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Randomized Trials

RCT | Treat-to-target strategy is noninferior to high-intensity statin therapy in patients with coronary artery disease

10 Mar, 2023 | 14:44h | UTC

Summary: This randomized, multicenter, noninferiority trial in South Korea enrolled 4,400 patients with known coronary artery disease. Patients were randomly assigned to one of two groups: a treat-to-target group and a high-intensity statin group.

The treat-to-target group received moderate or high-intensity statins and titrated their medication to achieve an LDL-C goal of 50-70 mg/dL, while the high-intensity statin group received rosuvastatin 20 mg or atorvastatin 40 mg. The primary endpoint was a 3-year composite of death, myocardial infarction, stroke, or coronary revascularization.

The study found that the primary endpoint occurred in 8.1% of the treat-to-target group and 8.7% of the high-intensity statin group, indicating that the treat-to-target strategy was noninferior to the high-intensity statin strategy.

Overall, the results of this study indicate that a treat-to-target strategy could be an appropriate substitute for high-intensity statin therapy in patients with coronary artery disease. This approach enables a personalized treatment plan that accounts for variations in individual drug response to statin therapy.

Article: Treat-to-Target or High-Intensity Statin in Patients With Coronary Artery Disease: A Randomized Clinical Trial – JAMA (free for a limited period)

Commentaries:

Investigating treat-to-target low-density lipoprotein-cholesterol versus high-intensity statins for coronary artery disease – News Medical

Not all patients with coronary artery disease require high intensity statins – MedicalResearch.com

 

Commentary on Twitter

 

RCT | The effect of skin traction on pain relief in patients with isolated intertrochanteric fractures

10 Mar, 2023 | 14:24h | UTC

The effect of skin traction on pain relief in patients with isolated intertrochanteric fractures, a randomized clinical trial – BMC Musculoskeletal Disorders

 

RCT | Tranexamic acid did not significantly reduce blood loss in pancreaticoduodenectomy

10 Mar, 2023 | 14:05h | UTC

Tranexamic acid and blood loss in pancreaticoduodenectomy: TAC-PD randomized clinical trial – British Journal of Surgery (link to abstract – $ for full-text)

 

RCT | Transanal vs. laparoscopic total mesorectal excision for mid and low rectal cancer

10 Mar, 2023 | 14:03h | UTC

Transanal versus laparoscopic total mesorectal excision for mid and low rectal cancer (Ta-LaTME study): multicentre, randomized, open-label trial – British Journal of Surgery (link to abstract – $ for full-text)

 

Crossover RCT | Atrial pacing to increase exercise HR did not improve performance in HFpEF patients with chronotropic incompetence

9 Mar, 2023 | 14:22h | UTC

Summary: The RAPID-HF randomized clinical trial investigated whether implanting and programming a pacemaker for rate-adaptive atrial pacing would improve exercise performance in patients with heart failure with preserved ejection fraction (HFpEF) and chronotropic incompetence.

The study involved 29 patients with symptomatic HFpEF and chronotropic incompetence who underwent pacemaker implantation for the study and then were randomized to atrial rate responsive pacing or no pacing for four weeks, followed by a four-week washout period and then crossover for an additional four weeks.

The study found that atrial pacing increased early and peak exercise heart rate, but there was no improvement in exercise performance or quality of life. Despite a higher exercise heart rate, there was no increase in exercise cardiac output due to a decrease in stroke volume. Moreover, pacemaker implantation was associated with adverse events.

Article: Rate-Adaptive Atrial Pacing for Heart Failure With Preserved Ejection Fraction: The RAPID-HF Randomized Clinical Trial – JAMA (free for a limited period)

Editorial: Rate-Adaptive Pacing for Heart Failure With Preserved Ejection Fraction – JAMA (free for a limited period)

Commentaries:

RAPID-HF: Rate-Adaptive Pacing Doesn’t Help in HFpEF – TCTMD

Atrial Pacing for HFpEF Shows Lack of Benefit on Exercise Capacity – HCP Live

 

Commentary on Twitter

 

RCT | Assessment of a text message–based smoking cessation intervention for adult smokers

9 Mar, 2023 | 14:09h | UTC

Assessment of a Text Message–Based Smoking Cessation Intervention for Adult Smokers in China: A Randomized Clinical Trial – JAMA Network Open

 

Commentary on Twitter

 

RCT/extended follow-up | Lenvatinib plus pembrolizumab vs. sunitinib in patients with advanced renal cell carcinoma

9 Mar, 2023 | 14:03h | UTC

Lenvatinib plus pembrolizumab versus sunitinib as first-line treatment of patients with advanced renal cell carcinoma (CLEAR): extended follow-up from the phase 3, randomised, open-label study – The Lancet Oncology (link to abstract – $ for full-text)

Original Study: Lenvatinib plus Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma – New England Journal of Medicine (link to abstract – $ for full-text)

 

Commentary on Twitter

 

RCT | Bempedoic acid shows modest reduction in cardiovascular events for statin-intolerant patients

8 Mar, 2023 | 14:39h | UTC

Summary:

Bempedoic acid is an ATP citrate lyase inhibitor that reduces LDL cholesterol levels and is associated with a low incidence of muscle-related adverse events. The study enrolled 13,970 patients at increased cardiovascular risk, with 6,992 randomized to bempedoic acid and 6,978 randomized to placebo, with a median duration of follow-up of 40.6 months.

The study found that bempedoic acid was associated with a statistically significant 13% reduction in the primary endpoint of major adverse cardiovascular events, which included death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization. However, the absolute risk reduction of events was modest, at 1.6% over nearly four years.

The study also reported higher incidences of gout and cholelithiasis with bempedoic acid compared to placebo, as well as small increases in serum creatinine, uric acid, and hepatic-enzyme levels.

Article: Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients – New England Journal of Medicine (link to abstract – $ for full-text)

Commentaries:

CLEAR Positives and Cautions With Bempedoic Acid for Statin Intolerance – Medscape (recommended reading – free registration required)

Cardiovascular Outcomes After “Statin-Intolerant” Patients Take Bempedoic Acid – NEJM Journal Watch (free for a limited period)

 

Commentary on Twitter

 

#ACC23 – RCT | Intravascular imaging–guided vs. angiography-guided complex PCI

7 Mar, 2023 | 13:20h | UTC

Intravascular Imaging–Guided or Angiography-Guided Complex PCI – New England Journal of Medicine (link to abstract – $ for full-text)

Commentary: Randomized Controlled Trial of Intravascular Imaging Guidance Versus Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention – RENOVATE-COMPLEX-PCI – American College of Cardiology

 

Commentary on Twitter

 

#ACC23 – RCT | Transcatheter repair for patients with tricuspid regurgitation

6 Mar, 2023 | 14:29h | UTC

Transcatheter Repair for Patients with Tricuspid Regurgitation – New England Journal of Medicine (link to abstract – $ for full-text)

Commentaries:

The TRILUMINATE Transcatheter Tricuspid Repair Trial: Positive but No Benefit? – Medscape (recommended reading – free registration required)

TRILUMINATE Pivotal: TEER With the TriClip Benefits Patients With Severe TR – TCTMD

Transcatheter Repair Benefits Quality of Life in Patients with Severe Tricuspid Regurgitation – HCP Live

 

Commentary on Twitter

 

RCT | Hydrochlorothiazide is not effective for the prevention of kidney-stone recurrence

6 Mar, 2023 | 14:26h | UTC

Summary:

This study aimed to assess the effectiveness of hydrochlorothiazide, a thiazide diuretic, in preventing the recurrence of calcium-containing kidney stones. The trial randomly assigned 416 patients with recurrent kidney stones to receive hydrochlorothiazide at a dose of 12.5 mg, 25 mg, or 50 mg once daily, or a placebo once daily, and followed them for a median of 2.9 years.

The results showed that the incidence of kidney stone recurrence did not differ significantly between the hydrochlorothiazide and placebo groups, regardless of the dose. Furthermore, patients who received hydrochlorothiazide were more likely to experience side effects such as hypokalemia, gout, new-onset diabetes mellitus, skin allergy, and a plasma creatinine level exceeding 150% of the baseline level.

Therefore, the effectiveness of hydrochlorothiazide in preventing kidney stone recurrence may be limited, and the common practice of prescribing it for these patients should be reevaluated.

 

Article: Hydrochlorothiazide and Prevention of Kidney-Stone Recurrence – New England Journal of Medicine (link to abstract – $ for full-text)

Video Summary: Hydrochlorothiazide and Kidney-Stone Recurrence | NEJM

Commentary: Hydrochlorothiazide and Prevention of Kidney Stones – NEJM Resident 360

 

#ACC23 – RCT | Five-year follow-up after transcatheter repair of secondary mitral regurgitation

6 Mar, 2023 | 14:28h | UTC

Five-Year Follow-up after Transcatheter Repair of Secondary Mitral Regurgitation – New England Journal of Medicine (link to abstract – $ for full-text)

Commentaries:

COAPT at 5 Years: MitraClip Still Ahead, but Deaths and Crossovers Cast Shadows – TCTMD

Minimally Invasive Mitral Valve Repair Reduces Hospitalizations and Deaths – American College of Cardiology

 

Commentary on Twitter

 

RCT | Antipsychotic association seems better than antidepressant switch in treatment-resistant geriatric depression

6 Mar, 2023 | 14:23h | UTC

Summary:

This open-label randomized trial compared the benefits and risks of augmenting therapy vs. switching antidepressants in older adults with treatment-resistant depression. In the first step, 619 patients were randomly assigned to augmentation of existing antidepressant medication with aripiprazole (an antipsychotic), augmentation with bupropion, or a switch from existing antidepressant medication to bupropion. In step 2, 248 patients who did not benefit from or were ineligible for step 1 were randomly assigned to augmentation with lithium or a switch to nortriptyline.

The aripiprazole-augmentation group showed significant improvement in well-being compared to the switch-to-bupropion group. Remission occurred in 28.9% of patients in the aripiprazole-augmentation group, 28.2% in the bupropion-augmentation group, and 19.3% in the switch-to-bupropion group. In step 2, similar remission rates occurred in the lithium-augmentation group (18.9%) and the switch-to-nortriptyline group (21.5%).

 

Article: Antidepressant Augmentation versus Switch in Treatment-Resistant Geriatric Depression – New England Journal of Medicine (link to abstract – $ for full-text)

News Release: Adding antipsychotic med to antidepressant may help older adults with treatment-resistant depression – Washington University School of Medicine in St. Louis

 

Commentary on Twitter

 

RCT | Perioperative vs. postoperative calcium and vitamin D supplementation to prevent symptomatic hypocalcemia after total thyroidectomy

6 Mar, 2023 | 14:09h | UTC

Summary:

This study aimed to compare the efficacy of perioperative vs. postoperative calcium and vitamin D supplementation in reducing symptomatic hypocalcemia in patients who underwent thyroidectomy.

In a randomized placebo-controlled trial involving 134 patients, one group received calcium carbonate and alfacalcidol both 3 days before surgery and for 14 days after surgery, while the other group received the same treatment only after surgery.

Results showed that the perioperative group had significantly lower rates of symptomatic and biochemical hypocalcemia compared to the postoperative group. Patients who underwent central neck dissection were at increased risk of symptomatic hypocalcemia in this study, so perioperative supplementation could be more beneficial for these patients.

 

Article: Perioperative versus postoperative calcium and vitamin D supplementation to prevent symptomatic hypocalcemia after total thyroidectomy: a randomized placebo controlled trial – International Journal of Surgery

 

Phase 2 RCT | Neoadjuvant–adjuvant pembrolizumab improves event-free survival vs. adjuvant-only therapy in advanced melanoma

6 Mar, 2023 | 14:11h | UTC

Summary:

This phase 2 clinical trial evaluated whether giving pembrolizumab before and after surgery (neoadjuvant-adjuvant therapy) would increase event-free survival in patients with resectable stage III or IV melanoma, compared to adjuvant therapy alone. The trial involved 313 patients, with 154 in the neoadjuvant-adjuvant group and 159 in the adjuvant-only group.

At a median follow-up of 14.7 months, the neoadjuvant-adjuvant group had significantly longer event-free survival than the adjuvant-only group, with similar rates of adverse events between groups, suggesting that pembrolizumab given both before and after surgery may be an effective treatment option for these patients.

 

Article: Neoadjuvant–Adjuvant or Adjuvant-Only Pembrolizumab in Advanced Melanoma – New England Journal of Medicine (link to abstract – $ for full-text)

News Release: Neoadjuvant immunotherapy improves outlook in high-risk melanoma – MD Anderson Cancer Center

 

Commentary on Twitter

 

RCT | Immediate vs. delayed urinary catheter removal following non-hysterectomy benign gynecological laparoscopy

3 Mar, 2023 | 13:55h | UTC

Summary: This randomized clinical trial compared the rates of urinary retention and postoperative urinary tract infection between women with immediate vs. delayed removal of the indwelling catheter following benign gynecological laparoscopic surgery, excluding hysterectomy, pelvic floor, or surgeries with concomitant bowel procedures. A total of 693 women aged 18 years or older were randomized to immediate or delayed urinary catheter removal. The results showed an increased risk of urinary retention with immediate vs. delayed removal of the urinary catheter (8.2% vs. 4.2%), highlighting the need to ensure patients report normal voiding and emptying before discharge to reduce the need for readmission for management of urinary retention.

Article: Immediate versus delayed urinary catheter removal following non-hysterectomy benign gynecological laparoscopy: a randomised trial – BJOG (link to abstract – $ for full-text)

Related: Feasibility of immediate removal of urinary catheter after laparoscopic gynecological surgery for benign diseases: A meta-analysis of randomized controlled trials – Obstetrics & Gynecology (link to abstract – $ for full-text)

 

RCT | Effects of a vibrating capsule for chronic constipation

3 Mar, 2023 | 13:41h | UTC

Randomized Placebo-Controlled Phase 3 Trial of Vibrating Capsule for Chronic Constipation – Gastroenterology (link to abstract – $ for full-text)

Commentary: Researchers reveal the impact of vibrating capsules in chronic constipation patients – News Medical

 

RCT | Baricitinib vs. placebo for systemic lupus erythematosus

3 Mar, 2023 | 13:39h | UTC

Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 3 trial (SLE-BRAVE-I) – The Lancet (link to abstract – $ for full-text)

See also: Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 3 trial (SLE-BRAVE-II) – The Lancet (link to abstract – $ for full-text)

Commentary: Benefit of baricitinib for treatment of patients with moderately to severely active SLE is unclear – Monash University

 

Commentary on Twitter

 

RCTs | Secukinumab in moderate-to-severe hidradenitis suppurativa

3 Mar, 2023 | 13:30h | UTC

Secukinumab in moderate-to-severe hidradenitis suppurativa (SUNSHINE and SUNRISE): week 16 and week 52 results of two identical, multicentre, randomised, placebo-controlled, double-blind phase 3 trials – The Lancet (link to abstract – $ for full-text)

 

RCT | Impact of supplementation with milk–cereal mix during 6–12 months of age on growth at 12 months in Delhi, India

2 Mar, 2023 | 12:50h | UTC

Impact of supplementation with milk–cereal mix during 6–12 months of age on growth at 12 months: a 3-arm randomized controlled trial in Delhi, India – The American Journal of Clinical Nutrition

Commentary: High-protein supplementation improves linear growth in infants – 2 Minute Medicine

 

RCT | Electrostimulation with the Alpha-Stim AID device is not better than sham treatment in major depression

2 Mar, 2023 | 12:49h | UTC

Clinical effectiveness of active Alpha-Stim AID versus sham Alpha-Stim AID in major depression in primary care in England (Alpha-Stim-D): a multicentre, parallel group, double-blind, randomised controlled trial – The Lancet Psychiatry

Commentary: Active AID Device Not More Effective Than Sham at Improving Depressive Symptoms – Neurology Advisor

 

RCT | Addition of preoperative transversus abdominis plane block to multimodal analgesia in open gynecological surgery

2 Mar, 2023 | 12:43h | UTC

Addition of preoperative transversus abdominis plane block to multimodal analgesia in open gynecological surgery: a randomized controlled trial – BMC Anesthesiology

 

RCT | Endovascular ultrasound renal denervation is modestly effective in the treatment of hypertension

1 Mar, 2023 | 14:11h | UTC

Summary: The RADIANCE II randomized clinical trial investigated the efficacy and safety of endovascular ultrasound renal denervation in patients with hypertension without the influence of antihypertensive medications. The trial enrolled 224 patients who were withdrawn from such medications and randomly assigned to receive either ultrasound renal denervation or a sham procedure. Results showed that ultrasound renal denervation reduced ambulatory systolic blood pressure by 6.3 mmHg on average at 2 months, compared to the sham procedure, without any reported adverse events. While these findings suggest that ultrasound renal denervation may be modestly effective in the treatment of hypertension, the short-term follow-up period limits the generalizability of these results to daily practice. Additionally, the clinical relevance of a procedure that reduces blood pressure only after withdrawing blood pressure medications should be considered.

Article: Endovascular Ultrasound Renal Denervation to Treat Hypertension: The RADIANCE II Randomized Clinical Trial – JAMA (free for a limited period)

Editorial: Is There a Role for Renal Denervation in the Treatment of Hypertension? – JAMA Cardiology (free for a limited period)

 

RCT | US-assisted carbon nanoparticle suspension mapping vs. dual tracer-guided sentinel lymph node biopsy in patients with early breast cancer

1 Mar, 2023 | 13:42h | UTC

Ultrasound-assisted carbon nanoparticle suspension mapping versus dual tracer-guided sentinel lymph node biopsy in patients with early breast cancer (ultraCars): phase III randomized clinical trial – British Journal of Surgery

 

RCT | Momelotinib vs. danazol in symptomatic patients with anemia and myelofibrosis

1 Mar, 2023 | 13:39h | UTC

Momelotinib versus danazol in symptomatic patients with anaemia and myelofibrosis (MOMENTUM): results from an international, double-blind, randomised, controlled, phase 3 study – The Lancet (link to abstract – $ for full-text)

News Release: Targeted therapy momelotinib provides significant symptom and anemia improvements in patients with myelofibrosis – University of Texas M. D. Anderson Cancer Center

 

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