Effect of Simvastatin Treatment on Vaso-occlusive Pain in Sickle Cell Disease

Phase 1/2 Completed 24 enrolled UCSF Benioff Children's Hospital Oakland University of California, Los Angeles · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine whether simvastatin is effective in reducing the frequency and intensity of vaso-occlusive pain episodes in patients with sickle cell disease.

Timeline

Start: 2012-02
Primary completion: 2015-05
Completion: 2015-06

Outcome

Met primary endpoint

registry analysis (superiority or other test); Baseline vs Simvastatin; p = 0.005; Wilcoxon (Mann-Whitney); note: Wilcoxon matched pairs signed rank test NCT01702246 ↗

Publications

Background Hoppe C, Kuypers F, Larkin S, Hagar W, Vichinsky E, Styles L. A pilot study of the short-term use of simvastatin in sickle cell disease: effects on markers of vascular dysfunction. Br J Haematol. 2011 Jun;153(5):655-63. doi: 10.1111/j.1365-2141.2010.08480.x. Epub 2011 Apr 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Simvastatin	Small molecule	40 mg	Oral