PURPOSE: Based on an internal request, GlaxoSmithKline conducted a retrospective pooled analysis of randomized controlled trials to compare suicidality in adult subjects with restless legs syndrome (RLS) who were being treated with ropinirole. The objective was to proactively evaluate the incidence of potentially suicidal thoughts or behaviors (suicidality) among patients with RLS treated with ropinirole immediate release (IR) or controlled release (CR).
METHODS: The US Food and Drug Administration approved methods previously used for the retrospective analysis of suicidality with antidepressants and anticonvulsants. Potential cases of suicidal thoughts and behavior were identified from searches of treatment-emergent adverse event preferred and verbatim terms; a review of serious adverse events; and searches of a priori-identified free text comment fields in the case report forms. Blinded case reports for these potential cases, in addition to all serious adverse events, were categorized by using the Columbia Classification Algorithm of Suicide Assessment.
FINDINGS: The dataset for this study comprised 1799 patients who received ropinirole (either formulation) and 1258 patients who received placebo. No signal for suicidality was detected for ropinirole in the treatment of patients with RLS. IMPLICATIONS: The pooled datasets in this study were not designed to prospectively assess for suicidal ideation or behavior. Any future studies in this area should include the collection of prespecified, detailed information regarding suicidality.