P0032INCIDENCE OF GALLSTONES AND ASSOCIATED COMPLICATIONS WITH USE OF THE SOMATOSTATIN ANALOGUE LANREOTIDE FOR POLYCYSTIC KIDNEY AND LIVER DISEASE
Abstract Background and Aims Recently, we performed a large randomized-controlled trial to assess the effects of the somatostatin analogue lanreotide on kidney function and kidney and liver volume in autosomal dominant polycystic kidney disease (ADPKD), the DIPAK-1 trial. Lanreotide had no effect on...
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Veröffentlicht in: | Nephrology, dialysis, transplantation dialysis, transplantation, 2020-06, Vol.35 (Supplement_3) |
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Sprache: | eng |
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Zusammenfassung: | Abstract
Background and Aims
Recently, we performed a large randomized-controlled trial to assess the effects of the somatostatin analogue lanreotide on kidney function and kidney and liver volume in autosomal dominant polycystic kidney disease (ADPKD), the DIPAK-1 trial. Lanreotide had no effect on rate of kidney function decline, but slowed kidney and especially liver growth and is used for this indication in clinical practice1,2. A higher incidence of gallstones has been suggested with lanreotide use, but the exact size and implications of this problem are unknown. Therefore, we systematically studied the incidence of gallstones with lanreotide in ADPKD patients.
Method
In the DIPAK-1 trial, 305 ADPKD patients (age 18-60 years and eGFR 30-60 ml/1.73m2/min) were randomized to lanreotide or standard of care. MRIs were performed at baseline and end of study (120 weeks). For this post-hoc study, patients with a medical history of cholecystectomy (n=7) or absence of a MRI at the end of study (n=28) were excluded. For the remaining study population (n=270), all MRIs were assessed for presence of gallstones by two trained investigators blinded for study treatment and study period and in case of disagreeing results, an abdominal radiologist was consulted for a final assessment. For patients with gallstones additional follow up after the end of the trial was obtained.
Results
In 2 baseline and 8 end-of -study MRIs, it was not possible to identify the gallbladder, due to multiple adjacent liver cysts. Of the remaining 260 patients (age 48.5 years, female 49.6%, eGFR 50.0 ml/min/1.73m2), 14 patients (5,4%) had gallstones at baseline, of whom 5 were randomized to lanreotide and 9 to standard care. At the end of study, 32 patients (12,3%) had gallstones, of whom 21 patients had received lanreotide and 11 standard care. During the 120 week lasting study, new gallstones occurred in 17 out of 128 patients receiving lanreotide (13.3%) and 3 out of 132 patients receiving standard care (2.3%), rendering an adjusted Odds Ratio for gallstone formation with lanreotide use of 6.9 (95% Confidence Interval 1.9-24.7) p |
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ISSN: | 0931-0509 1460-2385 |
DOI: | 10.1093/ndt/gfaa142.P0032 |