Background

It is unclear whether generics are as safe as brand-name drugs in cardiology. For public health surveillance purposes, we evaluated if switching from the brand-name losartan, valsartan, or candesartan impacted the occurrence of the following outcomes: emergency room (ER) consultations, hospitalizations, or death.

Study Design

This was a retrospective cohort study.

Methods

This study was conducted in the Quebec Integrated Chronic Disease Surveillance System, including healthcare administrative data of the population of Quebec, Canada. We included brand-name users of losartan, valsartan, or candesartan aged ≥ 66 years who had undergone ≥ 30 days of stable treatment on the brand-name drug prior to cohort entry (substitution time-distribution matching was used to prevent immortal time bias). Outcomes up to 1 year were compared between groups using multivariable Cox proportional hazards regression models (validity assumptions were verified).

Results

In our cohorts (losartan, n =15,783; valsartan, n =16,907; candesartan, n =26,178), mean age was 76–78 years, 59–66% were female, 90–92% had hypertension, and 13–15% had heart failure. Validity assumptions were violated for losartan only. For patients switched to generic valsartan, the hazard ratio (95% confidence interval) was 1.07 (0.99–1.14) for ER consultation, 1.26 (1.14–1.39) for hospitalization, and 1.01 (0.61–1.67) for death. The corresponding rates for candesartan were 1.00 (0.95–1.05), 0.96 (0.89–1.03), and 0.57 (0.37–0.88), respectively.

Conclusions

We observed an increased risk of hospitalizations for patients switched to generic valsartan, and a decreased risk of death for patients switched to generic candesartan, compared with those who continued taking the brand-name drug. The differences between generic and brand-name drugs may lead to some differences in public health outcomes, but this safety signal must be further studied using other cohorts and settings.

中文翻译：

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从品牌名称转换为通用血管紧张素II受体阻滞剂后，公共卫生结果可能会有所不同。

背景

目前尚不清楚仿制药在心脏病学中是否像名牌药物一样安全。为了进行公共卫生监视，我们评估了从商标名称洛沙坦，缬沙坦或坎地沙坦的转换是否会影响以下结果的发生：急诊（ER）咨询，住院或死亡。

学习规划

这是一项回顾性队列研究。

方法

这项研究是在魁北克综合慢性病监测系统中进行的，包括加拿大魁北克人口的医疗保健管理数据。我们纳入了年龄≥66岁的氯沙坦，缬沙坦或坎地沙坦的品牌用户，这些用户在进入队列之前已接受该品牌药物的≥30天稳定治疗（使用替代时间分布匹配来防止不朽的时间偏差） 。使用多变量Cox比例风险回归模型比较两组之间长达1年的结果（验证有效性假设）。

结果

在我们的队列中（洛沙坦，n  = 15783；缬沙坦，n  = 16907；坎地沙坦，n  = 26178），平均年龄为76-78岁，女性为59-66％，高血压为90-92％，以及13-15％得了心力衰竭。仅对氯沙坦违反了有效性假设。对于改用普通缬沙坦的患者，急诊咨询的风险比（95％置信区间）为1.07（0.99-1.14），住院的风险比为1.26（1.14-1.39），死亡的风险比为1.01（0.61-1.67）。坎地沙坦的相应发生率分别为1.00（0.95–1.05），0.96（0.89–1.03）和0.57（0.37–0.88）。

结论

与继续服用该名药的患者相比，我们发现转用通用缬沙坦的患者住院风险增加，而转用通用坎地沙坦的患者死亡风险降低。仿制药和名牌药品之间的差异可能会导致公共卫生结果方面的某些差异，但是必须使用其他队列和设置进一步研究此安全性信号。