Sandostatin^® LAR^® (microencapsulated octreotide acetate) in acromegaly: Pharmacokinetic and pharmacodynamic relationships

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.

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