Adjunctive Atorvastatin for Sepsis in the Acute Medical Unit: A Randomized Controlled Trial

Adjunctive Atorvastatin for Sepsis in the Acute Medical Unit: A Randomized Controlled Trial

Background: Sepsis, a devastating syndrome of organ dysfunction triggered by a dysregulated host response to infection, remains a leading cause of global mortality. Statins, renowned for lipid-lowering, also exhibit potent anti-inflammatory and endothelial-stabilizing properties, offering a theoretical advantage in the septic milieu. This study investigated whether adjunctive atorvastatin could improve survival and modulate key sepsis-related outcomes.
Methods: In this open-label, randomized controlled trial conducted in the acute medical unit of a tertiary academic center, adult patients with sepsis(defined as suspected infection plus a SOFA score increment of ≥2) were allocated to receive either standard sepsis management plus daily oral atorvastatin 20mg or standard management alone for up to 28 days. The primary endpoint was 28-day all-cause mortality. Secondary endpoints included requirements for organ support, duration of hospitalization, and kinetic changes in C-reactive protein(CRP), procalcitonin(PCT), and lactate. Analysis adhered to intention-to-treat principles.
Results: Sixty-eight patients were randomized(36 atorvastatin, 32 control). While 28-day mortality trended lower in the atorvastatin arm(36% vs. 56% in controls; Risk Difference -20%, 95% CI -45% to 5%), this difference did not achieve statistical significance(p=0.10). Similarly, no significant benefits were observed in organ support needs or hospital stay. Critically, atorvastatin administration led to a significant and more pronounced reduction in both procalcitonin(median change -8 vs 0 ng/ml, p=0.005) and lactate levels(median change -0.95 vs -0.62 mmol/l, p=0.048) by day 7.
Conclusion: While adjunctive atorvastatin did not demonstrably reduce 28-day mortality in this sepsis cohort, its significant impact on attenuating procalcitonin and lactate levels suggests a beneficial modulation of underlying inflammatory and metabolic derangements.

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Adjunctive Atorvastatin for Sepsis in the Acute Medical Unit: A Randomized Controlled Trial

11th October 2025
PMID: 41104567
Authors Affiliations
Ch Adrees Rashid MBBS, Junior Resident, Division of Acute Care and Emergency Medicine, Department of Internal Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, India
Mohan Kumar H MD, Associate Professor, Division of Acute Care and Emergency Medicine, Department of Internal Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, India
Mandip Singh Bhatia MD, Associate Professor, Division of Acute Care and Emergency Medicine, Department of Internal Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, India
Atul Saroch MD, Additional Professor, Division of Acute Care and Emergency Medicine, Department of Internal Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, India
Navneet Sharma MD, Professor, Division of Acute Care and Emergency Medicine, Department of Internal Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, India
Saurabh Chandrabhan Sharda MD, Associate Professor, Division of Acute Care and Emergency Medicine, Department of Internal Medicine, Post Graduate Institute of Medical Education and Research, Chandigarh, India

Adjunctive Atorvastatin for Sepsis in the Acute Medical Unit: A Randomized Controlled Trial

Cite this article as:

Rashid CA, Kumar H M, Bhatia MS, Saroch A, Sharma N, Sharda SC. Adjunctive Atorvastatin for Sepsis in the Acute Medical Unit: A Randomized Controlled Trial. Acute Med. 2025;24(1):27-34. doi: 10.52964/AMJA.1004. PMID: 41104567.

Adjunctive Atorvastatin for Sepsis in the Acute Medical Unit: A Randomized Controlled Trial

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