"Can simvastatin significantly reduce the amount of immunosuppressive medications required by patients with sight-threatening uveitis?" A phase IIb, single site, randomised, placebo-controlled, double-masked trial.
Purpose
Patients with uveitis are at risk of long-term complications from the inflammation as well as its treatment. Statins are used as cholesterol lowering agents and have also been shown to have an immunomodulatory effect independent of their cholesterol lowering effect.
Methods
Patients were randomly assigned at a 1:1 ratio to receive either simvastatin 80mg/day or placebo. 32 patients were enrolled (16 in each arm). The primary endpoint was mean reduction in the daily prednisolone dose on simvastatin and placebo at 12 months follow-up. Secondary endpoints were mean reduction in prednisolone dose at 24 months, percentage of patients with a reduction in second-line immunosuppressive agents, number of disease relapses and adverse events.
Results
Simvastatin 80mg/day did not have a significant corticosteroid-sparing effect at 12 months (estimate: 3.62 mg, 95% CI: -8.15 to 15.38; P = 0.54). There was no significant difference between the groups with regards to prednisolone dose or change in dose at 12 and 24 months. There was no difference between the two groups in percent of patients with reduction in second-line agent by 24 months. There was no significant difference in adverse events or serious adverse events between the two groups.
Conclusion
Simvastatin 80mg/day was not found to have an effect on the dose reduction of corticosteroids nor conventional immunosuppressive drugs at one and two-years of follow-up. The results suggest that it may extend the time to disease relapse among those that achieve disease quiescence.
Conflict of interest
No
Authors 1
Last name
AL-JANABI
Initials of first name(s)
A
Department
Moorfields Eye Hospital
City
London
Country
United Kingdom
Authors 2
Last name
Sharief
Initials of first name(s)
L
Department
Moorfields Eye Hospital
City
London
Country
United Kingdom
Authors 3
Last name
Al Qassimi
Initials of first name(s)
N
Department
Moorfields Eye Hospital
City
London
Country
United Kingdom
Authors 4
Last name
Chen1
Initials of first name(s)
Y
Department
Moorfields Eye Hospital
City
London
Country
United Kingdom
Authors 5
Last name
Ambler
Initials of first name(s)
G
Department
Department of Statistical Science, University College London
City
London
Country
United Kingdom
Authors 6
Last name
Ladas
Initials of first name(s)
D
Department
Moorfields Eye Hospital
City
London
Country
United Kingdom
Authors 7
Last name
Lightman
Initials of first name(s)
S
Department
Moorfields Eye Hospital
City
London
Country
United Kingdom
Authors 8
Last name
Tomkins-Netzer
Initials of first name(s)
O
Department
Moorfields Eye Hospital
City
London
Country
United Kingdom
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