Proprotein convertase subtilisin/kexin type 9 inhibitors treatment in dyslipidemic patients: a real world prescription

Aim Dyslipidemia is recognized as one of the major risk factors for cardiovascular diseases. This retrospective observational study was aimed to assess the effect of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors in dyslipidemic patients with a lipid profile not well controlled by maximally tolerated statin therapy or intolerant to these lipid-lowering drugs. We enrolled 151 patients, of whom, 119 were taking evolocumab and 32 alirocumab. Results Total cholesterol significantly decreased progressively until the fourth year; after 4 years there was a significant reduction (-125.5 mg/dl, -51.5%, P< 0.0001 vs baseline, and P< 0.05 vs 1 year and P< 0.05 vs 2 years) and -2.8 mg/dl (-2.3%) compared with the third year. Lowdensity lipoprotein-cholesterol (LDL-C) also decreased significantly until the fourth year. After 3 years, there was a significant reduction (-117.8 mg/dl, -71.5%, P< 0.0001 vs baseline, and P< 0.05 vs 1 year) and -13.9 mg/dl (-22.8%) compared with the second year; after 4 years there was a significant reduction (-121.4 mg/dl, -73.7%, P< 0.0001 vs baseline, and P< 0.05 vs 1 year and P< 0.05 vs 2 years) and -3.6 mg/dl (-7.7%) compared with the third year. Highdensity lipoprotein-cholesterol increased significantly only during the fourth year of detection. After 3 years, there was a nonsignificant increase (4.9mg/dl, 10.0%, P=0.061 vs baseline) and 1.6mg/dl (3.1%) compared with the second year; after 4 years, therewas a significant increase (5.2mg/dl, 10.6%, P< 0.05 vs baseline) and 0.3mg/dl (0.6%) compared with the third year. The value of Tg was significantly reduced progressively until the second year and then stabilized in the third and fourth years. After 3 years, the value of Tg stabilized (-48.6mg/dl, -32.4%, P< 0.01 vs baseline, and P< 0.05 vs 1 year) and -4.8mg/dl (S4.5%) compared with the second year; after 4 years (-46.4mg/dl, -31.0%, P< 0.01 vs baseline, and P< 0.05 vs 1 year) there was a slight and nonsignificant increase of 2.2mg/dl (2.2%) compared with the third year. Regarding adverse events, both drugs were well tolerated. Conclusions We showed that PCSK9 inhibitors are well tolerated and provide long-term significant LDL-C lowering in individuals with hyperlipidemia.

Automated summary

This study demonstrates that PCSK9 inhibitors are well tolerated and provide long-term significant lowering of LDL-C in individuals with hyperlipidemia.