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)
A randomized, controlled, multicentre trial comparing pegvisomant alone with combination therapy of pegvisomant and long-acting octreotide in patients with acromegaly. [2009.10]
OBJECTIVE: For patients with acromegaly who are suboptimally controlled on long-acting octreotide (LAR), treatment options are to switch to pegvisomant monotherapy (PM) or add pegvisomant to LAR (P-LAR). Our objective was to evaluate if the safety and efficacy of these regimens differ... CONCLUSIONS: In patients suboptimally controlled on LAR, PM and P-LAR were equally well tolerated and effective in normalizing IGF-I, and overall clinical improvement was observed with both regimens. Thus, pegvisomant monotherapy and adjunctive therapy are equally viable options for the treatment of LAR-resistant acromegaly.
High-dose intramuscular octreotide in patients with acromegaly inadequately controlled on conventional somatostatin analogue therapy: a randomised controlled trial. [2009.08]
OBJECTIVE: In acromegaly, 25-50% of patients respond inadequately to conventional long-acting somatostatin analogue (SSA) therapy. Response may be improved by increasing SSA frequency or dose. This study evaluated the biochemical efficacy and safety of high-dose octreotide in patients with acromegaly. DESIGN: A 24-week prospective, multicentre, randomised, open-label trial conducted from 12 December 2005 to 23 October 2007 in patients with persistently uncontrolled acromegaly despite > or =6 month conventional SSA therapy... CONCLUSION: High-dose octreotide treatment is safe and effective (normalisation of IGF1 levels) in a subset of patients with active acromegaly inadequately controlled with long-term SSA. Individualised octreotide doses up to 60 mg/28 days may improve outcomes of SSA therapy.
Treatment of advanced hepatocellular carcinoma with long-acting octreotide: a phase III multicentre, randomised, double blind placebo-controlled study. [2009.07]
BACKGROUND: A previous study reported a significant survival benefit for octreotide compared with no treatment in patients with advanced hepatocellular carcinoma (HCC). This was investigated further in this multicentre study... CONCLUSIONS: In patients with advanced HCC, octreotide has a favourable safety profile but does not improve OS and could have a negative impact on quality of life.
Octreotide LAR vs. surgery in newly diagnosed patients with acromegaly: a randomized, open-label, multicentre study. [2009.05]
OBJECTIVE: This prospective randomized study evaluated the efficacy and safety of octreotide LAR vs. surgery in newly diagnosed acromegalic patients... CONCLUSION: This first randomized study in unselected patients indicates that the 48-week treatment outcome of octreotide LAR as first-line treatment of acromegaly does not significantly differ from surgery. As a complete response to surgery in GH-secreting macro-adenomas can be difficult, first-line therapy with octreotide LAR can be considered as a viable alternative for most patients with acromegaly, due to its low complication rate.
Terlipressin vs. octreotide in bleeding esophageal varices as an adjuvant therapy with endoscopic band ligation: a randomized double-blind placebo-controlled trial. [2009.03]
OBJECTIVES: Data are scarce on the head-to-head efficacy of terlipressin and octreotide as an adjuvant therapy to endoscopic management of variceal bleed. The aim of this study was to compare the efficacy and safety of terlipressin with octreotide as an adjuvant therapy to endoscopic variceal band ligation in patients with esophageal variceal bleeding... CONCLUSIONS: The efficacy of terlipressin was not inferior to octreotide as an adjuvant therapy for the control of esophageal variceal bleed and in-hospital survival. The length of hospital stay in the terlipressin group was significantly shorter but not of any clinical importance. The predictors of prolonged hospital stay were low hemoglobin, high pulse, prolonged prothrombin time, blood at nasogastric aspirate, and PSE.
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.
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.
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]
To determine the efficacy and safety of Sandostatin (octreotide) compared to placebo in
controlling diarrhea which is a manifestation or complication of documented HIV infection and
which is refractory (does not respond) to all known treatment classes.
The Safety & Efficacy of Terlipressin vs Octreotide for the Control of Variceal Bleed [Completed]
Terlipressin and Octreotide are two common agents used as adjuvants in the management of
variceal bleeding. Both agents have been claimed equivalent to endoscopic therapy in
randomized studies. There are no head to head clinical trials of these two agents available
in the literature. We aimed to compare the efficacy and safety of Terlipressin and Octreotide
in combination with Endoscopic Variceal band Ligation (EVL)in patients presenting with
Esophageal Variceal Bleed (EVB).
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