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Somatuline Depot (Lanreotide Acetate) - Summary

 
 



SUMMARY

Somatuline Depot (lanreotide) Injection 60, 90 and 120 mg is a prolonged-release formulation for deep subcutaneous injection containing the drug substance lanreotide acetate, a synthetic octapeptide with a biological activity similar to naturally occurring somatostatin, and water for injection.

Somatuline Depot (lanreotide) Injection 60 mg, 90 mg and 120 mg is indicated for the long-term treatment of 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 growth hormone (GH) and insulin growth factor-1 (IGF-1) levels to normal.


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NEWS HIGHLIGHTS

Published Studies Related to Somatuline Depot (Lanreotide)

Preoperative lanreotide treatment in acromegalic patients with macroadenomas increases short-term postoperative cure rates: a prospective, randomised trial. [2010.04]
OBJECTIVE: To investigate whether 4-month preoperative lanreotide treatment would improve the surgical cure rate of newly diagnosed acromegalic patients with macroadenomas. DESIGN: A prospective, randomised study... CONCLUSIONS: Pretreatment with lanreotide before transsphenoidal surgery improves surgical cure rates in patients with GH-secreting pituitary macroadenomas. Pretreatment does not affect surgical complications or duration of hospital stay (ClinicalTrials.gov number, NCT00993356).

Rapid and sustained reduction of serum growth hormone and insulin-like growth factor-1 in patients with acromegaly receiving lanreotide Autogel therapy: a randomized, placebo-controlled, multicenter study with a 52 week open extension. [2010]
The study was designed to evaluate the long-term efficacy and safety of the 28-day prolonged-release Autogel formulation of the somatostatin analogue lanreotide (Lan-Autogel) in unselected patients with acromegaly. The study comprised four phases: washout; a double-blind comparison with placebo, at a single randomized dose (60, 90 or 120 mg) of Lan-Autogel; a single-blind, fixed-dose phase for four injections (placebo group was re-allocated to active treatment); and eight injections with doses tailored according to biochemical response...

Effects of lanreotide SR and Autogel on tumor mass in patients with acromegaly: a systematic review. [2010]
Long-acting somatostatin analogs (SSA) are widely used for the treatment of acromegaly achieving biochemical control of the disease in 50-75% of the patients. One of the goals of the treatment of acromegaly is the control of tumor growth, especially in patients in whom SSAs are used as first-line therapy...

Randomized, placebo-controlled, double-blind study of the efficacy of lanreotide 30 mg PR in the treatment of pancreatic and enterocutaneous fistulae. [2009.12]
OBJECTIVE: Continuous intravenous infusion of somatostatin improves the natural course of digestive fistulae. Lanreotide 30 mg PR is a synthetic analogue of somatostatin with pharmacological activity extending to at least 10 days after intramuscular administration. Its effectiveness was assessed in patients with simple externalized digestive fistulae in a randomized, doubleblind, placebo-controlled study... CONCLUSION: Compared with placebo, intramuscular lanreotide 30 mg PR significantly decreases digestive fistulae output at Day 3 and shortens time to fistula closure by 9 days. ClinicalTrials.gov registration number: NCT00729313.

Lanreotide reduces the volume of polycystic liver: a randomized, double-blind, placebo-controlled trial. [2009.11]
BACKGROUND & AIMS: Therapy for polycystic liver is invasive, expensive, and has disappointing long-term results. Treatment with somatostatin analogues slowed kidney growth in patients with polycystic kidney disease (PKD) and reduced liver and kidney volume in a PKD rodent model. We evaluated the effects of lanreotide, a somatostatin analogue, in patients with polycystic liver because of autosomal-dominant (AD) PKD or autosomal-dominant polycystic liver disease (PCLD)... CONCLUSIONS: In patients with polycystic liver, 6 months of treatment with lanreotide reduces liver volume.

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Clinical Trials Related to Somatuline Depot (Lanreotide)

An Efficacy and Safety Study of Somatuline Depot (Lanreotide) Injection to Treat Carcinoid Syndrome [Recruiting]
The purpose of this study is to determine whether monthly injections of Somatuline Depot are effective and safe in controlling diarrhea and flushing in patients with carcinoid syndrome. In countries where Somatuline Depot is not approved, patients well controlled at the end of the open-label phase will be able to participate in a long-term open-label extension phase.

Prevention of Lymphorrhea by Lanreotide in Axillary Dissection for Breast Cancer [Recruiting]

Lanreotide Autogel in the Treatment of Symptomatic Polycystic Liver Disease [Recruiting]
An open-label, Phase II clinical study to evaluate the efficacy and safety of lanreotide autogel 90mg every 4 weeks in the treatment of symptomatic polycystic liver disease, including a dose escalation at month 6 to lanreotide autogel 120mg for non responders.

Somatostatin Analogues as a Volume Reducing Treatment of Polycystic Livers (RESOLVE) [Recruiting]
The aim of this study is to determine the effect of Lanreotide on polycystic liver and kidneys in patients with autosomal dominant polycystic kidney disease.

Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours [Recruiting]
The study will compare the difference between lanreotide Autogel and placebo on progression free survival in patients who have an endocrine tumour in the pancreas or intestines.

more trials >>

Reports of Suspected Somatuline Depot (Lanreotide) Side Effects

Vomiting (9)Nausea (9)Condition Aggravated (9)Diarrhoea (9)Pneumonia (8)Blood Glucose Decreased (8)Weight Decreased (7)Dehydration (7)Death (6)OFF Label USE (6)more >>


Page last updated: 2010-10-05

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