Use of gabexate mesylate in Italian hospitals: a multicentre observational study.
BACKGROUND
Gabexate mesylate has been proposed as a therapeutic or prophylactic agent in a variety of diseases (e.g. disseminated intravascular coagulation, prophylaxis of pancreatic damage and acute pancreatitis), but its clinical effectiveness is still unclear. As the drug is widely used in Italy, we conducted an observational study to determine the pattern of prescription of gabexate in Italian hospitals and to assess the outcome of patients with acute pancreatitis when this treatment is given. An updated meta-analysis of the use of the drug is also presented.


METHODS
From 20 May to 20 July 2001, all consecutive patients admitted to 13 Italian hospitals were enrolled. The following information was recorded from each patient: indication for the use of gabexate, total dose and duration of gabexate administration, need for surgical treatment and outcome of hospitalization (alive or dead). In the patient subgroup with acute pancreatitis, the outcome data of our observational study were compared with those reported by the randomized trials (RCTs) previously published. For this purpose, the survival data of the RCTs were summarized in an updated meta-analysis.


RESULTS
A total of 170 patients were enrolled in the study. The main clinical indications were acute pancreatitis in 88 cases (52%) and prophylaxis of pancreatic damage in 62 cases (36%). At the end of the study, 80 of the 88 patients treated for acute pancreatitis (91%) were alive and eight (9%) had died. In the subgroup of patients with necrotic-haemorrhagic pancreatitis (n = 10), six died during the observation period. Our meta-analysis showed that gabexate mesylate did not improve survival in comparison with placebo. The meta-analytic odds ratio was 0.70 (95% CI: 0.45-1.09).


CONCLUSIONS
The study described the pattern of use of gabexate mesylate in Italian hospitals and provided information on the outcome of the subgroup treated for acute pancreatitis. A meta-analysis of current data from RCTs, together with our findings, indicates that gabexate mesylate does not significantly improve survival in acute pancreatitis.
Pelagotti
F
F
Laboratorio SIFO di Farmacoeconomia, U.O. Farmacia, Drug Information Center, Azienda Ospedaliera Careggi, viale Morgagni 85, 50134 Florence, Italy.
Cecchi
M
M
Messori
A
A
D000208:Acute Disease; D000368:Aged; D017723:Drug Utilization Review; D005260:Female; D016670:Gabexate / Q000627:therapeutic use*; D006801:Humans; D007297:Inpatients; D007558:Italy; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D016017:Odds Ratio; D010195:Pancreatitis / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data; D015842:Serine Proteinase Inhibitors / Q000627:therapeutic use*; D015996:Survival Rate
D015842:Serine Proteinase Inhibitors; D016670:Gabexate