BACKGROUND: In recent years, small-scale clinical trials have indicated that statins or 3-hydroxy-3-methylglutaryl coenzyme A (HMGCoA) reductase inhibitors exert pleiotropic immunomodulatory effects, with potential therapeutic implications in multiple sclerosis (MS). OBJECTIVE: To investigate whether simvastatin treatment (80 mg daily for 6 months) in patients with optic neuritis (ON) had a beneficial effect on visual outcome and on brain MRI. METHODS:Sixty-four patients with acute ON were randomized to simvastatin treatment (n = 32) or placebo (n = 32) for 6 months. None of the patients had been on immunosuppressive therapy for 6 months prior to inclusion or treated with steroids from symptom onset. Contrast sensitivity (Arden plates), visual acuity, colour perception, visual evoked potentials (VEP)--latency and amplitude, Visual Analogue Scale (VAS) score, and gadolinium enhancing and T2 lesions on brain MRI were evaluated at screening visit, day 14 (except brain MRI), day 90 and day 180. RESULTS:Simvastatin had a beneficial effect on VEP in both latency (p = 0.01) and amplitude (p = 0.01), a borderline effect on the Arden score (p = 0.06) and VAS (p = 0.04), and no effect on brain MRI or on relapse rate between the groups. CONCLUSION: This study provides Class I evidence that simvastatin 80 mg daily is well tolerated and possibly effective in patients with acute ON.
RCT Entities:
BACKGROUND: In recent years, small-scale clinical trials have indicated that statins or 3-hydroxy-3-methylglutaryl coenzyme A (HMGCoA) reductase inhibitors exert pleiotropic immunomodulatory effects, with potential therapeutic implications in multiple sclerosis (MS). OBJECTIVE: To investigate whether simvastatin treatment (80 mg daily for 6 months) in patients with optic neuritis (ON) had a beneficial effect on visual outcome and on brain MRI. METHODS: Sixty-four patients with acute ON were randomized to simvastatin treatment (n = 32) or placebo (n = 32) for 6 months. None of the patients had been on immunosuppressive therapy for 6 months prior to inclusion or treated with steroids from symptom onset. Contrast sensitivity (Arden plates), visual acuity, colour perception, visual evoked potentials (VEP)--latency and amplitude, Visual Analogue Scale (VAS) score, and gadolinium enhancing and T2 lesions on brain MRI were evaluated at screening visit, day 14 (except brain MRI), day 90 and day 180. RESULTS:Simvastatin had a beneficial effect on VEP in both latency (p = 0.01) and amplitude (p = 0.01), a borderline effect on the Arden score (p = 0.06) and VAS (p = 0.04), and no effect on brain MRI or on relapse rate between the groups. CONCLUSION: This study provides Class I evidence that simvastatin 80 mg daily is well tolerated and possibly effective in patients with acute ON.
Authors: Magí Andorrà; Salut Alba-Arbalat; Anna Camos-Carreras; Iñigo Gabilondo; Elena Fraga-Pumar; Ruben Torres-Torres; Irene Pulido-Valdeolivas; Ana I Tercero-Uribe; Ana M Guerrero-Zamora; Santiago Ortiz-Perez; Irati Zubizarreta; Nuria Sola-Valls; Sara Llufriu; Maria Sepulveda; Eugenia Martinez-Hernandez; Thais Armangue; Yolanda Blanco; Pablo Villoslada; Bernardo Sanchez-Dalmau; Albert Saiz; Elena H Martinez-Lapiscina Journal: JAMA Neurol Date: 2020-02-01 Impact factor: 18.302
Authors: Moones Heidari; Abigail B Radcliff; Gillian J McLellan; James N Ver Hoeve; Kore Chan; Julie A Kiland; Nicholas S Keuler; Benjamin K August; Dylan Sebo; Aaron S Field; Ian D Duncan Journal: Proc Natl Acad Sci U S A Date: 2019-12-16 Impact factor: 11.205
Authors: Daniel May de Oliveira; Enedina Maria Lobato de Oliveira; Merari de Fátima Ramires Ferrari; Patrícia Semedo; Meire Ioshie Hiyane; Marcos Antônio Cenedeze; Alvaro Pacheco-Silva; Niels Olsen Saraiva Câmara; Jean Pierre Schatzmann Peron Journal: Inflammopharmacology Date: 2015-11-11 Impact factor: 4.473
Authors: Laura J Balcer; Lisanne J Balk; Alexander U Brandt; Peter A Calabresi; Elena H Martinez-Lapiscina; Rachel C Nolan; Friedemann Paul; Axel Petzold; Shiv Saidha Journal: J Neuroophthalmol Date: 2018-12 Impact factor: 3.042