Evidence map›Paper›PMID 22773240›Full record

Trial reportNephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association2012

Somatostatin analog therapy for severe polycystic liver disease: results after 2 years.

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 and 2 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00426153 (Pilot Study Of Long-Acting Octreotide), which is not on this map. Cited by 67 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed, 4 pooled it
12.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00426153 phase2 / phase3completednot on this map

Pilot Study Of Long-Acting Octreotide (Octreotide LAR® Depot) In The Treatment Of Patients With Severe Polycystic Liver Disease

TypeinterventionalSponsorMayo ClinicRan2007 to 2008Enrolled42ConditionsPolycystic Kidney, Autosomal Dominant, Polycystic Liver Disease, Hepatomegaly, Liver DiseasesArmsOctreotide, Placebo
3 · Its place in the literature

Who cites it

67 citing papers in PubMed, 4 syntheses or guidelines pooled it, 133 citations in OpenAlex.

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  15. Autosomal Dominant Polycystic Kidney Disease: Is There a Role for Autophagy?International journal of molecular sciences · 2023
    Review
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7 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 2 institutions in 1 country.

Marie C HoganDepartment of Internal Medicine, Division of Nephrology and Hypertension, Mayo Clinic, Rochester, MN, USA. hogan.marie@mayo.edu
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
Mayo Clinic · USMayo Clinic in Arizona · US

Funding

MAYO CLINIC CENTER FOR TRANSLATIONAL SCIENCE ACTIVITIESUL1RR024150 · NCRR · MAYO CLINIC ROCHESTER · PI RIZZA, ROBERT A. · 2006 to 2011
$66.4M
PILOT AND FEASIBILTY PROGRAMP30DK084567 · NIDDK · MAYO CLINIC ROCHESTER · PI GREGORY J. GORES · 2009 to 2026
$22.2M
RENIN ANGIOTENSIN SYSTEM IN THE PATHOGENESIS OF ADPKDR01DK044863 · NIDDK · MAYO CLINIC ROCHESTER · PI TORRES, VICENTE E · 1991 to 2019
$4.5M
NCRR NIH HHS UL1 RR024150NIDDK NIH HHS P30 DK084567NIDDK NIH HHS R01 DK044863PHS HHS NIDDK P30 DK090728
6 · The paper itself

Abstract

backgroundWe 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).

methodsThe 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.

resultsForty-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.

conclusionOver 2 years, OctLAR significantly reduced the rate of increase in TLV and possibly the rate of increase in TKV.

Indexed as

AdolescentCross-Over StudiesCystsDouble-Blind MethodFemaleFollow-Up StudiesGlomerular Filtration RateHormonesHumansKidney DiseasesLiver DiseasesMagnetic Resonance ImagingMalePrognosisQuality of LifeRisk FactorsHormonesSomatostatin

Identifiers

PMID22773240
PMCPMC3433774
OpenAlexW2162753434

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.