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Summary: The ONWARDS 3 randomized clinical trial studied the efficacy of once-weekly insulin icodec in comparison to once-daily insulin degludec for glucose control in insulin-naive type 2 diabetes patients. The double-masked, double-dummy trial was conducted from March 2021 to June 2022 across 92 sites in 11 countries, enrolling 588 adults with type 2 diabetes. The participants were randomly divided into two groups: 294 receiving once-weekly icodec and daily placebo, and 294 receiving daily degludec and weekly placebo.

The primary endpoint was the change in Hemoglobin A1c (HbA1c) from baseline to week 26. Insulin icodec showed a noninferior HbA1c change from the baseline (-1.6 percentage points) compared to insulin degludec (-1.4 percentage points) and demonstrated confirmed statistical superiority. However, the trial showed a higher rate of combined level 2 (clinically significant) or level 3 (severe) hypoglycemic events in the insulin icodec group than in the insulin degludec group, despite the overall low rates in both groups. There was no significant difference in weight changes between the two groups.

The study concluded that once-weekly insulin icodec demonstrated superior HbA1c reduction compared to once-daily degludec after 26 weeks of treatment in insulin-naive type 2 diabetes patients. The convenience of once-weekly administration should be considered against the slightly higher absolute risk of hypoglycemia. The study’s limitations include its short duration (26 weeks) and a lack of data on sustained effects, patient-reported outcomes, and continuous glucose monitoring.

Article: Once-Weekly Insulin Icodec vs Once-Daily Insulin Degludec in Adults With Insulin-Naive Type 2 Diabetes: The ONWARDS 3 Randomized Clinical Trial – JAMA (link to abstract – $ for full-text)

See also: Visual Abstract

Related Study: Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin – New England Journal of Medicine (link to abstract – $ for full-text)

Open-label RCT | Weekly insulin Icodec proves noninferior to daily Glargine in type 2 diabetes

3 Jul, 2023 | 14:23h | UTC

Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin – New England Journal of Medicine (link to abstract – $ for full-text)

SR | Gonadotropin‐releasing hormone analogues for endometriosis

3 Jul, 2023 | 14:14h | UTC

Gonadotropin‐releasing hormone analogues for endometriosis – Cochrane Library

Summary: Gonadotrophin-releasing hormone analogues for pain associated with endometriosis – Cochrane Library

SR | Oral contraceptives containing drospirenone for premenstrual syndrome

3 Jul, 2023 | 14:13h | UTC

Oral contraceptives containing drospirenone for premenstrual syndrome – Cochrane Library

Summary: Birth control pills with drospirenone for treating premenstrual syndrome – Cochrane Library

USPSTF Recommendations | Screen for anxiety disorders in adults, including pregnant and postpartum women

30 Jun, 2023 | 15:03h | UTC

Screening for Anxiety Disorders in Adults: US Preventive Services Task Force Recommendation Statement – JAMA

Editorial: Are There Reasons to Fear Anxiety Screening? – JAMA

Evidence Report: Anxiety Screening: Evidence Report and Systematic Review for the US Preventive Services Task Force – JAMA

Patient Page: Screening for Anxiety Disorders in Adults – JAMA

Author Interview: USPSTF Recommendations: Screening for Depression and Suicide Risk in Adults, and Screening for Anxiety Disorders in Adults – JAMA

Commentary: U.S. Preventive Services Task Force Recommends Screening Adults for Anxiety Disorders – Psychiatric News Alert

From NAFLD to MASLD | New consensus changes fatty liver disease terminology to avoid stigmatization

30 Jun, 2023 | 15:01h | UTC

A multi-society Delphi consensus statement on new fatty liver disease nomenclature – Hepatology

Commentary on Twitter

Big news in the field of Hepatology

In 1980, Jurgen Ludwig and his colleagues at Mayo Clinic, identified a severe type of fatty liver disease in people who did not drink signficant amounts of alcohol. The disease was more common in women, most patients were obese and suffered… pic.twitter.com/aAq2vneIov

— TheLiverDoc (@theliverdr) June 25, 2023

Consensus Statement 2023 Update | Timing of elective surgery and risk assessment after SARS-CoV-2 infection

30 Jun, 2023 | 15:00h | UTC

Timing of elective surgery and risk assessment after SARS-CoV-2 infection: 2023 update – Anaesthesia

Commentary on Twitter

?"In most circumstances, surgery should proceed unless risk assessment indicates that the risk of proceeding exceeds the risk of delay."@Assoc_Anaes @RCoANews @UkFssa @RCSnews @elboghdadly @doctimcook @justin_kua @NigelMercer @rmoonesinghe

?https://t.co/gfjymze0oi pic.twitter.com/D8bEfAHBD7

— ??????????? (@Anaes_Journal) June 20, 2023

M-A | Metoclopramide effective in acute migraine relief, comparable to most active drugs, superior to placebo

30 Jun, 2023 | 14:51h | UTC

The efficacy and safety of metoclopramide in relieving acute migraine attacks compared with other anti-migraine drugs: a systematic review and network meta-analysis of randomized controlled trials – BMC Neurology

Post hoc analysis | Low-dose aspirin linked to increased risk of anemia in older adults

29 Jun, 2023 | 14:06h | UTC

Summary: In a post hoc analysis of the ASPREE randomized controlled trial, the impact of daily low-dose aspirin on anemia, hemoglobin, and serum ferritin concentrations in elderly individuals was investigated. The study included 19,114 community-dwelling individuals aged 70 years and older (or ≥65 years for Black and Hispanic individuals) from Australia and the United States.

Findings reveal an increased incidence of anemia in the aspirin group compared to the placebo group (51.2 events versus 42.9 events per 1000 person-years, respectively). This correlates to a 20% increase in risk (hazard ratio, 1.20 [95% CI, 1.12 to 1.29]). Hemoglobin concentrations displayed a more pronounced decline in the aspirin group by 0.6 g/L per 5 years. Additionally, among participants with ferritin measures, the aspirin group exhibited a greater prevalence of ferritin levels less than 45 µg/L at year 3 and overall decline in ferritin by 11.5%. The study found similar results even in the absence of major bleeding.

This research underscores the risk of anemia and decline in ferritin in otherwise healthy older adults taking low-dose aspirin, highlighting the need for periodic monitoring of hemoglobin levels. However, the study lacked data on the causes of anemia, indicating the need for further research.

Article: Effect of Low-Dose Aspirin Versus Placebo on Incidence of Anemia in the Elderly: A Secondary Analysis of the Aspirin in Reducing Events in the Elderly Trial – Annals of Internal Medicine (link to abstract – $ for full-text)

News Release: Low-dose aspirin may increase anaemia risk in healthy older adults: study – Monash University

Commentaries:

Aspirin Use Ups Risk of Anemia in Elderly Patients: ASPREE – TCTMD

Low-dose aspirin associated with 20% increase in risk of anemia among older adults – ACP Internist

Original Study: Effect of Aspirin on All-Cause Mortality in the Healthy Elderly – New England Journal of Medicine

Review | Breathing difficulties after covid-19: a guide for primary care

29 Jun, 2023 | 14:04h | UTC

Breathing difficulties after covid-19: a guide for primary care – The BMJ

Guidance on fecal immunochemical testing to help diagnose colorectal cancer among symptomatic patients in primary care

29 Jun, 2023 | 13:59h | UTC

Guidance on faecal immunochemical testing (FIT) to help diagnose colorectal cancer among symptomatic patients in primary care – British Journal of General Practice

RCT | Acupuncture, doxylamine–pyridoxine, and their combination in nausea treatment during pregnancy

29 Jun, 2023 | 13:56h | UTC

Acupuncture and Doxylamine–Pyridoxine for Nausea and Vomiting in Pregnancy: A Randomized, Controlled, 2 × 2 Factorial Trial – Annals of Internal Medicine (link to abstract – $ for full-text)

News Release: Acupuncture and doxylamine-pyridoxine beneficial for moderate to severe nausea and vomiting during pregnancy: Study – American College of Physicians

Commentary: Combo treatment eases nausea and vomiting of pregnancy – MDedge

Phase 2 RCT | Triple-hormone-receptor (GIP, GLP-1, and glucagon) agonist Retatrutide substantially reduces body weight in obesity

28 Jun, 2023 | 13:23h | UTC

Summary: This Phase 2, double-blind, randomized, placebo-controlled trial evaluated the efficacy and safety of Retatrutide, a triple-hormone-receptor agonist of GIP, GLP-1, and glucagon, for obesity treatment. The study recruited 338 adults, predominantly male, with a Body Mass Index (BMI) of 30 or higher, or 27 to 30 with at least one weight-related condition. Participants were administered subcutaneous Retatrutide at varying doses or a placebo, once weekly for 48 weeks.

The findings indicate a dose-dependent weight loss efficacy for Retatrutide. At 24 weeks, Retatrutide users exhibited a mean body weight decrease ranging from 7.2% (1 mg dose) to 17.5% (12 mg dose), compared to a 1.6% reduction in the placebo group. This effect was even more pronounced at 48 weeks, with changes ranging from 8.7% (1 mg dose) to a striking 24.2% (12 mg dose), contrasted with a 2.1% reduction in the placebo group. Adverse events, primarily gastrointestinal, were common with Retatrutide, reported by 73 to 94% of patients, and were dose-related.

Retatrutide demonstrated substantial body weight reduction in adults with obesity, with a side effects profile similar to existing GLP-1 and GIP–GLP-1 receptor agonists. These promising results warrant further investigation through a Phase 3 trial to further ascertain the safety and efficacy of Retatrutide in obesity treatment.

Article: Triple–Hormone-Receptor Agonist Retatrutide for Obesity — A Phase 2 Trial – New England Journal of Medicine (link to abstract – $ for full-text)

Commentary on Twitter

Late breaking at #ADA23: In this trial involving participants with obesity, 48 weeks of treatment with retatrutide, an agonist of the GIP, GLP-1, and GCG receptors, resulted in substantial reductions in body weight. https://t.co/jNL1GNna0l

— NEJM (@NEJM) June 26, 2023

Phase 2 RCT | Triple receptor agonist (GIP, GLP-1 and glucagon) Retatrutide shows promising results in obese patients with T2DM

28 Jun, 2023 | 13:21h | UTC

Summary: A Phase 2 Randomized Clinical Trial (RCT) was conducted to investigate the efficacy and safety of Retatrutide, a glucose-dependent insulinotropic polypeptide (GIP), GLP-1, and glucagon receptor agonist, in patients with type 2 diabetes. The study involved 281 adults aged between 18 and 75 years with type 2 diabetes. These patients, with a mean HbA1c level of 8·3%, a mean BMI of 35·0 kg/m², and a mean body weight of 98·2 kg, were randomized to Retatrutide at various doses, Dulaglutide 1.5 mg, and placebo. Patients were treated with diet and exercise alone or a stable dose of metformin for at least three months prior to the study.

The primary outcomes revealed that at 24 weeks, participants who received the higher doses of Retatrutide demonstrated substantial improvements in HbA1c compared to the placebo group and those who received Dulaglutide. Specifically, for the highest-dose Retatrutide group (12 mg), HbA1c level was reduced by an average of 2.02%, which was significantly greater compared to a reduction of 0.01% in the placebo group and 1.41% in the Dulaglutide group.

Regarding body weight, at 36 weeks, participants receiving the different doses of Retatrutide showed a dose-dependent decrease: 3.19% for the 0.5 mg group, 7.92% for the 4 mg escalation group, 10.37% for the 4 mg group, 16.81% for the 8 mg slow escalation group, 16.34% for the 8 mg fast escalation group, and 16.94% for the 12 mg escalation group. This was significantly higher compared to the 3.00% weight loss in the placebo group and the 2.02% loss with 1.5 mg Dulaglutide.

Mild-to-moderate gastrointestinal adverse events were reported among 35% of the participants in the Retatrutide groups, similar to those in the Dulaglutide group, and no severe hypoglycemia or deaths were reported.

The implications of these findings suggest that Retatrutide provides clinically meaningful improvements in glycaemic control and bodyweight reduction with a safety profile consistent with GLP-1 receptor agonists and GIP and GLP-1 receptor agonists. Limitations of the study include limitation of this study is the relatively short duration of the trial and small sample size. Long-term effects and safety of Retatrutide remain to be evaluated in further studies.

Article: Retatrutide, a GIP, GLP-1 and glucagon receptor agonist, for people with type 2 diabetes: a randomised, double-blind, placebo and active-controlled, parallel-group, phase 2 trial conducted in the USA – The Lancet (link to abstract – $ for full-text)

Cohort Study | Younger adults with modest kidney function reductions show increased risk of adverse outcomes

28 Jun, 2023 | 13:14h | UTC

Summary: This study was a retrospective, population-based cohort study exploring the implications of modest reductions in estimated glomerular filtration rate (eGFR) in young adults. The study was conducted on 8.7 million adult residents aged 18-65 years in Ontario, Canada, with no history of kidney disease. Data was collected from January 2008 to March 2021.

The research revealed that 18.0% of those aged 18-39, 18.8% of those aged 40-49, and 17.0% of those aged 50-65 had modestly reduced eGFR measurements specific to their age group. Adverse outcomes, including all-cause mortality, cardiovascular events, and kidney failure, were consistently higher by hazard ratio and incidence for ages 18-39 across all eGFR categories, compared to older groups. The hazard ratio for modest reductions (eGFR 70-80 mL/min/1.73m2) was found to be 1.42 for ages 18-39 years.

The findings suggest that even modest reductions in kidney function can significantly impact younger adults, necessitating frequent monitoring of kidney function in this demographic to prevent chronic kidney disease and its complications. It is noteworthy, however, that potential limitations of this study include possible misclassification of comorbidities, unmeasured confounding, and a lack of insight into the mechanism of these modest eGFR reductions.

Article: Associations between modest reductions in kidney function and adverse outcomes in young adults: retrospective, population based cohort study – The BMJ

News Release: Even a modest reduction in kidney function increases health risks in young adults – University of Ottawa

Podcast | Antiplatelets, anticoagulation for coronary artery disease and atrial fibrillation

28 Jun, 2023 | 13:11h | UTC

#400 Antiplatelets, Anticoagulation for Coronary Artery Disease and Afib – The Curbsiders

Podcast | Wisely ordering autoantibodies

28 Jun, 2023 | 13:09h | UTC

#399 Wisely Ordering Autoantibodies – ACP IM2023 – The Curbsiders

RCT | Oral Semaglutide at 25mg and 50mg improves glycemic control in overweight T2DM patients compared to standard 14mg dose

27 Jun, 2023 | 13:58h | UTC

Summary: The study was a global, multicenter, randomized, double-blind, phase 3b trial involving 1606 adults with inadequately controlled type 2 diabetes. The mean HbA1c in the study population was 9.0% and the mean BMI was 33.8 kg/m2. Participants were assigned to receive either 14mg, 25mg, or 50mg of once-daily oral semaglutide for 68 weeks. The trial aimed to investigate the effectiveness of a new formulation of semaglutide at higher investigational doses against the standard 14mg dose.

The primary endpoint was the change in glycated hemoglobin (HbA1c) levels from baseline to week 52. Results showed that at week 52, changes in HbA1c levels were significantly more substantial with the 25mg (-1.8 percentage points) and 50mg (-2.0 percentage points) doses compared to the 14mg dose (-1.5 percentage points). During the trial, ten deaths occurred, but none were considered treatment-related. No new safety concerns were identified, though adverse events, primarily mild to moderate gastrointestinal disorders, were slightly more frequent in the 25mg and 50mg groups.

The study limitations include a relatively short exposure to the higher doses due to the up to 16 weeks of dose-escalation period, non-adjustable doses due to masking requirements, and a cohort predominantly of White ethnicity, considering the high prevalence of type 2 diabetes in other racial groups. The study was unable to assess differences in efficacy and tolerability between the 25mg and 50mg doses, raising the question of whether the 50mg dosage is necessary if similar effects can be achieved with the 25mg dose.

The implications for further research highlight the need for real-world studies to investigate the clinical impact and safety of these higher doses of oral semaglutide. The superior glycemic control and bodyweight loss with oral semaglutide 25mg and 50mg suggest that these higher doses might help individualize treatment goals and intensify treatment by increasing the dose of a single oral agent. Future studies could consider comparing the 25mg and 50mg doses more directly to determine the most effective and tolerable dose for patients.

Article: Efficacy and safety of once-daily oral semaglutide 25 mg and 50 mg compared with 14 mg in adults with type 2 diabetes (PIONEER PLUS): a multicentre, randomised, phase 3b trial – The Lancet (free registration required)

RCT | Once-daily oral Semaglutide 50mg outperforms placebo in obesity treatment

27 Jun, 2023 | 13:57h | UTC

Summary: The referenced study is a phase 3, superiority, randomized, double-blind, placebo-controlled trial that investigated the effectiveness of oral semaglutide 50mg in treating overweight and obese adults without type 2 diabetes. The trial was conducted in 50 outpatient clinics across Asia, Europe, and North America, with a total of 667 participants randomly allocated to receive either the treatment or a placebo.

The primary outcome measured was the percentage change in bodyweight from baseline to week 68. Results showed a significant reduction in bodyweight among participants receiving semaglutide – a mean change of -15.1% compared to -2.4% for placebo recipients. Additionally, a higher percentage of semaglutide recipients achieved weight reductions of at least 5%, 10%, 15%, and 20% compared to placebo recipients.

However, it’s important to note that adverse events were more frequently observed in the semaglutide group. Specifically, 80% of participants receiving oral semaglutide 50 mg experienced gastrointestinal adverse events, mostly mild to moderate, compared to 46% in the placebo group. This highlights the need for careful patient monitoring during treatment.

The findings indicate that oral semaglutide 50mg, when taken once daily, can lead to a clinically meaningful decrease in bodyweight among overweight and obese adults without type 2 diabetes. Despite the higher occurrence of gastrointestinal adverse events, the significant weight loss potential positions oral semaglutide as a promising treatment option. Further research is recommended to establish long-term safety and efficacy.

Article: Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-controlled, phase 3 trial – The Lancet (link to abstract – $ for full-text)

Review | Hypertension management in patients with cardiovascular comorbidities

27 Jun, 2023 | 13:39h | UTC

Hypertension management in patients with cardiovascular comorbidities – European Heart Journal

Commentary on Twitter

Hypertension management in patients with cardiovascular comorbidities. A State-of-the-Art review just published in #EHJ.@escardio @ESC_Journals #CardioTwitter #hypertension https://t.co/esgOEkxlta pic.twitter.com/xDRHSWn6sZ

— EHJ Editor-in-Chief (@ehj_ed) June 21, 2023

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