Background: Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) alirocumab (Sanofi and Regeneron) and evolocumab (Amgen) were approved by the FDA in the summer of 2015 for use in patients on maximally tolerated statins with clinical atherosclerotic cardiovascular disease (ASCVD) and heterozygous familial hypercholesterolemia (HeFH) who require additional lowering of low-density lipoprotein cholesterol (LDL-C). Both clinical trial programs were skewed towards male participants so little is known about the characteristics of female patients treated with PCSK9i in real-world settings.
Objective: To understand the demographic and clinical differences between male and female patients prescribed a PCSK9i in real-world settings.
Methods: All patients 18 years of age and older with evidence of a PCSK9i prescription (Rx) between July 27, 2015 and November 1, 2016 were included from Accenture’s “Predictive Health Intelligence Environment”, a database consisting of electronic medical records (EMR) from 26 integrated delivery networks in the US. Patients were also required to have at least one encounter in the EMR in the 24-month period prior to the first PCSK9i Rx. Demographic and clinical characteristics of these patients were evaluated as well as the Rx history prior to the first PCSK9i Rx.
Results: The inclusion criteria were met by 1,754 patients with 906 (51.7%) being female. Mean (SD) age was 65.9 (10.4) for females compared to 64.3 (10.3) for males; however, a higher proportion of females (59.6%) were over age 65 as compared to males (51.5%, difference not significant). Females were statistically less likely to have a prior event for ASCVD (54% vs. 73%, p<0.0001). Additionally, females were significantly more likely to have a BMI < 25 kg/m2 compared to males (19.1% v. 11.0%, p<0.001). No differences were observed in prescribing specialty, prior lipid modifying treatment or history of smoking. Finally, females had a significantly higher mean baseline LDL-C as compared to males (149.4 mg/dL [58.2] v. 123.9 mg/dL [56.6], p<0.001).
Conclusions: Despite the clinical trial programs of both PCSK9i’s being skewed toward male participants, this real-world data consisted of nearly equal numbers of males and females. In this study, females were more likely to be identified as FH, as indicated by their significantly higher levels of LDL-C, despite similarities in prior treatment regimens as compared to males. Further research is warranted to understand diagnosis and treatment patterns in women as compared to men as well as how their cardiovascular health can be improved.