Comparable Effects of Lanreotide Autogel and Octreotide LAR on GH, IGF-I Levels and Patient Satisfaction
The morbidity and the mortality in acromegalic patients closely correspond to growth hormone (GH) levels and therefore efficient long-term treatment is important.
Neurosurgery is the first choice of treatment in acromegalic patients. Surgery normalizes GH levels in about 80% of patients with microadenomas, but less than 50 % of patients with macroadenomas respond sufficiently to surgery alone. In most patients, additional medical therapy is therefore needed.
Somatostatin analogues have successfully been used in treatment of acromegaly if surgery or radiotherapy can not lead to normal GH and IGF-I levels. Lanreotide Autogel (LAN) is a new formulation of lanreotide consisting of a prolonged release aqueous formulation, which can be injected intramuscularly or deep subcutaneously once every 28 days.
The aim of the present study was to compare the efficacy of OCT and LAN in obtaining GH and IGF-I levels according to the 2000 Consensus. Furthermore, we wanted to evaluate which treatment modality resulted in the lowest possible IGF-I and GH levels and the highest patient satisfaction.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Comparable Effects of Lanreotide Autogel and Octreotide LAR on GH, IGF-I Levels and Patient Satisfaction - A Twelve Month Randomized Cross-Over Study in Patients With Acromegaly|
- GH and IGF-I levels after 4, 6, 10, 12 months therapy.
|Study Start Date:||September 2002|
|Estimated Study Completion Date:||December 2004|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00145405
|Department of Endocrinology, Odense University Hospital|
|Odense, Funen, Denmark, 5000|
|Principal Investigator:||Marianne Andersen, MD, PhD||Odense University Hospital|