Publication highlights: 23 to 30 June 2023

1. Once-weekly #tirzepatide 10 mg and 15 mg provided substantial and clinically meaningful reduction in #bodyweight in patients with #type2diabetes

This was a double-blinded, placebo-controlled phase III randomized clinical trial SURMOUNT-2 conducted in seven countries. The study included adults aged ≥18 years with a body-mass index (BMI)≥ 27 kg/m2, with glycated hemoglobin (HbA1c) of 7–10, and type 2 diabetes (T2D).?Subjects received either once-weekly, subcutaneous tirzepatide 10 mg (n= 312), tirzepatide 15 mg (n= 311), or placebo (n=315) for 72 weeks.??Up to 83% of participants treated with tirzepatide attained clinically significant ≥5% weight reduction, with up to 50% and one-third of the participants reaching 15% or higher and 20% or higher weight reduction.?Also, 49% of the tirzepatide-treated participants reached normoglycaemia, i.e., HbA1c <5·7%, whereas only 3% attained this benchmark in the placebo group. More importantly, there were no cases of severe hypoglycemia among those reaching this HbA1c target post-tirzepatide treatment. Furthermore, tirzepatide treatment markedly improved the cardiometabolic risk factors such as systolic BP, fasting triglycerides, and high- and non-high-density lipoprotein cholesterol.?

2. Higher Doses of Oral #Semaglutide Beneficial for the Management of Type 2 Diabetes

This was a randomized, multicenter, double-blind, global phase 3b clinical trial to evaluate the efficacy, safety, and tolerability of once-daily oral #semaglutide 25 mg and 50 mg compared with the FDA-approved 14 mg dose in adults with inadequately controlled T2D. The study enrolled adults aged ≥18 years and older with T2D, an HbA1c between 8% and 10.5%, and a body mass index of ≥ 25 kg/m2 who were on a stable daily dose of 1 to 3 of the following oral glucose-lowering therapies: #metformin , #sulfonylurea , #SGLT2 inhibitor, or #DPP -4 inhibitor. Participants were randomly assigned, 1:1:1, to oral semaglutide 14 mg, 25 mg, or 50 mg for 68 weeks. Adults continued their existing glucose-lowering medication, except for those receiving DPP-4 inhibitors, who were asked to discontinue the therapy. Results showed that an HbA1c of <7% was achieved by 63% of participants in the 50 mg group and 51% of those in the 25 mg group compared with 39% of those in the 14 mg group. The percentage of participants who achieved an HbA1c of ≤6.5% was 51% in the 50 mg group, 40% in the 25 mg group, and 26% in the 14 mg group. Further, changes in body weight by week 52 were “significantly greater” in the oral semaglutide 25 mg and 50 mg groups compared with the 14 mg group.?

3. Should #eGFR be the basis for selecting #SGLT2 inhibitors or #GLP1 receptor agonists in patients with #T2D ?

A meta-analysis of 13 studies with a total of 111,565 participants? showed that decreased eGFR [significant] and albuminuria [trend] were found to predict a better efficacy for #SGLT2 inhibitors in 3-point major adverse cardiovascular events (3P-MACE) reduction. However, this was not the case for the #GLP1 receptor agonists treatment. Other factors including age, sex, #BMI , #HbA1c , and preexisting #CVD or #HeartFailure did not affect the efficacy of either treatment in reducing the risk of 3P-MACE.

4. #Ensifentrine , a Novel PDE3 and PDE4 Inhibitor for the Treatment of #COPD : Results of ENHANCE-1 and ENHANCE-2 trials

760 (ENHANCE-1) and 789 (ENHANCE-2) patients with #COPD were randomized to twice-daily (BID) #ensifentrine 3 mg or placebo over 24- weeks via a standard jet nebulizer. 69% and 55% of patients continued taking concomitant #LAMA or #LABA , respectively.?Patients were predominantly in GOLD B grade. There was a significant improvement in average FEV1 AUC0-12h compared to placebo at Week 12. Over 24 weeks in ENHANCE-1, ensifentrine-treated patients reported significant improvements from baseline in symptoms,?rescue medication use measures, and quality of life. In ENHANCE-2, a progressive improvement from baseline in the placebo group in all patient-reported endpoints was evident. ?Ensifentrine treatment reduced the rate of moderate/severe exacerbations vs placebo over 24 weeks and increased the time to first exacerbation. Adverse event rates were similar to placebo.

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