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Pharmacology/Pharmaceutical Industry

RCT | Direct oral challenge noninferior to skin testing followed by direct oral challenge in low-risk penicillin allergy patients

18 Jul, 2023 | 13:54h | UTC

Efficacy of a Clinical Decision Rule to Enable Direct Oral Challenge in Patients With Low-Risk Penicillin Allergy: The PALACE Randomized Clinical Trial – JAMA Internal Medicine (free for a limited period)

See also: Visual Abstract

News Release: World-first clinical trial to help millions with penicillin allergies – Vanderbilt University Medical Center

Commentary: Trial supports use of direct oral challenge for penicillin allergy – CIDRAP

 

RCT | Donanemab slows early symptomatic Alzheimer’s progression, but raises serious safety concerns

18 Jul, 2023 | 13:51h | UTC

Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial – JAMA (free for a limited period)

Editorials:

Donanemab for Alzheimer Disease—Who Benefits and Who Is Harmed? – JAMA (free for a limited period)

Amyloid-Targeting Monoclonal Antibodies for Alzheimer Disease – JAMA (free for a limited period)

Ushering in a New Era of Alzheimer Disease Therapy – JAMA (free for a limited period)

See also: Visual Abstract

Commentary: Expert reaction to results from Eli Lilly on its anti-amyloid drug donanemab – Science Media Centre

Related: RCT | Lecanemab slows cognitive decline in early Alzheimer’s disease but raises safety concerns.

 

Guideline | Antibiotic therapy in patients with suspected antibiotic allergy

17 Jul, 2023 | 13:59h | UTC

The Dutch Working Party on Antibiotic Policy (SWAB) guideline for the approach to suspected antibiotic allergy – Clinical Microbiology and Infection

 

Retrospective Analysis | Inconsistencies in pediatric drug dosing found in over half of prehospital emergency drug administrations

17 Jul, 2023 | 13:50h | UTC

Deviation From National Dosing Recommendations for Children Having Out-of-hospital Emergencies – Pediatrics

Commentaries:

Children and Drug Dosing Variations When in Transit to the Hospital – AAP Journals Blog

Variation Seen in Dosing of Meds at Prehospital Pediatric Encounters – HealthDay

 

Cohort Study | Long-acting antiretroviral therapy may achieve virologic suppression in HIV patients with adherence challenges

17 Jul, 2023 | 13:26h | UTC

Demonstration Project of Long-Acting Antiretroviral Therapy in a Diverse Population of People With HIV – Annals of Internal Medicine (link to abstract – $ for full-text)

Commentary: Long-Acting ART Achieves Virologic Suppression for People With HIV – HealthDay

 

Consensus Statement | Aerosol therapy in adult critically ill patients

14 Jul, 2023 | 13:01h | UTC

Aerosol therapy in adult critically ill patients: a consensus statement regarding aerosol administration strategies during various modes of respiratory support – Annals of Intensive Care

 

Intervention Study | Pharmacist review may reduce antibiotic overuse at discharge

12 Jul, 2023 | 13:37h | UTC

Improving antibiotic utilization through an outpatient stewardship initiative – Antimicrobial Stewardship & Healthcare Epidemiology

Commentary: Pharmacist review identifies improper antibiotic prescriptions – CIDRAP

 

Cohort Study | Fewer than half of new drugs add substantial therapeutic value over existing treatments

11 Jul, 2023 | 14:01h | UTC

News Release: Fewer than half of new drugs add substantial therapeutic value over existing treatments – BMJ Newsroom

Article: Therapeutic value of first versus supplemental indications of drugs in US and Europe (2011-20): retrospective cohort study – The BMJ

Editorial: Patients need better treatments, not just more of the same – The BMJ

 

RCT | No statistically significant impact of vitamin D on major cardiovascular events

5 Jul, 2023 | 01:11h | UTC

Vitamin D supplementation and major cardiovascular events: D-Health randomised controlled trial – The BMJ

Related:

2ry analysis of a RCT | Vitamin D supplementation does not affect cognitive function in older adults

RCT: Oral Vitamin D supplementation (60.000 IU per month) did not reduce mortality in patients 60 years or older (unscreened individuals in Australia, many without insufficiency, average 30ng/mL). Exploratory analyses pointed towards an increased risk of death from cancer.

Randomized Trial: Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease

Meta-Analysis: Vitamin D Not Effective for Cardiovascular Disease Prevention

Association between vitamin D supplementation and mortality: systematic review and meta-analysis – The BMJ

USPSTF Draft Statement: Insufficient evidence to recommend multivitamin supplements for the prevention of CVD or cancer. The statement also recommends against the use of beta-carotene (increases risk of CVD mortality and lung cancer) or vitamin E (clear evidence of no benefit)

Vitamin D, calcium, other vitamins, and supplements do not prevent cardiovascular diseases

 

Phase 2 RCT | Orforglipron, an oral GLP-1 receptor agonist, significantly reduces weight in adults with obesity

26 Jun, 2023 | 00:58h | UTC

Summary: The article reports a phase 2, randomized, double-blind trial investigating the efficacy of the GLP-1 receptor agonist, orforglipron, as an oral weight loss treatment for adults with obesity or overweight plus at least one weight-related condition. The study involved 272 participants, who were administered orforglipron at varying doses or a placebo over a 36-week period.

The key findings of the study indicated significant weight reduction in individuals who were administered orforglipron. At 26 weeks, weight changes in the orforglipron group ranged from -8.6% to -12.6% compared to -2.0% in the placebo group. At 36 weeks, these figures were -9.4% to -14.7% for the orforglipron group and -2.3% for the placebo group. Furthermore, 46-75% of orforglipron recipients experienced a weight reduction of at least 10% by week 36, compared to 9% in the placebo group.

Improvements were also observed in all prespecified weight-related and cardiometabolic measures among orforglipron users. However, the treatment was associated with some mild to moderate gastrointestinal side effects, leading to discontinuation in 10-17% of participants. The safety profile was in line with other GLP-1 receptor agonists. These findings suggest that orforglipron could potentially be an effective oral treatment for weight reduction in adults with obesity, though further research is needed to corroborate these results and assess long-term effects.

Article: Daily Oral GLP-1 Receptor Agonist Orforglipron for Adults with Obesity – New England Journal of Medicine (link to abstract – $ for full-text)

 

Position statement | Gastrointestinal bleeding and endoscopic procedures in patients on antiplatelet and/or anticoagulant therapy

21 Jun, 2023 | 13:22h | UTC

Position statement from the Indian Society of Gastroenterology, Cardiological Society of India, Indian Academy of Neurology and Vascular Society of India on gastrointestinal bleeding and endoscopic procedures in patients on antiplatelet and/or anticoagulant therapy – Indian Journal of Gastroenterology (if the link is paywalled, try this one)

 

RCT | Testosterone replacement does not appear to increase cardiovascular events in hypogonadal men at high risk

19 Jun, 2023 | 14:13h | UTC

Cardiovascular Safety of Testosterone-Replacement Therapy – New England Journal of Medicine (link to abstract – $ for full-text)

News Release: Cleveland Clinic-Led Trial Finds Testosterone-Replacement Therapy Does Not Increase Incidence of Major Adverse Cardiac Events for Men with Low Testosterone – Cleveland Clinic

 

Commentary on Twitter

 

RCT | Continuous vs. intermittent meropenem administration shows similar mortality and drug-resistance in sepsis patients

19 Jun, 2023 | 14:11h | UTC

Continuous vs Intermittent Meropenem Administration in Critically Ill Patients With Sepsis: The MERCY Randomized Clinical Trial – JAMA (free for a limited period)

Editorial: Do Prolonged Infusions of β-Lactam Antibiotics Improve Outcomes in Critically Ill Patients With Sepsis? – JAMA (free for a limited period)

See also: Visual Abstract

Commentary: Trial finds no difference between continuous, intermittent meropenem for sepsis patients – CIDRAP

 

Commentary on Twitter

 

Review | mRNA-based cancer therapeutics

19 Jun, 2023 | 13:53h | UTC

mRNA-based cancer therapeutics – Nature Reviews Cancer

 

Commentary on Twitter

 

Evidence-based clinical practice guideline for deprescribing opioid analgesics

15 Jun, 2023 | 15:08h | UTC

Evidence-based clinical practice guideline for deprescribing opioid analgesics – University of Sidney

 

M-A | Influencing factors of medication adherence in schizophrenic patients

15 Jun, 2023 | 14:56h | UTC

Influencing factors of medication adherence in schizophrenic patients: a meta-analysis – Schizophrenia

 

M-A | Biosimilar and reference biologics in rheumatoid arthritis show equivalent results

15 Jun, 2023 | 14:47h | UTC

Therapeutic Equivalence of Biosimilar and Reference Biologic Drugs in Rheumatoid Arthritis: A Systematic Review and Meta-analysis – JAMA Network Open

Commentary: Adalimumab, Etanercept, Infliximab Biosimilars Show Clinically Equivalence to Biologics in RA – HCP Live

 

Perspective | Inside the nascent industry of AI-designed drugs

14 Jun, 2023 | 14:50h | UTC

Inside the nascent industry of AI-designed drugs – Nature (if the link is paywalled, try this one)

 

AAP Technical Report | Dispensing medications at the hospital upon discharge from an emergency department

14 Jun, 2023 | 14:33h | UTC

Dispensing Medications at the Hospital Upon Discharge From an Emergency Department – Pediatrics

News Release: Report discusses ways to improve medication adherence after emergency visit – AAP News

Commentary: Dispensing Meds in Emergency Department Likely to Improve Adherence – HealthDay

 

M-A | Oseltamivir fails to lower hospitalization risk in adult and adolescent influenza patients

13 Jun, 2023 | 14:12h | UTC

Evaluation of Oseltamivir Used to Prevent Hospitalization in Outpatients With Influenza: A Systematic Review and Meta-analysis – JAMA Internal Medicine

 

Commentary on Twitter

 

Review | Drivers of inappropriate antibiotic use in low- and middle-income countries

12 Jun, 2023 | 13:35h | UTC

Drivers of inappropriate antibiotic use in low- and middle-income countries – JAC-Antimicrobial Resistance

 

RCT | Multivitamin supplementation may improve memory in aged adults

7 Jun, 2023 | 14:12h | UTC

Multivitamin Supplementation Improves Memory in Older Adults: A Randomized Clinical Trial – The American Journal of Clinical Nutrition (link to abstract – $ for full-text)

News Releases:

Study finds daily multivitamin supplements improved memory and slowed cognitive aging in older adults – Brigham and Women’s Hospital

Multivitamin Improves Memory in Older Adults, Study Finds – Columbia University

Related Research: Effects of cocoa extract and a multivitamin on cognitive function: A randomized clinical trial – Alzheimer’s & Dementia

 

SR | Limited evidence for vitamin and mineral supplements in delaying dementia in people with mild cognitive impairment

7 Jun, 2023 | 14:09h | UTC

Vitamin and mineral supplementation for preventing dementia or delaying cognitive decline in people with mild cognitive impairment – Cochrane Library

 

Commentary on Twitter

 

Podcast | Insulin, type 2 diabetes, and hypoglycemia

6 Jun, 2023 | 14:25h | UTC

#397: Insulin, Type 2 Diabetes, Fanny Packs, and Hypoglycemia with Dr. Jeff Colburn – The Curbsiders

 

RCT | Noninferiority shown between DOACs and LMWH for recurrent VTE prevention in cancer patients

5 Jun, 2023 | 13:50h | UTC

Summary: This unblinded, pragmatic, noninferiority randomized clinical trial aimed to assess the efficacy of direct oral anticoagulants (DOACs) against low-molecular-weight heparin (LMWH) in preventing recurrent venous thromboembolism (VTE) in patients with cancer. The study included 671 patients from 67 oncology centers, with a new clinical or radiological diagnosis of VTE.

Participants were randomly assigned to receive either a DOAC or LMWH for 6 months, and treating physicians selected and prescribed the drugs based on considerations like availability and drug-drug interactions. The primary outcome was the rate of recurrent VTE at 6 months. Findings revealed that the DOAC group had a recurrent VTE rate of 6.1% as compared to 8.8% in the LMWH group, showing noninferiority. Both groups had statistically similar rates of major bleeding and severe adverse events.

This pragmatic study included patients with advanced cancer and brain metastases, impaired performance status, and reduced liver or kidney function, making it more representative of routine oncology practice. Moreover, patient adherence to DOAC treatment was significantly higher than to LMWH. Nevertheless, the study had limitations, including the lack of blinding and underrepresentation of certain racial and ethnic groups.

In conclusion, this trial suggests that DOACs were noninferior to LMWH for preventing recurrent VTE in patients with cancer over a 6-month follow-up period, supporting the use of DOACs in this population for VTE prevention. Further research is needed to confirm these results and investigate long-term outcomes.

Article: Direct Oral Anticoagulants vs Low-Molecular-Weight Heparin and Recurrent VTE in Patients With Cancer: A Randomized Clinical Trial – JAMA (free for a limited period)

See also: Visual abstract

 

Commentary on Twitter

 

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