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

Abstract

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. Low-density 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. High-density lipoprotein-cholesterol increased significantly only during the fourth year of detection. After 3 years, there was a nonsignificant increase (4.9 mg/dl, 10.0%, P = 0.061 vs baseline) and 1.6 mg/dl (3.1%) compared with the second year; after 4 years, there was a significant increase (5.2 mg/dl, 10.6%, P < 0.05 vs baseline) and 0.3 mg/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 (-48.6 mg/dl, -32.4%, P < 0.01 vs baseline, and P < 0.05 vs 1 year) and -4.8 mg/dl (-4.5%) compared with the second year; after 4 years (-46.4 mg/dl, -31.0%, P < 0.01 vs baseline, and P < 0.05 vs 1 year) there was a slight and nonsignificant increase of 2.2 mg/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.

• Authors: Giuseppe Derosa, Pamela Maffioli, Angela D'Angelo, Andrea Girola, Emanuela Colombo, Anna Maria Fiorenza, José J Ceballos Macias, Carolina L Sanchez, Riccardo Raddino, Gian Franco Pasini, Marco Triggiani, Andrea M Maresca, Nicolò Tandurella, Luigina Guasti
• Journal: Journal of cardiovascular medicine (Hagerstown, Md.) (J Cardiovasc Med (Hagerstown)) Vol. 23 Issue 2 Pg. 91-97 (02 01 2022) ISSN: 1558-2035 [Electronic] United States
• PMID: 34690259 (Publication Type: Journal Article, Multicenter Study, Observational Study)
• Copyright: Copyright © 2021 Italian Federation of Cardiology - I.F.C. All rights reserved.

Chemical References

• Antibodies, Monoclonal, Humanized
• Cholesterol, HDL
• Cholesterol, LDL
• PCSK9 Inhibitors
• Cholesterol
• evolocumab
• alirocumab

Topics

• Antibodies, Monoclonal, Humanized (therapeutic use)
• Cholesterol (blood)
• Cholesterol, HDL (blood)
• Cholesterol, LDL (blood)
• Dyslipidemias (blood, drug therapy)
• Female
• Humans
• Male
• Middle Aged
• PCSK9 Inhibitors (therapeutic use)
• Retrospective Studies