Randomised clinical trial: the safety and efficacy of long-acting octreotide in patients with portal hypertension N. Chandok* ,† , P. S. Kamath*, A. Blei ‡,1 , J. Bosch § , W. Carey ¶ , N. Grace**, K. V. Kowdley †† , K. Benner ‡‡ & R. J. Groszmann §§ *Division of Gastroenterology and Hepatology, Mayo Clinic and Foundation, Rochester, MN, USA. † Division of Gastroenterology, University of Western Ontario, London, ON, Canada. ‡ Division of Gastroenterology, Northwestern Memorial Hospital, Chicago, IL, USA. § Hepatic Hemodynamic Laboratory, Hospital Clinic I Provincial and CIBERehd, Barcelona, Spain. ¶ Department of Hepatology, Cleveland Clinic, Cleveland, OH, USA. **Gastroenterology Division, Brigham and Women’ s Hospital, Harvard Medical School, Boston, MA, USA. †† Center for Liver Disease, Digestive Disease Institute, Virginia Mason Medical Center, Seattle, WA, USA. ‡‡ Section of Hepatology, Division of Gastroenterology and Hepatology, OHSU, Portland, OR, USA. §§ Hepatic Hemodynamics Laboratory and, Section of Digestive Diseases, Yale University School of Medicine, West Haven, CT, USA. Correspondence to: Dr P. S. Kamath, Division of Gastroenterology and Hepatology, Mayo Clinic and Foundation, 200 First Street SW, Rochester, MN, 55905 USA. E-mail: kamath.patrick@mayo.edu 1 Deceased. Publication data Submitted 11 January 2012 First decision 23 January 2012 Resubmitted 7 February 2012 Accepted 8 February 2012 EV Pub Online 1 March 2012 SUMMARY Background It remains unclear whether a long-acting preparation of octreotide (San- dostatin LAR) can be safely used for portal hypertension in patients with compensated cirrhosis. Aim To determine the safety and efficacy of LAR among patients with Child Pugh Class A or B cirrhosis and small oesophageal varices. Methods A randomised, double-blind, placebo-controlled study was conducted in 39 patients with cirrhosis and small oesophageal varices. Safety was based on frequency and severity of adverse events. Efficacy was determined by hepa- tic vein pressure gradient (HVPG) measured at baseline and day 84 follow- ing administration of LAR 10 mg (n = 15), 30 mg (n = 10) or saline (n = 14). Fasting and postprandial portal blood flow (PBF), superior mes- enteric artery pulsatility index (SMA-PI), glucagon and octreotide levels were measured. An intention-to-treat analysis was performed. Results Four patients in the LAR 30 group (40%) withdrew from the study due to serious adverse events. No patient in the LAR 10 or control group had seri- ous adverse events. There was no statistically significant decrease between HVPG at day 84 and baseline with LAR 30 mg (11.8 ± 2.3 mmHg vs. 14.1 ± 3.2), LAR 10 mg (15.3 ± 4.8 mmHg vs. 15.1 ± 3.8), or saline (13.3 ± 3.8 mmHg vs. 15.1 ± 4.3) (P = 0.26). Neither PBF, SMA-PI nor plasma glucagon levels were significantly decreased from baseline (P = 0.56). Conclusions The absence of significant haemodynamic benefit, as well as the high fre- quency of severe adverse events associated with use of LAR, do not support the use of this agent in the treatment of portal hypertension. Aliment Pharmacol Ther 2012; 35: 904–912 ª 2012 Blackwell Publishing Ltd doi:10.1111/j.1365-2036.2012.05050.x 904 Alimentary Pharmacology and Therapeutics