Eladawy, Sara MostafaElgendy, Mohamed Abd AlsalamZaki, Mamdouh AhmedBazan, Naglaa Samir2022-12-312022-12-312022-12http://repository.msa.edu.eg/xmlui/handle/123456789/5305OBJECTIVE: To evaluate the cost-effectiveness of de novo simvastatin plus standard therapy versus standard therapy alone in patients with sepsis during a 1-year period. METHODS: A total of 145 critically ill patients were recruited in an open-label, randomized, con- trolled clinical trial. Of these, 80 patients received standard therapy according to Surviving Sepsis Campaign Guidelines 2012, and 65 received oral simvastatin plus standard therapy. The outcomes assessed include survival at the end of 1-year follow-up and intensive care unit (ICU) length of stay. Per protocol analysis was used. RESULTS: The ICU length of stay was significantly decreased in the simvastatin group (P = .001). At 1 year, 46% of patients in the simvastatin group survived compared with 35% in the standard therapy group, although this was not significant (P = .173). However, a Kaplan-Meier curve showed a significant difference that favored the standard arm (P = .01). Simvastatin was the dominant treatment option based on lower total direct costs versus the standard group. Savings related to ICU length of stay was the main determinant of the cost-saving results of simvastatin. Incremental cost-effectiveness ratio was negative and thus was not calculated. Probabilistic sensitivity and one-way sensitivity analyses were done, and results were robust to change. CONCLUSION: de novo simvastatin as an adjunct to standard therapy in ICU patients with sepsis lowered the overall cost by shortening ICU length of stay and its associated costs, but generaliza- tion to patients with different magnitudes of sepsis severity and to different ethnic groups requires further investigation.en-USadjunctive simvastatinICU costs,ICU length of stay,sepsis,statinsArticle