Shereen Ezzat, MD; Peter J. Snyder, MD; William F. Young, MD; Louis D. Boyajy, PhD; Connie Newman, MD; Anne Klibanski, MD; Mark E. Molitch, MD; Aubrey E. Boyd, MD; Leslie Sheeler, MD; David M. Cook, MD; William B. Malarkey, MD; Ivor Jackson, MD; Mary Lee Vance, MD; Michael O. Thorner, MD; Ariel Barkan, MD; Lawrence A Frohman, MD; Shlomo Melmed, MD
▪ Objective: To determine the effects of the somatostatin analog, octreotide acetate, in patients with acromegaly.
▪ Design: Double-blind, randomized trial.
▪ Setting: Fourteen university-affiliated medical centers.
▪ Patients: One hundred fifteen acromegalic patients, 70% of whom had persistent disease after pituitary surgery or radiotherapy.
▪ Intervention: Subcutaneous octreotide, 100 µg, or placebo every 8 hours for 4 weeks. Four weeks after the end of treatment, patients were randomized to receive 100 or 250 µg octreotide subcutaneously every 8 hours for 6 months.
▪ Results: After 2 weeks of treatment, a single 100-µg 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 µg/L to 9 ± 2 µg/L (P < 0.001). Mean plasma insulin-like growth factor-1 (IGF-1) was reduced from 5100 µ 400 U/L to 2400 ± 400 U/L (P < 0.001). After 6 months, the mean GH was reduced from 39 ± 13 to 15 ± 4 µg/L by 300 µg of octreotide and from 29 ± 5 µg/L to 9 ± 2 µg/L by 750 µg of octreotide daily. The mean IGF-1 concentration was suppressed to 2100 ± 300 and 2500 ± 400 U/L after 300 and 750 µg octreotide, respectively. Integrated mean GH levels were reduced to less than 5 µg/L in 53% (95% Cl, 39% to 67%) and 49% (Cl, 35% to 63%), and IGF-1 levels were normal in 68% (Cl, 54% to 82%) and 55% (Cl, 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% (Cl, 5% to 33%) and 37% (Cl, 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.
▪ Conclusion: 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.
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Ezzat S, Snyder PJ, Young WF, Boyajy LD, Newman C, Klibanski A, et al. Octreotide Treatment of Acromegaly: A Randomized, Multicenter Study. Ann Intern Med. 1992;117:711-718. doi: 10.7326/0003-4819-117-9-711
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Published: Ann Intern Med. 1992;117(9):711-718.
Endocrine and Metabolism, Neurology, Pituitary Disorders.
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