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Randomized Trials

RCT: In patients with chronic kidney diseases and anemia not undergoing dialysis, Daprodustat (oral drug) was noninferior to darbepoetin alfa in increasing hemoglobin levels and regarding cardiovascular outcomes.

7 Nov, 2021 | 20:17h | UTC

Daprodustat for the Treatment of Anemia in Patients Not Undergoing Dialysis – New England Journal of Medicine (link to abstract – $ for full-text)

News Release: Oral pill as safe, efficacious as conventional treatment for anemia in patients with kidney disease – Brigham and Women’s Hospital

 

Commentary on Twitter

 

Among patients with atrial fibrillation, 4-year outcomes of PRAGUE-17 randomized trial showed that left atrial appendage closure was noninferior to non-warfarin oral anticoagulation for preventing net ischemic and bleeding events.

7 Nov, 2021 | 20:15h | UTC

Left Atrial Appendage Closure versus Non-Warfarin Oral Anticoagulation in Atrial Fibrillation: 4-Year Outcomes of PRAGUE-17 – Journal of the American College of Cardiology (link to abstract – $ for full-text)

Commentaries:

PRAGUE-17: LAA Occlusion Noninferior to DOACs Over Longer Term – TCTMD

PRAGUE-17: LAAC Noninferior to NOACs For Major AFib-Related CV, Neurological Events Longer-Term – American College of Cardiology

Left Atrial Appendage Closure vs. Novel Anticoagulation Agents in High-Risk Atrial Fibrillation Patients – PRAGUE-17 – American College of Cardiology

 

Commentary on Twitter

 

RCT: In patients with advanced chronic kidney disease and poorly controlled hypertension, Chlortalidone had a significant impact in blood-pressure control (−11.0 mm Hg vs. −0.5 mm Hg in the placebo group).

7 Nov, 2021 | 20:20h | UTC

Chlorthalidone for Hypertension in Advanced Chronic Kidney Disease – New England Journal of Medicine (link to abstract – $ for full-text)

Commentary: Cheap Diuretic, Chlorthalidone, Drops BP in Advanced Kidney Disease – Medscape (free registration required)

 

Commentary on Twitter

 

Cluster RCT: In older adults with advanced cancer, a geriatric assessment program reduced the toxic effects of cancer treatment.

5 Nov, 2021 | 09:48h | UTC

Evaluation of geriatric assessment and management on the toxic effects of cancer treatment (GAP70+): a cluster-randomised study – The Lancet

News Release: Less Chemotherapy, Personalized Care: Wilmot Study Reinforces Major Strides in Geriatric Oncology – University of Rochester Medical Center

Related:

RCT: A geriatric assessment–driven intervention can reduce chemotherapy-related toxic effects in older adults with cancer.

Perspective: A Cancer Care Approach Tailored to The Elderly May Have Better Results

 

Commentary from the author on Twitter (thread – click for more)

https://twitter.com/rochgerionc/status/1456046017766375425

 

RCT: Platelet-rich intra-articular plasma injections do not improve symptoms and function in patients with ankle osteoarthritis.

27 Oct, 2021 | 01:26h | UTC

Effect of Platelet-Rich Plasma Injections vs Placebo on Ankle Symptoms and Function in Patients With Ankle Osteoarthritis: A Randomized Clinical Trial – JAMA (free for a limited period)

Related:

RCT: No benefit from platelet-rich plasma injection for patients with debilitating Achilles tendinopathy.

M-A: Intra-articular saline injection is as effective as corticosteroids, platelet-rich plasma, and hyaluronic acid for hip osteoarthritis pain

 

RCT: In critically ill patients, an individualized glucose control targeting an ICU patient’s pre-admission usual glycemia did not demonstrate a survival benefit compared to conventional glucose control (targeting glycemia below 180 mg/dL).

27 Oct, 2021 | 01:17h | UTC

Individualised versus conventional glucose control in critically-ill patients: the CONTROLING study—a randomized clinical trial – Intensive Care Medicine

Editorial: The goal of personalized glucose control in the critically ill remains elusive – Intensive Care Medicine

 

RCT: Laparoscopic vs. open distal gastrectomy for locally advanced gastric cancer.

26 Oct, 2021 | 01:40h | UTC

Laparoscopic vs Open Distal Gastrectomy for Locally Advanced Gastric Cancer: Five-Year Outcomes From the CLASS-01 Randomized Clinical Trial – JAMA Surgery (free for a limited period)

 

Commentary on Twitter

 

RCT: In comatose survivors of out-of-hospital cardiac arrest, there was no difference in mortality and neurologic outcomes with mild (target temperature of 34 °C) vs. moderate therapeutic hypothermia (target temperature of 31 °C).

24 Oct, 2021 | 23:46h | UTC

Effect of Moderate vs Mild Therapeutic Hypothermia on Mortality and Neurologic Outcomes in Comatose Survivors of Out-of-Hospital Cardiac Arrest: The CAPITAL CHILL Randomized Clinical Trial – JAMA (free for a limited period)

Related:

Cooling After Cardiac Arrest – The Sclerosis of Therapeutic Fashion – “The story of how an ineffective therapy persisted for decades”

RCT: In patients with coma after out-of-hospital cardiac arrest, targeted hypothermia did not improve outcomes.

Study commentary: a history of hypothermia for cardiac arrest, 2002-2021 (RIP).

M-A: Targeted temperature management following out-of-hospital cardiac arrest – “Routine use of moderate or deep hypothermia in comatose survivors of OHCA may potentially be associated with more harm than benefit”.

 

Commentary on Twitter

 

RCT: The association of Varenicline and Nicotine patch was not better than Varenicline alone to increase smoking abstinence; there was also no difference between 24-week vs. 12-week treatment courses in abstinence rates.

24 Oct, 2021 | 23:45h | UTC

Effects of Combined Varenicline With Nicotine Patch and of Extended Treatment Duration on Smoking Cessation: A Randomized Clinical Trial – JAMA (free for a limited period)

Editorial: Is There a Role for Combined Use of Varenicline and Nicotine Patch or Extended Treatment Duration to Enhance Smoking Cessation? – JAMA (free for a limited period)

Commentary: Varenicline Combo, Extension No Better for Quitting Smoking – HealthDay

 

Commentary on Twitter

 

[Press release – not published yet] A phase 3 trial with more than 10,000 participants showed a booster dose of the Pfizer/BioNTech vaccine had an efficacy of 95.6% against disease; there were 5 cases in the booster group and 109 cases in the non-boosted group, not classified according to severity.

22 Oct, 2021 | 10:34h | UTC

Pfizer and BioNTech Announce Phase 3 Trial Data Showing High Efficacy of a Booster Dose of Their COVID-19 Vaccine

Commentary: Booster dose of Pfizer/BioNTech coronavirus vaccine shows 95.6% efficacy in Phase 3 trial, companies say – CNN

 

Commentaries on Twitter

 

RCT: Mirtazapine not better than placebo for the treatment of agitation in people with dementia and was possibly associated with increased mortality (7 vs.1 deaths, difference not statistically significant; p=0·065).

22 Oct, 2021 | 10:19h | UTC

Study of mirtazapine for agitated behaviours in dementia (SYMBAD): a randomised, double-blind, placebo-controlled trial – The Lancet

Commentary: Common antidepressant should no longer be used to treat people with dementia – University of Exeter

 

Five-year follow-up of RCT: Arthroscopic subacromial decompression provided no benefit over diagnostic arthroscopy or exercise therapy on return to work in patients with shoulder impingement syndrome.

21 Oct, 2021 | 09:54h | UTC

Return to work after subacromial decompression, diagnostic arthroscopy, or exercise therapy for shoulder impingement: a randomised, placebo-surgery controlled FIMPACT clinical trial with five-year follow-up – BMC Musculoskeletal Disorders

Related:

Randomized Trial: Subacromial Decompression vs Diagnostic Arthroscopy for Shoulder Impingement

Research: Arthroscopic subacromial decompression for subacromial shoulder pain

BMJ Guideline: Subacromial Decompression Surgery For Adults With Shoulder Pain Does Not Improve Outcomes

Systematic Review: Subacromial Decompression Surgery for Rotator Cuff Disease

Systematic Review: Surgery for Rotator Cuff Tears

 

RCT: Nivolumab vs. placebo in patients with relapsed malignant mesothelioma.

21 Oct, 2021 | 09:46h | UTC

Nivolumab versus placebo in patients with relapsed malignant mesothelioma (CONFIRM): a multicentre, double-blind, randomised, phase 3 trial – The Lancet Oncology

 

Commentary on Twitter

 

RCT: In patients with Type 2 Diabetes, Tirzepatide is associated with reduced weight, improved glycemic control, and lower risk of hypoglycemia compared to insulin glargine.

20 Oct, 2021 | 10:13h | UTC

Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial – The Lancet (link to abstract – $ for full-text)

Related:

RCT: Once-weekly tirzepatide vs. once-daily insulin degludec as add-on to metformin with or without SGLT2 inhibitors in patients with type 2 diabetes.

RCT: Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2.

RCT: Tirzepatide yielded greater glycated hemoglobin and body weight reductions compared to Semaglutide 1 mg.

 

RCT: In stable patients who have undergone PCI for acute myocardial infarction, de-escalation from aspirin + ticagrelor to aspirin + clopidogrel after 1 month reduced bleeding events without increasing cardiovascular risk.

12 Oct, 2021 | 00:06h | UTC

Unguided de-escalation from ticagrelor to clopidogrel in stabilised patients with acute myocardial infarction undergoing percutaneous coronary intervention (TALOS-AMI): an investigator-initiated, open-label, multicentre, non-inferiority, randomised trial – The Lancet (link to abstract – $ for full-text)

Commentary: Adopting a clopidogrel-based DAPT strategy after PCI boosts outcomes for heart attack patients – Cardiovascular Business

 

RCT: Spinal Anesthesia not Superior to General Anesthesia for Hip Surgery in Older Adults.

12 Oct, 2021 | 00:07h | UTC

Spinal Anesthesia or General Anesthesia for Hip Surgery in Older Adults – New England Journal of Medicine (link to abstract – $ for full-text)

News release: Myth busted: General anesthesia just as safe as spinal anesthesia after broken hip surgery – Penn Medicine

Commentary: Study Finds Spinal Anesthesia Not Superior to General Anesthesia for Hip-Fracture Surgery – BreakingMed

Related: RCT: Similar long-term survival after combined epidural–general anesthesia vs. general anesthesia alone.

 

RCT: Among patients with metastatic colorectal cancer, those randomized to systemic treatment alone had lower sixty-day mortality compared to those randomized to primary tumor resection followed by systemic treatment.

12 Oct, 2021 | 00:01h | UTC

Sixty-Day Mortality of Patients With Metastatic Colorectal Cancer Randomized to Systemic Treatment vs Primary Tumor Resection Followed by Systemic Treatment: The CAIRO4 Phase 3 Randomized Clinical Trial – JAMA Surgery (free for a limited period)

Editorial: Primary Tumor Resection and Patients With Asymptomatic Colorectal Cancer and Nonresectable Metastases: Results of Recent Randomized Trials – JAMA Surgery (free for a limited period)

Commentary: Systemic Therapy Alone Bests Surgical Tx for Metastatic CRC – BreakingMed

 

Commentary on Twitter

 

RCT: Early treatment with mild aerobic exercise safely speeds recovery from sport-related concussion in adolescents.

11 Oct, 2021 | 23:58h | UTC

Early targeted heart rate aerobic exercise versus placebo stretching for sport-related concussion in adolescents: a randomised controlled trial – The Lancet Child & Adolescent Health

News release: Aerobic exercise after a sport-related concussion speeds recovery in adolescent athletes – University at Buffalo

Related:

Randomized Trial: Early Aerobic Exercise for Sport-Related Concussion

RCT: Limiting screen time for young adults after concussion results in shorter duration of symptoms.

Selected issues in sport-related concussion for the team physician: a consensus statement – “Current evidence suggests strict rest after SRC slows recovery and increases the probability of prolonged symptoms”.

RCT: Prescribed light exercise vs. standard management for emergency department patients with acute mild traumatic brain injury

 

Commentaries on Twitter

 

RCT: Transanal drainage tube use does not prevent anastomotic leakage after laparoscopic low anterior resection in patients with rectal cancer.

7 Oct, 2021 | 10:27h | UTC

Transanal Drainage Tube Use for Preventing Anastomotic Leakage After Laparoscopic Low Anterior Resection in Patients With Rectal Cancer: A Randomized Clinical Trial – JAMA Surgery (free for a limited period)

Invited commentary: Transanal Drainage Tubes—Prevention of Leaks or Unnecessary Sump? – JAMA Surgery (free for a limited period)

 

RCT: REGEN-COV antibody combination reduces hospitalizations in outpatients with Covid-19.

30 Sep, 2021 | 10:33h | UTC

REGEN-COV Antibody Combination and Outcomes in Outpatients with Covid-19 – New England Journal of Medicine

 

RCT: Neurolytic splanchnic nerve block and pain relief, survival, and quality of life in unresectable pancreatic cancer.

30 Sep, 2021 | 10:16h | UTC

Neurolytic Splanchnic Nerve Block and Pain Relief, Survival, and Quality of Life in Unresectable Pancreatic Cancer: A Randomized Controlled Trial – Anesthesiology

 

Commentary on Twitter

 

RCT: Maintenance vs. discontinuation of antidepressants in patients who felt well enough to discontinue antidepressant therapy.

30 Sep, 2021 | 10:22h | UTC

Maintenance or Discontinuation of Antidepressants in Primary Care – New England Journal of Medicine

Commentaries:

Many can stop anti-depressants without relapse – BBC

Study highlights difficulty of stopping antidepressants – Associated Press

 

RCT: Overall survival benefit with Tebentafusp in metastatic uveal melanoma.

28 Sep, 2021 | 09:03h | UTC

Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma – New England Journal of Medicine

 

Commentary on Twitter

 

RCT: Tamsulosin may prevent postoperative urinary retention following female pelvic reconstructive surgery.

17 Sep, 2021 | 09:56h | UTC

Tamsulosin vs placebo to prevent postoperative urinary retention following female pelvic reconstructive surgery: a multicenter randomized controlled trial – American Journal of Obstetrics & Gynecology (link to abstract – $ for full-text)

 

RCT: Effect of Camrelizumab vs. placebo added to chemotherapy on survival and progression-free survival in patients with advanced or metastatic esophageal squamous cell carcinoma.

15 Sep, 2021 | 08:51h | UTC

Effect of Camrelizumab vs Placebo Added to Chemotherapy on Survival and Progression-Free Survival in Patients With Advanced or Metastatic Esophageal Squamous Cell Carcinoma: The ESCORT-1st Randomized Clinical Trial – JAMA (free for a limited period)

Editorial: Immunotherapy for Advanced Esophageal Squamous Cell Carcinoma—Renewed Enthusiasm and a Lingering Challenge – JAMA Oncology (free for a limited period)

 

Commentary on Twitter

 

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