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Randomized Trials

[Preprint] RCT: Both REGEN-COV 2400mg and 1200mg antibody cocktails significantly reduced Covid-19-related hospitalization or all-cause death compared to placebo (71.3% reduction and 70.4% reduction, respectively).

24 May, 2021 | 08:46h | UTC

REGEN-COV Antibody Cocktail Clinical Outcomes Study in Covid-19 Outpatients – medRxiv

 

Commentary on Twitter

 


#ACC21 – RCT: Among patients with resistant hypertension, ultrasound renal denervation resulted in a modest improvement in systolic BP (–4.5 mm Hg) vs. sham procedure.

24 May, 2021 | 08:28h | UTC

Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomised, multicentre, single-blind, sham-controlled trial – The Lancet (link to abstract – $ for full-text)

Commentary: Renal Denervation for Resistant Hypertension Is Not Back on Track – “A systolic blood pressure (SBP) reduction of 4.5 mm Hg is not good enough—for an invasive procedure”. – Medscape (free registration required)

 


RCT: Among patients with pemphigus vulgaris, rituximab was superior to mycophenolate mofetil in producing sustained complete remission at 52 weeks (40% vs 10%) but was associated with increased risk of serious adverse events (22% vs. 15%).

24 May, 2021 | 08:24h | UTC

Rituximab versus Mycophenolate Mofetil in Patients with Pemphigus Vulgaris – New England Journal of Medicine

 


RCT: In Africa, children hospitalized with severe pneumonia with oxygen saturations between 80 and 91% who did not receive oxygen had comparable mortality to children who received oxygen.

21 May, 2021 | 08:30h | UTC

Randomised controlled trial of oxygen therapy and high-flow nasal therapy in African children with pneumonia – Intensive Care Medicine

 

Commentary on Twitter

 


SPRINT Trial final report: targeting a systolic BP of less than 120 mm Hg in patients at increased CV risk is associated with improved CV and mortality outcomes but increases the risk of serious adverse events.

20 May, 2021 | 08:36h | UTC

Final Report of a Trial of Intensive versus Standard Blood-Pressure Control – New England Journal of Medicine

Commentary: Final results of SPRINT study confirm controlling blood pressure critically important in preventing heart disease and stroke – Cleveland Medical Center

 


24-week randomized controlled trial: Mixed tree nut snacks resulted in similar weight loss and increased satiety compared to refined carbohydrate snacks in a weight loss and maintenance program.

20 May, 2021 | 08:28h | UTC

Mixed Tree Nut Snacks Compared to Refined Carbohydrate Snacks Resulted in Weight Loss and Increased Satiety during Both Weight Loss and Weight Maintenance: A 24-Week Randomized Controlled Trial – Nutrients

Commentary: Mixed tree nut snacks result in significant weight loss and improved satiety – News Medical

 


[Preprint] Practice Changing RCT: Therapeutic-dose anticoagulation with heparin (LMWH or unfractionated heparin) improves outcomes in non-critically ill patients with Covid-19 – the superiority of therapeutic-dose anticoagulation was seen in both high and low D-dimer groups.

18 May, 2021 | 08:04h | UTC

Therapeutic Anticoagulation in Non-Critically Ill Patients with Covid-19 – medRxiv

Related: [Preprint] RCT: Full-dose/therapeutic anticoagulation provides no benefit in critically ill patients with Covid-19

 

Commentary on Twitter

 


RCT: Among patients with esophageal cancer, intrathoracic anastomosis after totally or hybrid minimally invasive esophagectomy resulted in lower anastomotic leakage rates and better outcomes when compared with cervical anastomosis.

18 May, 2021 | 07:21h | UTC

Intrathoracic vs Cervical Anastomosis After Totally or Hybrid Minimally Invasive Esophagectomy for Esophageal Cancer: A Randomized Clinical Trial – JAMA Surgery (free for a limited period)

Invited commentary: Does the Location Matter for the Anastomosis for Minimally Invasive Esophagectomy? (free for a limited period)

 

Commentary on Twitter

 


RECOVERY Trial: No benefit from convalescent plasma in patients admitted to hospital with COVID-19.

17 May, 2021 | 08:56h | UTC

Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial – The Lancet

Invited commentary: Convalescent plasma in patients hospitalised with COVID-19

 

Commentaries on Twitter

 


#ACC21 – [Not published yet] RCT: DARE-19: Dapagliflozin is safe, but did not significantly improve outcomes among high-risk patients hospitalized with COVID-19.

17 May, 2021 | 08:49h | UTC

DARE-19: Dapagliflozin in High-Risk Patients Hospitalized With COVID-19 – American College of Cardiology

See also: Dapagliflozin in Respiratory Failure in Patients With COVID-19 – DARE-19 – American College of Cardiology

 

Commentaries on Twitter

 


#ACC21 – Practice Changing RCT: In patients with atrial fibrillation (75% maintained on anticoagulation), left atrial appendage occlusion during cardiac surgery reduces the incidence of stroke and systemic embolism (4.8 vs. 7.0%) in the following years.

17 May, 2021 | 08:33h | UTC

Left Atrial Appendage Occlusion during Cardiac Surgery to Prevent Stroke – New England Journal of Medicine (link to abstract – $ for full-text)

Commentaries: Simple surgery prevents strokes in heart patients – McMaster University AND Occluding the LAA During Surgery Lowers Stroke Risk: LAAOS III – TCTMD

Video: The Left Atrial Appendage Occlusion Study (LAAOS) III

 

Commentary on Twitter

 


#ACC21 – RCT: No significant differences in cardiovascular events or major bleeding between patients receiving 81 mg vs. 325 mg of aspirin daily.

17 May, 2021 | 08:31h | UTC

Comparative Effectiveness of Aspirin Dosing in Cardiovascular Disease – New England Journal of Medicine (link to abstract – $ for full-text)

Commentaries: High- and Low-Dose Aspirin Equivalent in ASCVD: ADAPTABLE – TCTMD AND Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness – ADAPTABLE – American College of Cardiology

Video: Aspirin Dosing: A Patient-centric Trial Assessing Benefits And Long-term Effectiveness Trial

 


#ACC21 – RCT: Tailored, earlier heart failure rehabilitation program has physical and emotional benefits for older patients.

17 May, 2021 | 08:23h | UTC

Physical Rehabilitation for Older Patients Hospitalized for Heart Failure – New England Journal of Medicine

Commentaries: Tailored, earlier heart failure rehab has physical, emotional benefits for patients – National institutes of Health AND REHAB-HF: Tailored Cardiac Rehab Program Improved Function and Quality of Life in Older HF Patients – American College of Cardiology AND Rehabilitation Therapy in Older Acute Heart Failure Patients – REHAB-HF – American College of Cardiology

Video: A Novel Physical Rehabilitation Intervention For Older Patients With Acute Decompensated Heart Failure: The REHAB-HF Trial

 

Commentaries on Twitter

 


#ACC21 – RCT: In patients with STEMI undergoing complete revascularization, an FFR-guided strategy did not improve outcomes compared to an angiography-guided strategy.

17 May, 2021 | 08:26h | UTC

Multivessel PCI Guided by FFR or Angiography for Myocardial Infarction – New England Journal of Medicine (link to abstract – $ for full-text)

Commentary: FLOWER-MI: No Benefit to Multivessel PCI Guided by FFR vs. Angiography For MI – American College of Cardiology

 


#ACC21 – [Not published yet] RCT: PARADISE-MI: Sacubitril/Valsartan did not outperform ACE inhibitor after myocardial infarction with new onset heart failure.

17 May, 2021 | 08:17h | UTC

PARADISE-MI: Sacubitril/Valsartan Did Not Outperform ACE Inhibitor After MI – American College of Cardiology

See also: Prospective ARNI vs. ACE inhibitor trial to DetermIne Superiority in reducing heart failure Events after Myocardial Infarction – PARADISE-MI – American College of Cardiology

 


#ACC21 – [Not published yet] RCT: Among patients undergoing TAVR, full-dose apixaban is not superior to standard of care (vitamin K antagonist if indication for oral anticoagulation; antiplatelet therapy if no indication).

17 May, 2021 | 08:19h | UTC

Anti-Thrombotic Strategy to Lower All cardiovascular and Neurologic Ischemic and Hemorrhagic Events after Trans-Aortic Valve Implantation for Aortic Stenosis – ATLANTIS – American College of Cardiology

Commentaries: ATLANTIS: Apixaban Not Superior to Standard Care After TAVR – American College of Cardiology AND ATLANTIS: Apixaban Has No Benefit Over Standard of Care Post-TAVI – TCTMD

 


Pragmatic RCT: Among patients with advanced glaucoma, primary trabeculectomy resulted in similar quality of life and safety outcomes and achieved a lower intraocular pressure compared with primary medication.

17 May, 2021 | 08:06h | UTC

Primary trabeculectomy for advanced glaucoma: pragmatic multicentre randomised controlled trial (TAGS) – The BMJ

 


Large trial with over 200.000 patients finds ovarian cancer screening does not reduce deaths.

14 May, 2021 | 08:32h | UTC

Ovarian cancer population screening and mortality after long-term follow-up in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial – The Lancet

Commentaries: Screening for ovarian cancer did not reduce early deaths – Imperial College London AND Annual screening for ovarian cancer does not save lives, study finds – The Guardian

 


RCT: Tezepelumab can reduce exacerbations in adults and adolescents with severe, uncontrolled asthma.

14 May, 2021 | 08:25h | UTC

Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma – New England Journal of Medicine

Commentary: New drug shows promise against tough-to-manage asthma – MedicalXpress

 


RCT: Tympanostomy-tube placement does not reduce episodes of acute otitis media among children 6 to 35 months of age with recurrent acute otitis media

13 May, 2021 | 05:57h | UTC

Tympanostomy Tubes or Medical Management for Recurrent Acute Otitis Media – New England Journal of Medicine

Commentary: No lasting benefit to tubes over antibiotics for childhood ear infections – University of Pittsburgh

 


RCT: Among adults with idiopathic pulmonary fibrosis, antimicrobial therapy with co-trimoxazole or doxycycline is not associated with improved outcomes.

12 May, 2021 | 08:37h | UTC

Effect of Antimicrobial Therapy on Respiratory Hospitalization or Death in Adults With Idiopathic Pulmonary Fibrosis: The CleanUP-IPF Randomized Clinical Trial – JAMA (free for a limited period)

 

Commentary on Twitter

 


RCT: Inclusion of 18F-fluciclovine-PET/CT imaging to guide postprostatectomy salvage radiotherapy in patients with prostate cancer may improve survival free from biochemical recurrence or persistence.

10 May, 2021 | 00:46h | UTC

18F-fluciclovine-PET/CT imaging versus conventional imaging alone to guide postprostatectomy salvage radiotherapy for prostate cancer (EMPIRE-1): a single centre, open-label, phase 2/3 randomised controlled trial – The Lancet (link to abstract – $ for full-text)

 


RCT: Efficacy and safety of voclosporin for lupus nephritis – voclosporin + MMF + low dose corticosteroids achieved complete renal response at week 52 more often than MMF + low dose corticosteroids alone (41% vs. 23%).

10 May, 2021 | 00:48h | UTC

Efficacy and safety of voclosporin versus placebo for lupus nephritis (AURORA 1): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial – The Lancet (link to abstract – $ for full-text)

 


RCT: Community pharmacies provision of a progestogen-only pill + invitation to a sexual and reproductive health clinic as a bridging contraception intervention for women receiving emergency contraception is associated with increased subsequent use of long-term effective contraception.

10 May, 2021 | 00:45h | UTC

Provision of the progestogen-only pill by community pharmacies as bridging contraception for women receiving emergency contraception: the Bridge-it RCT – Health Technology Assessment

 


RCT: Therapeutic drug monitoring during infliximab induction does not improve disease remission in patients with chronic immune-mediated inflammatory diseases

7 May, 2021 | 08:27h | UTC

Effect of Therapeutic Drug Monitoring vs Standard Therapy During Infliximab Induction on Disease Remission in Patients With Chronic Immune-Mediated Inflammatory Diseases: A Randomized Clinical Trial – JAMA (free for a limited period)

Editorial: Treatment Strategies for Patients With Immune-Mediated Inflammatory Diseases – JAMA (free for a limited period)

Commentary: Mixed Results with Refined Treatment Strategies for Rheumatic Diseases – Physician’s Weekly

 

Commentary on Twitter

 


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