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💊 The trial that burst the fluoxetine bubble in stroke recovery 💊 After years of excitement about SSRIs for stroke recovery, the AFFINITY trial delivered a reality check that changed practice worldwide. Sometimes negative results are just as important as positive ones. The Backstory: The 2011 FLAME trial sparked huge excitement by showing fluoxetine improved motor recovery after stroke. This led to widespread off-label prescribing and three massive international trials to confirm the findings. What They Did: ✅ 1,280 patients from Australia (n=532), New Zealand (n=42), and Vietnam (n=706) ✅ 43 hospital stroke units across three countries ✅ Randomized within 2-15 days of acute stroke ✅ Fluoxetine 20mg daily vs placebo for 6 months ✅ Primary outcome: modified Rankin Scale at 6 months The Disappointing Results: ❌ NO improvement in functional outcome (mRS) ❌ NO benefit on any secondary efficacy measures ❌ INCREASED risks: falls, bone fractures, and seizures ❌ Mean treatment duration: 167 days with good compliance The Triple Blow: AFFINITY was one of three simultaneously published trials (alongside FOCUS and EFFECTS) that all showed the same thing: fluoxetine doesn't work for stroke recovery. Combined, these three trials included 6,956 patients - one of the largest stroke intervention datasets ever assembled. Why This Matters: These trials collectively ended the fluoxetine-for-stroke era that had lasted nearly a decade. The meta-analysis showed definitively: no functional benefit (RR 1.00, 95% CI 0.91-1.09) but real harms including increased fractures and seizures. Clinical Impact: Stopped widespread off-label fluoxetine prescribing for stroke Reinforced importance of large, diverse trial populations Showed even promising early-phase results need robust confirmation Led guidelines to recommend against routine SSRI use for stroke recovery The Lesson: Sometimes the most important trials are the ones that prove popular treatments don't work. AFFINITY saved countless stroke patients from ineffective therapy with real side effects. How did these results change your post-stroke prescribing? Do you still see colleagues using fluoxetine for stroke recovery? 🤔 👆 Follow for more practice-changing trials | Share with your stroke team | Visit NowyouknowNeuro.com for evidence-based stroke care #Neurology #Stroke #AFFINITY #Fluoxetine #SSRI #StrokeRecovery #EvidenceBasedMedicine #ClinicalTrials #NegativeTrials #StrokeRehabilitation [Links] Original Article: https://www.thelancet.com/journals/la... NowYouKnow Neuro: https://www.nowyouknowneuro.com/ Blog: https://www.nowyouknowneuro.com/safet... Subscribe: https://www.nowyouknowneuro.com/sign-... Instagram: NowyouknowNeuro