Sex differences in efficacy and side effects of proprotein convertase subtilisin / kexin 9 (PCSK9) inhibitors in real world data

Abstract

Background and Aims : Proprotein convertase subtilisin/Kexin 9 (PCSK9) effectively reduce low-density lipoprotein (LDLC) and have a favorable safety profile. Previously FOURIER data showed that LDLC reduction was lower in women compared to men. The aim of this study was to assess efficacy and safety in women and men who use PCSK9 inhibitors in real-world setting.Methods: In this prospective registry of all consecutive patients started with a PCSK9 inhibitor at a lipid clinic of a university hospital. We collected clinical information, including baseline and follow-up mean LDLC levels at 6 months after initiation of PCSK9 inhibitor treatment. Side effects, injection site reactions and drug discontinuation were recorded.Results: We analyzed 335 patients (154 women), mean age of 58±11 years. Women were older (60 vs 57 yrs P=0.03) and had less often cardiovascular events (58% vs 71% P<0.01). Women had higher baseline LDLC levels compared to men (4.8 vs 4.1 mmol/L, P<0.001) and higher on-treatment LDLC levels after 6 months (2.2 vs 1.6 mmol/L, P<0.001). LDLC reduction was 58%±19%. Women had lower LDLC reduction compared to men (53% vs 61% P<0.001). Women more often reported side effects than men (55% vs 45% P=0.03, while injection site reactions ( 10% vs 6%, P=NS) and drug discontinuation (6%vs 8%, P=NS) were similar.Conclusions: In line with the FOURIER study, we found that women had lower LDL-C reduction compared to men after initiation of PCSK9 inhibition. Moreover women reported more side effects. Future research is needed to assess reasons for these sex differences. Background and Aims : Proprotein convertase subtilisin/Kexin 9 (PCSK9) effectively reduce low-density lipoprotein (LDLC) and have a favorable safety profile. Previously FOURIER data showed that LDLC reduction was lower in women compared to men. The aim of this study was to assess efficacy and safety in women and men who use PCSK9 inhibitors in real-world setting. Methods: In this prospective registry of all consecutive patients started with a PCSK9 inhibitor at a lipid clinic of a university hospital. We collected clinical information, including baseline and follow-up mean LDLC levels at 6 months after initiation of PCSK9 inhibitor treatment. Side effects, injection site reactions and drug discontinuation were recorded. Results: We analyzed 335 patients (154 women), mean age of 58±11 years. Women were older (60 vs 57 yrs P=0.03) and had less often cardiovascular events (58% vs 71% P<0.01). Women had higher baseline LDLC levels compared to men (4.8 vs 4.1 mmol/L, P<0.001) and higher on-treatment LDLC levels after 6 months (2.2 vs 1.6 mmol/L, P<0.001). LDLC reduction was 58%±19%. Women had lower LDLC reduction compared to men (53% vs 61% P<0.001). Women more often reported side effects than men (55% vs 45% P=0.03, while injection site reactions ( 10% vs 6%, P=NS) and drug discontinuation (6%vs 8%, P=NS) were similar. Conclusions: In line with the FOURIER study, we found that women had lower LDL-C reduction compared to men after initiation of PCSK9 inhibition. Moreover women reported more side effects. Future research is needed to assess reasons for these sex differences.