobutamine. Successful inotrope withdrawal was defined as survival without catecholamine support, transplant, or definitive ventricular assist device at 30 days. Secondary outcomes included all-cause mortality at 30 and 90 days.

Among 349 patients with cardiogenic shock and failure to withdraw from dobutamine, levosimendan was administered in combination with dobutamine in 114 patients, and another type of dobutamine alone was administered in 235 patients. At 30 days, successful inotrope withdrawal occurred in 46 (43.4%) patients taking levosimendan plus dobutamine versus 24 (10.5%) patients in the dobutamine-only group (weighted odds ratio [OR] 4.99, 95% confidence interval [CI] 2.65-9.38; p < 0.001), with similar results at 90 days (weighted OR 6.16, 95% CI 3.22-11.78; p < 0.001). Levosimendan + dobutamine was associated with lower 30-day mortality (weighted OR 0.47, 95% CI 0.26-0.84; p = 0.01), with no difference at 90 days (weighted OR 0.67, 95% CI 0.39-1.14; p = 0.14).

Adding levosimendan to dobutamine may improve inotrope withdrawal success and reduce 30-day mortality in patients with initial weaning failure.

The Influence of High Body Mass Index (BMI > 35 kg/m2) on Apixaban Plasma Concentration in Patients with Atrial Fibrillation.

Cardiovascular Drugs

Apixaban, a direct oral anticoagulant is administered for stroke prevention in atrial fibrillation patients. Dosing adjustment is guided by renal function, age, and body weight. However, no data exist on its pharmacokinetics in patients with a body mass index (BMI) ≥ 35 kg/m2. The aim was to investigate the effects of BMI ≥ 35 kg/m2 on trough plasma concentrations of apixaban in patients with atrial fibrillation.

This prospective study compared steady-state trough concentrations of apixaban in patients with a BMI ≥ 35 kg/m2 and patients with a BMI < 35 kg/m2.

Sixty patients were included. In patients receiving 5 mg apixaban twice daily, the median trough plasma concentration was 29% lower in patients with a BMI ≥ 35 kg/m2 than in those with a BMI < 35 kg/m2 (148.9 ng/ml, interquartile range [IQR] 94.5-205.6, compared to 209.1 ng/ml, IQR 167-266.8 ng/ml, respectively; P = 0.044). However, median trough concentrations fell within the manufacturer's predicted range for effective steady-state apixaban exposure. A similar trend was observed with 2.5 mg apixaban twice daily, although statistical significance was not reached. Multivariate analysis revealed no correlation between BMI values and trough concentrations.

BMI ≥ 35 kg/m2 patients exhibited lower apixaban trough concentrations, while remaining within the manufacturer's established range for effective steady-state apixaban, suggesting that dose adjustment is unnecessary for this specific patient group.

Sodium-Glucose Cotransporter-2 Inhibitors After Acute Myocardial Infarction: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Cardiovascular Drugs

PROSPERO identifier number CRD42024540843.

A comprehensive search of PubMed, EMBASE, SCOPUS, and ClinicalTrials.gov was conducted up to 1 May 2024. Only randomized controlled trials studying the use of SGLT2i in post-AMI patients were included. We included adult patients aged 18 years old and older diagnosed with AMI and initiated on SGLT2i in the acute post-AMI setting. SGLT2i studies solely in heart failure settings were excluded.

Eight clinical trials were included in the systematic review, comprising 11,436 patients. Compared with placebo, SGLT2i initiation in post-AMI patients significantly reduced total number of heart failure hospitalizations (risk ratio [RR] 0.74, 95% confidence interval [CI] 0.62-0.90) and was associated with a lower N-terminal pro-B-type natriuretic peptide (NT-proBNP) level (- 26.67 pg/ml, 95% CI - 41.74 to - 11.59). There was no difference in all-cause mortality (RR 1.02, 95% CI 0.81-1.28), cardiovascular mortality (RR 1.03, 95% CI 0.83-1.28), change in left ventricular ejection fraction, and glycated hemoglobin (HbA1c), as compared with placebo.

SGLT2i use in patients with AMI was associated with a reduction in heart failure hospitalizations and a decrease in NT-proBNP. There were no significant differences in mortality outcomes.

Efficacy of Chronic Use of Sodium-Glucose Co-transporter 2 Inhibitors on the Prevention of Contrast-Induced Acute Kidney Injury in Patients with Type 2 Diabetes Mellitus Following Coronary Procedures: A Systematic Review and Meta-Analysis.

Cardiovascular Drugs

Contrast-induced acute kidney injury (CI-AKI) is a common complication of iodinated contrast administration during coronary procedures, especially in patients with diabetes mellitus (DM). Besides periprocedural hydration and statins, there are no other pharmacological strategies with consistent results to prevent CI-AKI up to date. This study aims to evaluate the efficacy of chronic use of sodium-glucose co-transporter 2 (SGLT2) inhibitors on the prevention of CI-AKI in patients with type 2 DM following coronary procedures.

A systematic literature search of MEDLINE, Google Scholar, Embase, and Cochrane Library was performed. Relevant observational studies and randomized controlled studies (RCTs) were identified. Results were pooled using a random-effect model meta-analysis. Subgroup analyses were performed to evaluate the potential benefit of SGLT2 inhibitors on the prevention of CI-AKI in patients undergoing urgent or elective coronary angiography/percutaneous coronary interventions (CAG/PCI).

Seven observational studies and one randomized controlled trial with 2740 patients were included. Chronic treatment (minimum duration 2 weeks to 6 months) with an SGLT2 inhibitor was associated with a significantly reduced risk of CI-AKI in diabetic patients undergoing coronary procedures compared with the control group [risk ratio (RR) 0.48; 95% confidence interval (CI) 0.39-0.59; p < 0.001). Results of subsequent subgroup analysis showed a significant reduction in the incidence of CI-AKI in diabetic patients undergoing both elective CAG/PCI (RR 0.49; 95% CI 0.35-0.68; p<0.001) and urgent CAG/PCI (RR 0.48; 95% Cl 0.35-0.66; p < 0.001).

Chronic use of SGLT2 inhibitors may be preventative against the incidence of CI-AKI in patients with type 2 DM undergoing coronary interventions. Further RCTs are needed to confirm our findings.

Cardiomodulatory Effects of Cardiometabolic and Antihyperglycemic Medications: The Roles of Oxidative and Endoplasmic Reticulum Stress.

Cardiovascular Drugs

Uncontrolled hyperglycemia in people with diabetes is an established risk of premature cardiovascular disease. Repeated hypoglycemic events are als...

Vitamin D-Parathyroid Hormone-Fibroblast Growth Factor 23 Axis and Cardiac Remodeling.

Cardiovascular Drugs

Cardiac remodeling is a compensatory adaptive response to chronic heart failure (HF) altering the structure, function, and metabolism of the heart....