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

Abstract

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.Key words: Octreotide, Acromegaly, GH, Insulin-like growth factor 1 (Endocrine Journal 56: [1095][1096][1097][1098][1099][1100][1101] 2009) The mAjoriTy of patients with acromegaly suffer from pituitary adenoma, from which excessive secretion of GH induces a high incidence of pathological complications including maladaptive changes in the face and limbs, as well as diabetes mellitus, hypertension, hyperlipidemia, arteriosclerosis, and cardiovascular disorders [1]. According to a previous report, acromegaly increased the rate of mortality, while the cumulative survival rate of untreated patients was <40% over the last 20 years [2]. Observing the relationship between GH level and mortality, the 50% survival rate in three groups with GH levels of >5 μg/

Efficacy, safety, and pharmacokinetics of sustained-release lanreotide (lanreotide Autogel) in Japanese patients with acromegaly or pituitary gigantism

“…are similar to those of a study on octreotide LAR in Japanese patients with acromegaly [19]. Sub-analysis results stratified according to the presence or absence of prior treatment with octreotide and dopamine agonist showed similar efficacy of lanreotide Autogel regardless of the type of pretreatments.…”

Efficacy and safety of long-acting pasireotide in Japanese patients with acromegaly or pituitary gigantism: results from a multicenter, open-label, randomized, phase 2 study

“…There are a number of drugs available for the treatment of acromegaly such as SSAs, dopamine agonists, and growth hormone receptor antagonist [2]. Clinical data supporting efficacy and safety of first-generation SSAs, long-acting octreotide [21] and lanreotide Autogel [22], in Japanese patients with acromegaly have previously been reported. In most of the studies, the response rate in patients treated with first-generation SSAs ranges from 17% to 41% [2,[23][24][25].…”

Medical Management of Functioning Pituitary Adenoma: An Update

“… 32) A study of Japanese patients also showed the same results. 33) In those patients, the alternative or additional therapies may be required. Common but transient side effects include nausea, white stool, abdominal discomfort, and diarrhea.…”