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Randomized Trials

RCT | Immediate vs. delayed sequential bilateral cataract surgery: non-inferior in safety, higher cost-effectiveness

6 Jun, 2023 | 14:41h | UTC

Safety, effectiveness, and cost-effectiveness of immediate versus delayed sequential bilateral cataract surgery in the Netherlands (BICAT-NL study): a multicentre, non-inferiority, randomised controlled trial – The Lancet (link to abstract – $ for full-text)

News Release: Cataract surgery: two-sided treatment better than one-by-one approach – Maastricht University

 


RCT | Tirzepatide outperforms insulin glargine in HbA1c reduction and weight loss in type 2 diabetes

6 Jun, 2023 | 14:39h | UTC

Tirzepatide versus insulin glargine as second-line or third-line therapy in type 2 diabetes in the Asia-Pacific region: the SURPASS-AP-Combo trial – Nature Medicine

 

Commentary on Twitter

 


RCT | Perioperative pembrolizumab improves pathological outcomes, event-free survival in early-stage NSCLC

6 Jun, 2023 | 14:36h | UTC

Perioperative Pembrolizumab for Early-Stage Non–Small-Cell Lung Cancer – New England Journal of Medicine (link to abstract – $ for full-text)

 

Commentary on Twitter

 


RCT | Befotertinib tops Icotinib in NSCLC progression-free survival, but increases serious adverse events

6 Jun, 2023 | 14:13h | UTC

Befotertinib (D-0316) versus icotinib as first-line therapy for patients with EGFR-mutated locally advanced or metastatic non-small-cell lung cancer: a multicentre, open-label, randomised phase 3 study – The Lancet Respiratory Medicine (link to abstract – $ for full-text)

 


RCT | Noninferiority shown between DOACs and LMWH for recurrent VTE prevention in cancer patients

5 Jun, 2023 | 13:50h | UTC

Summary: This unblinded, pragmatic, noninferiority randomized clinical trial aimed to assess the efficacy of direct oral anticoagulants (DOACs) against low-molecular-weight heparin (LMWH) in preventing recurrent venous thromboembolism (VTE) in patients with cancer. The study included 671 patients from 67 oncology centers, with a new clinical or radiological diagnosis of VTE.

Participants were randomly assigned to receive either a DOAC or LMWH for 6 months, and treating physicians selected and prescribed the drugs based on considerations like availability and drug-drug interactions. The primary outcome was the rate of recurrent VTE at 6 months. Findings revealed that the DOAC group had a recurrent VTE rate of 6.1% as compared to 8.8% in the LMWH group, showing noninferiority. Both groups had statistically similar rates of major bleeding and severe adverse events.

This pragmatic study included patients with advanced cancer and brain metastases, impaired performance status, and reduced liver or kidney function, making it more representative of routine oncology practice. Moreover, patient adherence to DOAC treatment was significantly higher than to LMWH. Nevertheless, the study had limitations, including the lack of blinding and underrepresentation of certain racial and ethnic groups.

In conclusion, this trial suggests that DOACs were noninferior to LMWH for preventing recurrent VTE in patients with cancer over a 6-month follow-up period, supporting the use of DOACs in this population for VTE prevention. Further research is needed to confirm these results and investigate long-term outcomes.

Article: Direct Oral Anticoagulants vs Low-Molecular-Weight Heparin and Recurrent VTE in Patients With Cancer: A Randomized Clinical Trial – JAMA (free for a limited period)

See also: Visual abstract

 

Commentary on Twitter

 


RCT | Osimertinib improves overall survival in resected EGFR-mutated NSCLC, but validity of control group questioned on social media

5 Jun, 2023 | 13:46h | UTC

Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC – New England Journal of Medicine (link to abstract – $ for full-text)

 

Commentary on Twitter by Dr. Vinay Prasad (recommended – click to see the video)

 


Clinical Trial Update | Olaparib plus bevacizumab first-line maintenance in ovarian cancer

5 Jun, 2023 | 13:07h | UTC

Olaparib plus bevacizumab first-line maintenance in ovarian cancer: final overall survival results from the PAOLA-1/ENGOT-ov25 trial – Annals of Oncology

Original Study: Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer – New England Journal of Medicine

 


RCT | Dupilumab improves lung function and reduces exacerbations in COPD patients with elevated eosinophils

1 Jun, 2023 | 12:20h | UTC

Dupilumab for COPD with Type 2 Inflammation Indicated by Eosinophil Counts – New England Journal of Medicine (link to abstract – $ for full-text)

Commentary: Dupilumab Improves Outcomes for COPD, Type 2 Inflammation in Randomized Trial – HCP Live

 

Commentary on Twitter

 


Phase 2b RCT | Danuglipron, an oral GLP-1R agonist, reduces body weight and improves glycemic control in type 2 diabetes

1 Jun, 2023 | 12:17h | UTC

Efficacy and Safety of Oral Small Molecule Glucagon-Like Peptide 1 Receptor Agonist Danuglipron for Glycemic Control Among Patients With Type 2 Diabetes: A Randomized Clinical Trial – JAMA Network Open

Commentary: What is the efficacy, safety, and tolerability of novel danuglipron in adults with type two diabetes? – News Medical

 


RCT | JAK inhibitor Upadacitinib shows superiority over placebo for moderate-to-severe Crohn’s disease

1 Jun, 2023 | 12:08h | UTC

Upadacitinib Induction and Maintenance Therapy for Crohn’s Disease – New England Journal of Medicine (link to abstract – $ for full-text)

 


RCT | Adapted mindfulness training shows efficacy in reducing elevated office blood pressure

1 Jun, 2023 | 12:03h | UTC

Effect of Adapted Mindfulness Training in Participants With Elevated Office Blood Pressure: The MB‐BP Study: A Randomized Clinical Trial – Journal of the American Heart Association

 


Cluster RCT | Point-of-care CRP testing cuts antibiotic prescriptions in respiratory illnesses in primary care

1 Jun, 2023 | 11:58h | UTC

Implementation of point-of-care testing of C-reactive protein concentrations to improve antibiotic targeting in respiratory illness in Vietnamese primary care: a pragmatic cluster-randomised controlled trial – The Lancet Infectious Diseases

Commentary: Use of CRP testing reduced antibiotics for respiratory infections, trial finds – CIDRAP

 


RCT | Prophylactic platelet transfusion reduces CVC-related bleeding in patients with platelets 10-50 K/mm³

31 May, 2023 | 14:20h | UTC

Platelet Transfusion before CVC Placement in Patients with Thrombocytopenia – New England Journal of Medicine (link to abstract – $ for full-text)

News Release: Research from Amsterdam UMC shows that the bottom has been reached in restrictive blood transfusion policy – Amsterdam University Medical Centers

 

Commentary on Twitter

 


RCT | Early initiation of DOACs not statistically superior to later use in atrial fibrillation-related stroke

31 May, 2023 | 14:17h | UTC

Early versus Later Anticoagulation for Stroke with Atrial Fibrillation – New England Journal of Medicine (link to abstract – $ for full-text)

Commentaries:

ELAN: Early DOACs Safe, May Help After Ischemic Stroke in AF Patients – TCTMD

Early Versus Late Initiation of Direct Oral Anticoagulants in Post-Ischemic Stroke Patients With Atrial Fibrillation – ELAN – American College of Cardiology

 

Commentary on Twitter

 


RCT | Ketamine non-Inferiority to ECT for nonpsychotic resistant depression

31 May, 2023 | 14:15h | UTC

Ketamine versus ECT for Nonpsychotic Treatment-Resistant Major Depression – New England Journal of Medicine (link to abstract – $ for full-text)

News Release: Study Finds Ketamine is at Least as Effective as ECT for Treating Major Depression – Mass General Brigham

Commentary: Expert reaction to trial looking at ketamine versus ECT for nonpsychotic treatment-resistant major depression – Science Media Centre

 


RCT | Sulbactam-durlobactam non-inferior to colistin in reducing 28-day mortality from carbapenem-resistant ABC

30 May, 2023 | 12:08h | UTC

Efficacy and safety of sulbactam–durlobactam versus colistin for the treatment of patients with serious infections caused by Acinetobacter baumannii–calcoaceticus complex: a multicentre, randomised, active-controlled, phase 3, non-inferiority clinical trial (ATTACK) – The Lancet Infectious Diseases (link to abstract – $ for full-text)

News Release: Novel antibiotic succeeds in trial against hospital-acquired pneumonia – Rutgers University

 


RCT | NmCV-5 pentavalent meningococcal vaccine shows non-inferiority to quadrivalent MenACWY-D in Mali and Gambia

30 May, 2023 | 11:46h | UTC

Meningococcal ACWYX Conjugate Vaccine in 2-to-29-Year-Olds in Mali and Gambia – New England Journal of Medicine

 

Commentary on Twitter

 


RCT | Preliminary evidence for right median nerve stimulation in awakening from acute traumatic coma

30 May, 2023 | 11:36h | UTC

Acute traumatic coma awakening by right median nerve electrical stimulation: a randomised controlled trial – Intensive Care Medicine

 

Commentary on Twitter

 


RCT | Group support and skill-based learning reduce opioid use in chronic pain, but leads to no effect on pain perception

29 May, 2023 | 11:14h | UTC

Reducing Opioid Use for Chronic Pain With a Group-Based Intervention: A Randomized Clinical Trial – JAMA (free for a limited period)

See also: Visual Abstract

News Release: New treatment helps people stop addictive opioid painkillers used for chronic pain – University of Warwick

 


RCT | Communication-priming intervention boosts goals-of-care discussions for seriously ill patients

29 May, 2023 | 11:12h | UTC

Intervention to Promote Communication About Goals of Care for Hospitalized Patients With Serious Illness: A Randomized Clinical Trial – JAMA (free for a limited period)

Editorial: Conversations on Goals of Care With Hospitalized, Seriously Ill Patients – JAMA (free for a limited period)

See also: Visual Abstract

Commentary: Some Surrogate Endpoints Are Fine – By Dr John Mandrola

 


Phase 2 RCT | Peresolimab outperforms placebo in patients with moderate-to-severe rheumatoid arthritis

24 May, 2023 | 13:07h | UTC

A Phase 2 Trial of Peresolimab for Adults with Rheumatoid Arthritis – New England Journal of Medicine (link to abstract – $ for full-text)

Commentary: Peresolimab Demonstrates Efficacy in Treating Patients With Rheumatoid Arthritis – HCP Live

 

Commentary on Twitter

 


Cluster RCT | Single-dose rifapentine reduces 4-year leprosy incidence in household contacts

23 May, 2023 | 13:09h | UTC

Single-Dose Rifapentine in Household Contacts of Patients with Leprosy – New England Journal of Medicine (link to abstract – $ for full-text)

Commentary:

Tuberculosis drug shows protective effect against leprosy – CIDRAP

Study: Giving an antibiotic to household contacts of people with leprosy slashes chances of spread – STAT

 


RCT | Effectiveness of genotype-specific tricyclic antidepressant dosing in patients with major depressive disorder

23 May, 2023 | 12:52h | UTC

Effectiveness of Genotype-Specific Tricyclic Antidepressant Dosing in Patients With Major Depressive Disorder: A Randomized Clinical Trial – JAMA Network Open

 

Commentary on Twitter

 


RCT | No significant differences among three exercise strategies for knee osteoarthritis

23 May, 2023 | 12:38h | UTC

Improving the Effectiveness of Exercise Therapy for Adults with Knee Osteoarthritis: A Pragmatic Randomised Controlled Trial (BEEP trial) – Archives of Rehabilitation Research and Clinical Translation

 


RCT | Remote pulmonary artery monitoring may improve QoL, reduce hospitalizations in symptomatic (NYHA III) heart failure

22 May, 2023 | 13:47h | UTC

Remote haemodynamic monitoring of pulmonary artery pressures in patients with chronic heart failure (MONITOR-HF): a randomised clinical trial – The Lancet (link to abstract – $ for full-text)

News Release: Remote monitoring reduces heart failure hospitalisations and improves quality of life – European Society of Cardiology

Commentary: CardioMEMS Beats Standard Care in First European RCT: MONITOR-HF – TCTMD

 

Commentary on Twitter

 


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