Long-acting octreotide and prolonged-release lanreotide formulations have different pharmacokinetic profiles

J Clin Pharmacol. 2005 Jul;45(7):836-44. doi: 10.1177/0091270005277936.

Abstract

Single-dose pharmacokinetic (PK) profiles and multiple-dose PK modeling were compared for long-acting octreotide (20 or 60 mg) and prolonged-release lanreotide (90 or 120 mg) over 91 days; steady-state profiles were simulated. All treatments were well tolerated. Octreotide 20-mg profile showed increased concentration on day 1, lag from days 2 to 6, then prolonged plateau phase (days 11-41); 60-mg PK was dose proportional. Lanreotide 90-mg profile showed C(max) on day 1 then elimination (apparent t1/2 25.5 days); 120-mg profile was underproportional. Steady-state PK of octreotide 20 mg/28 d suggested a C(mean) of 1216 rhog/mL (range, 1065-1585) with low fluctuation index (43%). Steady-state PK of lanreotide 90 mg/28 d suggested a C(mean) of 4455 rhog/mL (range, 2499-9279) with high fluctuation index (152%). Long-acting octreotide had more predictable PK than prolonged-release lanreotide. Simulated steady-state profiles suggest long-acting octreotide could be optimized to meet individual patient needs. In contrast, prolonged-release lanreotide requires exposure constantly above the therapeutic target to enable monthly long-term therapy.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Abdominal Pain / etiology
  • Adolescent
  • Adult
  • Antineoplastic Agents, Hormonal / administration & dosage
  • Antineoplastic Agents, Hormonal / adverse effects
  • Antineoplastic Agents, Hormonal / blood
  • Antineoplastic Agents, Hormonal / pharmacokinetics*
  • Delayed-Action Preparations
  • Diarrhea / etiology
  • Humans
  • Male
  • Middle Aged
  • Octreotide / administration & dosage
  • Octreotide / adverse effects
  • Octreotide / blood
  • Octreotide / pharmacokinetics*
  • Peptides, Cyclic / administration & dosage
  • Peptides, Cyclic / adverse effects
  • Peptides, Cyclic / blood
  • Peptides, Cyclic / pharmacokinetics*
  • Somatostatin / administration & dosage
  • Somatostatin / adverse effects
  • Somatostatin / analogs & derivatives*
  • Somatostatin / blood
  • Somatostatin / pharmacokinetics

Substances

  • Antineoplastic Agents, Hormonal
  • Delayed-Action Preparations
  • Peptides, Cyclic
  • lanreotide
  • Somatostatin
  • Octreotide