Sandostatin LAR (microencapsulated octreotide acetate) in acromegaly: pharmacokinetic and pharmacodynamic relationships

Metabolism. 1996 Aug;45(8 Suppl 1):27-30. doi: 10.1016/s0026-0495(96)90075-x.

Abstract

Double-blind, single-dose studies of 120 acromegalic patients given 10, 20, and 30 mg Sandostatin LAR (Sandoz Pharma Ltd, Basel, Switzerland) established the drug's pharmacokinetic profile. Patients then entered open-labeled extension phases, with Sandostatin LAR intramuscular (IM) injections every 4 weeks. These produced broadly constant octreotide concentrations with dose proportionality. Area fluctuations were minimal. Steady-state conditions were generally reached after the second to third injection. There was no evidence of downregulation with Sandostatin LAR over 1 year of study. Based on the pharmacokinetic/pharmacodynamic relationship of octreotide, a starting dose of 20 mg Sandostatin LAR and administrations every 4 weeks provide growth hormone (GH) control comparable to the thrice-daily subcutaneous (SC) injection regimen, which is commonly 0.3 to 0.6 mg/d. The reduction from the burden of two to three SC injections per day is a particular advantage of Sandostatin LAR, which is an attractive alternative to the approved Sandostatin injection.

Publication types

  • Clinical Trial

MeSH terms

  • Acromegaly / drug therapy*
  • Acromegaly / metabolism
  • Capsules
  • Delayed-Action Preparations
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Growth Hormone / blood
  • Humans
  • Injections, Intramuscular
  • Octreotide / administration & dosage*
  • Octreotide / blood
  • Octreotide / therapeutic use
  • Time Factors

Substances

  • Capsules
  • Delayed-Action Preparations
  • Growth Hormone
  • Octreotide