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.
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. ;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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