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Study · Randomized controlled trial · n = 249 · 2021

5 results

Incident Gallstones During Somatostatin Analog Treatment are Associated with Acute Biliary Complications Especially After Discontinuation.

Aapkes SE, de Haas RJ, Bernts LHP, Blijdorp CJ, Dekker SEI, van Gastel MDA, Meijer E, Veldman A, Drenth JPH, Gansevoort RT

Drugs in R&D29 Mar 2021Cited by 12 (Europe PMC)

PMID33779943 (opens in a new tab)PMCIDPMC8206401 (opens in a new tab)DOI10.1007/s40268-021-00342-7 (opens in a new tab)PepBankPUB-33779943
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In polycystic kidney disease, gallstones formed in 19/124 lanreotide patients (15%) versus 1/125 standard-care patients (1%), with odds ratio 25.9.

    In plain wordsIn polycystic kidney disease, new gallstones occurred in 15% with lanreotide versus 1% with standard care.

    Peptide
    Lanreotide
    Outcome
    IncreaseIncident gallstones
    Study

    n = 249

    Comparator
    standard of care
    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    Dose not stated · 120 weeksAs given in this study (human).

    Measurements

    Patients with new gallstones
    19 patients
    lanreotide, of 124 patients
    Patients with new gallstones
    15%
    lanreotide
    Patients with new gallstones
    1 patients
    standard of care, of 125 patients
    Patients with new gallstones
    1%
    standard of care
    Odds ratio for gallstone formation with lanreotide
    25.9
    lanreotide vs standard of care
    95% CI of odds ratio for gallstone formation
    3.37 to 198.8
    lanreotide vs standard of care
    p value
    < 0.001
    gallstone formation, lanreotide vs standard of care

    Source sentences

    Summary
    During the study, new gallstones were formed in 19/124 patients using lanreotide (15%) and 1/125 patients receiving SoC (1%).
    2 context sentences
    Summary · context
    The odds ratio for gallstone formation with lanreotide use was 25.9 (95% confidence interval 3.37-198.8; p < 0.001).
    Summary · context
    Data from the DIPAK 1 trial, in which 305 polycystic kidney disease patients were randomized to standard of care (SoC) or lanreotide for 120 weeks, were used. Magnetic resonance imaging (MRI) was performed at baseline and end of treatment and was assessed for the presence, number, and size of gallstones.
  2. 02HumanNon-randomized trialSafety outcome

    During lanreotide treatment, gallstones numbered more than 20 in 69% of patients with gallstones.

    In plain wordsDuring lanreotide treatment, 69% of patients with gallstones had more than 20 stones.

    Peptide
    Lanreotide
    Outcome
    Not applicableMultiple gallstones
    Study

    n: not reported in source

    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    Dose not stated · 120 weeksAs given in this study (human).

    Measurements

    Patients with more than 20 gallstones
    69%
    patients with gallstones during lanreotide treatment

    Source sentences

    Summary
    Gallstones during lanreotide treatment were multiple (> 20 stones in 69% of patients) and small (≤ 3 mm in 63% of patients).
    1 context sentence
    Summary · context
    Data from the DIPAK 1 trial, in which 305 polycystic kidney disease patients were randomized to standard of care (SoC) or lanreotide for 120 weeks, were used. Magnetic resonance imaging (MRI) was performed at baseline and end of treatment and was assessed for the presence, number, and size of gallstones.
  3. 03HumanNon-randomized trialSafety outcome

    During lanreotide treatment, gallstones measured no more than 3 mm in 63% of patients with gallstones.

    In plain wordsDuring lanreotide treatment, 63% of patients with gallstones had stones no larger than 3 mm.

    Peptide
    Lanreotide
    Outcome
    Not applicableSmall gallstones
    Study

    n: not reported in source

    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    Dose not stated · 120 weeksAs given in this study (human).

    Measurements

    Patients with gallstones of 3 mm or less
    ≤ 63%
    patients with gallstones during lanreotide treatment

    Source sentences

    Summary
    Gallstones during lanreotide treatment were multiple (> 20 stones in 69% of patients) and small (≤ 3 mm in 63% of patients).
    1 context sentence
    Summary · context
    Data from the DIPAK 1 trial, in which 305 polycystic kidney disease patients were randomized to standard of care (SoC) or lanreotide for 120 weeks, were used. Magnetic resonance imaging (MRI) was performed at baseline and end of treatment and was assessed for the presence, number, and size of gallstones.
  4. 04HumanObservational studySafety outcome

    Among 19 patients with new gallstones during lanreotide, nine developed gallstone-associated complications.

    In plain wordsAmong 19 patients with new gallstones during lanreotide, nine developed related complications.

    Peptide
    Lanreotide
    Outcome
    Not applicableGallstone-associated complications
    Study

    n = 19

    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    Dose not stated · 120 weeksAs given in this study (human).

    Measurements

    Patients with gallstone-associated complications
    9 patients
    of 19 patients with incident gallstones during lanreotide

    Source sentences

    Summary
    Of the 19 patients with incident gallstones during lanreotide treatment, 9 experienced gallstone-associated complications, 8 of whom experienced gallstone-associated complications after discontinuation of treatment (median time after discontinuation 2.5 years).
    1 context sentence
    Summary · context
    Data from the DIPAK 1 trial, in which 305 polycystic kidney disease patients were randomized to standard of care (SoC) or lanreotide for 120 weeks, were used. Magnetic resonance imaging (MRI) was performed at baseline and end of treatment and was assessed for the presence, number, and size of gallstones.
  5. 05HumanObservational studySafety outcome

    Eight patients with new lanreotide-associated gallstones had complications after treatment discontinuation, at a median of 2.5 years.

    In plain wordsEight patients with new lanreotide-associated gallstones had complications after treatment stopped, at a median of 2.5 years.

    Peptide
    Lanreotide
    Outcome
    Not applicableGallstone complications after discontinuation
    Study

    n = 19

    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    Dose not stated · 120 weeksAs given in this study (human).

    Measurements

    Patients with complications after discontinuation
    8 patients
    of 19 patients with incident gallstones during lanreotide
    Median time after discontinuation
    ≈ 2.5 years
    patients with complications after discontinuation

    Source sentences

    Summary
    Of the 19 patients with incident gallstones during lanreotide treatment, 9 experienced gallstone-associated complications, 8 of whom experienced gallstone-associated complications after discontinuation of treatment (median time after discontinuation 2.5 years).
    1 context sentence
    Summary · context
    Data from the DIPAK 1 trial, in which 305 polycystic kidney disease patients were randomized to standard of care (SoC) or lanreotide for 120 weeks, were used. Magnetic resonance imaging (MRI) was performed at baseline and end of treatment and was assessed for the presence, number, and size of gallstones.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · source ClinicalTrials.gov (opens in a new tab)

Status unknownPhase 3NCT01616927

Study of Lanreotide to Treat Polycystic Kidney Disease

University Medical Center Groningenn = 300Jun 2012 to est. Dec 2017

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Trial pageClinicalTrials.govUpdated 23 May 2017

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:36 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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