| Autor: |
Ahmed Al-Janabi, PhD, FRCOphth, Lazha Sharief, PhD, FRCOphth, Noura Al Qassimi, MD, Yi-Hsing Chen, MD, PhD, Tao Ding, PhD, Gareth Ambler, PhD, Dimitris Ladas, MD, PhD, Sue Lightman, PhD, FRCOphth, Oren Tomkins-Netzer, MD, PhD |
| Jazyk: |
angličtina |
| Rok vydání: |
2023 |
| Předmět: |
|
| Zdroj: |
Ophthalmology Science, Vol 3, Iss 4, Pp 100333- (2023) |
| Druh dokumentu: |
article |
| ISSN: |
2666-9145 |
| DOI: |
10.1016/j.xops.2023.100333 |
| Popis: |
Objective: To assess the efficacy of simvastatin 80 mg/day versus placebo in patients with noninfectious nonanterior uveitis receiving prednisolone ≥ 10 mg/day. Design: Randomized, double-masked, controlled trial. Subjects: Adult patients with noninfectious nonanterior uveitis on oral prednisolone dose of ≥ 10 mg/day. Methods: Patients were randomly assigned at a 1:1 ratio to receive either simvastatin 80 mg/day or placebo. A total of 32 patients were enrolled (16 in each arm), all of whom completed the primary end point, and 21 reached the 2-year visit (secondary end points). Main Outcome Measures: The primary end point was mean reduction in the daily prednisolone dose at 12 months follow-up. Secondary end points were mean reduction in prednisolone dose at 24 months, percent of patients with a reduction in second-line immunomodulatory agents, time to disease relapse, and adverse events. Results: Our results show that simvastatin 80 mg/day did not have a significant corticosteroid-sparing effect at 12 months (estimate: 3.62; 95% confidence interval [CI]: −8.15 to 15.38; P = 0.54). There was no significant difference between the groups with regard to prednisolone dose or change in dose at 12 and 24 months. There was no difference between the 2 groups in percent of patients with reduction in second-line agent by 24 months. Among patients who achieved disease quiescence, the median time to first relapse was longer for those receiving simvastatin (38 weeks, 95% CI: 14–54) than placebo (14 weeks, 95% CI: 12–52), although this was not statistically significant. There was no significant difference in adverse events or serious adverse events between the 2 groups. Conclusions: Simvastatin 80 mg/day did not have an effect on the dose reduction of corticosteroids or conventional immunomodulatory drugs at 1 and 2 years. The results suggest that it may extend the time to disease relapse among those who achieve disease quiescence. Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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