Transcript Long-acting Somatostatin in Severe Polycystic Liver Disease

Long-acting Somatostatin in Severe Polycystic Liver Disease
Reference
Hogan MC. Randomized clinical trial of long-acting somatostatin for autosomal
dominant polycystic kidney and liver disease. Am Soc Nephrol. 2010;21:1052–1061.
Background
This study will evaluate the effect of long-acting Somatostatin on the liver volumes of
patients with severe polycystic liver disease who are not candidates or decline surgical
treatments such as liver cyst fenestration, liver resection or liver transplantation.
Preliminary evidence indicates that this drug is safe and non-toxic in other disease
states. Treatment with this drug holds promise not only for individuals with liver
involvement, but also for many more patients with polycystic kidney disease.
Aim
To study the effect of long-acting Somatostatin in severe polycystivc liver disease.
Method
Study design: This trial was a randomized, double-blind placebo-controlled trial.
Study population: A total of 42 patients will be recruited, 28 will receive study drug
and remaining 14 will receive placebo.
Treatment regimen: The 42 patients were randomly assigned in a 2:1 ratio to longacting Somatostatin depot (up to 40 mg every 28±5 days) or placebo for 1 year.
End point: The primary end point was change in the liver volume from base line to 1
year measured by MRI. The secondary end point was changes in the total kidney
volume, GFR, quality of life, safety, vital signs and clinical laboratory tests.
Result
34 patients had ADPKD and 8 had ADPLD. The liver volumes reduced by 4.95–6.77% in
the Somatostatin group but remained unchanged in the placebo group. The total
kidney volume remained unchanged (0.25–7.53%) in the Somatostatin group but
increased
by
around
8–10% in the placebo group. Somatistatin was well tolerated in both the groups.
5 out of 8 patients in the placebo group showed an increase in the total kidney
volume during the 12 months of therapy. The GFR in 30 ADKPD patients reduced
significantly in the Somatostatin group as compared to the placebo. No significant
difference was seen in the rates of change in serum creatinine in both the groups.
Conclusion
Somatostatin analogs may reduce cAMP accumulation and cyst growth by multiple
mechanisms. Somatostatin was well tolerated in the patients.
Somatostatin slowed the progressive increase in liver volume and total kidney
volume, improved health perception among patients with PLD, and had an
acceptable side-effect profile. Somatostatin was well tolerated in the patient group.