Abstract | CONTEXT: OBJECTIVE: Our objective was to evaluate the efficacy and safety of three different doses of pasireotide in patients with acromegaly. DESIGN: We conducted a phase II, randomized, multicenter, open-label, three-way, crossover study. PATIENTS: Sixty patients with acromegaly, defined by a 2-h five-point mean GH level higher than 5 microg/liter, lack of suppression of GH to less than 1 microg/liter after oral glucose tolerance test, and elevated IGF-I for age- and sex-matched controls. Patients could have had previous surgery, radiotherapy, and/or medical therapy or no previous treatment. INTERVENTION: MAIN OUTCOME MEASURE: A biochemical response was defined as a reduction in GH to no more than 2.5 microg/liter and normalization of IGF-I to age- and sex-matched controls. RESULTS: After 4 wk of octreotide, 9% of patients achieved a biochemical response. After 4 wk of pasireotide 200-600 microg s.c. bid, 19% of patients achieved a biochemical response, which increased to 27% after 3 months of pasireotide; 39% of patients had a more than 20% reduction in pituitary tumor volume. Pasireotide was generally well tolerated. CONCLUSIONS:
|
Authors | S Petersenn, J Schopohl, A Barkan, P Mohideen, A Colao, R Abs, A Buchelt, Y-Y Ho, K Hu, A J Farrall, S Melmed, B M K Biller, Pasireotide Acromegaly Study Group |
Journal | The Journal of clinical endocrinology and metabolism
(J Clin Endocrinol Metab)
Vol. 95
Issue 6
Pg. 2781-9
(Jun 2010)
ISSN: 1945-7197 [Electronic] United States |
PMID | 20410233
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Blood Glucose
- Human Growth Hormone
- Somatostatin
- Insulin-Like Growth Factor I
- pasireotide
- Octreotide
|
Topics |
- Acromegaly
(drug therapy)
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Blood Glucose
(metabolism)
- Cross-Over Studies
- Dose-Response Relationship, Drug
- Double-Blind Method
- Endpoint Determination
- Female
- Human Growth Hormone
(blood)
- Humans
- Insulin-Like Growth Factor I
(metabolism)
- Magnetic Resonance Imaging
- Male
- Middle Aged
- Octreotide
(adverse effects, therapeutic use)
- Pituitary Neoplasms
(pathology)
- Somatostatin
(adverse effects, analogs & derivatives, pharmacokinetics, therapeutic use)
- Young Adult
|