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- Title
Octreotide treatment of acromegaly. A randomized, multicenter study.
- Authors
Ezzat, S; Snyder, P J; Young, W F; Boyajy, L D; Newman, C; Klibanski, A; Molitch, M E; Boyd, A E; Sheeler, L; Cook, D M
- Abstract
<bold>Objective: </bold>To determine the effects of the somatostatin analog, octreotide acetate, in patients with acromegaly.<bold>Design: </bold>Double-blind, randomized trial.<bold>Setting: </bold>Fourteen university-affiliated medical centers.<bold>Patients: </bold>One hundred fifteen acromegalic patients, 70% of whom had persistent disease after pituitary surgery or radiotherapy.<bold>Intervention: </bold>Subcutaneous octreotide, 100 micrograms, or placebo every 8 hours for 4 weeks. Four weeks after the end of treatment, patients were randomized to receive 100 or 250 micrograms octreotide subcutaneously every 8 hours for 6 months.<bold>Results: </bold>After 2 weeks of treatment, a single 100-micrograms injection reduced mean serum growth hormone (GH) to 30% of the pretreatment concentration within 2 hours. The integrated mean GH level was reduced over 8 hours from 39 +/- 11 micrograms/L to 9 +/- 2 micrograms/L (P less than 0.001). Mean plasma insulin-like growth factor-1 (IGF-1) was reduced from 5100 +/- 400 U/L to 2400 +/- 400 U/L (P less than 0.001). After 6 months, the mean GH was reduced from 39 +/- 13 to 15 +/- 4 micrograms/L by 300 micrograms of octreotide and from 29 +/- 5 micrograms/L to 9 +/- 2 micrograms/L by 750 micrograms of octreotide daily. The mean IGF-1 concentration was suppressed to 2100 +/- 300 and 2500 +/- 400 U/L after 300 and 750 micrograms octreotide, respectively. Integrated mean GH levels were reduced to < 5 micrograms/L in 53% (95% CI, 39% to 67%) and 49% (CI, 35% to 63%), and IGF-1 levels were normal in 68% (CI, 54% to 82%) and 55% (CI, 40% to 70%) of patients receiving low- and high-dose octreotide, respectively. A substantial decrease in headache, amount of perspiration, joint pain, and finger circumference occurred in two thirds of the patients. The pituitary size was reduced in 19% (CI, 5% to 33%) and 37% (CI, 22% to 52%) of patients receiving 6 months of low- and high-dose octreotide, respectively. Ten percent and 13% of patients in each treatment group developed transient diarrhea; 10% and 14%, biliary sludge; and 6% and 18%, cholelithiasis, respectively.<bold>Conclusion: </bold>Octreotide effectively decreased GH and IGF-1 concentrations in 53% and 68% of patients, respectively. The higher dose resulted in increased frequency of tumor shrinkage but added no biochemical or clinical benefit.
- Subjects
ACROMEGALY; ADENOMA; AMINO acids; CLINICAL trials; COMPARATIVE studies; DOCUMENTATION; LONGITUDINAL method; RESEARCH methodology; MEDICAL cooperation; OCTREOTIDE acetate; PITUITARY tumors; RESEARCH; SOMATOMEDIN; EVALUATION research; HUMAN growth hormone; RANDOMIZED controlled trials; BLIND experiment; DISEASE complications
- Publication
Annals of Internal Medicine, 1992, Vol 117, Issue 9, p711
- ISSN
0003-4819
- Publication type
journal article
- DOI
10.7326/0003-4819-117-9-711