title: Safety study of somatostatin analogue octreotide for autosomal dominant polycystic kidney disease in Japan.
abstract: BACKGROUND
  The total kidney volume (TKV) and total liver volume (TLV) increase and renal function decreases progressively in patients with autosomal dominant polycystic kidney disease (ADPKD). Somatostatin analogues, such as octreotide, reduce these increases in TKV and TLV. The aim of this study was to examine the safety of the short-term administration of octreotide long-acting release (octreotide-LAR) in a small number of cases.
  
  
  METHODS
  Four ADPKD patients with an estimated glomerular filtration rate (eGFR) > 45 mL/min/1.73 m(2), TKV > 1,000 mL, and TLV > 3,000 mL were enrolled. Two 20-mg octreotide-LAR intramuscular injections were repeated every 4 weeks for 24 weeks. Laboratory and clinical assessments were repeated every 4 weeks, and TKV and TLV were measured by magnetic resonance imaging before and after the study.
  
  
  RESULTS
  In the laboratory tests, there was no abnormal variable except for a significant decrease of alanine aminotransferase. The means of TKV and TLV decreased from 2,007 to 1,903 mL and from 9,197 to 8,866 mL, respectively, but the changes were not significant. eGFR did not change significantly. Adverse events involved loose stools in two patients, as well as injection site granuloma and abdominal pain in one patient each, which resolved spontaneously.
  
  
  CONCLUSIONS
  Octreotide-LAR may be safe and effective for preventing TKV and TLV increases (UMIN000009214).
authors.affiliation: Department of ADPKD Research, Kyorin University School of Medicine, 6-20-2 Shinkawa, Mitaka, Tokyo, 181-8611, Japan, ehigashi@ks.kyorin-u.ac.jp.
authors.forename: Eiji
authors.initials: E
authors.lastname: Higashihara
authors.forename: Kikuo
authors.initials: K
authors.lastname: Nutahara
authors.forename: Takatsugu
authors.initials: T
authors.lastname: Okegawa
authors.forename: Mitsuhiro
authors.initials: M
authors.lastname: Tanbo
authors.forename: Hideaki
authors.initials: H
authors.lastname: Mori
authors.forename: Isao
authors.initials: I
authors.lastname: Miyazaki
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Nitatori
authors.forename: Kuninori
authors.initials: K
authors.lastname: Kobayashi
mesh_terms: D000328:Adult; D005260:Female; D005765:Gastrointestinal Agents / Q000009:adverse effects*; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D015282:Octreotide / Q000009:adverse effects*; D016891:Polycystic Kidney, Autosomal Dominant / Q000188:drug therapy*; D013004:Somatostatin / Q000031:analogs & derivatives
chemical_list: D005765:Gastrointestinal Agents; D013004:Somatostatin; D015282:Octreotide