Abstract | INTRODUCTION AND AIMS: METHODS: The DIPAK-1 Study is an ongoing investigator-driven, randomized, controlled, open-label multicenter trial. Patients ( ADPKD, ages 18-60 years, estimated glomerular filtration rate 30-60 mL/min/1.73 m2) were randomized 1:1 to receive lanreotide 120 mg subcutaneously every 28 days or standard care during 120 weeks. Hepatic cyst infection was diagnosed by local physicians. RESULTS: We included 309 ADPKD patients of which seven (median age 53 years [interquartile range: 48-55], 71% female, median estimated glomerular filtration rate 42 mL/min/1.73 m2 [interquartile range: 41-58]) developed eight episodes of hepatic cyst infection during 342 patient-years of lanreotide use (0.23 cases per 10 patient-years). These events were limited to patients receiving lanreotide (p < 0.001 vs. standard care). Baseline characteristics were similar between subjects who did or did not develop a hepatic cyst infection during lanreotide use, except for a history of hepatic cyst infection (29 vs. 0.7%, p < 0.001). Previous studies with somatostatin analogs reported cyst infections, but did not identify a causal relationship. CONCLUSIONS: These data suggest an increased risk for hepatic cyst infection during use of somatostatin analogs, especially in ADPKD patients with a history of hepatic cyst infection. The main results are still awaited to fully appreciate the risk-benefit ratio. CLINICALTRIALS. GOV IDENTIFIER: NCT 01616927.
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Authors | Marten A Lantinga, Hedwig M A D'Agnolo, Niek F Casteleijn, Johan W de Fijter, Esther Meijer, Annemarie L Messchendorp, Dorien J M Peters, Mahdi Salih, Edwin M Spithoven, Darius Soonawala, Folkert W Visser, Jack F M Wetzels, Robert Zietse, Joost P H Drenth, Ron T Gansevoort, DIPAK Consortium |
Journal | Drug safety
(Drug Saf)
Vol. 40
Issue 2
Pg. 153-167
(02 2017)
ISSN: 1179-1942 [Electronic] New Zealand |
PMID | 27995519
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Peptides, Cyclic
- lanreotide
- Somatostatin
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Topics |
- Adolescent
- Adult
- Cysts
(epidemiology, etiology)
- Female
- Glomerular Filtration Rate
- Humans
- Liver Diseases
(epidemiology, etiology)
- Male
- Middle Aged
- Peptides, Cyclic
(administration & dosage, adverse effects)
- Polycystic Kidney, Autosomal Dominant
(complications, drug therapy)
- Somatostatin
(administration & dosage, adverse effects, analogs & derivatives)
- Young Adult
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