Lexipafant and acute pancreatitis: a critical appraisal of the clinical trials.
The recent clinical trials of lexipafant in the treatment of acute pancreatitis were undertaken with considerable optimism. It was expected that this single agent anticytokine would reduce the morbidity and mortality of this disease. Published clinical trials of lexipafant (BB-882) in acute pancreatitis were retrieved by MEDLINE, EM Base, and Science Citation Index. The critical appraisal included the question asked, design of the study, group and selection of patients, results, and statistical analysis. The historical sequence of the trials and the impact of commerce on their performance were highlighted. Lexipafant did not reduce mortality in severe acute pancreatitis. Comparison between the trials is difficult because of changes in study groups and dose. The clinical trials were designed without the benefit of open discussion of the preliminary pharmacological studies. The results of the trials have not been communicated in an open, timely, and systematic manner, probably because of commercial constraints.
Abu-Zidan
Fikri M
FM
Department of Surgery, Faculty of Medicine and Health Sciences, United Arab Emirates University, Ain-Ain. fabuzidan@hotmail.com
Windsor
John A
JA
D000208:Acute Disease; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000191:economics / Q000592:standards*; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use*; D007930:Leucine / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D010195:Pancreatitis / Q000188:drug therapy* / Q000401:mortality; D010972:Platelet Activating Factor / Q000037:antagonists & inhibitors*
D000893:Anti-Inflammatory Agents; D007093:Imidazoles; D010972:Platelet Activating Factor; D007930:Leucine; C103289:lexipafant