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Pharmacology/Pharmaceutical Industry

An analysis of Scotland’s mortality in 114,000 SARS-CoV2–infected people revealed that the vaccine effectiveness against death from the Delta variant was 90% for the Pfizer vaccine and 91% for AstraZeneca.

21 Oct, 2021 | 10:15h | UTC

BNT162b2 and ChAdOx1 nCoV-19 Vaccine Effectiveness against Death from the Delta Variant – New England Journal of Medicine

 


Pfizer vaccine showed estimated effectiveness of 93% against symptomatic SARS-CoV-2 Delta variant infection in adolescents.

21 Oct, 2021 | 10:17h | UTC

Effectiveness of BNT162b2 Vaccine against Delta Variant in Adolescents – New England Journal of Medicine

Related: CDC Study: Pfizer vaccine showed 93% effectiveness against Covid-19 hospitalization among children aged 12-18 years.

 

Commentary on Twitter

 


A case-controlled study showed Covid-19 vaccination during early pregnancy was not associated with increased risk of first-trimester miscarriage.

21 Oct, 2021 | 10:14h | UTC

Covid-19 Vaccination during Pregnancy and First-Trimester Miscarriage – New England Journal of Medicine

Related:

Editorial: Covid-19 treatments and vaccines must be evaluated in pregnancy.

Cohort study: Vaccinated pregnant patients had 90% lower risk of severe or critical Covid-19 compared with unvaccinated pregnant patients.

Two observational studies suggest spontaneous abortion is not increased following COVID-19 mRNA vaccination during pregnancy.

Study shows high effectiveness of the Pfizer mRNA COVID-19 vaccine in pregnancy.

5 Crucial Things to Know About COVID-19 Vaccines and Pregnancy.

CDC Guidance: Pregnant people should be vaccinated against COVID-19.

ACOG and SMFM Recommend COVID-19 Vaccination for Pregnant Individuals – “ACOG encourages its members to enthusiastically recommend vaccination to their patients.”

Cohort study: Pfizer/BioNTech COVID vaccine associated with 78% lower risk of Covid-19 in pregnancy.

 


FDA authorizes booster doses of Moderna and Johnson & Johnson vaccines, says mix and match OK.

21 Oct, 2021 | 10:09h | UTC

FDA authorizes booster doses of Moderna and Johnson & Johnson vaccines, says mix and match OK – CNN

See also:

FDA OKs mixing COVID vaccines; backs Moderna, J&J boosters – Associated Press

FDA OKs Moderna, J&J boosters, along with ‘mix and match’ approach – NBC News

 


NCCN Guideline: Cancer-Associated Venous Thromboembolic Disease.

21 Oct, 2021 | 10:06h | UTC

Cancer-Associated Venous Thromboembolic Disease, Version 2.2021, NCCN Clinical Practice Guidelines in Oncology – Journal of the National Comprehensive Cancer Network

Related:

ASH 2021 guidelines for prevention and treatment of venous thromboembolism in patients with cancer

Review: venous and arterial thromboembolism in patients with cancer.

Systematic Review: Does testing for cancer in people with unprovoked blood clots in the legs and lungs reduce cancer- and blood clot-related death and illness?

M-A: Extended thromboprophylaxis after hospital discharge for medically ill patients with cancer – Extended thromboprophylaxis is not associated with a reduced rate of venous thromboembolic events and is associated with increased risk of hemorrhage

Systematic review: Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy

 


The International Cannabis Toolkit (iCannToolkit): a multidisciplinary expert consensus on minimum standards for measuring cannabis use.

21 Oct, 2021 | 09:48h | UTC

The International Cannabis Toolkit (iCannToolkit): a multidisciplinary expert consensus on minimum standards for measuring cannabis use – Addiction

Commentary: How to measure cannabis use: introducing the ‘International Cannabis Toolkit’ or iCannToolkit – The Mental Elf

 


CDC Study: Pfizer vaccine showed 93% effectiveness against Covid-19 hospitalization among children aged 12-18 years.

20 Oct, 2021 | 10:31h | UTC

Effectiveness of Pfizer-BioNTech mRNA Vaccination Against COVID-19 Hospitalization Among Persons Aged 12–18 Years — United States, June–September 2021 – CDC Morbidity and Mortality Weekly Report

 

Commentary on Twitter (thread – click for more)

 


RCT: Nivolumab vs. placebo in patients with relapsed malignant mesothelioma.

21 Oct, 2021 | 09:46h | UTC

Nivolumab versus placebo in patients with relapsed malignant mesothelioma (CONFIRM): a multicentre, double-blind, randomised, phase 3 trial – The Lancet Oncology

 

Commentary on Twitter

 


Cohort Study: The effectiveness of heterologous AstraZeneca (AZ)/mRNA prime-boost vaccination was more significant (68%) compared to the effectiveness of homologous AZ/AZ vaccination (50%) against symptomatic Covid-19 infection in Sweden.

20 Oct, 2021 | 10:27h | UTC

Effectiveness of heterologous ChAdOx1 nCoV-19 and mRNA prime-boost vaccination against symptomatic Covid-19 infection in Sweden: A nationwide cohort study – The Lancet Regional Health Europe

Commentary: High effectiveness of mix-and-match COVID-19 vaccines – UMEA University

Related:

Study evaluated several heterologous SARS-CoV-2 vaccine regimens; no efficacy data but there was increased antibody production on study days 15 and 29 after booster shots from Moderna and Pfizer.

A primer on what we know about mixing and matching Covid vaccines.

Real-world data shows increased reactogenicity in adults after heterologous compared to homologous prime-boost COVID-19 vaccination.

RCT: Safety and immunogenicity of heterologous vs. homologous prime-boost schedules with an adenoviral vectored and mRNA COVID-19 vaccine.

Another study shows increased immune response with heterologous Oxford-AstraZeneca/mRNA vaccination.

Heterologous Oxford–AstraZeneca and Moderna Vaccination induce increased levels of neutralizing antibody compared to 2 doses of Oxford–AstraZeneca.

Heterologous Oxford–AstraZeneca and BioNTech/Pfizer Vaccination induce increased levels of neutralizing antibody compared to 2 doses of Oxford–AstraZeneca.

[Preprint] Mixing Covid jabs has good immune response, study finds – “The Com-Cov trial looked at the efficacy of either two doses of Pfizer, two of AstraZeneca, or one of them followed by the other. All combinations worked well, priming the immune system”.

Phase 2 RCT: Immunogenicity and reactogenicity of a Pfizer-BioNTech booster in patients that have received a single dose of AstraZeneca vaccine – “BNT162b2 (Pfizer) given as a second dose in individuals prime vaccinated with ChAdOx1-S (AstraZeneca) induced a robust immune response, with an acceptable and manageable reactogenicity profile”.

Lab study shows heterologous AstraZeneca/Pfizer vaccination produces strong immune response against SARS-CoV-2 Delta variant.

Lab study shows a heterologous AstraZeneca + Pfizer immunization strategy provides stronger immunogenicity against Covid compared to homologous AZ + AZ or Pfizer + Pfizer strategies.

RCT: Mixing 2 different Covid vaccines is associated with increased risk of side effects.

 

Commentary on Twitter

 


Should You Mix and Match Your Booster Shot?

20 Oct, 2021 | 10:25h | UTC

Should You Mix and Match Your Booster Shot? – The Atlantic

Related:

Study evaluated several heterologous SARS-CoV-2 vaccine regimens; no efficacy data but there was increased antibody production on study days 15 and 29 after booster shots from Moderna and Pfizer.

A primer on what we know about mixing and matching Covid vaccines.

Real-world data shows increased reactogenicity in adults after heterologous compared to homologous prime-boost COVID-19 vaccination.

RCT: Safety and immunogenicity of heterologous vs. homologous prime-boost schedules with an adenoviral vectored and mRNA COVID-19 vaccine.

Another study shows increased immune response with heterologous Oxford-AstraZeneca/mRNA vaccination.

Heterologous Oxford–AstraZeneca and Moderna Vaccination induce increased levels of neutralizing antibody compared to 2 doses of Oxford–AstraZeneca.

Heterologous Oxford–AstraZeneca and BioNTech/Pfizer Vaccination induce increased levels of neutralizing antibody compared to 2 doses of Oxford–AstraZeneca.

[Preprint] Mixing Covid jabs has good immune response, study finds – “The Com-Cov trial looked at the efficacy of either two doses of Pfizer, two of AstraZeneca, or one of them followed by the other. All combinations worked well, priming the immune system”.

Phase 2 RCT: Immunogenicity and reactogenicity of a Pfizer-BioNTech booster in patients that have received a single dose of AstraZeneca vaccine – “BNT162b2 (Pfizer) given as a second dose in individuals prime vaccinated with ChAdOx1-S (AstraZeneca) induced a robust immune response, with an acceptable and manageable reactogenicity profile”.

Lab study shows heterologous AstraZeneca/Pfizer vaccination produces strong immune response against SARS-CoV-2 Delta variant.

Lab study shows a heterologous AstraZeneca + Pfizer immunization strategy provides stronger immunogenicity against Covid compared to homologous AZ + AZ or Pfizer + Pfizer strategies.

RCT: Mixing 2 different Covid vaccines is associated with increased risk of side effects.

 


RCT: Interferon does not improve outcomes for hospitalized adults with COVID-19.

20 Oct, 2021 | 10:28h | UTC

News release: Interferon does not improve outcomes for hospitalized adults with COVID-19 – NIH News Releases

Original study: Efficacy of interferon beta-1a plus remdesivir compared with remdesivir alone in hospitalised adults with COVID-19: a double-bind, randomised, placebo-controlled, phase 3 trial – The Lancet Respiratory Medicine

 


[Preprint] Observational study in Brazil showed the J&J vaccine adjusted effectiveness was 50.9% against any symptomatic Covid-19, 72.9% for hospitalization, 92.5% for ICU admission, 88.7% for mechanical ventilation, and 90.5% for death.

20 Oct, 2021 | 10:24h | UTC

Vaccine effectiveness of Ad26.COV2.S against symptomatic COVID-19 and clinical outcomes in Brazil: a test-negative study design – medRxiv

 


Global Initiative for Asthma (GINA) Strategy 2021 – Executive summary and rationale for key changes.

20 Oct, 2021 | 10:20h | UTC

Global Initiative for Asthma (GINA) Strategy 2021 – Executive summary and rationale for key changes – European Respiratory Journal

 


Systematic Review: anti-interleukin-13 or anti-interleukin-4 agents may be appropriate for adults with moderate-to-severe uncontrolled asthma who have not responded to other treatments.

20 Oct, 2021 | 10:19h | UTC

Anti‐interleukin‐13 and anti‐interleukin‐4 agents versus placebo, anti‐interleukin‐5 or anti‐immunoglobulin‐E agents, for people with asthma – Cochrane Library

Summary: Anti-interleukin-13 or anti-interleukin-4 agents versus placebo, anti-interleukin-5 or anti-immunoglobulin-E agents, for children and adults with asthma – Cochrane Library

 

Commentary on Twitter (thread – click for more)

 


RCT: In patients with Type 2 Diabetes, Tirzepatide is associated with reduced weight, improved glycemic control, and lower risk of hypoglycemia compared to insulin glargine.

20 Oct, 2021 | 10:13h | UTC

Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial – The Lancet (link to abstract – $ for full-text)

Related:

RCT: Once-weekly tirzepatide vs. once-daily insulin degludec as add-on to metformin with or without SGLT2 inhibitors in patients with type 2 diabetes.

RCT: Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2.

RCT: Tirzepatide yielded greater glycated hemoglobin and body weight reductions compared to Semaglutide 1 mg.

 


Large observational study suggests Tramadol is associated with increased risk of adverse outcomes compared to Codeine.

20 Oct, 2021 | 10:11h | UTC

Association of Tramadol vs Codeine Prescription Dispensation With Mortality and Other Adverse Clinical Outcomes – JAMA (free for a limited period)

Editorial: Tramadol, Codeine, and Risk of Adverse Outcomes – JAMA (free for a limited period)

Related: Tramadol: Where do we go from here? – “Tramadol’s unpredictability, unique potential harms, and lack of advantage over other opioids or NSAIDs are now well recognized”.

 


Long-term consequences of the misuse of ivermectin data.

19 Oct, 2021 | 09:56h | UTC

Long-term consequences of the misuse of ivermectin data – The Lancet Infectious Diseases

Related:

Ivermectin: How false science created a Covid ‘miracle’ drug.

Fraudulent ivermectin studies open up new battleground between science and misinformation.

The lesson of ivermectin: meta-analyses based on summary data alone are inherently unreliable.

Ivermectin: Cochrane’s most talked about review so far, ever. Why?

Flawed ivermectin preprint highlights challenges of COVID drug studies.

Systematic review: no evidence to support the use of Ivermectin for treating or preventing COVID-19.

Why was a major study on ivermectin for covid-19 just retracted?

RCT: Ivermectin does not prevent hospitalizations in patients with COVID-19.

Ivermectin for the treatment of COVID-19: A systematic review and meta-analysis of randomized controlled trials – “IVM did not reduce all-cause mortality, length of stay or viral clearance in RCTs in COVID-19 patients with mostly mild disease”.

Ivermectin is the new hydroxychloroquine, take 2 – “Ivermectin shouldn’t be used to treat COVID-19 outside of the context of a well-designed clinical trial”.

Therapeutics and COVID-19 | WHO guideline update advises Ivermectin should only be used to treat COVID-19 within clinical trials

RCT: Ivermectin does not improve time to resolution of symptoms among adults with mild COVID-19

 

Commentary on Twitter

 


RECOVERY Trial: In patients admitted to hospital with COVID-19, Colchicine did not reduce 28-day mortality, duration of hospital stay, or risk of progressing to invasive mechanical ventilation or death.

19 Oct, 2021 | 10:14h | UTC

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

Related:

[Preprint] PRINCIPLE RCT: Colchicine does not improve time to recovery in outpatients with Covid-19 at higher risk of complications.

COLCORONA RCT: Colchicine for community-treated patients with COVID-19 – findings suggest it may lower death and hospital admission rates, but further studies are required.

[Preprint] RECOVERY Trial: Colchicine does not improve outcomes in patients admitted to hospital with COVID-19.

 


Systematic Review: Colchicine for the treatment of COVID‐19 – not beneficial for hospitalized patients; inconclusive evidence for the treatment of non-hospitalized patients, “probably slightly reduces the need for hospitalization or death within 28 days compared to placebo”.

19 Oct, 2021 | 10:13h | UTC

Colchicine for the treatment of COVID‐19 – Cochrane Library

Related:

[Preprint] PRINCIPLE RCT: Colchicine does not improve time to recovery in outpatients with Covid-19 at higher risk of complications.

COLCORONA RCT: Colchicine for community-treated patients with COVID-19 – findings suggest it may lower death and hospital admission rates, but further studies are required.

[Preprint] RECOVERY Trial: Colchicine does not improve outcomes in patients admitted to hospital with COVID-19.

 

Commentary on Twitter

 


China’s COVID vaccines have been crucial — now immunity is waning.

19 Oct, 2021 | 09:53h | UTC

China’s COVID vaccines have been crucial — now immunity is waning – Nature

Related:

[Preprint] Breakthrough SARS-CoV-2 infections in 620,000 U.S. Veterans, February 1, 2021 to August 13, 2021 – “Vaccine protection declined by mid-August 2021, decreasing from 91.9% in March to 53.9%”.

Observational study in Qatar showed the effectiveness of Pfizer vaccine against any SARS-CoV-2 infection dropped to 20% in months 5 through 7 after the second dose, but effectiveness against severe Covid-19 remained high.

Cohort study: Pfizer vaccine effectiveness against any infections declined from 88% during the first month after full vaccination to 47% after 5 months. Vaccine effectiveness against hospital admissions remained high; 87% within 1 month, and 88% at 5 months after full vaccination, with no significant waning.

Editorial | Covid-19 vaccination: evidence of waning immunity is overstated.

COVID vaccine immunity is waning — how much does that matter? – “As debates about booster shots heat up, what’s known about the duration of vaccine-based immunity is still evolving”.

COVID vaccine effects wane over time but still prevent death and severe illness.

Perspective | What we actually know about waning immunity.

Another study shows Pfizer mRNA vaccine immunity is reduced over time.

[Press release – not published yet] Study shows vaccine protection wanes over time, but vaccines still offer good protection against severe disease.

Studies: COVID vaccine protection waning against infection but not hospitalization.

 


Another observational study suggests Rivaroxaban is associated with higher rates of gastrointestinal bleeding than other direct oral anticoagulants.

19 Oct, 2021 | 09:47h | UTC

Rivaroxaban Is Associated with Higher Rates of Gastrointestinal Bleeding Than Other Direct Oral Anticoagulants: A Nationwide Propensity Score–Weighted Study – Annals of Internal Medicine (link to abstract – $ for full-text)

Commentary: Rivaroxaban Again Linked to More Bleeding vs Other DOACs – TCTMD

Related: Gastrointestinal Safety of Direct Oral Anticoagulants: A Large Population-Based Study – Gastroenterology

 

Commentary on Twitter

 


Guideline: Management of anticoagulants and antiplatelet agents in cutaneous surgery.

19 Oct, 2021 | 09:50h | UTC

S3 guideline: Management of anticoagulants and antiplatelet agents in cutaneous surgery – Journal of the German Society of Dermatology

 


Systematic Review: Calcium channel blockers versus other classes of drugs for hypertension – “there is moderate certainty evidence that diuretics reduce major cardiovascular events and congestive heart failure more than CCBs”.

19 Oct, 2021 | 08:56h | UTC

Summary: Calcium channel blockers versus other classes of drugs for hypertension – Cochrane Library

Original Study: Calcium channel blockers versus other classes of drugs for hypertension – Cochrane Library

 

Commentary on Twitter

 


RCT supports the use of therapeutic heparin in moderately ill patients admitted to the hospital with Covid-19.

17 Oct, 2021 | 21:35h | UTC

Effectiveness of therapeutic heparin versus prophylactic heparin on death, mechanical ventilation, or intensive care unit admission in moderately ill patients with covid-19 admitted to hospital: RAPID randomised clinical trial – The BMJ

Commentary: High-dose of readily available blood thinner reduces risk of death for moderately ill COVID-19 patients – St. Michael’s Hospital

Related studies (some conflicting results)

RCT: Therapeutic-dose heparin superior to standard prophylactic or intermediate-dose heparins for thromboprophylaxis in high-risk hospitalized patients with COVID-19.

Another meta-analysis suggests standard-dose prophylactic anticoagulation is the best option for patients hospitalized with Covid-19.

M-A: Safety and efficacy of different prophylactic anticoagulation dosing regimens in critically and non-critically ill patients with COVID-19 – According to this analysis, standard-dose prophylactic anticoagulation should be the standard of care for hospitalized patients with COVID-19 who do not have an indication for therapeutic anticoagulation, irrespective of disease severity.

RCT: In noncritically ill patients hospitalized with Covid-19, therapeutic-dose anticoagulation with heparin increased the probability of survival to hospital discharge compared with usual-care thromboprophylaxis.

RCT: In critically ill patients with Covid-19, therapeutic anticoagulation with heparin did not result in improved outcomes compared to usual-care pharmacologic thromboprophylaxis.

RCT: In patients hospitalized with Covid-19 with elevated D-Dimer, a full-dose anticoagulation strategy based on rivaroxaban (full-dose heparins in unstable patients) + rivaroxaban to day 30 was not better than prophylactic anticoagulation and increased bleeding risk.

 

Commentary on Twitter

 


J&J COVID-19 Vaccine: FDA recommends booster shot for all adults aged 18 and older at least two months following initial vaccination with the single-shot vaccine.

17 Oct, 2021 | 21:32h | UTC

News release: Johnson & Johnson COVID-19 Vaccine Booster Shot Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee

Commentaries:

FDA panel endorses booster shot for J&J COVID-19 vaccine – Associated Press

The Johnson & Johnson one-dose vaccine offers good protection now. A booster shot will maximize that, experts say – CNN

FDA advisers recommend J&J Covid-19 vaccine boosters, talk mix and match boosters – CNN

Related: [Press release – not published yet] J&J says booster shot at two months provided 75% protection against moderate to severe COVID-19 globally and 94% of such cases in the U.S.

 


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