Introduction: Colchicine acts upstream in the cytokines cascade by inhibiting the nod-like receptor protein 3 (NLRP3) inflammasome while interleukin 6 (IL-6) receptor antagonists, such as tocilizumab, block the end result of the cytokines cascade. Hence, adding colchicine to tocilizumab with the aim of blocking the early and end products of the cytokines cascade, might reduce the risk of developing cytokine storm. Methods and analysis: We aim to conduct an open-label randomized controlled trial to evaluate the efficacy and safety of adding colchicine to tocilizumab among patients with severe COVID-19 pneumonia to reduce the rate of invasive mechanical ventilation and mortality. We will include patients with severe COVID-19 pneumonia who received tocilizumab according to our local guidelines. Enrolled patients will be then randomized in 1:1 to colchicine versus no colchicine. Patients will be followed up for 30 days. The primary outcome is the rate of invasive mechanical ventilation and will be determined using Cox proportional hazard model. Discussion: Given colchicine’s ease of use, low cost, good safety profile, and having different anti-inflammatory mechanism of action than other IL-6 blockade, colchicine might serve as a potential anti-inflammatory agent among patients with severe COVID-19 pneumonia. This study will provide valuable insights on the use of colchicine in severe COVID-19 when added to IL-6 antagonists. Ethics and dissemination: The Medical Research Center and Institutional Review Board at Hamad Medical Corporation in Qatar approved the study protocol (MRC-01-21-299). Results of the analysis will be submitted for publication in a peer-reviewed journal.
Background Statins use has been linked with increased risk of new onset diabetes and impaired glycemic control in the JUPITER trial and meta-analyses of randomized controlled trials. Nevertheless, the evidence is scarce in the real-world clinical settings, particularly among those receiving high-intensity statin post-acute coronary syndrome (ACS). Methods We conducted a retrospective observational study to determine the impact of statin use post-ACS on glycosylated hemoglobin (HbA1c) and the incidence of diabetes. The study included adults admitted with ACS between January 1, 2017 and December 31, 2018 and newly started on a high-intensity statin (rosuvastatin or atorvastatin). The outcomes assessed within 12 months of statin initiation were: (a) HbA1c before and after statin use among diabetic and non-diabetic patients; (b) incidence of diabetes. Paired sample t-test was used to compare HbA1c values pre and post statin use. Results Of the 1,253 patients included, 627 received rosuvastatin and 626 received atorvastatin following ACS. Most of the patients were Asian (77.3%), male (95.8%) with a median age of 51 years. The baseline HbA1c was 7.2±2.2% and 45% of the study population were diabetic at baseline. Among non-diabetic patients, statin use resulted in HbA1c increase from 5.7±0.7% to 6.0±0.8%, p<0.001, while among diabetic patients who were receiving treatment for diabetes, HbA1c decreased from 8.8±1.9% to 7.8±1.9%, p<0.001. New onset diabetes occurred in 41 (6%) of the non-diabetic patients, of whom 13 (1.9%) were receiving atorvastatin, while 28 (4.1%) were on rosuvastatin, p-value = 0.032. The use of both statins resulted in a significant increase of HbA1c among non-diabetic patients as demonstrated in Figure 1. Conclusion High intensity statin post-ACS was associated with increased HbA1c among non-diabetic patients. In particular, rosuvastatin significantly increased the new onset of diabetes compared to atorvastatin which might provide preference of atorvastatin use over rosuvastatin among non-diabetic patients post-acute coronary syndrome. Funding Acknowledgement Type of funding sources: None.
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