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 10,008 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 patients 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.
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 10,008 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 patients 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.