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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

Related: Faecal immunochemical testing (FIT) in patients with signs or symptoms of suspected colorectal cancer (CRC): a joint guideline from the Association of Coloproctology of Great Britain and Ireland (ACPGBI) and the British Society of Gastroenterology (BSG) – Gut

 

RCT | Intravitreal therapy for uveitic macular edema—ranibizumab versus methotrexate versus the dexamethasone implant

29 Jun, 2023 | 13:57h | UTC

Intravitreal Therapy for Uveitic Macular Edema—Ranibizumab versus Methotrexate versus the Dexamethasone Implant – Ophthalmology (link to abstract – $ for full-text)

News Release: Intraocular corticosteroids best for treating complications of chronic inflammatory eye condition – National Institutes of Health

 

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

 

Consensus Paper | Care for older forensic mental health patients

29 Jun, 2023 | 13:54h | UTC

Care for older forensic mental health patients: A consensus guidance document – European Psychiatry

 

FIGO staging of endometrial cancer: 2023

29 Jun, 2023 | 13:53h | UTC

FIGO staging of endometrial cancer: 2023 – Gynecology & Obstetrics

 

Review | Silent cerebral lesions following catheter ablation for atrial fibrillation

29 Jun, 2023 | 13:51h | UTC

Silent cerebral lesions following catheter ablation for atrial fibrillation: a state-of-the-art review – EP Europace

 

Commentary on Twitter

 

Liver Transplantation 2023 | Status report, current and future challenges

29 Jun, 2023 | 13:50h | UTC

Liver Transplantation 2023: Status Report, Current and Future Challenges – Clinical Gastroenterology and Hepatology

 

SR | Anti‐vascular endothelial growth factors in combination with vitrectomy for complications of proliferative diabetic retinopathy

29 Jun, 2023 | 13:49h | UTC

Anti‐vascular endothelial growth factors in combination with vitrectomy for complications of proliferative diabetic retinopathy – Cochrane Library

 

RCT | Arthroscopic capsular shift surgery shows no significant pain or functional improvement in atraumatic shoulder instability

29 Jun, 2023 | 13:45h | UTC

Arthroscopic capsular shift surgery in patients with atraumatic shoulder joint instability: a randomised, placebo-controlled trial – British Journal of Sports Medicine (link to abstract – $ for full-text)

 

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

 

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)

 

RCT | Bulevirtide reduces HDV RNA and ALT levels in chronic hepatitis D patients

28 Jun, 2023 | 13:20h | UTC

Summary: This randomized phase 3 trial evaluated the efficacy of bulevirtide, an inhibitor of HDV entry into hepatocytes, in patients with chronic hepatitis D. Patients were randomized to receive either 2 mg or 10 mg of bulevirtide daily for 144 weeks, or no treatment for 48 weeks followed by 10 mg bulevirtide daily for 96 weeks. The study involved 150 patients, 49 in the 2-mg group, 50 in the 10-mg group, and 51 in the control group.

After 48 weeks of treatment, 45% and 48% of patients in the 2-mg and 10-mg groups respectively achieved the primary end point of undetectable HDV RNA level or a decrease of at least 2 log10 IU per milliliter from baseline, and normalization of ALT level. Only 2% in the control group reached the primary endpoint. ALT levels normalized in 51% and 56% of patients in the 2-mg and 10-mg groups respectively, a significant difference from the 12% normalization in the control group. Notably, loss of HBsAg did not occur by week 48 in the bulevirtide groups. No serious adverse events related to the treatment were reported, though side effects including headache, pruritus, and fatigue were more common in the bulevirtide groups.

These results demonstrate the effectiveness of bulevirtide in reducing HDV RNA and ALT levels in patients with chronic hepatitis D. However, the absence of HBsAg loss in bulevirtide groups raises questions about its long-term implications.

Article: A Phase 3, Randomized Trial of Bulevirtide in Chronic Hepatitis D – New England Journal of Medicine (link to abstract – $ for full-text)

 

Commentary on Twitter

 

Perspective | Psychedelic treatments for mental health conditions pose challenges for informed consent

28 Jun, 2023 | 13:17h | UTC

Psychedelic treatments for mental health conditions pose challenges for informed consent – Nature Medicine

 

Perspective | Ensuring ethical postprogression therapy for patients in randomized trial control arms

28 Jun, 2023 | 13:16h | UTC

Ensuring Ethical Postprogression Therapy for Patients in Randomized Trial Control Arms – Journal of Clinical Oncology

 

Commentary on Twitter

 

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

 

RCT | Total breast reconstruction with autologous fat transfer using an expansion device vs implants in patients with breast cancer

28 Jun, 2023 | 13:12h | UTC

Effect of Total Breast Reconstruction With Autologous Fat Transfer Using an Expansion Device vs Implants on Quality of Life Among Patients With Breast Cancer: A Randomized Clinical Trial – JAMA Surgery (link to abstract – $ for full-text)

See also: Visual Abstract

Author Interview: Effect of Breast Reconstruction With Autologous Fat Transfer vs Implants on Quality of Life – JAMA

 

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

 

KDOQI US commentary on the 2021 KDIGO clinical practice guideline for the management of glomerular diseases

28 Jun, 2023 | 13:07h | UTC

KDOQI US Commentary on the 2021 KDIGO Clinical Practice Guideline for the Management of Glomerular Diseases – American Journal of Kidney Diseases

Original Guideline: KDIGO 2021 clinical practice guideline for the management of glomerular diseases – Kidney Disease: Improving Global Outcomes

 

Position Statement | Prehospital hemorrhage control and treatment by clinicians

27 Jun, 2023 | 14:02h | UTC

Prehospital Hemorrhage Control and Treatment by Clinicians: A Joint Position Statement – Annals of Emergency Medicine

 

EASL Clinical Practice Guidelines on acute-on-chronic liver failure

27 Jun, 2023 | 14:00h | UTC

EASL Clinical Practice Guidelines on acute-on-chronic liver failure – Journal of Hepatology

 

Commentary on Twitter

 

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)

 

RCT | Cyclophosphamide-based regimen enhances GVHD-free survival after hematopoietic stem-cell transplantation

27 Jun, 2023 | 13:54h | UTC

Summary: The article details a phase 3 trial comparing the efficacy of two graft-versus-host disease (GVHD) prophylactic regimens in hematologic cancer patients undergoing allogeneic hematopoietic stem-cell transplantation (HSCT). The experimental group received cyclophosphamide–tacrolimus–mycophenolate mofetil, and the standard group received tacrolimus–methotrexate. The patients, a total of 431, underwent HSCT from an HLA-matched related donor or a matched or 7/8 mismatched unrelated donor.

The primary end point was GVHD-free, relapse-free survival at 1 year. Results indicated a significantly higher incidence of this outcome in the experimental group (hazard ratio, 0.64; 95% confidence interval [CI], 0.49 to 0.83; P=0.001). At 1 year, adjusted GVHD-free, relapse-free survival was 52.7% (95% CI, 45.8 to 59.2) in the experimental group, compared to 34.9% (95% CI, 28.6 to 41.3) in the standard group.

Notably, patients in the experimental-prophylaxis group appeared to have less severe acute or chronic GVHD and a higher incidence of immunosuppression-free survival at 1 year. Overall survival, disease-free survival, relapse, transplantation-related death, and engraftment did not show a substantial difference between the groups. These results suggest that cyclophosphamide–tacrolimus–mycophenolate mofetil may offer a more effective prophylaxis against GVHD in HSCT patients.

Article: Post-Transplantation Cyclophosphamide-Based Graft-versus-Host Disease Prophylaxis – New England Journal of Medicine (link to abstract – $ for full-text)

News Release: Study Sets New Standard for Graft-Versus-Host Disease Prevention After Stem Cell Transplant – Johns Hopkins Medicine

 

Commentary on Twitter

 

RCT | Dolutegravir is noninferior as a replacement for ritonavir-boosted protease inhibitor in HIV therapy

27 Jun, 2023 | 13:52h | UTC

Summary: This randomized clinical trial (RCT) assessed the switch from ritonavir-boosted protease inhibitor (PI) to dolutegravir in HIV patients without genotype information but with viral suppression. The multicenter, open-label trial, involving 795 participants across four sites in Kenya, compared those who switched to dolutegravir (398) with those continuing with their current ritonavir-boosted PI regimen (397). The primary end point was an HIV type 1 RNA level of at least 50 copies per milliliter at week 48.

At the end of the trial period, the number of patients in both groups who met the primary end point was nearly the same (5.0% in the dolutegravir group and 5.1% in the ritonavir-boosted PI group). This indicates the noninferiority of dolutegravir, within a 4% margin. Additionally, no mutations conferring resistance to either drug were detected. The incidence of treatment-related adverse events of grade 3 or 4 was similar in both groups (5.7% for dolutegravir and 6.9% for ritonavir-boosted PI).

The study concludes that dolutegravir is a noninferior alternative to ritonavir-boosted PI for previously treated, virally suppressed HIV patients lacking drug-resistance mutation data. The similar safety profiles also support the switch. However, further research may provide valuable insights on the long-term implications of the switch.

Article: Second-Line Switch to Dolutegravir for Treatment of HIV Infection – New England Journal of Medicine (link to abstract – $ for full-text)

Commentary: Second-Line Switch to Dolutegravir Noninferior in HIV – HealthDay

 

Commentary on Twitter

 

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