Atorvastatin (CKD Cardiovascular Risk)

Source: UK SPC (eMC) for Atorvastatin 10 mg film-coated tablets, §4.2 (https://www.medicines.org.uk/emc/product/13672/smpc). The patient should be placed on a standard cholesterol-lowering diet before receiving atorvastatin and should continue on this diet during treatment. OTHER INDICATIONS: primary hypercholesterolaemia and combined (mixed) hyperlipidaemia — the majority of patients are controlled with 10 mg once a day, with a therapeutic response evident within 2 weeks and the maximum therapeutic response usually achieved within 4 weeks, maintained during chronic therapy; heterozygous familial hypercholesterolaemia — start at 10 mg daily, individualise and adjust every 4 weeks to 40 mg daily, thereafter either increase to a maximum of 80 mg daily or combine a bile acid sequestrant with 40 mg atorvastatin once daily; homozygous familial hypercholesterolaemia — only limited data are available, the dose is 10 to 80 mg daily and atorvastatin should be used as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable. DOSE CAPS FOR CO-ADMINISTRATION (§4.2): in patients taking the hepatitis C antiviral agents elbasvir/grazoprevir, or letermovir for cytomegalovirus infection prophylaxis, the dose of atorvastatin should NOT exceed 20 mg/day; use of atorvastatin is NOT recommended in patients taking letermovir co-administered with ciclosporin. ELDERLY: efficacy and safety in patients older than 70 using recommended doses are similar to those seen in the general population; the US label adds that advanced age (65 years or over) is a risk factor for myopathy and rhabdomyolysis and that dose selection should be cautious. HEPATIC IMPAIRMENT: use with caution; contraindicated in active liver disease. PAEDIATRIC (fixed dose, not per-kg, so paedDose is null): paediatric use should only be carried out by physicians experienced in the treatment of paediatric hyperlipidaemia, with regular re-evaluation; for patients with heterozygous familial hypercholesterolaemia aged 10 years and above the recommended starting dose is 10 mg per day, which may be increased to 80 mg daily according to response and tolerability, with adjustments at intervals of 4 weeks or more. There are limited safety and efficacy data in children with HeFH between 6 and 10 years of age from open-label studies; atorvastatin is NOT indicated in the treatment of patients below the age of 10 years and no recommendation on a posology can be made for them; other pharmaceutical forms/strengths may be more appropriate for this population. Verify any under-18 use against a children's formulary. MUSCLE SAFETY (§4.4, relevant to CKD): a CK level should be measured BEFORE starting statin treatment in renal impairment, hypothyroidism, personal or familial history of hereditary muscular disorders, previous muscular toxicity with a statin or fibrate, and previous liver disease and/or substantial alcohol consumption; in the elderly (age over 70 years) the necessity of such measurement should be considered. Rhabdomyolysis is characterised by markedly elevated CK (greater than 10 times ULN), myoglobinaemia and myoglobinuria, which MAY LEAD TO RENAL FAILURE. SPARCL: a higher incidence of haemorrhagic stroke was seen in patients initiated on atorvastatin 80 mg compared with placebo in a post-hoc analysis of patients without CHD who had a recent stroke or TIA, particularly in those with prior haemorrhagic stroke or lacunar infarct. NOTE ON SOURCES: eMC §4.5 was NOT captured in this bundle — the interaction entries below come from UK §4.2/§4.3 plus §2.5 and §7 of the US label (Atorvastatin calcium, Bryant Ranch Prepack, label date 2025-08-28) and must be verified against the full SPC. §4.4, §4.8 and the US §5/§6/§7 sections were truncated at the source-fetch limit.