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Antidepressant reduces hospitalisations and deaths

Bywebmaster

May 3, 2024



Common antidepressant, $4 per course and it works

Effect of early treatment with fluvoxamine on risk of emergency care and hospitalisation among patients with COVID-19: the TOGETHER randomised, platform clinical trial
https://clinicaltrials.gov/ct2/show/NCT04727424

https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(21)00448-4/fulltext

https://www.togethertrial.com

Background

Potential therapeutic role of fluvoxamine

TOGETHER trial for acutely symptomatic patients

To assess the efficacy of fluvoxamine versus placebo

In preventing hospitalisation

Methods

Placebo-controlled

Randomised

Double blind

Adaptive platform trial

(Factoring in analyses at key points

So study design parameters like sample size, dosage, or patient selection can be adjusted accordingly)

https://www.parexel.com/experience/adaptive-flexible-trials?KW=adaptive%20trial%20design&AG=%7Badgroup%7D&CS=MSS&utm_source=google&utm_medium=paid&utm_campaign=mss&utm_term=adaptive%20trial%20design&utm_content=106310559248&gclid=CjwKCAjw2vOLBhBPEiwAjEeK9t9AW3N8ysMeIkLgKabG5MRPEtJD9EJsq8hzBhnQ0ztDLPPUm5gppBoCe_oQAvD_BwE

High-risk symptomatic Brazilian adults

Age ranges and 58% female

Confirmed positive for SARS-CoV-2

Within 7 days from first symptoms or diagnosis

Patients from 11 clinical sites in Brazil

Patients were randomly assigned (1:1)

Fluvoxamine (100 mg twice daily for 10 days), n = 741

Placebo, n = 756

Primary outcome

Hospitalisation, retention or transfer

Up to 28 days post-random assignment

Findings, Jan 20 to Aug 5, 2021

The proportion of patients observed in a COVID-19 emergency setting for more than 6 h

Or transferred to a teritary hospital due to COVID-19 (87%)

Lower for the fluvoxamine group compared with placebo

Fluvoxamine group

79 [11%] of 741

Placebo group

119 [16%] of 756

Relative risk 0·68

95% credible interval, 0·52–0·88

Probability of superiority, 99·8%

Fluvoxamine group

17 deaths

Placebo group

25 deaths

Odds ratio [OR] 0·68

95% credible interval, 0·36–1·27

No significant differences in number of treatment emergent adverse events among patients in the fluvoxamine and placebo groups

Fluvoxamine group

84 stopped taking

Placebo group

64

The absolute number of serious adverse events associated with fluvoxamine was lower than for placebo

this might reflect the modulatory effect of fluvoxamine on systemic inflammation

Mechanism?

Anti-inflammatory

Preventing cytokine storm

Antiplatelet activity

Increasing plasma levels of melatonin

It is now crucial to establish whether a class effect exists?

Interactions with vaccines, improved effect?

stopped taking

https://bnf.nice.org.uk/drug/fluvoxamine-maleate.html

For Adult

Initially 50–100 mg daily

Source

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