Can Simvastatin Reduce the Need for Immunomodulatory Drugs to Treat Uveitis?
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 d...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2023-12-01
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| Series: | Ophthalmology Science |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2666914523000659 |
| _version_ | 1797377755749285888 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Ahmed Al-Janabi, PhD, FRCOphth |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-08T19:58:05Z |
| format | Article |
| id | doaj.art-5c1b15bcfe6144bda981646bdef80dd0 |
| institution | Directory Open Access Journal |
| issn | 2666-9145 |
| language | English |
| last_indexed | 2024-03-08T19:58:05Z |
| publishDate | 2023-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Ophthalmology Science |
| spelling | doaj.art-5c1b15bcfe6144bda981646bdef80dd02023-12-24T04:47:05ZengElsevierOphthalmology Science2666-91452023-12-0134100333Can Simvastatin Reduce the Need for Immunomodulatory Drugs to Treat Uveitis?Ahmed Al-Janabi, PhD, FRCOphth0Lazha Sharief, PhD, FRCOphth1Noura Al Qassimi, MD2Yi-Hsing Chen, MD, PhD3Tao Ding, PhD4Gareth Ambler, PhD5Dimitris Ladas, MD, PhD6Sue Lightman, PhD, FRCOphth7Oren Tomkins-Netzer, MD, PhD8Moorfields Eye Hospital, UCL/Institute of Ophthalmology, London, UKMoorfields Eye Hospital, UCL/Institute of Ophthalmology, London, UKMoorfields Eye Hospital, UCL/Institute of Ophthalmology, London, UKMoorfields Eye Hospital, UCL/Institute of Ophthalmology, London, UKDepartment of Statistical Science, University College London, London, UKDepartment of Statistical Science, University College London, London, UKMoorfields Eye Hospital, UCL/Institute of Ophthalmology, London, UKMoorfields Eye Hospital, UCL/Institute of Ophthalmology, London, UKMoorfields Eye Hospital, UCL/Institute of Ophthalmology, London, UK; Department of Ophthalmology, Carmel Medical Center, Technion, Haifa, Israel; Correspondence: Oren Tomkins-Netzer, MD, PhD, Department of Ophthalmology, Lady Davis Carmel Medical Center, Technion, 7 Michal Street, Haifa, Israel.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.http://www.sciencedirect.com/science/article/pii/S2666914523000659CorticosteroidsImmunomodulatory drugsPrednisoloneNoninfectious uveitisSimvastatin |
| spellingShingle | 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 Can Simvastatin Reduce the Need for Immunomodulatory Drugs to Treat Uveitis? Ophthalmology Science Corticosteroids Immunomodulatory drugs Prednisolone Noninfectious uveitis Simvastatin |
| title | Can Simvastatin Reduce the Need for Immunomodulatory Drugs to Treat Uveitis? |
| title_full | Can Simvastatin Reduce the Need for Immunomodulatory Drugs to Treat Uveitis? |
| title_fullStr | Can Simvastatin Reduce the Need for Immunomodulatory Drugs to Treat Uveitis? |
| title_full_unstemmed | Can Simvastatin Reduce the Need for Immunomodulatory Drugs to Treat Uveitis? |
| title_short | Can Simvastatin Reduce the Need for Immunomodulatory Drugs to Treat Uveitis? |
| title_sort | can simvastatin reduce the need for immunomodulatory drugs to treat uveitis |
| topic | Corticosteroids Immunomodulatory drugs Prednisolone Noninfectious uveitis Simvastatin |
| url | http://www.sciencedirect.com/science/article/pii/S2666914523000659 |
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