TY - JOUR
T1 - Effectiveness and Safety of Statin Therapy in Children
T2 - A Real-World Clinical Practice Experience
AU - Kavey, Rae Ellen W.
AU - Manlhiot, Cedric
AU - Runeckles, Kyle
AU - Collins, Tanveer
AU - Gidding, Samuel S.
AU - Demczko, Matthew
AU - Clauss, Sarah
AU - Harahsheh, Ashraf S.
AU - Mietus-Syder, Michele
AU - Khoury, Michael
AU - Madsen, Nicolas
AU - McCrindle, Brian W.
N1 - Publisher Copyright:
© 2020 Canadian Cardiovascular Society
PY - 2020/11
Y1 - 2020/11
N2 - Background: Statin use for hypercholesterolemia in children is predominantly reported from short-term clinical trials. In this study, we assess the efficacy and safety of statin treatment in clinical pediatric practice. Methods: Records of all patients who began statin treatment at age <18 years and remained on statins for >6 months from 5 pediatric lipid clinics were reviewed. Information at baseline and from all clinic evaluations after statin initiation was recorded, including lipid measurements, statin drug/dose, safety measures (anthropometry, hepatic enzymes, creatine kinase levels), and symptoms. Lipid changes on statin therapy were assessed from baseline to 6 ± 3 months and from 6 ± 3 months to last follow-up with a mixed-effects model, using piecewise linear splines to describe temporal changes, controlling for repeated measures, sex, and age. Results: There were 289 patients with median low-density lipoprotein cholesterol (LDL-C) of 5.3 mmol/L (interquartile range [IQR]:4.5–6.5) and mean age of 12.4 ± 2.9 years at statin initiation. Median duration of therapy was 2.7 years (IQR: 1.6–4.5) with 95% on statins at last evaluation. There were significant decreases in total cholesterol, LDL-C, and non–high-density lipoprotein cholesterol (non–HDL-C) from baseline to 6 ± 3 months (P < 0.001) and from 6 ±3 months to last follow-up (P < 0.001). Triglycerides and HDL-C were unchanged but the triglyceride to HDL-C ratio decreased significantly by late follow-up. At final evaluation, median LDL-C had decreased to 3.4 mmol/L (IQR:2.8–4.2). No patient had statins discontinued for safety measures or symptoms. Conclusions: In real-world clinical practice, intermediate-term statin treatment is effective and safe in children and adolescents with severe LDL-C elevation.
AB - Background: Statin use for hypercholesterolemia in children is predominantly reported from short-term clinical trials. In this study, we assess the efficacy and safety of statin treatment in clinical pediatric practice. Methods: Records of all patients who began statin treatment at age <18 years and remained on statins for >6 months from 5 pediatric lipid clinics were reviewed. Information at baseline and from all clinic evaluations after statin initiation was recorded, including lipid measurements, statin drug/dose, safety measures (anthropometry, hepatic enzymes, creatine kinase levels), and symptoms. Lipid changes on statin therapy were assessed from baseline to 6 ± 3 months and from 6 ± 3 months to last follow-up with a mixed-effects model, using piecewise linear splines to describe temporal changes, controlling for repeated measures, sex, and age. Results: There were 289 patients with median low-density lipoprotein cholesterol (LDL-C) of 5.3 mmol/L (interquartile range [IQR]:4.5–6.5) and mean age of 12.4 ± 2.9 years at statin initiation. Median duration of therapy was 2.7 years (IQR: 1.6–4.5) with 95% on statins at last evaluation. There were significant decreases in total cholesterol, LDL-C, and non–high-density lipoprotein cholesterol (non–HDL-C) from baseline to 6 ± 3 months (P < 0.001) and from 6 ±3 months to last follow-up (P < 0.001). Triglycerides and HDL-C were unchanged but the triglyceride to HDL-C ratio decreased significantly by late follow-up. At final evaluation, median LDL-C had decreased to 3.4 mmol/L (IQR:2.8–4.2). No patient had statins discontinued for safety measures or symptoms. Conclusions: In real-world clinical practice, intermediate-term statin treatment is effective and safe in children and adolescents with severe LDL-C elevation.
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U2 - 10.1016/j.cjco.2020.06.002
DO - 10.1016/j.cjco.2020.06.002
M3 - Article
C2 - 33305206
AN - SCOPUS:85094587776
SN - 2589-790X
VL - 2
SP - 473
EP - 482
JO - CJC Open
JF - CJC Open
IS - 6
ER -