Sandostatin LAR Depot (Octreotide Acetate Long Acting) - Summary

SUMMARY

Octreotide is the acetate salt of a cyclic octapeptide. It is a long-acting octapeptide with pharmacologic properties mimicking those of the natural hormone somatostatin.

Sandostatin LAR Depot 10 mg, 20 mg, and 30 mg is indicated in patients in whom initial treatment with Sandostatin Injection has been shown to be effective and tolerated.

Acromegaly

Long-term maintenance therapy in acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option. The goal of treatment in acromegaly is to reduce GH and IGF-1 levels to normal [see Clinical Studies and Dosage and Administration].

Carcinoid Tumors

Long-term treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid tumors.

Vasoactive Intestinal Peptide Tumors (VIPomas)

Long-term treatment of the profuse watery diarrhea associated with VIP-secreting tumors.

Important Limitations of Use

In patients with carcinoid syndrome and VIPomas, the effect of Sandostatin Injection and Sandostatin LAR Depot on tumor size, rate of growth and development of metastases, has not been determined.

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NEWS HIGHLIGHTS

Published Studies Related to Sandostatin LAR Depot (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

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.

Objective radiological disease control with Sandostatin monotherapy in metastatic neuroendocrine tumours. [2010.06]
Conventional cytotoxic chemotherapy is not usually effective in neuroendocrine tumours (NET)... Further investigation in prospective trials is warranted and the possibility for late responses might have implications for trial design.

Octreotide acetate in prevention of chemoradiation-induced diarrhea in anorectal cancer: randomized RTOG trial 0315. [2010.04.21]
BACKGROUND: In anorectal cancer patients, an acute side effect of chemoradiotherapy is gastrointestinal toxicity, which often impedes treatment delivery. Based on previous trials, octreotide acetate is widely recommended for the control of chemotherapy-induced diarrhea. However, the effectiveness of octreotide in preventing or controlling radiation- and chemoradiation-induced diarrhea is not known... CONCLUSION: In this study, the prophylactic use of LAO did not prevent the incidence or reduce the severity of diarrhea and had no notable impact on patient-reported bowel function or QoL.

A randomized, double-masked controlled clinical trial of Sandostatin long-acting release depot in patients with postsurgical cystoid macular edema. [2010.01]
PURPOSE: The purpose of this study was to evaluate the safety and efficacy of octreotide, a somatostatin analog, for treatment of postsurgical cystoid macular edema... CONCLUSION: Although there were no statistically significant differences between both groups in retinal thickening or angiographic leakage, octreotide-treated patients were more likely to experience a > or =2-line improvement in visual acuity. However, this observation cannot be generalized because of the small sample size.

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Clinical Trials Related to Sandostatin LAR Depot (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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