通用型与品牌型氟替卡松-沙美特罗治疗慢性阻塞性肺疾病的疗效和安全性比较
Comparative Effectiveness and Safety of Generic Versus Brand-Name Fluticasone-Salmeterol to Treat Chronic Obstructive Pulmonary Disease.
作者信息
Feldman William B, Kesselheim Aaron S, Avorn Jerry, Russo Massimiliano, Wang Shirley V
机构信息
Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital, and Harvard Medical School, Boston, Massachusetts (W.B.F.).
Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, and Harvard Medical School, Boston, Massachusetts (A.S.K., J.A.).
出版信息
Ann Intern Med. 2023 Aug;176(8):1047-1056. doi: 10.7326/M23-0615. Epub 2023 Aug 8.
BACKGROUND
In 2019, the U.S. Food and Drug Administration (FDA) approved the first generic maintenance inhaler for asthma and chronic obstructive pulmonary disease (COPD). The inhaler, Wixela Inhub (fluticasone-salmeterol; Viatris), is a substitutable version of the dry powder inhaler Advair Diskus (fluticasone-salmeterol; GlaxoSmithKline). When approving complex generic products like inhalers, the FDA applies a special "weight-of-evidence" approach. In this case, manufacturers were required to perform a randomized controlled trial in patients with asthma but not COPD, although the product received approval for both indications.
OBJECTIVE
To compare the effectiveness and safety of generic (Wixela Inhub) and brand-name (Advair Diskus) fluticasone-salmeterol among patients with COPD treated in routine care.
DESIGN
A 1:1 propensity score-matched cohort study.
SETTING
A large, longitudinal health care database.
PATIENTS
Adults older than 40 years with a diagnosis of COPD.
MEASUREMENTS
Incidence of first moderate or severe COPD exacerbation (effectiveness outcome) and incidence of first pneumonia hospitalization (safety outcome) in the 365 days after cohort entry.
RESULTS
Among 45 369 patients (27 305 Advair Diskus users and 18 064 Wixela Inhub users), 10 012 matched pairs were identified for the primary analysis. Compared with Advair Diskus use, Wixela Inhub use was associated with a nearly identical incidence of first moderate or severe COPD exacerbation (hazard ratio [HR], 0.97 [95% CI, 0.90 to 1.04]) and first pneumonia hospitalization (HR, 0.99 [CI, 0.86 to 1.15]).
LIMITATIONS
Follow-up times were short, reflecting real-world clinical practice. The possibility of residual confounding cannot be completely excluded.
CONCLUSION
Use of generic and brand-name fluticasone-salmeterol was associated with similar outcomes among patients with COPD treated in routine practice.
PRIMARY FUNDING SOURCE
National Heart, Lung, and Blood Institute.
背景
2019年，美国食品药品监督管理局（FDA）批准了首款用于哮喘和慢性阻塞性肺疾病（COPD）的通用型维持吸入器。这款名为Wixela Inhub（氟替卡松-沙美特罗；维特里斯公司）的吸入器，是干粉吸入器Advair Diskus（氟替卡松-沙美特罗；葛兰素史克公司）的可替代版本。在批准像吸入器这样的复杂通用产品时，FDA采用了一种特殊的“证据权重”方法。在这种情况下，制造商被要求在哮喘患者而非COPD患者中进行一项随机对照试验，尽管该产品获得了两种适应症的批准。
目的
比较通用型（Wixela Inhub）和品牌型（Advair Diskus）氟替卡松-沙美特罗在接受常规治疗的COPD患者中的有效性和安全性。
设计
一项1:1倾向评分匹配队列研究。
地点
一个大型纵向医疗保健数据库。
患者
年龄超过40岁且诊断为COPD的成年人。
测量指标
队列入组后365天内首次中度或重度COPD急性加重的发生率（有效性指标）和首次因肺炎住院的发生率（安全性指标）。
结果
在45369名患者（27305名Advair Diskus使用者和18064名Wixela Inhub使用者）中，确定了10012对匹配组用于主要分析。与使用Advair Diskus相比，使用Wixela Inhub时首次中度或重度COPD急性加重的发生率（风险比[HR]，0.97[95%CI，0.90至1.04]）和首次因肺炎住院的发生率（HR，0.99[CI，0.86至1.15]）几乎相同。
局限性
随访时间较短，反映了现实世界的临床实践。残余混杂的可能性无法完全排除。
结论
在接受常规治疗的COPD患者中，使用通用型和品牌型氟替卡松-沙美特罗的结果相似。
主要资金来源
国家心肺血液研究所。
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