Sandostatin (Octreotide Acetate) - Summary

SANDOSTATIN SUMMARY

Sandostatin®

Sandostatin^® (octreotide acetate) Injection, a cyclic octapeptide prepared as a clear sterile solution of octreotide, acetate salt, in a buffered lactic acid solution for administration by deep subcutaneous (intrafat) or intravenous injection.

Sandostatin^® (octreotide acetate) is indicated to reduce blood levels of growth hormone and IGF-I (somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. The goal is to achieve normalization of growth hormone and IGF-I (somatomedin C) levels (see DOSAGE AND ADMINISTRATION). In patients with acromegaly, Sandostatin^® (octreotide acetate) reduces growth hormone to within normal ranges in 50% of patients and reduces IGF-I (somatomedin C) to within normal ranges in 50%-60% of patients. Since the effects of pituitary irradiation may not become maximal for several years, adjunctive therapy with Sandostatin^® (octreotide acetate) to reduce blood levels of growth hormone and IGF-I (somatomedin C) offers potential benefit before the effects of irradiation are manifested.

Improvement in clinical signs and symptoms or reduction in tumor size or rate of growth were not shown in clinical trials performed with Sandostatin^® (octreotide acetate); these trials were not optimally designed to detect such effects.

Sandostatin^® (octreotide acetate) is indicated for the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease.

Sandostatin^® (octreotide acetate) studies were not designed to show an effect on the size, rate of growth or development of metastases.

Sandostatin^® (octreotide acetate) is indicated for the treatment of the profuse watery diarrhea associated with VIP-secreting tumors. Sandostatin^® (octreotide acetate) studies were not designed to show an effect on the size, rate of growth or development of metastases.

SANDOSTATIN NEWS HIGHLIGHTS

Published Studies Related to Sandostatin (Octreotide)

Comparison of octreotide and standard therapy versus standard therapy alone for the treatment of sulfonylurea-induced hypoglycemia. [2008.04]

Prophylactic octreotide and delayed gastric emptying after pancreaticoduodenectomy: Results of a prospective randomized double-blinded placebo-controlled trial. [2008.02.23]

Octreotide enhances portal pressure reduction induced by propranolol in cirrhosis: a randomized, controlled trial. [2007.10]

Efficacy of the combination of long-acting release octreotide and tamoxifen in patients with advanced hepatocellular carcinoma: a randomised multicentre phase III study. [2007.09.03]

Comparison of Octreotide and Standard Therapy Versus Standard Therapy Alone for the Treatment of Sulfonylurea-Induced Hypoglycemia. [2007.08.29]

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Clinical Trials Related to Sandostatin (Octreotide)

A Multicenter Placebo-Controlled Double Blind Study to Evaluate the Efficacy and Safety of Sandostatin ( SMS 201-995 ) in Patients With Acquired Immunodeficiency Related Diarrhea Who Were Either "Responders" or "Non-Responders" in a Prior Placebo-Controlled Double-Blind Sandostatin Study. [Completed]

Pegvisomant And Sandostatin LAR Combination Study [Completed]

Preoperative Octreotide Treatment of Acromegaly [Active, not recruiting]

A Multicenter Placebo-Controlled Dose Titration Study to Evaluate the Efficacy and Safety of Sandostatin (SMS 201-995) in the Treatment of Patients With Acquired Immunodeficiency Related Diarrhea [Completed]

The Safety & Efficacy of Terlipressin vs Octreotide for the Control of Variceal Bleed [Completed]

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