A CCEPTED MANUSCRIPT
confirm if Bif195 has long-term clinical efficacy in a larger intention-to-treat population of chronic
users of ASA taking lower doses for CVD prevention.
In addition, we acknowledge that the division of the small intestine into tertiles by VCE is based on
assumptions and that tertile-specific data are an approximation.
As expected, the ASA intake was associated with robust inhibition downstream of the COX enzyme
on serum PGE2 and TXB2 concentrations. It is noteworthy that the Bif195 intervention did not alter
these well-described ASA-induced changes in metabolites downstream of COX 24,25 . This suggests
that the small-intestinal protective actions of Bif195 is unlikely to interfere with the specific
cardiovascular-protective properties of ASA. Close monitoring of adverse events during this trial
suggests that daily, oral intake of Bif195 is safe and without side-effects. Further clinical trials are
required to test whether the strain has clinical efficacy also in other settings and populations, i.e. in
chronic users of ASA.
MANUSCRIPT
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