Department of Pharmacy, Taichung Armed Forces General Hospital, Taichung, Taiwan.
School of Pharmacy, National Defense Medical Center, Taipei, Taiwan.
BMC Psychiatry. 2024 Nov 22;24(1):844. doi: 10.1186/s12888-024-06293-y.
To date, the clinical equivalence between branded and generic medications remains debate and may sometimes be a reason why psychiatrists are hesitant to prescribe generic medications. Depression is recognized to exacerbate suicide risk globally and selective serotonin reuptake inhibitors, such as fluoxetine are common treatment options. Therefore, this study aimed to explores differences in suicidal risks between users of branded and generic fluoxetine in Taiwan.
This cohort study used Taiwan Longitudinal Health Insurance Database, encompassing 2 million individuals covered by National Health Insurance (NHI) program. The full cohort consisted of 32,298 fluoxetine new users. Then, 7,380 branded and 7,380 propensity score matched (PSM) generic fluoxetine new users were identified. The study further utilized Cox proportional hazards models to assess risk of 5-year suicidal ideation, suicide mortality, and all-cause mortality.
The study revealed that the adjusted hazard ratios (HRs) for suicidal ideation, suicide mortality and all-cause mortality in branded users were 0.766 (95% CI, 0.497 - 1.181), 0.660 (95% CI, 0.447 - 0.975), and 0.942 (95% CI, 0.849 - 1.045), respectively, when compared with matched generic fluoxetine users. Stratified and sensitivity analyses showed the lower risk of suicide mortality in specific subgroups, such as male (adjusted HRs = 0.536, 95% CI = 0.306-0.939) and young branded users (adjusted HRs = 0.549, 95% CI = 0.334-0.904).
This study observed trends in the prevention effects of suicide-related risks. However, only suicide mortality was statistically significant, especially in males and those aged < 40 years. These insights may assist clinicians and policymakers in decision-making.
NA (This study is a cohort study utilizing the national health insurance database, not a clinical trial).
迄今为止，品牌药和仿制药在临床疗效上是否具有等效性仍存在争议，这可能也是精神科医生不愿开仿制药的原因之一。抑郁症被认为会在全球范围内增加自杀风险，而选择性 5-羟色胺再摄取抑制剂（SSRIs），如氟西汀，是常见的治疗选择。因此，本研究旨在探讨在台湾，使用品牌氟西汀和仿制药氟西汀的患者自杀风险是否存在差异。
本队列研究使用了台湾全民健康保险数据库，涵盖了参加国民健康保险计划的 200 万人。全队列包括 32298 名氟西汀新使用者。然后，确定了 7380 名品牌氟西汀和 7380 名倾向评分匹配（PSM）仿制药氟西汀新使用者。研究进一步利用 Cox 比例风险模型评估了 5 年自杀意念、自杀死亡率和全因死亡率的风险。
研究结果表明，与匹配的仿制药氟西汀使用者相比，品牌氟西汀使用者的自杀意念、自杀死亡率和全因死亡率的调整后危险比（HR）分别为 0.766（95%CI，0.497-1.181）、0.660（95%CI，0.447-0.975）和 0.942（95%CI，0.849-1.045）。分层和敏感性分析显示，在特定亚组中，如男性（调整 HRs=0.536，95%CI=0.306-0.939）和年轻的品牌氟西汀使用者（调整 HRs=0.549，95%CI=0.334-0.904），自杀死亡率的风险较低。
本研究观察到与自杀相关风险预防效果的趋势。然而，只有自杀死亡率具有统计学意义，尤其是在男性和年龄<40 岁的患者中。这些发现可能有助于临床医生和决策者做出决策。
