Pharmacology/Pharmaceutical Industry | Links Medicus Content Curation & Alerts in Medicine

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

What are the effects of therapeutic heparin compared with prophylactic heparin among moderately ill patients with covid-19 admitted to hospital? #BMJResearch by @sholzberg and colleagues.

Includes a #VisualAbstract summarising the study #BMJInfographic https://t.co/82VisuBKSU pic.twitter.com/b06TdIJvLX

— The BMJ (@bmj_latest) October 15, 2021

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

[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%”.

17 Oct, 2021 | 21:29h | UTC

Breakthrough SARS-CoV-2 infections in 620,000 U.S. Veterans, February 1, 2021 to August 13, 2021 – medRxiv

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.

Commentary on Twitter

New on breakthrough infections in 620,000 Veterans
"Vaccine protection declined by mid-August 2021, decreasing from 91.9% in March to 53.9%"https://t.co/xonBb4aEqJ highest reduction with J&J vaccine pic.twitter.com/rbhXOREFPP

— Eric Topol (@EricTopol) October 15, 2021

Eight months later: Researchers compare immune responses elicited by three COVID-19 vaccines.

17 Oct, 2021 | 21:27h | UTC

News release: Eight months later: Researchers compare immune responses elicited by three COVID-19 vaccines – Beth Israel Deaconess Medical Center

Original study: Differential Kinetics of Immune Responses Elicited by Covid-19 Vaccines – New England Journal of Medicine

Commentary on Twitter

Just published @NEJM
Neutralizing antibody levels and T cells response out to 8 months for Pfizer, Moderna and J&J vaccines https://t.co/ghAgk3Y4kR
Moderna highest antibody response; J&J while lower doesn't fall off and best CD8 T-cell response at 8 months pic.twitter.com/uANSzAylMF

— Eric Topol (@EricTopol) October 15, 2021

RCT: After third molar surgery, Ibuprofen doses above 400 mg did not significantly increase the analgesic effect, and Paracetamol 1000/codeine 60 mg was not more effective than ibuprofen 400 mg.

17 Oct, 2021 | 21:16h | UTC

Analgesic effect of oral ibuprofen 400, 600, and 800 mg; paracetamol 500 and 1000 mg; and paracetamol 1000 mg plus 60 mg codeine in acute postoperative pain: a single-dose, randomized, placebo-controlled, and double-blind study – European Journal of Clinical Pharmacology

M-A: Effectiveness and safety of non-steroidal anti-inflammatory drugs and opioid treatment for knee and hip osteoarthritis – although Etoricoxib 60 mg/day and diclofenac 150 mg/day seem to be most effective treatments, topical diclofenac 70-81 mg/day is safer and should be considered as first line treatment.

17 Oct, 2021 | 21:14h | UTC

Effectiveness and safety of non-steroidal anti-inflammatory drugs and opioid treatment for knee and hip osteoarthritis: network meta-analysis – The BMJ

News release: Topical pain-killers more effective, safer than opioids for knee osteoarthritis pain – St. Michael’s Hospital

Commentary: Network meta-analysis compares analgesic regimens for osteoarthritis – medwire News

Commentary on Twitter

Etoricoxib 60 mg/day and diclofenac 150 mg/day seem to be the most effective oral NSAIDs for knee and hip osteoarthritis pain and physical function, but might not be appropriate in the presence of comorbidities or for long term use, concludes #BMJResearch https://t.co/rrtX3BnQE5

— The BMJ (@bmj_latest) October 16, 2021

Review: Timing of antibiotic therapy in the ICU.

17 Oct, 2021 | 21:05h | UTC

Timing of antibiotic therapy in the ICU – Critical Care

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.

15 Oct, 2021 | 02:49h | UTC

Heterologous SARS-CoV-2 Booster Vaccinations: Preliminary Report – medRxiv

Commentary: Study: Mixing and Matching COVID-19 Booster Shots Is Effective, Safe – U.S. News

Commentary on Twitter

So yes, mRNA vaccines are great at generating antibodies but what does that mean? Where is the efficacy data? How come JnJ gets really great efficacy at preventing symptomatic COVID and severe disease with low antibodies? T-cells? Still much to learn. https://t.co/YwKUyogAhQ

— Daniel Griffin MD PhD (@DanielGriffinMD) October 13, 2021

Statins linked to reduced risk of death from COVID-19 in major population study – “Randomized studies will be needed to ascertain whether there is a causal relationship, note the researchers”.

15 Oct, 2021 | 02:47h | UTC

News release: Statins linked to reduced risk of death from COVID-19 in major population study – Karolinska Institutet

Original study: HMG-CoA reductase inhibitors and COVID-19 mortality in Stockholm, Sweden: A registry-based cohort study – PLOS Medicine

Commentaries:

Expert reaction to study looking at statins and risk of death from COVID-19 – Science Media Centre

People taking statins less likely to die from Covid, study suggests – The Guardian

Perspective | Trying to Block SARS-CoV-2 Transmission With Intranasal Vaccines.

15 Oct, 2021 | 02:44h | UTC

Trying to Block SARS-CoV-2 Transmission With Intranasal Vaccines – JAMA

FDA panel green-lights Moderna COVID boosters for risk groups.

15 Oct, 2021 | 02:43h | UTC

FDA panel green-lights Moderna COVID boosters for risk groups – CIDRAP

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

15 Oct, 2021 | 02:41h | UTC

Covid-19 treatments and vaccines must be evaluated in pregnancy – The BMJ

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.

Commentary on Twitter

Inconsistent messaging from authorities, driven by lack of trial data, has increased covid-19 vaccine hesitancy among pregnant women@DrAllyah and colleagues argue that pregnant women should be included in drug and vaccine development from the outsethttps://t.co/P3v1ouk8tQ

— The BMJ (@bmj_latest) October 14, 2021

Trastuzumab for early-stage, HER2-positive breast cancer: a meta-analysis of 13 864 women in seven randomized trials.

15 Oct, 2021 | 02:07h | UTC

Trastuzumab for early-stage, HER2-positive breast cancer: a meta-analysis of 13 864 women in seven randomised trials – The Lancet Oncology

Commentary on Twitter

@OncoAlert Success of a monoclonal antibody when @ right target – 10 yr benefits of trastuzumab – #EBCTCG meta-analysis (N>13,000):
👉Impressive absolute and relative ~1/3 reduced deaths, ~1/3 recurrences
👉ER-: Recur⬇️ 11%
👉ER+: Recur⬇️ 8%@kevinpunie @prat_aleix @itsnot_pink https://t.co/O1WKcEEuGG

— Nicole Kuderer (@NicoleKuderer) August 4, 2021

[Preprint] In RCT with 29,949 participants, the Novavax vaccine demonstrated high overall efficacy (>90%) for the prevention of Covid-19, and all moderate-to-severe cases occurred in placebo recipients.

14 Oct, 2021 | 10:17h | UTC

Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico – medRxiv

Commentary: Novel vaccine demonstrates high efficacy for prevention of COVID-19 – News Medical

RCT: Novavax vaccine conferred 89.7% protection against symptomatic SARS-CoV-2 infection and 100% protection against hospitalizations or deaths.

Opinion | The mRNA vaccines are extraordinary, but Novavax is even better.

(Press release – not published yet) Novavax COVID-19 vaccine demonstrates 90% overall efficacy and 100% protection against moderate and severe disease.

RCT: Novavax vaccine is 49.4% effective against B.1.351 SARS-CoV-2 variant.

[Press release – not published yet] Novavax reports 96% efficacy against original strain of COVID-19, 86% efficacy against B.1.1.7 variant, and 55% efficacy against B1.351 variant

New COVID-19 vaccines: here’s how the promising Novavax and Johnson & Johnson jabs work

Covid-19: Novavax vaccine efficacy is 86% against UK variant and 60% against South African variant

Commentary on Twitter

Remember Novavax's #COVID vaccine?

Recent data looks really good.

~30K participants enrolled in a prospective clinical trial.

The vaccine appeared to be safe & effective (>90%).

Unclear why approval is taking so long.

Preprint 👉 https://t.co/MQkJXdgJyR pic.twitter.com/217Erw2stC

— Isaac Bogoch (@BogochIsaac) October 12, 2021

Video: Merck’s Covid pill could transform treatment. Here’s how it works.

14 Oct, 2021 | 10:10h | UTC

Watch: Merck’s Covid pill could transform treatment. Here’s how it works – STAT

How antiviral pill Molnupiravir shot ahead in the COVID drug hunt.

What we know — and don’t know — about Merck’s new Covid-19 pill.

[Press release – not published yet] Merck announces oral antiviral Molnupiravir reduced the risk of hospitalization or death by approximately 50 Percent compared to placebo for patients with mild or moderate COVID-19.

Merck’s Covid-19 pill is great news but may not be a game-changer.

Video | A Pill For COVID? A Doctor Explains Molnupiravir.

RCT: Oxytocin does not improve social functioning in children with autism spectrum disorder.

14 Oct, 2021 | 09:52h | UTC

News release: Oxytocin does not improve social functioning in children with autism spectrum disorder, NIH-funded study suggests – National Institutes of Health

Original study: Intranasal Oxytocin in Children and Adolescents with Autism Spectrum Disorder – New England Journal of Medicine

Systematic Review: Direct oral anticoagulants (DOACs) may be beneficial for people being treated for cancer who have no therapeutic or prophylactic indication for anticoagulation.

14 Oct, 2021 | 09:44h | UTC

Oral anticoagulation in people with cancer who have no therapeutic or prophylactic indication for anticoagulation – Cochrane Library

WHO advisers recommend 3rd COVID vaccine dose for highest-risk groups.

13 Oct, 2021 | 01:48h | UTC

WHO advisers recommend 3rd COVID vaccine dose for highest-risk groups – CIDRAP

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

13 Oct, 2021 | 01:44h | UTC

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

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.

USPSTF draft statement revises previous guidance and now recommends against initiating low-dose aspirin use for the primary prevention of CVD in adults aged 60 years or older.

13 Oct, 2021 | 01:36h | UTC

USPSTF Draft Recommendation Statement: Aspirin Use to Prevent Cardiovascular Disease – U.S. Preventive Services Task Force

Commentaries:

Advice shifting on aspirin use for preventing heart attacks – Associated Press

Taking aspirin to prevent heart attack may cause more harm than good, task force says – NPR

Related Randomized Trials:

Randomized Trial: Aspirin for Primary Prevention of Cardiovascular Disease

Randomized Trial: Effects of Aspirin for Primary Prevention in Persons with Diabetes

Randomized Trial: Effect of Aspirin on All-Cause Mortality in the Healthy Elderly

Related Meta-Analysis:

Meta-Analysis: Association of Aspirin Use for Primary Prevention with Cardiovascular Events and Bleeding Events

Meta-Analysis: Efficacy and Safety of Aspirin for Primary Prevention of Cardiovascular Events

Aspirin for primary prevention of cardiovascular disease: a meta-analysis with a particular focus on subgroups – BMC Medicine

Related Opinions:

Aspirin for Primary Prevention: Is This the End of the Road?

Evidence evolving on aspirin as prevention – ACP Internist

Commentary on Twitter

Low Dose Aspirin in the Primary Prevention of Cardiovascular Disease: #USPSTF recommends individualized decision making between 50 and 59 years, and against aspirin use in 60 years+. What a difference a few years can make, with more data and evidence. https://t.co/3nC3jpjTDq pic.twitter.com/SN8K3Z9XJj

— Muin J. Khoury (@MuinJKhoury) October 12, 2021

M-A: New pharmacologic agents (Ditans and Gepants) are not as good as triptans for treating migraines.

13 Oct, 2021 | 01:17h | UTC

Comparison of New Pharmacologic Agents With Triptans for Treatment of Migraine: A Systematic Review and Meta-analysis – JAMA Network Open

Commentary: Migraine: Older Drugs May Be Best Bet for Lessening Pain – Physician’s Weekly

Commentary on Twitter

This systematic review and meta-analysis found that ditans and gepants were associated with less efficacy compared with triptans, whereas gepants were associated with fewer adverse events compared with triptans for migraine treatment. https://t.co/PFCHg4MZ8r

— JAMA Network Open (@JAMANetworkOpen) October 11, 2021

RCT: No benefit from antithrombotic therapy (aspirin or apixaban) in outpatients with clinically stable symptomatic COVID-19.

12 Oct, 2021 | 00:28h | UTC

Effect of Antithrombotic Therapy on Clinical Outcomes in Outpatients With Clinically Stable Symptomatic COVID-19: The ACTIV-4B Randomized Clinical Trial – JAMA

Editorial: Antithrombotic Therapy for Outpatients With COVID-19: Implications for Clinical Practice and Future Research – JAMA

Commentary on Twitter

Data do not support the use of aspirin or apixaban in the outpatient setting to reduce the major adverse cardiovascular or pulmonary consequences associated with symptomatic but clinically stable #SARSCoV2 infection https://t.co/SH6OefXOCj #COVID19

— JAMA (@JAMA_current) October 11, 2021