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Sandostatin LAR in acromegalic patients: a dose-range study
A K Fløgstad1, J Halse, T Haldorsen
1Medical Department B, Rikshospitalet, Oslo, Norway.
The Journal of Clinical Endocrinology and Metabolism
|December 1, 1995
Summary
Sandostatin LAR, a new octreotide formulation, effectively suppresses growth hormone (GH) in acromegaly patients. Higher doses (20-30 mg) provided sustained GH and IGF-I reduction, showing good tolerability.
Area of Science:
- Endocrinology
- Pharmacology
- Drug Delivery Systems
Background:
- Acromegaly is a disorder caused by excess growth hormone (GH).
- Octreotide, administered subcutaneously (sc), is used to manage acromegaly.
- Sandostatin LAR is a novel microencapsulated, sustained-release formulation of octreotide.
Purpose of the Study:
- To evaluate the efficacy and tolerability of Sandostatin LAR administered intramuscularly (im) in patients with active acromegaly.
- To determine optimal dosing for sustained GH and insulin-like growth factor I (IGF-I) suppression.
Main Methods:
- Two double-blind studies were conducted with patients pretreated with octreotide sc.
- Study 1: 14 patients received single im doses of 3, 6, 9, or 12 mg Sandostatin LAR.
- Study 2: 15 patients received single im doses of 20 or 30 mg Sandostatin LAR, with assessments up to 60 days.
Main Results:
- Only 20 mg and 30 mg im doses effectively suppressed basal GH and IGF-I to levels comparable to sc treatment.
- GH suppression to <5 µg/L lasted 4 weeks with 20 mg and >6 weeks with 30 mg Sandostatin LAR.
- Pharmacokinetic analysis revealed a biphasic release model, with serum octreotide concentrations correlating to dose and achieving efficacy at >600 ng/L.
Conclusions:
- Sandostatin LAR at 20 mg and 30 mg im demonstrates promising efficacy in treating acromegaly.
- The sustained-release formulation offers a potentially valuable alternative for managing acromegaly.
- Further long-term studies are necessary to fully elucidate the drug's potential.