Randomized Trials
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 | UTCReducing 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 | UTCIntervention 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 | UTCA 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
Peresolimab showed efficacy in a phase 2a trial in patients with rheumatoid arthritis. These results provide evidence that stimulation of the PD-1 receptor has potential efficacy in the treatment of rheumatoid arthritis. https://t.co/2MkxLBrKTf
— NEJM (@NEJM) May 20, 2023
Cluster RCT | Single-dose rifapentine reduces 4-year leprosy incidence in household contacts
23 May, 2023 | 13:09h | UTCSingle-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
RCT | Effectiveness of genotype-specific tricyclic antidepressant dosing in patients with major depressive disorder
23 May, 2023 | 12:52h | UTC
Commentary on Twitter
Genotype-guided tricyclic antidepressant dosing may help patients with depression reach faster therapeutic plasma concentrations, with potentially fewer adverse effects. https://t.co/06cIaQjmwV pic.twitter.com/ZBdXZLeWc3
— JAMA Network Open (@JAMANetworkOpen) May 8, 2023
RCT | No significant differences among three exercise strategies for knee osteoarthritis
23 May, 2023 | 12:38h | UTC
RCT | Remote pulmonary artery monitoring may improve QoL, reduce hospitalizations in symptomatic (NYHA III) heart failure
22 May, 2023 | 13:47h | UTCRemote 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
Remote monitoring reduces #HeartFailure hospitalisations and improves quality of life 👇#HeartFailure2023 #HF #HFA_ESC #MONIT0R_HF pic.twitter.com/Rvg1y45tCQ
— European Society of Cardiology (@escardio) May 20, 2023
RCT | Apixaban fails to match warfarin in preventing valve thrombosis in On-X mechanical heart valve patients
22 May, 2023 | 13:44h | UTCApixaban or Warfarin in Patients with an On-X Mechanical Aortic Valve – NEJM Evidence
Commentary: Apixaban or Warfarin in Patients With On-X Mechanical Aortic Valve – American College of Cardiology
Commentary on Twitter
“…in patients with an On-X mechanical aortic valve, apixaban was not noninferior to warfarin and failed to meet our safety threshold… for the prevention of valve thrombosis or valve-related thromboembolism.” https://t.co/XEcOJiGIYU#CardioTwitter #Afib
— NEJM Evidence (@NEJMEvidence) May 11, 2023
RCT | Ruxolitinib achieves greater molecular response and EFS in hydroxycarbamide-resistant Polycythemia Vera
22 May, 2023 | 13:35h | UTCCommentary: Ruxolitinib Appears to Yields Superior Responses in Polycythemia Vera Subtype – Cancer Network
RCT | Superior progression-free survival with Venetoclax-based regimens in first-line CLL treatment
22 May, 2023 | 13:32h | UTCFirst-Line Venetoclax Combinations in Chronic Lymphocytic Leukemia – New England Journal of Medicine (link to abstract – $ for full-text)
Commentary: First-Line Venetoclax Combinations vs Chemoimmunotherapy in Fit Patients With CLL – The ASCO Post
Commentary on Twitter
Venetoclax with obinutuzumab or rituximab as first-line treatment for pts with CLL & coexisting conditions has resulted in a large percentage of pts with undetectable minimal residual disease & long progression-free survival.
Read the Research Summary: https://t.co/2i45QN55Hz
— NEJM (@NEJM) May 14, 2023
RCT | Once-weekly insulin icodec shows non-inferiority to daily insulin glargine in type 2 diabetes patients
18 May, 2023 | 13:48h | UTCSwitching to once-weekly insulin icodec versus once-daily insulin glargine U100 in individuals with basal-bolus insulin-treated type 2 diabetes (ONWARDS 4): a phase 3a, randomised, open-label, multicentre, treat-to-target, non-inferiority trial – The Lancet (link to abstract – $ for full-text)
RCT | The addition of Quizartinib to chemotherapy improves overall survival vs placebo in FLT3-ITD-positive AML patients
18 May, 2023 | 13:40h | UTCQuizartinib plus chemotherapy in newly diagnosed patients with FLT3-internal-tandem-duplication-positive acute myeloid leukaemia (QuANTUM-First): a randomised, double-blind, placebo-controlled, phase 3 trial – The Lancet (link to abstract – $ for full-text)
Commentary on Twitter (thread – click for more)
Acute myeloid leukaemia (AML) is a genetically heterogeneous disease with poor clinical outcomes.
A new study assessed the effect of quizartinib on overall survival in patients with FLT3-ITD-positive newly diagnosed AML, in addition to chemotherapy. https://t.co/MGOoVF5QOa
— The Lancet (@TheLancet) April 27, 2023
RCT | Cabozantinib addition to nivolumab and ipilimumab extends progression-free survival in renal-cell carcinoma
18 May, 2023 | 13:38h | UTCCabozantinib plus Nivolumab and Ipilimumab in Renal-Cell Carcinoma – New England Journal of Medicine (link to abstract – $ for full-text)
Commentary: Cabozantinib in Renal-Cell Carcinoma – NEJM Resident 360
Commentary on Twitter
Clinical Pearls & Morning Reports: Cabozantinib in Renal-Cell Carcinoma. How did the addition of cabozantinib to nivolumab and ipilimumab affect outcomes in the trial by Choueiri et al.? https://t.co/x1FzWBiasr #MedEd #MedTwitter pic.twitter.com/w4sns1ifLG
— NEJM Resident 360 (@NEJMres360) May 16, 2023
Phase 2 RCT | Ropeginterferon shows better results in hematocrit control vs phlebotomy alone in patients withr polycythemia vera
18 May, 2023 | 13:37h | UTCRopeginterferon versus Standard Therapy for Low-Risk Patients with Polycythemia Vera – NEJM Evidence
Cluster RCT | Early detection and treatment bundle reduces postpartum hemorrhage complications
16 May, 2023 | 15:02h | UTCSummary: An international, cluster-randomized trial assessed the effectiveness of a multicomponent clinical intervention for postpartum hemorrhage in patients having vaginal delivery. The study involved 80 secondary-level hospitals across Kenya, Nigeria, South Africa, and Tanzania, with 210,132 patients. The intervention group utilized a calibrated blood-collection drape for early detection of postpartum hemorrhage and a first-response treatment bundle, while the control group received usual care.
The primary outcome measured was a composite of severe postpartum hemorrhage (blood loss ≥1000 ml), laparotomy for bleeding, or maternal death from bleeding. The results showed a significant reduction in primary-outcome events in the intervention group (1.6%) compared to the usual-care group (4.3%) with a risk ratio of 0.40 (95% CI, 0.32 to 0.50; P<0.001). Postpartum hemorrhage detection rates were 93.1% and 51.1% in the intervention and usual-care groups, respectively, and treatment bundle adherence was 91.2% and 19.4%, respectively.
These findings demonstrate that early detection of postpartum hemorrhage and the use of a bundled treatment approach can significantly reduce the risk of severe postpartum hemorrhage, laparotomy for bleeding, or death from bleeding among patients having vaginal delivery. The results have important implications for improving clinical practice and reducing postpartum hemorrhage complications globally.
Article: Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage – New England Journal of Medicine (link to abstract – $ for full-text)
Commentary: Lifesaving solution dramatically reduces severe bleeding after childbirth – World Health Organization
Commentary on Twitter
In a large, cluster-randomized trial involving patients with PPH after vaginal delivery, a multicomponent intervention lowered the risk of severe PPH, laparotomy for bleeding, or maternal death from bleeding. Full results of the E-MOTIVE trial: https://t.co/NjcE4Q1rxM#IMNHC2023
— NEJM (@NEJM) May 9, 2023
RCT | Motixafortide and G-CSF to mobilize hematopoietic stem cells for autologous transplantation in multiple myeloma
16 May, 2023 | 14:48h | UTCNews Release: Investigational drug may improve stem cell transplantation for multiple myeloma patients – Washington University in St. Louis
Commentary on Twitter
A new compound, motixafortide, can safely mobilize an optimal number of stem cells for collection and transplantation in over 90% of 80 patients with multiple myeloma with one injection, reports a phase 3 clinical trial published in @NatureMedicine. https://t.co/23bBzCyoor pic.twitter.com/d9DTs4X1cO
— Nature Portfolio (@NaturePortfolio) April 17, 2023
RCT | Colchicine ineffective for pain relief in hand osteoarthritis patients
16 May, 2023 | 14:42h | UTCColchicine twice a day for hand osteoarthritis (COLOR): a double-blind, randomised, placebo-controlled trial – The Lancet Rheumatology (link to abstract – $ for full-text)
Commentary: Colchicine Does Not Relieve OA-Related Hand Pain Compared With Placebo – DocWireNews
Commentary on Twitter
NEW RESEARCH—@AnnaDossing and colleagues report the results of the COLOR trial; #colchicine twice a day did not relieve #pain vs placebo in people with hand #osteoarthritis https://t.co/LfKTwVONGM pic.twitter.com/jTBh076LZ6
— The Lancet Rheumatology (@TheLancetRheum) April 5, 2023
RCT | Per-oral endoscopic myotomy outperforms pneumatic dilation for post-laparoscopic heller myotomy achalasia
16 May, 2023 | 14:36h | UTC
RCT | Gefitinib plus chemotherapy vs. Gefitinib alone in untreated EGFR-mutant NSCLC with brain metastases
16 May, 2023 | 14:30h | UTC
Commentary on Twitter
RCT: In patients with untreated EGFR-mutated non-small cell lung cancer with brain metastases, gefitinib + chemo improved survival and PFS vs gefitinib, with manageable adverse events, and may be a viable first-line treatment. #NSCLC https://t.co/Oe6zHYVsPV pic.twitter.com/oUvs12pYS7
— JAMA Network Open (@JAMANetworkOpen) February 9, 2023
Clinical Trial Update | Pembrolizumab plus chemotherapy in squamous non–small-cell lung cancer
16 May, 2023 | 14:25h | UTCCommentaries:
Original Study: Pembrolizumab plus Chemotherapy for Squamous Non–Small-Cell Lung Cancer – New England Journal of Medicine
RCT | Bortezomib-Dexamethasone, Rituximab, and Cyclophosphamide for Waldenström’s Macroglobulinemia
16 May, 2023 | 14:24h | UTCBortezomib-Dexamethasone, Rituximab, and Cyclophosphamide as First-Line Treatment for Waldenström’s Macroglobulinemia: A Prospectively Randomized Trial of the European Consortium for Waldenström’s Macroglobulinemia – Journal of Clinical Oncology (link to abstract – $ for full-text)
RCT | Interrupted vs. continuous suture technique for biliary-enteric anastomosis
16 May, 2023 | 14:22h | UTC
Commentary on Twitter
Interrupted vs continuous suture for bilioenteric anastomosis?#RCT 🧑🤝🧑=82
⏱️Cont. suture approx 10mins quicker
⚖️No difference in biliary complications#some4hpb #SoMe4Surgery https://t.co/7Vo7GlBG9V pic.twitter.com/mdRM7xWkIS— BJS Open (@BjsOpen) February 6, 2023
RCT | Rivaroxaban doesn’t reduce thrombotic events, hospitalization, or death in outpatients with COVID-19
15 May, 2023 | 13:19h | UTCSummary: The PREVENT-HD trial, a double-blind, placebo-controlled randomized study, was conducted to evaluate the effectiveness of prophylactic anticoagulation in reducing venous and arterial thrombosis, hospitalization, and death in nonhospitalized patients with symptomatic COVID-19 and at least one thrombosis risk factor. The trial took place between August 2020 and April 2022 across 14 US integrated healthcare delivery networks, with 1,284 patients enrolled and randomly assigned to receive either 10 mg of oral rivaroxaban or placebo daily for 35 days.
However, the study was terminated prematurely due to enrollment challenges and lower-than-expected event rates. The primary efficacy outcome, a composite of various hazardous events, occurred in 3.4% of the rivaroxaban group and 3.0% of the placebo group, with no significant difference between the two groups (hazard ratio, 1.16 [95% CI, 0.63–2.15]; P=0.63). No critical-site or fatal bleeding was observed, and only one patient in the rivaroxaban group experienced a major bleed.
In conclusion, rivaroxaban prescribed for 35 days in nonhospitalized patients with symptomatic COVID-19 at risk for thrombosis does not appear to reduce the composite end point of venous and arterial thrombotic events, hospitalization, and death. The study’s premature termination and lower-than-expected event rates may limit the generalizability of these findings.
Commentary on Twitter
#OriginalArticle: In this #RCT, Rivaroxaban did not appear to reduce a composite endpoint of venous and arterial thrombotic events, hospitalization, and death among non‐hospitalized patients with symptomatic COVID‐19 #AHAJournals https://t.co/PhdXnTJ0V9 pic.twitter.com/f04uYu2M5f
— Circulation (@CircAHA) May 10, 2023
RCT | Cognitive behavioral therapy proves effective for severe post-COVID-19 fatigue
15 May, 2023 | 13:16h | UTCNews Release: Cognitive behavioral therapy lessens post-viral fatigue after COVID-19 – Amsterdam UMC
Commentary on Twitter
Efficacy of Cognitive Behavioral Therapy Targeting Severe Fatigue Following COVID-19: Results of a Randomized Controlled Trial
✅ Just Accepted
🔓 Open Access@amsterdamUMChttps://t.co/P1jwLOcfvw— Clinical Infectious Diseases (@CIDJournal) May 13, 2023
RCT | Peanut patch therapy is effective in desensitizing young children with allergies, but raises risk of serious adverse events
15 May, 2023 | 13:10h | UTCPhase 3 Trial of Epicutaneous Immunotherapy in Toddlers with Peanut Allergy – New England Journal of Medicine (link to abstract – $ for full-text)
Commentary on Twitter
In the phase 3 EPITOPE trial involving children 1 to 3 years of age with peanut allergy, epicutaneous immunotherapy by means of a peanut patch was superior to placebo in desensitizing children to peanut. https://t.co/USk6HBI9Qh#pediatrics
— NEJM (@NEJM) May 10, 2023