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Daily Archives: June 27, 2023

Position Statement | Prehospital hemorrhage control and treatment by clinicians

27 Jun, 2023 | 14:02h | UTC

Prehospital Hemorrhage Control and Treatment by Clinicians: A Joint Position Statement – Annals of Emergency Medicine

 

EASL Clinical Practice Guidelines on acute-on-chronic liver failure

27 Jun, 2023 | 14:00h | UTC

EASL Clinical Practice Guidelines on acute-on-chronic liver failure – Journal of Hepatology

 

Commentary on Twitter

 

RCT | Oral Semaglutide at 25mg and 50mg improves glycemic control in overweight T2DM patients compared to standard 14mg dose

27 Jun, 2023 | 13:58h | UTC

Summary: The study was a global, multicenter, randomized, double-blind, phase 3b trial involving 1606 adults with inadequately controlled type 2 diabetes. The mean HbA1c in the study population was 9.0% and the mean BMI was 33.8 kg/m2. Participants were assigned to receive either 14mg, 25mg, or 50mg of once-daily oral semaglutide for 68 weeks. The trial aimed to investigate the effectiveness of a new formulation of semaglutide at higher investigational doses against the standard 14mg dose.

The primary endpoint was the change in glycated hemoglobin (HbA1c) levels from baseline to week 52. Results showed that at week 52, changes in HbA1c levels were significantly more substantial with the 25mg (-1.8 percentage points) and 50mg (-2.0 percentage points) doses compared to the 14mg dose (-1.5 percentage points). During the trial, ten deaths occurred, but none were considered treatment-related. No new safety concerns were identified, though adverse events, primarily mild to moderate gastrointestinal disorders, were slightly more frequent in the 25mg and 50mg groups.

The study limitations include a relatively short exposure to the higher doses due to the up to 16 weeks of dose-escalation period, non-adjustable doses due to masking requirements, and a cohort predominantly of White ethnicity, considering the high prevalence of type 2 diabetes in other racial groups. The study was unable to assess differences in efficacy and tolerability between the 25mg and 50mg doses, raising the question of whether the 50mg dosage is necessary if similar effects can be achieved with the 25mg dose.

The implications for further research highlight the need for real-world studies to investigate the clinical impact and safety of these higher doses of oral semaglutide. The superior glycemic control and bodyweight loss with oral semaglutide 25mg and 50mg suggest that these higher doses might help individualize treatment goals and intensify treatment by increasing the dose of a single oral agent. Future studies could consider comparing the 25mg and 50mg doses more directly to determine the most effective and tolerable dose for patients.

Article: Efficacy and safety of once-daily oral semaglutide 25 mg and 50 mg compared with 14 mg in adults with type 2 diabetes (PIONEER PLUS): a multicentre, randomised, phase 3b trial – The Lancet (free registration required)

 

RCT | Once-daily oral Semaglutide 50mg outperforms placebo in obesity treatment

27 Jun, 2023 | 13:57h | UTC

Summary: The referenced study is a phase 3, superiority, randomized, double-blind, placebo-controlled trial that investigated the effectiveness of oral semaglutide 50mg in treating overweight and obese adults without type 2 diabetes. The trial was conducted in 50 outpatient clinics across Asia, Europe, and North America, with a total of 667 participants randomly allocated to receive either the treatment or a placebo.

The primary outcome measured was the percentage change in bodyweight from baseline to week 68. Results showed a significant reduction in bodyweight among participants receiving semaglutide – a mean change of -15.1% compared to -2.4% for placebo recipients. Additionally, a higher percentage of semaglutide recipients achieved weight reductions of at least 5%, 10%, 15%, and 20% compared to placebo recipients.

However, it’s important to note that adverse events were more frequently observed in the semaglutide group. Specifically, 80% of participants receiving oral semaglutide 50 mg experienced gastrointestinal adverse events, mostly mild to moderate, compared to 46% in the placebo group. This highlights the need for careful patient monitoring during treatment.

The findings indicate that oral semaglutide 50mg, when taken once daily, can lead to a clinically meaningful decrease in bodyweight among overweight and obese adults without type 2 diabetes. Despite the higher occurrence of gastrointestinal adverse events, the significant weight loss potential positions oral semaglutide as a promising treatment option. Further research is recommended to establish long-term safety and efficacy.

Article: Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-controlled, phase 3 trial – The Lancet (link to abstract – $ for full-text)

 

RCT | Cyclophosphamide-based regimen enhances GVHD-free survival after hematopoietic stem-cell transplantation

27 Jun, 2023 | 13:54h | UTC

Summary: The article details a phase 3 trial comparing the efficacy of two graft-versus-host disease (GVHD) prophylactic regimens in hematologic cancer patients undergoing allogeneic hematopoietic stem-cell transplantation (HSCT). The experimental group received cyclophosphamide–tacrolimus–mycophenolate mofetil, and the standard group received tacrolimus–methotrexate. The patients, a total of 431, underwent HSCT from an HLA-matched related donor or a matched or 7/8 mismatched unrelated donor.

The primary end point was GVHD-free, relapse-free survival at 1 year. Results indicated a significantly higher incidence of this outcome in the experimental group (hazard ratio, 0.64; 95% confidence interval [CI], 0.49 to 0.83; P=0.001). At 1 year, adjusted GVHD-free, relapse-free survival was 52.7% (95% CI, 45.8 to 59.2) in the experimental group, compared to 34.9% (95% CI, 28.6 to 41.3) in the standard group.

Notably, patients in the experimental-prophylaxis group appeared to have less severe acute or chronic GVHD and a higher incidence of immunosuppression-free survival at 1 year. Overall survival, disease-free survival, relapse, transplantation-related death, and engraftment did not show a substantial difference between the groups. These results suggest that cyclophosphamide–tacrolimus–mycophenolate mofetil may offer a more effective prophylaxis against GVHD in HSCT patients.

Article: Post-Transplantation Cyclophosphamide-Based Graft-versus-Host Disease Prophylaxis – New England Journal of Medicine (link to abstract – $ for full-text)

News Release: Study Sets New Standard for Graft-Versus-Host Disease Prevention After Stem Cell Transplant – Johns Hopkins Medicine

 

Commentary on Twitter

 

RCT | Dolutegravir is noninferior as a replacement for ritonavir-boosted protease inhibitor in HIV therapy

27 Jun, 2023 | 13:52h | UTC

Summary: This randomized clinical trial (RCT) assessed the switch from ritonavir-boosted protease inhibitor (PI) to dolutegravir in HIV patients without genotype information but with viral suppression. The multicenter, open-label trial, involving 795 participants across four sites in Kenya, compared those who switched to dolutegravir (398) with those continuing with their current ritonavir-boosted PI regimen (397). The primary end point was an HIV type 1 RNA level of at least 50 copies per milliliter at week 48.

At the end of the trial period, the number of patients in both groups who met the primary end point was nearly the same (5.0% in the dolutegravir group and 5.1% in the ritonavir-boosted PI group). This indicates the noninferiority of dolutegravir, within a 4% margin. Additionally, no mutations conferring resistance to either drug were detected. The incidence of treatment-related adverse events of grade 3 or 4 was similar in both groups (5.7% for dolutegravir and 6.9% for ritonavir-boosted PI).

The study concludes that dolutegravir is a noninferior alternative to ritonavir-boosted PI for previously treated, virally suppressed HIV patients lacking drug-resistance mutation data. The similar safety profiles also support the switch. However, further research may provide valuable insights on the long-term implications of the switch.

Article: Second-Line Switch to Dolutegravir for Treatment of HIV Infection – New England Journal of Medicine (link to abstract – $ for full-text)

Commentary: Second-Line Switch to Dolutegravir Noninferior in HIV – HealthDay

 

Commentary on Twitter

 

RCT | Evaluating the viability of dolutegravir monotherapy in primary HIV infection

27 Jun, 2023 | 13:50h | UTC

Summary: The study in focus is a randomized, controlled, non-inferiority trial spanning over 192 weeks, titled “EARLY-SIMPLIFIED”. It evaluated the effect of simplifying combination antiretroviral therapy (cART) to dolutegravir (DTG) monotherapy in patients with early-stage HIV-1 infection. The trial recruited 101 people who had begun cART within 180 days of a documented primary HIV-1 infection with suppressed viral load.

The patients were randomly divided into two groups: DTG monotherapy (n=68) and continued cART (n=33). The primary endpoints were viral failure rates at 48, 96, 144, and 192 weeks. Results revealed no difference in viral response between the two groups at 96 weeks, suggesting non-inferiority of DTG monotherapy. At the end of the trial (192 weeks), no virological failures were recorded in either group.

The study indicates that early initiation of cART during primary HIV infection might permit sustained virological suppression after switching to DTG monotherapy. However, the study was limited by its highly selected patient population and the transition to an observational design after 96 weeks. It provides insight into the potential for minimizing ART toxicity by stratifying patients according to the latent reservoir size or duration of active infection before starting therapy.

Article: Sustained viral suppression with dolutegravir monotherapy over 192 weeks in patients starting combination antiretroviral therapy during primary HIV infection (EARLY-SIMPLIFIED): a randomized, controlled, multi-site, non-inferiority trial – Clinical Infectious Diseases

 

Cohort Study | Increased revision rates seen in shoulder replacement surgeries by surgeons with less than 10 procedures annually

27 Jun, 2023 | 13:48h | UTC

Summary: This prospective cohort study investigated the correlation between surgeon volume and patient outcomes after elective shoulder replacement surgeries. Utilizing data from 39,281 procedures performed by 638 surgeons in UK public and private hospitals between 2012-20, the study focuses on adults aged 18 years or older.

The results indicate a significant connection between a surgeon’s mean annual volume and risk of adverse patient outcomes. Surgeons performing fewer than 10.4 procedures per year demonstrated a significantly increased risk of revision surgery, with the hazard ratio being almost twice as high as that of the lowest risk surgeons. Higher mean annual surgical volume correlated with lower risks of reoperations, fewer serious adverse events, and shorter hospital stays.

These findings suggest the need for strategic resource planning in surgical services, with considerations given to surgeon’s annual procedure volume to improve patient outcomes after shoulder replacement surgery. It should be noted that the study was limited in scope to surgeries performed within the NHS and private hospitals in England. Furthermore, potential confounding factors like patients’ social circumstances, carer availability, or body mass index were not considered.

Article: Association between surgeon volume and patient outcomes after elective shoulder replacement surgery using data from the National Joint Registry and Hospital Episode Statistics for England: population based cohort study – The BMJ

Editorial: Surgeon volume and patient outcomes in shoulder replacement surgery – The BMJ

News Release: Patients do better when surgeon averages 10 + annual shoulder ops – BMJ Newsroom

 

Position Paper | Assessing and managing frailty in emergency laparotomy

27 Jun, 2023 | 13:45h | UTC

Assessing and managing frailty in emergency laparotomy: a WSES position paper – World Journal of Emergency Surgery

 

SR | Medically assisted hydration in palliative care: uncertain effects on quality of life and survival

27 Jun, 2023 | 13:47h | UTC

Summary: The Cochrane Review analyzed Randomized Controlled Trials (RCTs) to evaluate the impact of Medically Assisted Hydration (MAH) on the Quality of Life (QoL) and survival of adults receiving palliative care. A total of four studies involving 422 participants, all diagnosed with advanced cancer, were considered. Two studies compared MAH with placebo, and two compared it with standard care.

The primary outcome was QoL, assessed through validated scales, with survival and adverse events being secondary outcomes. Mean differences (MD) and risk ratios (RR) were calculated for continuous and dichotomous outcomes, respectively. However, results were inconclusive due to a very low certainty of evidence. Hence, it is unclear whether MAH improves QoL, prolongs survival, or leads to adverse events when compared to placebo or standard care.

The findings are only applicable to inpatients with advanced cancer at the end of life and do not transfer to other adults in palliative care with non-cancer, dementia, or neurodegenerative diseases, or those with an extended prognosis. The lack of high-quality evidence leaves clinicians to make decisions based on perceived benefits and harms for individual circumstances.

Article: Medically assisted hydration for adults receiving palliative care – Cochrane Library

 

Review | Contemporary artery-first approaches in pancreatoduodenectomy

27 Jun, 2023 | 13:43h | UTC

Contemporary artery-first approaches in pancreatoduodenectomy – British Journal of Surgery

 

Review | Management of short-term mechanical circulatory support for cardiogenic shock in adults in the intensive cardiac care unit

27 Jun, 2023 | 13:42h | UTC

Step by step daily management of short-term mechanical circulatory support for cardiogenic shock in adults in the intensive cardiac care unit: a clinical consensus statement of the Association for Acute CardioVascular Care of the European Society of Cardiology SC, the European Society of Intensive Care Medicine, the European branch of the Extracorporeal Life Support Organization, and the European Association for Cardio-Thoracic Surgery – European Heart Journal. Acute Cardiovascular Care

 

Special Series | Emergencies in vascular surgery

27 Jun, 2023 | 13:41h | UTC

Homepage – Seminars in Vascular Surgery

Descending thoracic aortic emergencies: Past, present, and future

Thoracic aortic emergencies involving the aortic arch: An integrated cardiovascular surgical treatment approach

Ruptured abdominal aorto-iliac aneurysms: Diagnosis, treatment, abdominal compartment syndrome, and role of simulation-based training

Contemporary multimodal approach to diagnosis and treatment of vascular graft and endograft infections

Acute management of mesenteric emergencies: Tailoring the solution to the problem

Resuscitative balloon occlusion of the aorta in the modern era: Expanding indications, optimal techniques, unresolved issues, and current results

Acute perioperative complications after arterial and venous femoral access in major vascular and cardiac procedures: Ischemic or hemorrhagic patterns and how to solve them

 

Review | Hypertension management in patients with cardiovascular comorbidities

27 Jun, 2023 | 13:39h | UTC

Hypertension management in patients with cardiovascular comorbidities – European Heart Journal

 

Commentary on Twitter

 

EULAR points to consider for the definition of clinical and imaging features suspicious for progression from psoriasis to psoriatic arthritis

27 Jun, 2023 | 13:37h | UTC

EULAR points to consider for the definition of clinical and imaging features suspicious for progression from psoriasis to psoriatic arthritis – Annals of the Rheumatic Diseases

 

Commentary on Twitter

 

Review | Renal thrombotic microangiopathy

27 Jun, 2023 | 13:34h | UTC

Renal Thrombotic Microangiopathy: A Review – American Journal of Kidney Diseases

 

Commentary on Twitter

 

Review | Functional coronary angiography for the assessment of the epicardial vessels and the microcirculation

27 Jun, 2023 | 13:33h | UTC

Functional coronary angiography for the assessment of the epicardial vessels and the microcirculation – EuroIntervention

 

Commentary on Twitter

 

The exposome in respiratory diseases: multiple preventable risk factors from early life to adulthood

27 Jun, 2023 | 13:32h | UTC

The exposome in respiratory diseases: multiple preventable risk factors from early life to adulthood – Breathe

 

Commentary on Twitter

 

M-A | Effectiveness of physical therapy in axillary web syndrome after breast cancer

27 Jun, 2023 | 13:28h | UTC

Effectiveness of physical therapy in axillary web syndrome after breast cancer: a systematic review and meta-analysis – Supportive Care in Cancer

 

M-A | Risk factors for non-tuberculous mycobacterial pulmonary disease

27 Jun, 2023 | 13:27h | UTC

Risk Factors for Non-tuberculous Mycobacterial Pulmonary Disease (NTM-PD) A systematic literature review and meta-analysis – Chest

Commentary: Comorbid respiratory disease key predictor of NTM-PD – MDedge

 

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