Randomized Trials | Page 3 of 52 | Links Medicus Content Curation & Alerts in Medicine

RCT | No definitive benefit of enoxaparin over placebo in preventing VTE in hospitalized older adults

17 Jul, 2023 | 13:57h | UTC

Enoxaparin versus Placebo to Prevent Symptomatic Venous Thromboembolism in Hospitalized Older Adult Medical Patients – NEJM Evidence

RCT | 4-week course of subcutaneous ketamine shows efficacy in treatment-resistant depression

17 Jul, 2023 | 13:17h | UTC

Efficacy and safety of a 4-week course of repeated subcutaneous ketamine injections for treatment-resistant depression (KADS study): randomised double-blind active-controlled trial – British Journal of Psychiatry

News Release: Ketamine effective for treatment-resistant depression: Clinical trial – University of New South Wales

M-A | Electroconvulsive therapy may be superior to ketamine for patients with major depressive episode

RCT | Assessing low-dose ketamine’s antidepressant & antisuicidal effects in patients with treatment-resistant depression

M-A | Efficacy and safety of ketamine vs. electroconvulsive therapy among patients with major depressive episode.

RCT | Swallowing and oral-care program enhances oral-feeding resumption and reduces pneumonia post-extubation

14 Jul, 2023 | 12:44h | UTC

Effects of a swallowing and oral-care program on resuming oral feeding and reducing pneumonia in patients following endotracheal extubation: a randomized, open-label, controlled trial – Critical Care

RCT | Efficacy of different treatment regimens in unresectable colorectal cancer liver metastases

14 Jul, 2023 | 12:42h | UTC

First-line systemic treatment strategies in patients with initially unresectable colorectal cancer liver metastases (CAIRO5): an open-label, multicentre, randomised, controlled, phase 3 study from the Dutch Colorectal Cancer Group – The Lancet Oncology (link to abstract – $ for full-text)

Commentary on Twitter

ICYMI: The CAIRO5 open-label, multicentre, randomised, phase 3 trial of first-line systemic treatment strategies in patients with initially unresectable colorectal cancer liver metastases. #ccsm https://t.co/PiiwFcktLn pic.twitter.com/wlQbmuDLOW

— The Lancet Oncology (@TheLancetOncol) July 5, 2023

RCT | Metformin boosts effectiveness of lifestyle interventions for diabetes prevention in individuals with impaired glucose regulation

13 Jul, 2023 | 13:07h | UTC

Safety and effectiveness of metformin plus lifestyle intervention compared with lifestyle intervention alone in preventing progression to diabetes in a Chinese population with impaired glucose regulation: a multicentre, open-label, randomised controlled trial – The Lancet Diabetes & Endocrinology (link to abstract – $ for full-text)

Related Study: Reduction in the Incidence of Type 2 Diabetes with Lifestyle Intervention or Metformin – New England Journal of Medicine (link to abstract – $ for full-text)

RCT | Cytisinicline shows significant efficacy in smoking cessation over placebo

13 Jul, 2023 | 12:58h | UTC

Cytisinicline for Smoking Cessation: A Randomized Clinical Trial – JAMA (link to abstract – $ for full-text)

See also: Visual Abstract

News Release: First large US clinical trial of cytisinicline finds the smoking cessation medication effective and well tolerated – Massachusetts General Hospital

RCT | Self-administered intranasal etripamil superior to placebo for acute supraventricular tachycardia conversion

12 Jul, 2023 | 13:54h | UTC

Self-administered intranasal etripamil using a symptom-prompted, repeat-dose regimen for atrioventricular-nodal-dependent supraventricular tachycardia (RAPID): a multicentre, randomised trial – The Lancet

RCT | Supplementing CPVI with low-voltage-area ablation lowers atrial arrhythmia recurrence in elderly with paroxysmal AF

12 Jul, 2023 | 13:31h | UTC

Circumferential Pulmonary Vein Isolation With vs Without Additional Low-Voltage-Area Ablation in Older Patients With Paroxysmal Atrial Fibrillation: A Randomized Clinical Trial – JAMA Cardiology (link to abstract – $ for full-text)

RCT | Butylphthalide may enhance functional outcomes in acute ischemic stroke patients undergoing reperfusion therapy

11 Jul, 2023 | 13:46h | UTC

Efficacy and Safety of Butylphthalide in Patients With Acute Ischemic Stroke: A Randomized Clinical Trial – JAMA Neurology (link to abstract – $ for full-text)

See also: Visual Abstract

Phase 2b RCT | Therapeutic ammonia oxidising bacteria B244 shows promising efficacy in atopic dermatitis

11 Jul, 2023 | 13:40h | UTC

Efficacy and safety of topically applied therapeutic ammonia oxidising bacteria in adults with mild-to-moderate atopic dermatitis and moderate-to-severe pruritus: a randomised, double-blind, placebo-controlled, dose-ranging, phase 2b trial – eClinicalMedicine

RCT | Atezolizumab in platinum-ineligible NSCLC elevates median survival to 10.3 months vs. 9.2 months with chemotherapy

10 Jul, 2023 | 13:33h | UTC

First-line atezolizumab monotherapy versus single-agent chemotherapy in patients with non-small-cell lung cancer ineligible for treatment with a platinum-containing regimen (IPSOS): a phase 3, global, multicentre, open-label, randomised controlled study – The Lancet (link to abstract – $ for full-text)

News Release: Immunotherapy for ‘difficult to treat’ lung cancer patients improves long-term survival – University College London

RCT | Perioperative nivolumab plus chemotherapy increases pathological response vs. chemotherapy alone in stage III NSCLC

10 Jul, 2023 | 13:27h | UTC

Perioperative Nivolumab and Chemotherapy in Stage III Non–Small-Cell Lung Cancer – New England Journal of Medicine (link to abstract – $ for full-text)

Commentary: Addition of Neoadjuvant Nivolumab to Platinum-Based Chemotherapy in Stage III NSCLC – The ASCO Post

Commentary on Twitter

Original Article: Perioperative Nivolumab and Chemotherapy in Stage III Non–Small-Cell Lung Cancer https://t.co/DCcs0tkyPN #oncology pic.twitter.com/0zG9SUbqQj

— NEJM (@NEJM) June 30, 2023

RCT | Mirikizumab outperforms placebo in inducing and maintaining remission in ulcerative colitis

10 Jul, 2023 | 13:25h | UTC

Mirikizumab as Induction and Maintenance Therapy for Ulcerative Colitis – New England Journal of Medicine (link to abstract – $ for full-text)

Commentary: Mirikizumab Bests Placebo in Treating Patients With Ulcerative Colitis – HCP Live

Commentary on Twitter

In two placebo-controlled, phase 3 trials, mirikizumab, a p19-directed anti–interleukin-23 antibody, was superior with regard to clinical remission of ulcerative colitis at 12 weeks (induction) and 40 weeks (maintenance). https://t.co/H4reu33hF1

— NEJM (@NEJM) June 28, 2023

RCT | Weekly Tirzepatide outperforms placebo in weight management for type 2 diabetes patients

7 Jul, 2023 | 16:24h | UTC

Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial – The Lancet (link to abstract – $ for full-text)

Commentary: Tirzepatide triumphs in significant weight reduction for people with type 2 diabetes – News Medical

RCT | Brachytherapy alone sufficient for intermediate-risk prostate cancer, no FFP improvement with additional EBRT

7 Jul, 2023 | 16:06h | UTC

Effect of Brachytherapy With External Beam Radiation Therapy Versus Brachytherapy Alone for Intermediate-Risk Prostate Cancer: NRG Oncology RTOG 0232 Randomized Clinical Trial – Journal of Clinical Oncology (link to abstract – $ for full-text)

News Release: Addition of EBRT to brachytherapy did not improve outcomes for men with intermediate-risk prostate cancer, brachytherapy alone remains standard of care – NRG Oncology

RCT | Opioids not more effective than placebo for acute low back and neck pain

5 Jul, 2023 | 01:15h | UTC

Opioid analgesia for acute low back pain and neck pain (the OPAL trial): a randomised placebo-controlled trial – The Lancet (link to abstract – $ for full-text)

News Releases:

Opioids no more effective than placebo for acute back and neck pain – University of Sidney

Opioid pain relievers do not reduce acute lower back and neck pain, study suggests – The Lancet

Commentary from the authors: Opioids don’t relieve acute low back or neck pain – and can result in worse pain, new study finds – The Conversation

RCT | Transcranial direct current stimulation fails to outperform sham in major depressive disorder treatment

5 Jul, 2023 | 01:12h | UTC

Transcranial direct current stimulation as an additional treatment to selective serotonin reuptake inhibitors in adults with major depressive disorder in Germany (DepressionDC): a triple-blind, randomised, sham-controlled, multicentre trial – The Lancet (link to abstract – $ for full-text)

RCT | No statistically significant impact of vitamin D on major cardiovascular events

5 Jul, 2023 | 01:11h | UTC

Vitamin D supplementation and major cardiovascular events: D-Health randomised controlled trial – The BMJ

RCT: Oral Vitamin D supplementation (60.000 IU per month) did not reduce mortality in patients 60 years or older (unscreened individuals in Australia, many without insufficiency, average 30ng/mL). Exploratory analyses pointed towards an increased risk of death from cancer.

Randomized Trial: Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease

Meta-Analysis: Vitamin D Not Effective for Cardiovascular Disease Prevention

Association between vitamin D supplementation and mortality: systematic review and meta-analysis – The BMJ

USPSTF Draft Statement: Insufficient evidence to recommend multivitamin supplements for the prevention of CVD or cancer. The statement also recommends against the use of beta-carotene (increases risk of CVD mortality and lung cancer) or vitamin E (clear evidence of no benefit)

Vitamin D, calcium, other vitamins, and supplements do not prevent cardiovascular diseases

RCT | Lower rates of treatment failure with standard-course vs. short-course therapy in pediatric UTIs

5 Jul, 2023 | 01:09h | UTC

Short-Course Therapy for Urinary Tract Infections in Children: The SCOUT Randomized Clinical Trial – JAMA Pediatrics (link to abstract – $ for full-text)

See also: Visual Abstract

Commentary: Treatment Failure Down With Standard-Course Therapy in Pediatric UTI – HealthDay

RCT | Weekly insulin Icodec proves effective in glucose control in insulin-naive type 2 diabetes patients

3 Jul, 2023 | 14:32h | UTC

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)

Phase 2 RCT | FGF21 analogue Pegozafermin treatment leads to improvement in NASH fibrosis

30 Jun, 2023 | 14:58h | UTC

Summary: In a phase 2b, multicenter, double-blind, randomized, placebo-controlled trial, the fibroblast growth factor 21 (FGF21) analogue pegozafermin was examined for its efficacy and safety in treating patients with biopsy-confirmed noncirrhotic nonalcoholic steatohepatitis (NASH). A total of 222 patients with moderate or severe fibrosis (stage F2 or F3) were assigned to receive either subcutaneous pegozafermin at varying doses or a placebo. The primary endpoints were an improvement in fibrosis and resolution of NASH without worsening of fibrosis at 24 weeks.

The results showed that a larger percentage of patients receiving pegozafermin met the criteria for fibrosis improvement and NASH resolution compared to those receiving placebo. The most significant improvements were observed in the 44-mg pegozafermin group, with 27% showing fibrosis improvement and 26% meeting NASH resolution criteria, compared to 7% and 2% in the placebo group, respectively. Adverse events were mainly gastrointestinal and included nausea and diarrhea. These findings support the progression of pegozafermin into phase 3 development.

Article: Randomized, Controlled Trial of the FGF21 Analogue Pegozafermin in NASH – New England Journal of Medicine (link to abstract – $ for full-text)

Commentary on Twitter

Late breaking at #EASLCongress: In this phase 2b, placebo-controlled trial involving patients with nonalcoholic steatohepatitis, pegozafermin, a long-acting glycopegylated FGF21 analogue, reduced fibrosis at 24 weeks. Full results by @drloomba et al.: https://t.co/mfRRrV2yX2

— NEJM (@NEJM) June 24, 2023