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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.


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NEWS HIGHLIGHTS

Published Studies Related to Sandostatin (Octreotide)

Randomised clinical trial: the safety and efficacy of long-acting octreotide in patients with portal hypertension. [2012]
Class A or B cirrhosis and small oesophageal varices... CONCLUSIONS: The absence of significant haemodynamic benefit, as well as the high

Is Octreotide Treatment Useful in Patients with Congenital Chylothorax? [2011.11.10]
Background: Congenital chylothorax (CC) is a severe congenital disorder characterized by the collection of chyle in the pleural space...

Octreotide for the treatment of diarrhea in patients with ileal pouch anal anastomosis: a placebo controlled cross-over study. [2011.09.23]
Background and aim: Diarrhea and urgency is a debilitating long term complication of ileal pouch anal anastomosis (IPAA) after a proctocolectomy... Conclusion: Octreotide has no clear beneficial effect on the stool pattern nor on pouchitis severity in patients with high stool frequency after IPAA.

Serum angiotensin I-converting enzyme levels and the therapeutic effects of octreotide in esophageal variceal hemorrhage. [2011.07]
INTRODUCTION: The aim of this study is to investigate the relationship between serum angiotensin I-converting enzyme (ACE) levels and therapeutic effects of octreotide in the treatment of esophageal variceal hemorrhage (EVH) as a result of liver cirrhosis... CONCLUSIONS: Octreotide treatment in patients with EVH can result in decreased serum ACE levels, which correlated with the dose of octreotide. The decline in serum ACE levels may be involved in the mechanisms by which octreotide lowers portal vein pressure in EVH treatment.

Six-month preoperative octreotide treatment in unselected, de novo patients with acromegaly: effect on biochemistry, tumour volume, and postoperative cure. [2011.06]
OBJECTIVE: Treatment with somatostatin analogues is the primary medical treatment of acromegaly. Controversies still exist whether acute octreotide effect predicts long-term biochemical effects, tumour regression or surgical cure. This prospective study investigates effect of 6-month treatment with octreotide long-acting repeatable (LAR) on insulin-like growth factor-1 (IGF-1) and growth hormone (GH) levels, pituitary function, tumour regression and postoperative cure in de novo acromegalic patients... CONCLUSION: Six months of long-acting octreotide using a fixed dose, 1/3 of the patients came in biochemical remission, while 2/3 had significant tumour reduction. Moreover, an acute effect of octreotide seemed to be a prerequisite for long-term effect. (c) 2011 Blackwell Publishing Ltd.

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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]
The primary objective of this study is to determine the relapse rate in patients with AIDS-related diarrhea who were found to be "Responders" in a previous placebo-controlled,

double-blind study of Sandostatin (Study #D203 - FDA 102A).

The secondary objectives include: 1) To evaluate clinical efficacy and safety of open-label

Sandostatin in patients who were "Non-Responders" in Study #D203 - FDA 102A; 2) To evaluate

the efficacy and safety of Sandostatin during prolonged open-label treatment in "Responders"

from Study #D03 - FDA 102A.

Pegvisomant And Sandostatin LAR Combination Study [Completed]
The purpose of this study is to compare the safety and tolerability of combination therapy with Sandostatin LAR plus Pegvisomant to that of Sandostatin LAR alone or Pegvisomant alone.

Combination of Bevacizumab, Pertuzumab, and Sandostatin for Adv. Neuroendocrine Cancers [Recruiting]
The purpose of this Phase II trial will be to define the activity of a VEGF inhibitor bevacizumab, HER1/HER2 inhibitor pertuzumab, and sandostatin for patients with advanced neuroendocrine cancers. In particular, the efficacy of bevacizumab and pertuzumab treatment is of great interest. The primary endpoint of this trial will be response rate. Toxicity and progression-free survival will be obtained and evaluated.

Preoperative Octreotide Treatment of Acromegaly [Active, not recruiting]
The purpose of this study is to investigate whether 6 months preoperative treatment with the somatostatin analogue octreotide improves the surgical outcome in patients with acromegaly.

Effects of Sandostatin LAR´┐Ż in Acromegaly [Recruiting]
This study aims primarily to determine the effect Insulin-like Growth Factor 1 (IGF1) normalization into current IGF1 normal ranges with Sandostatin LAR« therapy on biochemical metabolic, cardiovascular and body composition parameters in patients with active acromegaly.

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Reports of Suspected Sandostatin (Octreotide) Side Effects

Diarrhoea (121)Malaise (88)Abdominal Pain (79)Asthenia (70)Fatigue (68)Nausea (68)Vomiting (60)Injection Site Pain (58)Flushing (52)Blood Pressure Increased (48)more >>


Page last updated: 2013-02-10

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