Dataset Information

Can Simvastatin Reduce the Need for Immunomodulatory Drugs to Treat Uveitis?: A Prospective, Randomized, Placebo-Controlled Trial.

ABSTRACT:

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 disclosures

The author(s) have no proprietary or commercial interest in any materials discussed in this article.

SUBMITTER: Al-Janabi A

PROVIDER: S-EPMC10336795 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature

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Can Simvastatin Reduce the Need for Immunomodulatory Drugs to Treat Uveitis?: A Prospective, Randomized, Placebo-Controlled Trial.

Al-Janabi Ahmed A Sharief Lazha L Al Qassimi Noura N Chen Yi-Hsing YH Ding Tao T Ambler Gareth G Ladas Dimitris D Lightman Sue S Tomkins-Netzer Oren O

Ophthalmology science 20230519 4

<h4>Objective</h4>To assess the efficacy of simvastatin 80 mg/day versus placebo in patients with noninfectious nonanterior uveitis receiving prednisolone ≥ 10 mg/day.<h4>Design</h4>Randomized, double-masked, controlled trial.<h4>Subjects</h4>Adult patients with noninfectious nonanterior uveitis on oral prednisolone dose of ≥ 10 mg/day.<h4>Methods</h4>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 eac ...[more]

PMID: 37449048

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Dataset Information

Can Simvastatin Reduce the Need for Immunomodulatory Drugs to Treat Uveitis?: A Prospective, Randomized, Placebo-Controlled Trial.

Objective

Design

Subjects

Methods

Main outcome measures

Results

Conclusions

Financial disclosures

Publications

Can Simvastatin Reduce the Need for Immunomodulatory Drugs to Treat Uveitis?: A Prospective, Randomized, Placebo-Controlled Trial.

Similar Datasets

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