Safety and efficacy of long term octreotide therapy of acromegaly: Results of a multicenter trial in 103 patients - A clinical research center study

C. B. Newman, S. Melmed, P. J. Snyder, William Francis Young, L. D. Boyajy, R. Levy, W. N. Stewart, A. Klibanski, M. E. Molitch, R. F. Gagel, A. E. Boyd, L. Sheeler, D. Cook, W. B. Malarkey, I. M D Jackson, M. L. Vance, M. O. Thorner, P. J. Ho, C. A. Jaffe

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Abstract

One hundred and three acromegalic patients from 14 medical centers were enrolled in this study to determine the efficacy and safety of the somatostatin analog, octreotide acetate, during long term treatment. Seventy percent of the patients had undergone previous surgery or radiation treatment. Octreotide was initiated at a dose of 100 μg, sc, every 8 h and gradually increased to a maximum of 1500 μg daily depending upon the individual patient's clinical and biochemical response [GH and insulin-like growth factor I (IGF-I) reduction]. The mean duration of treatment was 24 months (range, 3-30 months). However, most patients were treated for a mean of 30 months, because this study took place after an initial 6 month study previously reported. Mean serum GH fell from 30.9 μg/L (range, 2.7-350) to 5.7 μg/L (range, 0.6-59) at the 3 month visit and remained suppressed (P < 0.001). Plasma IGF-I concentrations were also significantly reduced and remained in the normal range for at least half of the treatment visits in 56 of 87 patients (64%) treated for 12-30 months. Patients with higher initial GH concentrations were less likely to normalize IGF-I concentrations during treatment (P < 0.001). There was no evidence of drug tachyphylaxis in those patients who continued taking stable doses of medication. With some exceptions, dose increments above 800 μg daily in 31 patients did not provide additional benefit in terms of GH and IGF-I reduction. Headache, excessive perspiration, fatigue, and joint pain were ameliorated in 83-95% of patients. Mean linger circumference was decreased significantly at the 12 month visit (P < 0.05). The most common adverse events reported were diarrhea, abdominal discomfort, loose stools, and nausea; these symptoms usually disappeared within 3 months of treatment. Five patients discontinued octreotide because of adverse events. Of 102 patients with normal baseline ultrasound examinations of the gallbladder, 24 patients (23.5%) developed gallstones (usually during the first year of treatment), and 21 patients developed sludge alone. Gallstone formation was not related to the dose of octreotide. Most patients with cholelithiasis were asymptomatic, and none developed cholecystitis. These observations suggest that octreotide is a valuable long term medical treatment for acromegaly.

Original languageEnglish (US)
Pages (from-to)2768-2775
Number of pages8
JournalJournal of Clinical Endocrinology and Metabolism
Volume80
Issue number9
StatePublished - 1995

Fingerprint

Acromegaly
Octreotide
Multicenter Studies
Insulin-Like Growth Factor I
Safety
Research
Therapeutics
Somatostatin
Surgery
Dosimetry
Gallstones
Ultrasonics
Fatigue of materials
Plasmas
Radiation
Tachyphylaxis
Pharmaceutical Preparations
Cholecystitis
Cholelithiasis
Arthralgia

ASJC Scopus subject areas

  • Biochemistry
  • Endocrinology, Diabetes and Metabolism

Cite this

Safety and efficacy of long term octreotide therapy of acromegaly : Results of a multicenter trial in 103 patients - A clinical research center study. / Newman, C. B.; Melmed, S.; Snyder, P. J.; Young, William Francis; Boyajy, L. D.; Levy, R.; Stewart, W. N.; Klibanski, A.; Molitch, M. E.; Gagel, R. F.; Boyd, A. E.; Sheeler, L.; Cook, D.; Malarkey, W. B.; Jackson, I. M D; Vance, M. L.; Thorner, M. O.; Ho, P. J.; Jaffe, C. A.

In: Journal of Clinical Endocrinology and Metabolism, Vol. 80, No. 9, 1995, p. 2768-2775.

Research output: Contribution to journalArticle

Newman, CB, Melmed, S, Snyder, PJ, Young, WF, Boyajy, LD, Levy, R, Stewart, WN, Klibanski, A, Molitch, ME, Gagel, RF, Boyd, AE, Sheeler, L, Cook, D, Malarkey, WB, Jackson, IMD, Vance, ML, Thorner, MO, Ho, PJ & Jaffe, CA 1995, 'Safety and efficacy of long term octreotide therapy of acromegaly: Results of a multicenter trial in 103 patients - A clinical research center study', Journal of Clinical Endocrinology and Metabolism, vol. 80, no. 9, pp. 2768-2775.
Newman, C. B. ; Melmed, S. ; Snyder, P. J. ; Young, William Francis ; Boyajy, L. D. ; Levy, R. ; Stewart, W. N. ; Klibanski, A. ; Molitch, M. E. ; Gagel, R. F. ; Boyd, A. E. ; Sheeler, L. ; Cook, D. ; Malarkey, W. B. ; Jackson, I. M D ; Vance, M. L. ; Thorner, M. O. ; Ho, P. J. ; Jaffe, C. A. / Safety and efficacy of long term octreotide therapy of acromegaly : Results of a multicenter trial in 103 patients - A clinical research center study. In: Journal of Clinical Endocrinology and Metabolism. 1995 ; Vol. 80, No. 9. pp. 2768-2775.
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abstract = "One hundred and three acromegalic patients from 14 medical centers were enrolled in this study to determine the efficacy and safety of the somatostatin analog, octreotide acetate, during long term treatment. Seventy percent of the patients had undergone previous surgery or radiation treatment. Octreotide was initiated at a dose of 100 μg, sc, every 8 h and gradually increased to a maximum of 1500 μg daily depending upon the individual patient's clinical and biochemical response [GH and insulin-like growth factor I (IGF-I) reduction]. The mean duration of treatment was 24 months (range, 3-30 months). However, most patients were treated for a mean of 30 months, because this study took place after an initial 6 month study previously reported. Mean serum GH fell from 30.9 μg/L (range, 2.7-350) to 5.7 μg/L (range, 0.6-59) at the 3 month visit and remained suppressed (P < 0.001). Plasma IGF-I concentrations were also significantly reduced and remained in the normal range for at least half of the treatment visits in 56 of 87 patients (64{\%}) treated for 12-30 months. Patients with higher initial GH concentrations were less likely to normalize IGF-I concentrations during treatment (P < 0.001). There was no evidence of drug tachyphylaxis in those patients who continued taking stable doses of medication. With some exceptions, dose increments above 800 μg daily in 31 patients did not provide additional benefit in terms of GH and IGF-I reduction. Headache, excessive perspiration, fatigue, and joint pain were ameliorated in 83-95{\%} of patients. Mean linger circumference was decreased significantly at the 12 month visit (P < 0.05). The most common adverse events reported were diarrhea, abdominal discomfort, loose stools, and nausea; these symptoms usually disappeared within 3 months of treatment. Five patients discontinued octreotide because of adverse events. Of 102 patients with normal baseline ultrasound examinations of the gallbladder, 24 patients (23.5{\%}) developed gallstones (usually during the first year of treatment), and 21 patients developed sludge alone. Gallstone formation was not related to the dose of octreotide. Most patients with cholelithiasis were asymptomatic, and none developed cholecystitis. These observations suggest that octreotide is a valuable long term medical treatment for acromegaly.",
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AU - Newman, C. B.

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AU - Snyder, P. J.

AU - Young, William Francis

AU - Boyajy, L. D.

AU - Levy, R.

AU - Stewart, W. N.

AU - Klibanski, A.

AU - Molitch, M. E.

AU - Gagel, R. F.

AU - Boyd, A. E.

AU - Sheeler, L.

AU - Cook, D.

AU - Malarkey, W. B.

AU - Jackson, I. M D

AU - Vance, M. L.

AU - Thorner, M. O.

AU - Ho, P. J.

AU - Jaffe, C. A.

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N2 - One hundred and three acromegalic patients from 14 medical centers were enrolled in this study to determine the efficacy and safety of the somatostatin analog, octreotide acetate, during long term treatment. Seventy percent of the patients had undergone previous surgery or radiation treatment. Octreotide was initiated at a dose of 100 μg, sc, every 8 h and gradually increased to a maximum of 1500 μg daily depending upon the individual patient's clinical and biochemical response [GH and insulin-like growth factor I (IGF-I) reduction]. The mean duration of treatment was 24 months (range, 3-30 months). However, most patients were treated for a mean of 30 months, because this study took place after an initial 6 month study previously reported. Mean serum GH fell from 30.9 μg/L (range, 2.7-350) to 5.7 μg/L (range, 0.6-59) at the 3 month visit and remained suppressed (P < 0.001). Plasma IGF-I concentrations were also significantly reduced and remained in the normal range for at least half of the treatment visits in 56 of 87 patients (64%) treated for 12-30 months. Patients with higher initial GH concentrations were less likely to normalize IGF-I concentrations during treatment (P < 0.001). There was no evidence of drug tachyphylaxis in those patients who continued taking stable doses of medication. With some exceptions, dose increments above 800 μg daily in 31 patients did not provide additional benefit in terms of GH and IGF-I reduction. Headache, excessive perspiration, fatigue, and joint pain were ameliorated in 83-95% of patients. Mean linger circumference was decreased significantly at the 12 month visit (P < 0.05). The most common adverse events reported were diarrhea, abdominal discomfort, loose stools, and nausea; these symptoms usually disappeared within 3 months of treatment. Five patients discontinued octreotide because of adverse events. Of 102 patients with normal baseline ultrasound examinations of the gallbladder, 24 patients (23.5%) developed gallstones (usually during the first year of treatment), and 21 patients developed sludge alone. Gallstone formation was not related to the dose of octreotide. Most patients with cholelithiasis were asymptomatic, and none developed cholecystitis. These observations suggest that octreotide is a valuable long term medical treatment for acromegaly.

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