SANDOSTATIN(R) LAR(R) (MICROENCAPSULATED OCTREOTIDE ACETATE) IN ACROMEGALY - PHARMACOKINETIC AND PHARMACODYNAMIC RELATIONSHIPS

Double-blind, single-dose studies of 120 acromegalic patients given 10 , 20, and 30 mg Sandostatin(R) LAR(R) (Sandoz Pharma Ltd, Basel, Switz erland) established the drug's pharmacokinetic profile. Patients then entered open-labeled extension phases, with Sandostatin(R) LAR(R) intr amuscular (IM) injections every 4 weeks. These produced broadly consta nt octreotide concentrations with dose proportionality. Area fluctuati ons were minimal. Steady-state conditions were generally reached after the second to third injection. There was no evidence of downregulatio n with Sandostatin(R) LAR(R) over 1 year of study. Based on the pharma cokinetic/pharmacodynamic relationship of octreotide, a starting dose of 20 mg Sandostatin(R) LAR(R) and administrations every 4 weeks provi de growth hormone (GH) control comparable to the thrice-daily subcutan eous (SC) injection regimen, which is commonly 0.3 to 0.6 mg/d. The re duction from the burden of two to three SC injections per day is a par ticular advantage of Sandostatin(R) LARD, which is an attractive alter native to the approved Sandostatin(R) injection. Copyright (C) 1996 by W.B. Saunders Company