Simvastatin (cancer chemoprevention context; statin class proxy)
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| ID | DRUG-SIMVASTATIN-CHEMOPREVENTION |
|---|---|
| Тип | Препарат |
| Синоніми | SimgalSimvastatin (cancer chemoprevention)Statin (simvastatin proxy)VasilipZocorСимвастатин (хіміопрофілактика раку; представник статинів) |
| Статус | переглянуто 2026-05-18 | очікує клінічного підпису |
| Хвороби | Не вказано |
| Джерела | SRC-NCCN-BCELL-2025 SRC-WCRF-AICR-CUP-2018 |
Дані про препарат
| Клас | HMG-CoA reductase inhibitor (statin) — lipophilic, first-generation |
|---|---|
| Механізм дії | Lipophilic prodrug statin; intracellularly hydrolyzed to the active beta-hydroxy acid form, which competitively inhibits HMG-CoA reductase. Cancer-prevention rationale: shared statin pleiotropic effects (decreased isoprenoid prenylation of Ras/Rho, anti-inflammatory, antiproliferative, pro-apoptotic) plus the original 4S-secondary-CV- prevention RCT observational signal (lower colorectal-cancer incidence). RCT-level cancer-prevention evidence remains ABSENT. Higher rhabdomyolysis risk than atorvastatin/rosuvastatin at high doses; FDA dose-limit 80 mg restricted in 2011 due to myopathy signal. Primary regulatory indication is cardiovascular risk reduction. |
| Типове дозування | Cardiovascular-prevention dosing range: 5-40 mg PO once daily (evening dosing recommended due to peak nocturnal cholesterol synthesis). Typical starting dose 10-20 mg/day; titrate per LDL target. 80 mg restricted by FDA (2011) — limit to patients who have tolerated 80 mg ≥12 months without myopathy. No specific oncology-prevention dose. Hepatic monitoring (baseline LFTs); CK only if symptomatic. CrCl <30: start at 5 mg. |
| Зареєстровано в Україні | True |
| Відшкодовується НСЗУ | True |
| Остання перевірка для України | 2026-05-18 |
Нотатки
STUB — v0.2 chemoprevention-workstream authoring (batch 3); pending two- Clinical-Co-Lead signoff per CHARTER §6.1 dev-mode. STATIN CLASS-DETAIL entity (alongside DRUG-ATORVASTATIN-CHEMOPREVENTION and DRUG- ROSUVASTATIN-CHEMOPREVENTION). Primary clinical use remains cardiovascular. Cancer-incidence signals from observational meta- analyses are modest (~5-15% relative reductions in select sites) and have NOT translated to RCT-level cancer-prevention recommendations from USPSTF, NCCN, or ESMO. Engine should NOT recommend statin initiation for cancer prevention; appropriate when CV indications justify use. Heavy CYP3A4-substrate profile — substantial contraindicated-combination list — makes simvastatin a riskier choice than atorvastatin/rosuvastatin in patients on polypharmacy.
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