Safety and Efficacy of Moderate vs High Intensity Statin Therapy After Nontraumatic Intracerebral Hemorrhage: A Real-World Evidence Analysis.

Abstract

Background and purpose: The optimal intensity of statin therapy after nontraumatic intracerebral hemorrhage (ICH) remains controversial. This study aimed to compare safety and efficacy outcomes between moderate- and high-intensity statin therapy in post-ICH patients using real-world data to inform secondary prevention strategies.

Methods: In this retrospective analysis of the TriNetX Global Collaborative Network database (a federated electronic health records platform) patients with nontraumatic ICH who initiated statin therapy ≥7 days post-ICH were identified. Moderate-intensity statin therapy was defined as atorvastatin 10-20 mg, simvastatin 20-40 mg, rosuvastatin 5-10 mg, pravastatin 40-80 mg, lovastatin 40 mg, fluvastatin 40-80 mg, or pitavastatin 2-4 mg. High-intensity therapy included atorvastatin 40-80 mg or rosuvastatin 20-40 mg. Primary outcomes included recurrent ICH, ischemic stroke, composite vascular events, and all-cause mortality. Safety outcomes included rhabdomyolysis and hepatic injury.

Results: After matching, 8,925 patient pairs were well balanced on baseline demographics and comorbidities. Mean follow-up was 283 days (median 365 days) in both groups.Compared with high-intensity statins, moderate-intensity therapy was associated with lower risks of recurrent ICH (23.4% vs 24.9%; hazard ratio [HR], 0.91; 95% confidence interval [CI], 0.86-0.97; p=0.002), ischemic stroke (7.1% vs 10.2%; HR, 0.68; 95% CI, 0.59-0.78; p<0.001), composite vascular events (15.1% vs 19.5%; HR, 0.74; 95% CI, 0.66-0.82; p<0.001), and all-cause mortality (9.0% vs 10.2%; HR, 0.87; 95% CI, 0.79-0.96; p=0.004). Rates of rhabdomyolysis (0.3% vs 0.4%) and hepatic injury (0.5% vs 0.4%) were low and not significantly different between groups.

Conclusions: In this large, real-world analysis, moderate-intensity statins demonstrated statistically significant but modest reductions in recurrent ICH, ischemic stroke, composite vascular events, and all-cause mortality compared with high-intensity statins, without increased adverse events. These findings may support preferential use of moderate-intensity statin therapy in selected post-ICH patients pending confirmation from randomized trials. While these observational findings suggest potential benefits of moderate-intensity statin therapy in selected post-ICH patients, confirmation from randomized controlled trials is needed before definitive clinical recommendations can be made.