calcitriol + acetylsalicylic acid + calcium carbonate

A fixed-dose oral combination of calcitriol (active vitamin D3), acetylsalicylic acid (aspirin), and calcium carbonate investigated primarily for colorectal adenoma/cancer chemoprevention. Mechanistically, calcitriol activates the vitamin D receptor to regulate gene transcription affecting calcium homeostasis and potentially antiproliferative pathways; acetylsalicylic acid irreversibly inhibits cyclooxygenase-1 and -2 (COX-1/COX-2) to reduce prostaglandin synthesis and inflammation; calcium carbonate provides elemental calcium that can bind luminal bile acids/fatty acids and supports calcium balance. A large randomized, double-blind, placebo-controlled trial using 0.5 mcg calcitriol + 75 mg acetylsalicylic acid + 1250 mg calcium carbonate daily for 3 years found no reduction in colorectal adenoma recurrence versus placebo and was stopped for futility. A prior patent disclosed single-dosage-form compositions addressing stability challenges of co-formulating these chemically incompatible actives.

Other names

calcitriol + aspirin + calcium carbonate1,25-dihydroxycholecalciferol + acetylsalicylic acid + calcium carbonate