VAPREOTIDE, A SOMATOSTATIN ANALOG, IN CRYPTOSPORIDIOSIS AND OTHER AIDS-RELATED DIARRHEAL DISEASES

Objective: To evaluate the efficacy and tolerance of vapreotide, a new somatostatin analogue, in the treatment of refractory AIDS-related diarrhoea. Design: An open, non-comparative pilot trial. Setting: The trial was conducted in 10 medical centres in France. Patients, participants: Thirty-four AIDS patients with chronic diarrhoea unresponsive to conventional antidiarrhoeal therapy were enrolled. Cryptosporidiosis was diagnosed in 21 out of 30 evaluable patients. Mean number of stools prior to therapy was 10.1 +/- 4.9 per day (range, 3-20 stools per day). Intervention: After initial baseline studies, patients received subcutaneous vapreotide at escalating doses of 400 (23 patients) or 500-mu-g (seven patients), between two and six times daily. Main outcome measures: Efficacy was assessed after 14 days of therapy, when it was found to be effective. Responders were offered the opportunity to continue receiving therapy. Results: Four patients demonstrated a complete response and 12 a partial response with > 50% reduction in daily stool emission. Fourteen patients did not respond to doses up to 2400-mu-g/day. Patients with conditions other than cryptosporidiosis had a significantly higher probability of response (P = 0.013), as did those with milder diarrhoea (< 10 stools per day). Median duration of response was 1.5 months (range, 0.5-5 months), relapse occurred in five out of eight responders despite maintenance therapy. Toxicity was minimal. Conclusions: We conclude that AIDS patients with diarrhoea not caused by Cryptosporidium may benefit from vapreotide therapy.