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Showing 39 results for “Safety”.

November 2023

Efficacy, Safety, and Tolerability of Inclisiran in Patients With Homozygous Familial Hypercholesterolemia: Results From the ORION-5 Randomized Clinical Trial

Circulation. 2023; online ahead of print DOI: 10.1161/CIRCULATIONAHA.122.063460

A proof-of-concept trial showed that inclisiran, a small interfering RNA that prevents production of the hepatic PCSK9 protein, could lead to durable reductions in LDL-C levels when added to statins and ezetimibe in 3 out of 4 patients with homozygous familial hypercholesterolaemia (HoFH).

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October 2023

Daily Oral GLP-1 Receptor Agonist Orforglipron for Adults with Obesity

N Engl J Med. 2023; DOI: 10.1056/NEJMoa2302392

Orforglipron is a once-daily oral nonpeptide GLP-1RA in development for weight management and the treatment of T2D. This phase 2 double-blind trial evaluated the efficacy and safety of orforglipron in adults with obesity, or with overweight plus at least one weight-related coexisting condition, and without T2D. In total, 272 participants were randomised to orforglipron (12, 24, 36 or 45 mg) or placebo once daily for 36 weeks, with a primary endpoint of change from baseline in body weight at week 26.

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September 2023

Mineralocorticoid Receptor Antagonist Use and the Effects of Empagliflozin on Clinical Outcomes in Patients Admitted for Acute Heart Failure: Findings from EMPULSE

Eur J Heart Fail. 2023; online ahead of print DOI: 10.1002/ejhf.2982

In the EMPULSE trial, empagliflozin produced greater clinical benefit than placebo in patients hospitalised for AHF. Although many patients with AHF are treated with MRAs, the interplay between empagliflozin and MRAs in AHF has not been explored. A post-hoc analysis of the EMPULSE trial aimed to evaluate the efficacy and safety of empagliflozin versus placebo according to MRA use at baseline.

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August 2023

Safety of Sodium-Glucose Cotransporter 2 Inhibitors in Elderly Patients with Type 2 Diabetes: A Meta-Analysis of Randomised Controlled Trials

Diabetes Obes Metab 2023 DOI 10.1111/dom.15193

SGLT2is are effective in preventing adverse outcomes of heart failure and chronic kidney disease, which are highly prevalent in the elderly. While SGLT2is are generally well tolerated, elderly patients may be more susceptible to developing AEs reported with this class of drug, such as infections, fracture, and AKI. Clinical experience with SGLT2is in the elderly and very elderly is limited.

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July 2023

Effect of Semaglutide versus Other Glucagon-Like Peptide-1 Receptor Agonists on Cardio-Metabolic Risk Factors in Patients with Type 2 Diabetes: A Systematic Review and Meta-Analysis of Head-to-Head, Phase 3, Randomized Controlled Trials

J Diabetes Complications. 2023;37:108529 DOI: 10.1016/j.jdiacomp.2023.108529

 GLP-1RAs vary in their abilities to control glycaemia, reduce body weight and improve other cardiometabolic risk factors. A recent systematic review and meta-analysis assessed the efficacy and safety of semaglutide compared with other GLP-1RAs in head-to-head phase 3 RCTs in adults with T2D.

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Efficacy and Safety of Oral Orforglipron in Patients with Type 2 Diabetes: A Multicentre, Randomised, Dose-Response, Phase 2 Study

Lancet. 2023. DOI: 10.1016/S0140-6736(23)01302-8

Orforglipron, an oral, non-peptide GLP-1RA, was assessed at various once-daily doses (3 mg, 12 mg, 24 mg, 36 mg, 45 mg) and dose-escalation schedules vs placebo and dulaglutide in 383 patients with T2D, with or without metformin, and BMI ≥23 kg/m2, with no food or water restrictions.

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Efficacy and Safety of Co-Administered Once-weekly Cagrilintide 2.4 mg with Once-Weekly Semaglutide 2.4 mg in Type 2 Diabetes: a Multicentre, Randomised, Double-Blind, Active-Controlled, Phase 2 Trial

Lancet. 2023. DOI: 10.1016/ S0140-6736(23)01163-7

Combining the GLP-1 RA semaglutide with the long-acting amylin analogue cagrilintide has been shown to have weight-loss benefits. However, the impact of the combination of cagrilintide and semaglutide (CagriSema) on HbA1c is unknown. In a 32-week, double-blind, phase 2 trial, 92 adults with T2D and a BMI ≥27 kg/m2 on metformin, with or without an SGLT2i, were randomised to once-weekly subcutaneous CagriSema, semaglutide or cagrilintide (all escalated to 2.4 mg). 

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June 2023

Efficacy and Safety of Tirzepatide for Treatment of Overweight or Obesity. A Systematic Review and Meta-analysis

Int J Obes (Lond). 2023. DOI: 10.1038/s41366-023-01321-5

 This systematic review and meta-analysis aimed to assess the efficacy and safety of tirzepatide for weight loss in patients with overweight or obesity.

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April 2023

Outcomes with Finerenone in Participants with Stage 4 CKD and Type 2 Diabetes: A FIDELITY Subgroup Analysis

Clin J Am Soc Nephrol. 2023; online ahead of print DOI: 10.2215/CJN.0000000000000149

Patients with stage 4 CKD and T2D have limited treatment options to reduce their persistent CV and kidney risk. This post hoc analysis of the FIDELITY database evaluated the effect of finerenone vs placebo in 890 patients with stage 4 CKD and T2D.

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March 2023

Patient Characteristics, Outcomes, and Effects of Dapagliflozin According to the Duration of Heart Failure: A Prespecified Analysis of the DELIVER Trial

Circulation 2023; online ahead of print DOI: 10.1161/CIRCULATIONAHA.122.062918

Whether the efficacy and safety of SGLT2i therapy are maintained with increasing duration of HFmrEF or HFpEF is unknown. In this prespecified analysis of DELIVER, HF duration was categorised as ≤6 months, >6 to 12 months, >1 to 2 years, >2 to 5 years, or >5 years.

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