Rene M M van Aerts1, Wietske Kievit1, Hedwig M A D'Agnolo1, Charles J Blijdorp2, Niek F Casteleijn3, Shosha E I Dekker4, Johan W de Fijter4, Maatje van Gastel5, Tom J Gevers1, Liyanne F M van de Laarschot1, Marten A Lantinga1, Monique Losekoot6, Esther Meijer5, A Lianne Messchendorp5, Myrte K Neijenhuis1, Michelle J Pena5, Dorien J M Peters6, Mahdi Salih2, Darius Soonawala7, Edwin M Spithoven5, Folkert W Visser8, Jack F Wetzels9, Robert Zietse2, Ron T Gansevoort5, Joost P H Drenth10. 1. Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands. 2. Department of Internal Medicine, Erasmus Medical Center Rotterdam, Rotterdam, The Netherlands. 3. Department of Urology, University Medical Center Groningen, Groningen, The Netherlands. 4. Department of Nephrology, Leiden University Medical Center, Leiden, The Netherlands. 5. Department of Nephrology, University Medical Center Groningen, Groningen, The Netherlands. 6. Department of Human Genetics, Leiden University Medical Center, Leiden, The Netherlands. 7. Department of Nephrology, Leiden University Medical Center, Leiden, The Netherlands; Department of Internal Medicine, Haga teaching hospital, The Hague, The Netherlands. 8. Department of Nephrology, University Medical Center Groningen, Groningen, The Netherlands; Department of Internal Medicine, Hospital group Twente, Almelo, The Netherlands. 9. Deptartment of Nephrology, Radboud University Medical Center, Nijmegen, The Netherlands. 10. Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands. Electronic address: joostphdrenth@cs.com.
Abstract
BACKGROUND & AIMS: Polycystic liver disease is the most common extrarenal manifestation of autosomal dominant polycystic kidney disease (ADPKD). There is need for robust long-term evidence for the volume-reducing effect of somatostatin analogues. We made use of data from an open-label, randomized trial to determine the effects of lanreotide on height-adjusted liver volume (hTLV) and combined height-adjusted liver and kidney volume (hTLKV) in patients with ADPKD. METHODS: We performed a 120-week study comparing the reno-protective effects of lanreotide vs standard care in 305 patients with ADPKD (the DIPAK-1 study). For this analysis, we studied the 175 patients with polycystic liver disease with hepatic cysts identified by magnetic resonance imaging and liver volume ≥2000 mL. Of these, 93 patients were assigned to a group that received lanreotide (120 mg subcutaneously every 4 weeks) and 82 to a group that received standard care (blood pressure control, a sodium-restricted diet, and antihypertensive agents). The primary endpoint was percent change in hTLV between baseline and end of treatment (week 120). A secondary endpoint was change in hTLKV. RESULTS: At 120 weeks, hTLV decreased by 1.99% in the lanreotide group (95% confidence interval [CI], -4.21 to 0.24) and increased by 3.92% in the control group (95% CI, 1.56-6.28). Compared with the control group, lanreotide reduced the growth of hTLV by 5.91% (95% CI, -9.18 to -2.63; P < .001). Growth of hTLV was still reduced by 3.87% at 4 months after the last injection of lanreotide compared with baseline (95% CI, -7.55 to -0.18; P = .04). Lanreotide reduced growth of hTLKV by 7.18% compared with the control group (95% CI, -10.25 to -4.12; P < .001). CONCLUSIONS: In this subanalysis of a randomized trial of patients with polycystic liver disease due to ADPKD, lanreotide for 120 weeks reduced the growth of liver and combined liver and kidney volume. This effect was still present 4 months after the last injection of lanreotide. ClinicalTrials.gov, Number: NCT01616927.
RCT Entities:
BACKGROUND & AIMS:Polycystic liver disease is the most common extrarenal manifestation of autosomal dominant polycystic kidney disease (ADPKD). There is need for robust long-term evidence for the volume-reducing effect of somatostatin analogues. We made use of data from an open-label, randomized trial to determine the effects of lanreotide on height-adjusted liver volume (hTLV) and combined height-adjusted liver and kidney volume (hTLKV) in patients with ADPKD. METHODS: We performed a 120-week study comparing the reno-protective effects of lanreotide vs standard care in 305 patients with ADPKD (the DIPAK-1 study). For this analysis, we studied the 175 patients with polycystic liver disease with hepatic cysts identified by magnetic resonance imaging and liver volume ≥2000 mL. Of these, 93 patients were assigned to a group that received lanreotide (120 mg subcutaneously every 4 weeks) and 82 to a group that received standard care (blood pressure control, a sodium-restricted diet, and antihypertensive agents). The primary endpoint was percent change in hTLV between baseline and end of treatment (week 120). A secondary endpoint was change in hTLKV. RESULTS: At 120 weeks, hTLV decreased by 1.99% in the lanreotide group (95% confidence interval [CI], -4.21 to 0.24) and increased by 3.92% in the control group (95% CI, 1.56-6.28). Compared with the control group, lanreotide reduced the growth of hTLV by 5.91% (95% CI, -9.18 to -2.63; P < .001). Growth of hTLV was still reduced by 3.87% at 4 months after the last injection of lanreotide compared with baseline (95% CI, -7.55 to -0.18; P = .04). Lanreotide reduced growth of hTLKV by 7.18% compared with the control group (95% CI, -10.25 to -4.12; P < .001). CONCLUSIONS: In this subanalysis of a randomized trial of patients with polycystic liver disease due to ADPKD, lanreotide for 120 weeks reduced the growth of liver and combined liver and kidney volume. This effect was still present 4 months after the last injection of lanreotide. ClinicalTrials.gov, Number: NCT01616927.
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