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 (S125.5 mg/dl, S51.5%, P < 0.0001 vs baseline, and P < 0.05 vs 1 year and P < 0.05 vs 2 years) and S2.8 mg/dl (S2.3%) 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 (S117.8 mg/dl, S71.5%, P < 0.0001 vs baseline, and P < 0.05 vs 1 year) and S13.9 mg/dl (S22.8%) compared with the second year; after 4 years there was a significant reduction (S121.4 mg/dl, S73.7%, P < 0.0001 vs baseline, and P < 0.05 vs 1 year and P < 0.05 vs 2 years) and S3.6 mg/dl (S7.7%) 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 (4.9 mg/dl, 10.0%, P U 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 (S48.6 mg/dl, S32.4%, P < 0.01 vs baseline, and P < 0.05 vs 1 year) and S4.8 mg/dl (S4.5%) compared with the second year; after 4 years (S46.4 mg/dl, S31.0%, 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.

Proprotein convertase subtilisin/kexin type 9 inhibitors on the horns of a dilemma: which lipoprotein we should primarily target – low-density lipoprotein or lipoprotein(a)?

“…We have perused with interest the study of Derosa et al regarding the hypolipidemic effect of proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) in an Italian cohort of patients suffering either from hypercholesterolemia or mixed hyperlipidemia. 1 This study adds further evidence to the growing body of literature providing real-world data about the long-term lipid-lowering impact of PCSK9i prescription. In particular, the authors demonstrated that PCSK9i are well tolerated and can significantly ameliorate patients' lipidemic profile as their 4-year prescription was associated with a progressive decrease in patients' total cholesterol (TC) and lowdensity lipoprotein cholesterol (LDL-C) levels.…”

“…We have perused with interest the study of Derosa et al regarding the hypolipidemic effect of proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) in an Italian cohort of patients suffering either from hypercholesterolemia or mixed hyperlipidemia 1 . This study adds further evidence to the growing body of literature providing real-world data about the long-term lipid-lowering impact of PCSK9i prescription.…”

PCSK9 Inhibitor Use and Outcomes Using Concomitant Lipid-Lowering Therapies in the Veterans Health Administration

“…Other studies of LDL lowering and side effects involve relatively small numbers of patients (eg, <300). 7 , 8 , 9 , 10 , 16 , 20 , 28 Furthermore, we compared PCSK9-I monotherapy versus PCSK9-I combination therapy with a statin and/or ezetimibe, and we found good adherence among all treatment groups and greater LDL lowering with PCSK9-I combination therapy. These findings have implications for the optimal use of PCSK9-Is in VHA and other health care systems.…”

“…While several real-world studies have assessed the side effects and effectiveness (eg, LDL lowering, CV events) of PCSK9-Is, 7 , 8 , 9 , 10 all involved small numbers of patients. Furthermore, while there are multiple studies on the patterns of use, cost, accessibility, adherence, discontinuation, and overall place in therapy of PCSK9-Is in the treatment of hyperlipidemia, 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 these were conducted in populations outside of the VHA. VHA is the largest integrated health care system in the United States and provides access to needed medications with nominal, or no, copayment.…”