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 (octreotide acetate for injectable suspension) is indicated for long-term maintenance therapy in acromegalic patients for whom medical treatment is appropriate and who have been shown to respond to and can tolerate Sandostatin® (octreotide acetate) Injection. The goal of treatment in acromegaly is to reduce GH and IGF-1 levels to normal. Sandostatin LAR® Depot can be used in patients who have had an inadequate response to surgery or in those for whom surgical resection is not an option. It may also be used in patients who have received radiation and have had an inadequate therapeutic response
(see CLINICAL TRIALS and DOSAGE AND ADMINISTRATION).
Sandostatin LAR® Depot is indicated for long-term treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid tumors in patients in whom initial treatment with Sandostatin® Injection has been shown to be effective and tolerated.
Sandostatin LAR® Depot is indicated for long-term treatment of the profuse watery diarrhea associated with VIP-secreting tumors in patients in whom initial treatment with Sandostatin® Injection has been shown to be effective and tolerated.
In patients with acromegaly, 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 Long Acting)
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.
Long-acting octreotide treatment causes a sustained decrease in ghrelin concentrations but does not affect weight, behaviour and appetite in subjects with Prader-Willi syndrome. [2008.10]
OBJECTIVE: Ghrelin is secreted primarily by the stomach and circulates as both acylated and desacyl ghrelin. Acylated (but not desacyl) ghrelin stimulates appetite. Both concentrations are elevated in Prader-Willi syndrome (PWS), suggesting that ghrelin may contribute to hyperphagia and overweight in these subjects. We evaluated whether long-acting octreotide (Oct) decreases acylated and desacyl ghrelin concentrations, body mass, appetite and compulsive behaviour towards food in adolescents with PWS. DESIGN: A 56-week prospective, randomized, cross-over trial... CONCLUSIONS: Oct treatment caused a prolonged decrease in ghrelin concentrations in adolescents with PWS but did not improve body mass or appetite. Future intervention studies aiming at clarifying the role of ghrelin in PWS should focus on the administration of specific inhibitors of ghrelin secretion or ghrelin receptor activity that do not interfere with other appetite-regulating peptides.
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]
To assess the efficacy of the combination of long-acting release (LAR) octreotide and tamoxifen (TMX) for the treatment of advanced hepatocellular carcinoma (HCC). A total of 109 patients with advanced HCC were randomised to receive octreotide LAR combined with TMX (n=56) (experimental treatment group) or TMX alone (n=53; control group)...
Clinical Trials Related to Sandostatin LAR Depot (Octreotide Long Acting)
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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