Seoul National University, Seoul-t'ukpyolsi, Republic of Korea
Background: Carfilzomib is increasingly used for relapsed/refractory multiple myeloma (RRMM). However, since carfilzomib was approved though expedited review and cardiovascular adverse events were reported in randomized controlled trials (RCTs), safety study in real world is needed. The goal of this study is to analyze the cardiovascular safety of carfilzomib in Korea using a nationwide administrative claim database. Methods: To evaluate the cardiovascular safety of carfilzomib in the RRMM patients, the new users of KRd (combination therapy of carfilzomib, lenalidomide and dexamethasone) and the Rd (combination therapy of lenalidomide and dexamethasone) regimens were compared using a nationwide administrative claim database in South Korea. The study design was a propensity-matched, retrospective cohort study. The outcome variables were heart failure and hypertension. Diagnosis (Korean Standard Classification of Disease version 8) and drug prescription were used to define variables. The hazard ratio (HR) and 95% confidence interval (CI) was calculated using the Cox proportional hazards model. Results: There were 4,580 patients with RRMM who received KRd or Rd from January 1, 2018 to May 31, 2020. The risks of heart failure (HR 2.04; 95% CI 1.24–3.35) and hypertension (HR 1.58; 95% CI 1.15–2.17) were significantly higher in the KRd group compared to the Rd group. Conclusion: This study suggests that carfilzomib should be used with caution in Asian with RRMM as it significantly increases the risk of cardiovascular adverse events such as heart failure and hypertension.