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Pharmacokinetics of oral cyanocobalamin formulated with sodium N-[8-(2-hydroxybenzoyl)amino]caprylate (SNAC): an open-label, randomized, single-dose, parallel-group study in healthy male subjects
Discontinuation is a valid choice when symptoms exceed the benefit
doi: 10.1080/01635581.2019.1679194 76 HaoRYuPGuiLWangNPanDWangS
mechanism unexplained Relative contributions of direct peptide effects versus downstream IGF-1 actions inadequately characterized Long-term receptor sensitivity and potential for desensitization inadequately studied Individual patient variability in response not well-characterized Potential for differential effects based on endogenous growth hormone status unclear Long-Term Safety Considerations Critical safety questions remain unanswered regarding chronic peptide administration: Cardiovascular safety concerns FDA warnings cite risks of increased heart rate, systemic vasodilation, flushing, and transient hypotension Immunogenicity risks FDA identifies both peptides as potentially immunogenic with risk of serious immune reactions including anaphylaxis Cancer risk theoretical concern that chronic growth hormone/IGF-1 elevation could promote cellular proliferation
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