Randomised clinical trial: the safety and efficacy of long-acting octreotide in
patients with portal hypertension.
Author(s): Chandok N, Kamath PS, Blei A, Bosch J, Carey W, Grace N, Kowdley KV, Benner K,
Groszmann RJ.
Affiliation(s): Division of Gastroenterology and Hepatology, Mayo Clinic and Foundation,
Rochester, MN 55905, USA.
Publication date & source: 2012, Aliment Pharmacol Ther. , 35(8):904-12
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.
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 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.
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