Effect of atorvastatin on dyslipidemia and carotid intima-media thickness in children with refractory nephrotic syndrome: a randomized controlled trial

Abstract

Atorvastatin, administered at a fixed daily dose of 10 mg, was not beneficial in lowering lipid levels in children with SRNS; rise in serum albumin was associated with improvement in dyslipidemia.

Safety of Prescribing Statins in Childhood Dyslipidemia

“…This can be translated into less than expected efficacy, and thus lower CVD risk reduction that imposes a need for treatment change. 22,25 On the other hand, in a study with rosuvastatin, efficiency was equal for children above or below 10 years old with atorvastatin, 4 and it was similar regardless of age/ezetimibe use/apheresis. 3 In a simvastatin study, 21 simvastatin was given for children with mild typical Smith-Lemli-Opitz syndrome (SLOS; autosomal recessive multiple cognitive impairment syndrome characterized by accumulation of a cholesterol precursor due to gene mutation(s) of a related enzyme) concurrently with dietary cholesterol supplementation, and was found to be effective even in decreasing cerebrospinal fluid, levels of cholesterol (simvastatin is lipophilic and can enter blood-brain barrier), and children irritability (symptom of SLOS).…”

“…In all trials studying efficacy and/or safety, children enrolled were generally 8 years old and above, except for some studies that lowered the age range to reach 4 year olds for simvastatin, 21 5 years old for atorvastatin, 22 and 6 year olds for rosuvastatin, 3 atorvastatin, 4 and pitavastatin. 23 All of these studies had not reported any safety issues or discontinuations, and if present, they were not related to any adverse side effect encountered.…”

“…No side effects were witnessed in the rosuvastatin trial, 3 except for low bicarbonate levels at a single visit. In a study using atorvastatin, 22 the most reported side effects in both groups were respiratory infections, acute gastroenteritis, and pyoderma, whereas knee pain, abdominal pain, and headaches were all seen in the atorvastatin group, besides a normalized creatine kinase (CK) level after a slight increase. Also, dosages as high as 20 mg atorvastatin/day for children older than 10 years were clearly safe.…”

“…For example, the mean number of enrolled children was 20 in studies testing for rosuvastatin, 3 pitavastatin, 25 simvastatin, 21 and atorvastatin. 22 In a study initiated with pravastatin, 17 a limitation in the form of a small sample size was stated even though the study included 214 children. This is mainly because compared with the FDA report of fatal rhabdomyolysis of (0.15/1 million) risk ratio, encountering the latter condition in a sample of 214 children is nearly negligible.…”

“…And due to the small sample size, it was inapplicable to stratify patients on different molecules with different potencies and dosages in an attempt to test if this can alter gonads functions. In an atorvastatin study, 22 the susceptibility of type two errors was high owing to its low power (68%). In addition, they claimed that treatment effects may be altered because of diet and angiotensin-converting enzyme inhibitor variables.…”