RESUMO
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 4âyears there was a significant reduction (-125.5âmg/dl, -51.5%, Pâ<â0.0001 vs baseline, and Pâ<â0.05 vs 1âyear and Pâ<â0.05 vs 2âyears) and -2.8âmg/dl (-2.3%) compared with the third year. Low-density lipoprotein-cholesterol (LDL-C) also decreased significantly until the fourth year. After 3âyears, there was a significant reduction (-117.8âmg/dl, -71.5%, Pâ<â0.0001 vs baseline, and Pâ<â0.05 vs 1âyear) and -13.9âmg/dl (-22.8%) compared with the second year; after 4âyears there was a significant reduction (-121.4âmg/dl, -73.7%, Pâ<â0.0001 vs baseline, and Pâ<â0.05 vs 1âyear and Pâ<â0.05 vs 2âyears) and -3.6âmg/dl (-7.7%) compared with the third year. High-density lipoprotein-cholesterol increased significantly only during the fourth year of detection. After 3âyears, there was a nonsignificant increase (4.9âmg/dl, 10.0%, Pâ=â0.061 vs baseline) and 1.6âmg/dl (3.1%) compared with the second year; after 4âyears, there was a significant increase (5.2âmg/dl, 10.6%, Pâ<â0.05 vs baseline) and 0.3âmg/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 3âyears, the value of Tg stabilized (-48.6âmg/dl, -32.4%, Pâ<â0.01 vs baseline, and Pâ<â0.05 vs 1âyear) and -4.8âmg/dl (-4.5%) compared with the second year; after 4âyears (-46.4âmg/dl, -31.0%, Pâ<â0.01 vs baseline, and Pâ<â0.05 vs 1âyear) there was a slight and nonsignificant increase of 2.2âmg/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.