Characteristics of diarrhoea in 10,008 users of lansoprazole in daily practice: which co-factors contribute?

Purpose Diarrhoea is one of the most frequently reported adverse events during proton pump inhibitor use in any setting. Because of the limited available information, this study was set up with the aim of assessing the incidence and characteristics of diarrhoea and to investigate possible associated co-factors in proton pump inhibitor users in daily practice. Methods Data were used from a prospective, observational study in which 4 0 008 lansprazole users were followed over time (1994-1998). The study was designed according to the SAMM guidelines. A nested case-control design was used to compare proton pump inhibitor users reporting diarrhoea with those reporting no diarrhoea. Results The frequency of diarrhoea was 3.7% and the incidence density 10.7 per 1000 patient months of proton pump inhibitor use. The diarrhoea was most commonly loose and occurred on average 4.4 times per day. The analysis of co-factors revealed that patients with concomitant use of oral antibiotics and patients reporting neurological and/or dermatological adverse events, were at risk of developing diarrhoea during proton pomp inhibitor use. Conclusions In conclusion, diarrhoea was as frequently reported in our study as in clinical trials and observational data of lansoprazole users. We found the concomitant use of oral antibiotics and the reporting of certain other adverse events to be associated with the reporting of diarrhoea during lansoprazole use. Although a relationship with the proton pump inhibitor intake seemed very plausible, we recommend that use of concomitant medicines as a cause of diarrhoea must be taken into consideration in lansoprazole users. Copyright (C) 2002 John Wiley Sons, Ltd.