Key result
Switching to generic valsartan increased the risk of hospitalization (HR 1.26), while switching to generic candesartan decreased the risk of death (HR 0.57) compared to continuing brand-name drugs.
Why the study?
It was unclear whether generic cardiovascular drugs are as safe as brand-name versions.
Does switching from brand-name to generic angiotensin II receptor blockers impact the risk of emergency room consultations, hospitalizations, or death in elderly patients?
Cohort (n=58,868)
Does switching from brand-name to generic angiotensin II receptor blockers impact the risk of emergency room consultations, hospitalizations, or death in elderly patients?
Hazard Ratio: 1.26 (95% CI 1.14–1.39)
Absolute Event Rate: 15.6% vs 11%
p-value: p=<0.0001
Switching from brand-name to generic ARBs may be associated with differences in clinical outcomes, such as increased hospitalizations with generic valsartan and decreased mortality with generic candesartan, though causality remains uncertain.
May warrant caution with generic ARB switches; leaves open differential outcome effects by agent.
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.
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Leclerc et al. (2020) conducted a cohort in Hypertension and heart failure (n=58,868). Switching to generic angiotensin II receptor blockers (valsartan or candesartan) vs. Continued use of brand-name drug was evaluated on Hospitalization (valsartan cohort) (HR 1.26, 95% CI 1.14-1.39, p=<0.0001). Switching to generic valsartan increased the risk of hospitalization (HR 1.26), while switching to generic candesartan decreased the risk of death (HR 0.57) compared to continuing brand-name drugs.
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