#15,605
While COVID vaccines are on the way, what is still desperately needed is a safe, easy to administer, and (hopefully cheap) therapeutic drug that can lower mortality and decrease morbidity in those who are already infected.
Unfortunately, despite some initial anecdotal reports that suggested several pre-existing drugs had shown promise in treating COVID, the results of clinical trials have been disappointing.- In late October we saw Eli Lilly & ViralClear Halt Their Clinical Trials For COVID-19 Treatments after early data suggested that the drugs being tested were not providing a benefit to hospitalized COVID patients.
- A week earlier, in BMJ: Clinical Trial On Convalescent Plasma Showed Little Benefit For COVID-19, convalescent plasma was dealt another blow (see last July's Dutch Convalescent Plasma Study For COVID-19 was Halted For Redesign).
- While in mid-October, in WHO Solidarity Therapeutics Trial: Remdesivir, HCQ, Lopinar/Ritonavir & Interferon Disappoint, we saw that 4 highly touted drug therapies were found to have `. . . had little or no effect on 28-day mortality or in-hospital course of illness.'
While it may have limited use (see Limited Role Of Cytokine Storm In COVID-19 Patients), Dexamethasone - a corticosteroid - has been shown to be beneficial for treating some severe COVID patients (see JAMA study) - but most hospital treatments remain primarily supportive (i.e. oxygen, blood thinners, fluids, etc.) in nature.
As stated, other drugs are under review - not only for COVID - but for other potential pandemic candidates.
For many years Dr. David Fedson – former Professor of Medicine at the University of Virginia School of Medicine and formerly Director of Medical Affairs, Aventis Pasteur MSD - has championed the idea that we should be looking at cheap, easy to produce, generic statins for this role, which he believes may help modulate the immune response.Over the years we've looked at his proposals, and some (admittedly) conflicting studies, on the effectiveness of statins against influenza and pneumonia.
Pandemic Influenza: A Potential Role for Statins in Treatment and Prophylaxis - David S. Fedson
New Approaches to Confronting an Imminent Influenza Pandemic - Dr. Fedson and Peter Dunnill, DSc,FREng
Statins & Pneumonia: Revisited
Study: Statins, Influenza, & MortalityBeyond pandemic influenza, we've also seen the pleiotropic effects of statins explored for other types of life threatening infections, including:
mBio Letter: Statins Suggested As Possible Treatment For MERS
Study: Statins & Cerebral Malaria
While we haven't seen any home runs come out of this research, over the past 10 months we've seen a number of reports and/or studies suggesting that statins may be useful in reducing the impact of COVID-19.
Today, however, we have a new report published (Dec. 4th) in the BMJ Open Journal, which failed to find a survival benefit among patients who were taking statins when infected. While this study doesn't preclude the use of statins in the treatment of COVID - and additional research is ongoing - it isn't the hoped for result.
You'll find the abstract and conclusion from the study below, but follow the link to read the paper in its entirety. I'll have a brief postscript when you return.
Infectious diseases
Original research
Association between statin use and outcomes in patients with coronavirus disease 2019 (COVID-19): a nationwide cohort study
Jawad Haider Butt1, Thomas Alexander Gerds2,3, Morten Schou4, Kristian Kragholm5, Matthew Phelps2, Eva Havers-Borgersen1, Adelina Yafasova1, Gunnar Hilmar Gislason2,6, Christian Torp-Pedersen7, Lars Køber1, Emil Loldrup Fosbøl1 Author affiliations
Abstract
Objective To investigate the association between recent statin exposure and risk of severe COVID-19 infection and all-cause mortality in patients with COVID-19 in Denmark.
Design and setting Observational cohort study using data from Danish nationwide registries.
Participants Patients diagnosed with COVID-19 from 22 February 2020 to 17 May 2020 were followed from date of diagnosis until outcome of interest, death or 17 May 2020.
Interventions Use of statins, defined as a redeemed drug prescription in the 6 months prior to COVID-19 diagnosis.
Primary and secondary outcome measures All-cause mortality, severe COVID-19 infection and the composite.
Results The study population comprised 4842 patients with COVID-19 (median age 54 years (25th–75th percentile, 40–72), 47.1% men), of whom 843 (17.4%) redeemed a prescription of statins. Patients with statin exposure were more often men and had a greater prevalence of comorbidities. The median follow-up was 44 days.
After adjustment for age, sex, ethnicity, socioeconomic status and comorbidities, statin exposure was not associated with a significantly different risk of mortality (HR 0.96 (95% CI 0.78 to 1.18); 30-day standardised absolute risk (SAR), 9.8% (8.7% to 11.0%) vs 9.5% (8.2% to 10.8%); SAR difference, −0.4% (−1.9% to 1.2%)), severe COVID-19 infection (HR 1.16 (95% CI 0.95 to 1.41); 30-day SAR, 13.0% (11.8% to 14.2%) vs 14.9% (12.8% to 17.1%); SAR difference, 1.9% (−0.7% to 4.5%)), and the composite outcome of all-cause mortality or severe COVID-19 infection (HR 1.05 (95% CI 0.89 to 1.23); 30-day SAR, 17.6% (16.4% to 18.8%) vs 18.2% (16.4% to 20.1%); SAR difference, 0.6% (−1.6% to 2.9%)).
The results were consistent across subgroups of age, sex and presumed indication for statin therapy. Among patients with statin exposure, there was no difference between statin drug or treatment intensity with respect to outcomes.
Conclusions Recent statin exposure in patients with COVID-19 infection was not associated with an increased or decreased risk of all-cause mortality or severe infection.
Strengths and limitations of this study
- The study was based on high-quality and complete data from nationwide administrative registries.
- The Danish healthcare system provides equal access to healthcare services for all residents regardless of socioeconomic or insurance status.
- The observational nature of this study precludes the assessment of cause–effect relationships.
- Residual confounding and confounding by indication cannot be excluded.
(SNIP)
Conclusions
In this Danish nationwide cohort study, recent statin exposure in patients with COVID-19 infection was not associated with an increased or decreased risk of all-cause mortality or severe infection. Hence, our study does not suggest benefit or harm of statin therapy in patients with COVID-19. However, further studies are needed to establish the role of statins in patients with COVID-19 with and without an indication for statin therapy. Several randomised clinical trials have been initiated to assess this clinically relevant issue in patients with COVID-19, and the results from these trials are anticipated.
Conflicting studies are nothing new, and cherry picking the results of one study over another can be misleading, particularly if other results (and methods) are not weighed against it.
- Last April, in When Studies Collide (COVID-19 Edition), we looked at some wildly different `conclusions' regarding the level of acquired community immunity in the UK and Austria.
- In 2016, in When Flu Vaccine Studies Collide, we looked at widely differing assessments on the effectiveness of the nasal spray (LAIV) flu vaccine from here in the United States and elsewhere in the world.
- While in 2010, in When Studies Collide (Revisited), we looked at conflicting research on the efficacy of N95 respirators vs surgical masks, the effectiveness of Tamiflu (r) in treating influenza, and the dueling studies over whether seasonal flu shots can reduce the risk of heart attack and strokes.
A reminder that gaining scientific knowledge is a process . . . one that evolves over time and often involves detours, setbacks, and constant reevaluation. Assuming scientific certainty about anything is often the first step towards a humbling.
