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Most common side effects (12mg dose, across TRIUMPH-4 and TRIUMPH-1): Nausea: 43% TRIUMPH-4 / ~38% TRIUMPH-1 (mostly during dose escalation) Diarrhea: 33% / ~28% (peaks weeks 48, improves by week 16) Dysesthesia: 20.9% (tingling sensations onset variable, long-term persistence unknown) Vomiting: 21% / ~25% (decreases after month 3) Constipation: 25% Discontinuation rates: 18.2% in TRIUMPH-4 (osteoarthritis population), 11.3% in TRIUMPH-1 (general obesity population)
Accordingly, treating DPN with oral ALA is considered a beneficial option, as it alleviates pain symptoms and addresses motor and nerve damage while demonstrating an excellent safety profile [204,205]
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