Investigation into the Efficacy and Safety of Octreotide LAR in Japanese Patients with Acromegaly: Shizuoka Study

The efficacy and safety of the long-acting repeatable formulation of octreotide (OCT-LAR) treatment in patients suffering from acromegaly was investigated retrospectively in Shizuoka prefecture, Japan. Thirty patients (11 male, 19 female; average age, 48.9 years old), 29 of whom had undergone transs...

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Published inEndocrine Journal Vol. 56; no. 9; pp. 1095 - 1101
Main Authors OKI, Yutaka, INOUE, Tatsuhide, IMURA, Mitsuo, TANAKA, Tokutaro, GENMA, Rieko, IWABUCHI, Masayasu, HATAYA, Yuji, MATSUZAWA, Yuji, IINO, Kazumi, NISHIZAWA, Shigeru, NAKAMURA, Hirotoshi
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Abstract The efficacy and safety of the long-acting repeatable formulation of octreotide (OCT-LAR) treatment in patients suffering from acromegaly was investigated retrospectively in Shizuoka prefecture, Japan. Thirty patients (11 male, 19 female; average age, 48.9 years old), 29 of whom had undergone transsphenoidal surgery previously, were treated with OCT-LAR. OCT-LAR was injected i.m. every 4 weeks with an intended protocol of 20 mg over 24 months, however, 46.7% of patients required the dose of OCT-LAR to be increased. The final average dose of OCT-LAR was 25.0 ± 6.8 mg. Administering OCT-LAR significantly decreased serum GH and insulin-like growth factor 1 (IGF-1) levels (from 13.7 ± 11.9 to 5.8 ± 7.3 μg/L and from 585 ± 263 to 339 ± 193.7 μg/L after 3 months, respectively). Among patients treated with OCT-LAR, 56.7% expressed ≤2.5 μg/L serum GH and 53.3% displayed serum IGF-1 levels within the normal range, while 36.7% met both criteria that indicated treatment success. A sufficient outcome was achieved in 73.3% of patients when the rate of GH ≤2.5 μg/L or normalization of IGF-1 was accumulated. OCT-LAR did not have a negative effect on glucose tolerance when hemoglobin A1c was used as a marker. A gallbladder polyp was found only in 1 patient but it was uncertain whether OCT-LAR was involved in its development because the patient was not examined before OCT-LAR treatment. There were no abnormalities on liver function tests in any patients. In conclusion, our results showed that OCT-LAR was safe and effective as a therapeutic option for Japanese patients with acromegaly in a postoperative setting, by controlling the disease activity.
AbstractList The efficacy and safety of the long-acting repeatable formulation of octreotide (OCT-LAR) treatment in patients suffering from acromegaly was investigated retrospectively in Shizuoka prefecture, Japan. Thirty patients (11 male, 19 female; average age, 48.9 years old), 29 of whom had undergone transsphenoidal surgery previously, were treated with OCT-LAR. OCT-LAR was injected i.m. every 4 weeks with an intended protocol of 20 mg over 24 months, however, 46.7% of patients required the dose of OCT-LAR to be increased. The final average dose of OCT-LAR was 25.0 ± 6.8 mg. Administering OCT-LAR significantly decreased serum GH and insulin-like growth factor 1 (IGF-1) levels (from 13.7 ± 11.9 to 5.8 ± 7.3 μg/L and from 585 ± 263 to 339 ± 193.7 μg/L after 3 months, respectively). Among patients treated with OCT-LAR, 56.7% expressed ≤2.5 μg/L serum GH and 53.3% displayed serum IGF-1 levels within the normal range, while 36.7% met both criteria that indicated treatment success. A sufficient outcome was achieved in 73.3% of patients when the rate of GH ≤2.5 μg/L or normalization of IGF-1 was accumulated. OCT-LAR did not have a negative effect on glucose tolerance when hemoglobin A1c was used as a marker. A gallbladder polyp was found only in 1 patient but it was uncertain whether OCT-LAR was involved in its development because the patient was not examined before OCT-LAR treatment. There were no abnormalities on liver function tests in any patients. In conclusion, our results showed that OCT-LAR was safe and effective as a therapeutic option for Japanese patients with acromegaly in a postoperative setting, by controlling the disease activity.
The efficacy and safety of the long-acting repeatable formulation of octreotide (OCT-LAR) treatment in patients suffering from acromegaly was investigated retrospectively in Shizuoka prefecture, Japan. Thirty patients (11 male, 19 female; average age, 48.9 years old), 29 of whom had undergone transsphenoidal surgery previously, were treated with OCT-LAR. OCT-LAR was injected i.m. every 4 weeks with an intended protocol of 20 mg over 24 months, however, 46.7% of patients required the dose of OCT-LAR to be increased. The final average dose of OCT-LAR was 25.0 +/- 6.8 mg. Administering OCT-LAR significantly decreased serum GH and insulin-like growth factor 1 (IGF-1) levels (from 13.7 +/- 11.9 to 5.8 +/- 7.3 microg/L and from 585 +/- 263 to 339 +/- 193.7 microg/L after 3 months, respectively). Among patients treated with OCT-LAR, 56.7% expressed <or=2.5 microg/L serum GH and 53.3% displayed serum IGF-1 levels within the normal range, while 36.7% met both criteria that indicated treatment success. A sufficient outcome was achieved in 73.3% of patients when the rate of GH <or=2.5 microg/L or normalization of IGF-1 was accumulated. OCT-LAR did not have a negative effect on glucose tolerance when hemoglobin A1c was used as a marker. A gallbladder polyp was found only in 1 patient but it was uncertain whether OCT-LAR was involved in its development because the patient was not examined before OCT-LAR treatment. There were no abnormalities on liver function tests in any patients. In conclusion, our results showed that OCT-LAR was safe and effective as a therapeutic option for Japanese patients with acromegaly in a postoperative setting, by controlling the disease activity.
Author TANAKA, Tokutaro
NAKAMURA, Hirotoshi
IWABUCHI, Masayasu
INOUE, Tatsuhide
IMURA, Mitsuo
MATSUZAWA, Yuji
IINO, Kazumi
GENMA, Rieko
OKI, Yutaka
HATAYA, Yuji
NISHIZAWA, Shigeru
Author_xml – sequence: 1
  fullname: OKI, Yutaka
  organization: Second Division, Department of Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan
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  fullname: INOUE, Tatsuhide
  organization: Diabetes and Endocrinology Center, Shizuoka General Hospital, Shizuoka, Japan
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  fullname: IMURA, Mitsuo
  organization: Department of Endocrinology and Metabolism, Yaizu City Hospital, Shizuoka, Japan
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  fullname: TANAKA, Tokutaro
  organization: Department of Neurosurgery, Seirei Hamamatsu General Hospital, Hamamatsu, Japan
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  fullname: GENMA, Rieko
  organization: Division of Endocrinology, Department of Internal Medicine, Seirei Hamamatsu General Hospital, Hamamatsu, Japan
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  fullname: IWABUCHI, Masayasu
  organization: Department of Endocrinology and Metabolism, Seirei Mikatahara General Hospital, Hamamatsu, Japan
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  organization: Department of Endocrinology and Metabolism, Shizuoka Hospital, Shizuoka, Japan
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  organization: Second Division, Department of Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan
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SubjectTerms Acromegaly
Acromegaly - drug therapy
Acromegaly - etiology
Adult
Aged
Delayed-Action Preparations - administration & dosage
Delayed-Action Preparations - adverse effects
Delayed-Action Preparations - therapeutic use
Drug Administration Schedule
Drug Monitoring
Female
Gigantism - drug therapy
Growth Hormone-Secreting Pituitary Adenoma - complications
Growth Hormone-Secreting Pituitary Adenoma - surgery
Hormone Antagonists - administration & dosage
Hormone Antagonists - adverse effects
Hormone Antagonists - therapeutic use
Human Growth Hormone - antagonists & inhibitors
Human Growth Hormone - blood
Humans
Insulin-like growth factor 1
Insulin-Like Growth Factor I - analysis
Japan
Male
Middle Aged
Octreotide
Octreotide - administration & dosage
Octreotide - adverse effects
Octreotide - therapeutic use
Pituitary Neoplasms - complications
Pituitary Neoplasms - surgery
Retrospective Studies
Time Factors
Treatment Outcome
Young Adult
Title Investigation into the Efficacy and Safety of Octreotide LAR in Japanese Patients with Acromegaly: Shizuoka Study
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