TY - JOUR
T1 - Octreotide treatment of acromegaly
T2 - A randomized, multicenter study
AU - Ezzat, Shereen
AU - Snyder, Peter J.
AU - Young, William F.
AU - Boyajy, Louis D.
AU - Newman, Connie
AU - Klibanski, Anne
AU - Molitch, Mark E.
AU - Boyd, Aubrey E.
AU - Sheeler, Leslie
AU - Cook, David M.
AU - Malarkey, William B.
AU - Jackson, Ivor
AU - Vance, Mary Lee
AU - Thorner, Michael O.
AU - Barkan, Ariel
AU - Frohman, Lawrence A.
AU - Melmed, Shlomo
PY - 1992/11/1
Y1 - 1992/11/1
N2 - 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 ± 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.
AB - 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 ± 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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M3 - Article
C2 - 1416572
AN - SCOPUS:0026787125
SN - 0003-4819
VL - 117
SP - 711
EP - 718
JO - Annals of internal medicine
JF - Annals of internal medicine
IS - 9
ER -