Sulindac (FAP duodenal/rectal polyposis chemoprevention — off-label)
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| ID | DRUG-SULINDAC-CHEMOPREVENTION |
|---|---|
| Тип | Препарат |
| Синоніми | ClinorilSulindac (FAP polyposis chemoprevention)Sulindac chemopreventionСулиндак (хіміопрофілактика поліпозу при FAP — off-label) |
| Статус | переглянуто 2026-05-18 | очікує клінічного підпису |
| Хвороби | Не вказано |
| Джерела | SRC-BISGAARD-FAP-2006 SRC-NCCN-GENETIC-FAMILIAL-CRC-2025 SRC-PACES-EFLORNITHINE-SULINDAC-2008 |
Дані про препарат
| Клас | Non-selective cyclooxygenase (COX-1/COX-2) inhibitor — prodrug NSAID (arylalkanoic acid) |
|---|---|
| Механізм дії | Sulfoxide prodrug reduced by gut microbiota and hepatic enzymes to active sulindac sulfide, which non-selectively inhibits COX-1 and COX-2, suppressing prostaglandin (especially PGE2) synthesis. Cancer- prevention rationale: COX-2 is upregulated in FAP adenomas; sulindac reduces polyp number and size in FAP (Giardiello NEJM 1993 RCT — 150 mg BID for 9 months, ~56% reduction in polyp number, ~65% in size; pooled trials in retained rectum post-colectomy show similar effect). PACES RCT (Meyskens 2008) combined eflornithine + sulindac reduced sporadic colorectal adenoma recurrence by ~70%. NOT FDA- labeled for chemoprevention; used off-label per NCCN Genetic Familial Colorectal 2025 in selected FAP patients (e.g., retained rectum, duodenal disease) under specialist hereditary-CRC team supervision. |
| Типове дозування | FAP duodenal / retained-rectum polyposis chemoprevention (off-label, NCCN Genetic Familial CRC 2025): 150 mg PO BID (= 300 mg/day) ongoing, with food. Some specialist regimens go to 200 mg BID short-term during active polyp regression phase. Used as ADJUNCT to surveillance endoscopy and polypectomy — does not replace surveillance. Renal function and GI symptom monitoring at 1 month, 3 months, then every 6 months. Hold for elective surgery 1 week prior. Withhold or switch agent if CrCl <30 mL/min, peptic ulcer, GI bleed, severe HF, hyperkalemia. |
| Зареєстровано в Україні | False |
| Відшкодовується НСЗУ | False |
| Остання перевірка для України | 2026-05-18 |
Застереження
- Cardiovascular thrombotic events (MI, stroke) — NSAID class effect; contraindicated in CABG perioperative period
- GI bleeding, ulceration, perforation — can occur without warning, especially in elderly
Нотатки
STUB — v0.2 chemoprevention-workstream authoring (batch 2); pending two-Clinical-Co-Lead signoff per CHARTER §6.1 dev-mode. OFF-LABEL FAP CHEMOPREVENTION. Primary supporting trial: Giardiello NEJM 1993 (sulindac 150 mg BID × 9 months → ~56% polyp-number reduction in FAP); subsequent retained-rectum and duodenal studies confirm effect. PACES (Meyskens NEJM 2008) — DFMO (eflornithine) + sulindac combination reduced sporadic adenoma recurrence ~70%. NCCN Genetic Familial Colorectal 2025: sulindac retained as off-label adjunct option in selected FAP patients (retained rectum after IRA, duodenal disease) under specialist hereditary-CRC team. Engine should NOT auto-recommend; reserved for specialist hereditary-cancer center decision-making. SAFETY CONCERNS distinguishing sulindac from other NSAIDs: (a) higher rate of pancreatitis, (b) higher rate of hepatotoxicity, (c) reported SJS/TEN cluster (Stevens-Johnson), (d) lithium interaction. Ukraine availability is limited — confirm registration status before prescribing or substitute with another NSAID under specialist guidance. Primary RCT (Giardiello NEJM 1993) not yet ingested as standalone SRC-*; cited sources cover the NCCN guideline +...
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