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The effect of ddI buffer on bowel function in normal volunteers.
Valentine C; McPhillips P; MRC HIV Clinical Trials Centre, London, UK.
December 30, 1995
Natl Conf Hum Retroviruses Relat Infect (1st). 1993 Dec 12-16;:135.

Introduction: didanosine (ddI) is acid labile and therefore it must be administered with a buffering agent to prevent degradation by stomach acidity. Two preparations of ddI are available: one with a citrate phosphate buffer (CPB), the other dihydroxyaluminum sodium carbonate, magnesium hydroxide and sodium citrate dihydrate to form a chewable/dispersible tablet. Both in Phase I/II trials and in large comparative clinical trials diarrhoea was a frequently reported side effect associated with use of ddI. This side effect did not appear to be dose related. We undertook this study to determine the effects of CPB on frequency and consistency of bowel action. Methodology: Ten healthy volunteers were recruited. They kept a diary documenting bowel action over a one-week period. After one week the volunteers took CPB twice daily for a further week. They recorded frequency and consistency in bowel actions in the diary. Results: (Table: see text). Conclusion: There was not a consistent effect of CPB on frequency of bowel action but volunteers consistently reported a subjective change in stool texture. This may be particularly disconcerting to many patients. It seems likely that CPB by itself causes this and contributes to the diarrhoea frequently reported by patients treated with ddI.

Antiviral Agents/PHARMACOKINETICS/*THERAPEUTIC USE Didanosine/*THERAPEUTIC USE Drug Interactions Drug Therapy, Combination Female Human HIV Infections/*DRUG THERAPY Male ABSTRACT