title: Randomised clinical trial: the safety and efficacy of long-acting octreotide in patients with portal hypertension.
abstract: BACKGROUND
  It remains unclear whether a long-acting preparation of octreotide (Sandostatin LAR) can be safely used for portal hypertension in patients with compensated cirrhosis.
  
  
  OBJECTIVE
  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 hepatic vein pressure gradient (HVPG) measured at baseline and day 84 following administration of LAR 10 mg (n = 15), 30 mg (n = 10) or saline (n = 14). Fasting and postprandial portal blood flow (PBF), superior mesenteric 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 serious 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 frequency of severe adverse events associated with use of LAR, do not support the use of this agent in the treatment of portal hypertension.
authors.affiliation: Division of Gastroenterology and Hepatology, Mayo Clinic and Foundation, Rochester, MN 55905, USA.
authors.forename: N
authors.initials: N
authors.lastname: Chandok
authors.forename: P S
authors.initials: PS
authors.lastname: Kamath
authors.forename: A
authors.initials: A
authors.lastname: Blei
authors.forename: J
authors.initials: J
authors.lastname: Bosch
authors.forename: W
authors.initials: W
authors.lastname: Carey
authors.forename: N
authors.initials: N
authors.lastname: Grace
authors.forename: K V
authors.initials: KV
authors.lastname: Kowdley
authors.forename: K
authors.initials: K
authors.lastname: Benner
authors.forename: R J
authors.initials: RJ
authors.lastname: Groszmann
mesh_terms: D000368:Aged; D000704:Analysis of Variance; D018931:Antineoplastic Agents, Hormonal / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004932:Esophageal and Gastric Varices / Q000150:complications / Q000188:drug therapy*; D005260:Female; D006207:Half-Life; D006503:Hepatic Veins / Q000502:physiology; D006801:Humans; D006975:Hypertension, Portal / Q000150:complications / Q000188:drug therapy*; D008103:Liver Cirrhosis / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D015282:Octreotide / Q000009:adverse effects / Q000627:therapeutic use*; D011169:Portal Vein / Q000502:physiology; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D018931:Antineoplastic Agents, Hormonal; D015282:Octreotide