Assessment of alpelisib-induced hyperglycemia in a real-world setting: A nationwide claims data analysis

Abstract

Introduction

Alpelisib exhibits variability in length of drug exposure and clinical safety outside of clinical trials. This study aimed to bridge the gap between clinical trial outcomes and real-world evidence by quantifying the Time on Therapy (TOT) and examining the type and duration of antidiabetic agents used to manage alpelisib-induced hyperglycemia.

Methods

This is a retrospective longitudinal study utilizing nationwide claims data to analyze the treatment patterns of adults with breast cancer treated with alpelisib. Generalized estimating equation and Cox proportional hazards modeling were used to assess the impact of demographic and clinical characteristics on having an antidiabetic agent(s) and TOT of alpelisib, respectively.

Results

In 546 participants treated with alpelisib, the median TOT was 87.5 days (IQR, 28.0–173.7) and the median of Proportion of Days Covered (PDC) was 97.62% (IQR, 87.7–100.0). Antidiabetic agent(s) usage increased from 20.0% to 34.3% pre- and post-alpelisib initiation, respectively. Among those who started antidiabetic agents after alpelisib, 81.8% were prescribed metformin and 44% insulin. Initiation of alpelisib therapy was associated with higher antidiabetic agent(s) usage (OR = 2.19, 95% CI, 1.61–2.97, p < 0.001). The use of antidiabetic agent(s) after starting alpelisib was associated with a longer TOT (HR = 0.76, 95% CI, 0.61–0.93, p = 0.008) compared to those who did not receive antidiabetic agent(s).

Conclusion

The study shows that individuals who started antidiabetic agents after initiating alpelisib had longer TOT. This necessitates the need for close monitoring and proactive hyperglycemia management to improve adherence and clinical outcomes for individuals taking alpelisib.