Sandostatin (Octreotide Acetate) - Summary

SANDOSTATIN SUMMARY

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)

Study to Evaluate the Efficacy and Safety of Sandostatin LAR at High Dose or in Combination Either With GH-receptor Antagonist or Dopamine-agonist in Acromegalic Patients [Completed]
This study will assess the efficacy of 8 months treatment of Sandostatin® LAR® High Dose monotherapy or Sandostatin® LAR® High Dose in combination either with growth hormone antagonist or dopamine agonist to control biochemical parameters (GH and insulin-like growth factor I [IGF I]) of acromegalic patients not achieving biochemical normalization at conventional regimen.

Ultrasound Guided Sandostatin LAR Injection in Acromegaly [Recruiting]
The purpose of this study is to determine the difference in drug levels of Sandostatin after IM injection of Sandostatin LAR without ultrasound guidance (as is the standard of care) compared to drug levels of Sandostatin after IM injection of Sandostatin LAR with ultrasound guidance in subjects with Acromegaly.

Combination of Bevacizumab, Pertuzumab, and Sandostatin for Adv. Neuroendocrine Cancers [Active, not 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.

Sandostatin in the Prevention of Postoperative Complications After Pancreaticoduodenectomy [Active, not recruiting]
pancreaticoduodenectomy (PD) is the standard operation for treatment of patients with benign and malignant pancreatic and periampullary diseases. Despite improved surgical technique and postoperative care, the mortality rate after PD is high reaching up to 30%, due to high incidence of postoperative complications . Pancreatic fistula (PF) is the one of the most frequent complications of PD and the major contributor to postoperative morbidity The aim of this study to evaluate the effect of the perioperative octreotide use after PD for prevention of the postoperative pancreatic fistula. The secondary outcomes are overall postoperative complications, mortality and the cost benefit relationship of the use of the perioperative octreotide.

Effects of Sandostatin LAR® in Acromegaly [Active, not 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 >>