Document Detail


Somatostatin analog therapy for severe polycystic liver disease: results after 2 years.
MedLine Citation:
PMID:  22773240     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: We showed in a randomized double-blinded placebo-controlled clinical trial that octreotide long-acting repeatable depot.® (OctLAR(®)) for 12 months reduces kidney and liver growth in autosomal dominant polycystic kidney patients with severe polycystic liver disease (PLD) and liver growth in patients with severe isolated PLD. We have now completed an open-label extension for one additional year to assess safety and clinical benefits of continued use of OctLAR for 2 years (O → O) and examined drug effect in the placebo group who crossed over to OctLAR in Year 2 (P → O).
METHODS: The primary end point was change in total liver volume (TLV) measured by magnetic resonance imaging (MRI); secondary end points were changes in total kidney volume (TKV) measured by MRI, glomerular filtration rate (GFR), quality of life (QOL), safety, vital signs and laboratory parameters.
RESULTS: Forty-one of 42 patients received OctLAR (n = 28) or placebo (n = 14) in Year 1 and received OctLAR in Year 2 (maximum dose 40 mg). Patients originally randomized to placebo (P → O) showed substantial reduction in TLV after treatment with OctLAR in Year 2 (Δ% -7.66 ± 9.69%, P = 0.011). The initial reduction of TLV in the OctLAR group (O → O) was maintained for 2 years (Δ% -5.96 ± 8.90%), although did not change significantly during Year 2 (Δ% -0.77 ± 6.82%). OctLAR inhibited renal enlargement during Year 1 (Δ% +0.42 ± 7.61%) in the (O → O) group and during Year 2 (Δ% -0.41 ± 9.45%) in the (P → O) group, but not throughout Year 2 (Δ% +6.49 ± 7.08%) in the (O → O) group. Using pooled analyses of all individuals who received OctLAR for 12 months, i.e. in Year 1 for O → O patients and Year 2 for P → O patients, average reduction in TLV was -6.08 ± 7.58% (P = 0.001) compared to net growth of 0.9 ± 8.35% in the original placebo group. OctLAR-treated individuals continued to experience improvements in QOL in Year 2, although overall physical and mental improvements were not significant during Year 2 compared to Year 1. Changes in GFR were similar in both groups.
CONCLUSION: Over 2 years, OctLAR significantly reduced the rate of increase in TLV and possibly the rate of increase in TKV.
Authors:
Marie C Hogan; Tetyana V Masyuk; Linda Page; David R Holmes; Xujian Li; Eric J Bergstralh; Maria V Irazabal; Bohyun Kim; Bernard F King; James F Glockner; Nicholas F Larusso; Vicente E Torres
Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural     Date:  2012-07-06
Journal Detail:
Title:  Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association     Volume:  27     ISSN:  1460-2385     ISO Abbreviation:  Nephrol. Dial. Transplant.     Publication Date:  2012 Sep 
Date Detail:
Created Date:  2012-09-03     Completed Date:  2013-07-08     Revised Date:  2014-06-24    
Medline Journal Info:
Nlm Unique ID:  8706402     Medline TA:  Nephrol Dial Transplant     Country:  England    
Other Details:
Languages:  eng     Pagination:  3532-9     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Cross-Over Studies
Cysts / complications,  drug therapy*
Double-Blind Method
Female
Follow-Up Studies
Glomerular Filtration Rate
Hormones / therapeutic use*
Humans
Kidney Diseases / etiology*,  pathology
Liver Diseases / complications,  drug therapy*
Magnetic Resonance Imaging
Male
Prognosis
Quality of Life
Risk Factors
Somatostatin / analogs & derivatives,  therapeutic use*
Time Factors
Grant Support
ID/Acronym/Agency:
NIDDK P30 DK090728//PHS HHS; P30 DK084567/DK/NIDDK NIH HHS; P30 DK090728/DK/NIDDK NIH HHS; R01 DK044863/DK/NIDDK NIH HHS; UL1 RR024150/RR/NCRR NIH HHS
Chemical
Reg. No./Substance:
0/Hormones; 51110-01-1/Somatostatin
Comments/Corrections

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