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Somatuline Depot (Lanreotide Acetate) - 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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Media Articles Related to Somatuline Depot (Lanreotide)

Clinical Practice Guideline on acromegaly - condition caused by excess growth hormone
Source: Endocrinology News From Medical News Today [2014.11.03]
The Endocrine Society has issued a Clinical Practice Guideline (CPG) for the diagnosis and treatment of acromegaly, a rare condition caused by excess growth hormone in the blood.

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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.

Study of Lanreotide to Treat Polycystic Kidney Disease [Recruiting]
Autosomal dominant polycystic kidney disease (ADPKD) is characterized by progressive cyst formation in both kidneys, in most patients leading to end stage renal disease. It is the most common hereditary renal disease with a prevalence of approximately 1 in 1,000 persons. The majority of patients also have progressive cyst formation in the liver, leading to pain, gastrointestinal discomfort and sometimes the need for liver transplantation. At present there is no proven therapeutic intervention to slow the rate of disease progression in human ADPKD. The development of renoprotective treatments that are well tolerated, is therefore of major importance.

In this respect, somatostatin analogues are promising for especially polycystic liver disease, but also for the renal phenotype. However, the studies that have been performed thus far with these agents, were underpowered and of too short duration to reach a definitive conclusion on the potential reno- and hepatoprotective efficacy of somatostatin analogues. Therefore, the present study is designed as a randomised clinical trial with sufficient duration of follow-up to investigate whether the somatostatin analogue Lanreotide slows progression of polycystic kidney and liver disease in ADPKD-patients.

To this end, 300 ADPKD patients, aged 18-60years, with an eGFR 30-60 ml/min/1. 73 m2) will be randomized 1: 1 to standard care or monthly subcutaneous lanreotide injections on top off standard care. These 300 subjects will go through 15 study visits in 3 years and 1 follow up visit. During these visits, questionnaires will be filled in, physical examinations will be performed, blood will be drawn and urine collected. After study completion, rate of renal function decline in lanreotide treated subjects will be compared to that of subject who received standard care.

Somatuline´┐Ż Depot (Lanreotide) for Acromegaly Post-Marketing Observational Study [Recruiting]
To assess the safety and effectiveness of Somatuline« Depot (lanreotide) Injection when administered by a health care professional (HCP), the patient, the patient's partner or parent/guardian as part of their routine acromegaly care.

Lanreotide Autogel Treatment of Patients With Congenital Hyperinsulinism of Infancy [Recruiting]
The purpose of our study is to evaluate the efficacy and safety of Lanreotide Autogel in children with congenital hyperinsulinism already treated with Octreotide by pump.

Congenital hyperinsulinism is a genetic disorder characterized by inappropriate insulin secretion resulting in persistent hypoglycemia (low blood sugars. Patients exposed to recurrent hypoglycemic episodes are at increased risk of developmental disorders, so identification and prompt management of patients are essential. Many patients are treated with the somatostatin analog Octreotide which is administered by continuous infusion using a pump (we use an insulin pump). This treatment may pose a huge burden and be stressful for patients and families as it demands intensive daily care. In an effort to simplify the daily care of our patients and improve their quality of life we will study the efficacy and safety

of Lanreotide Autogel - a long-acting somatostatin analog that can be administered by

injection once a month

Influence of Somatuline Autogel 120mg on Post-operative Drainage After Total Mesorectum Excision for Rectumcarcinoma [Recruiting]
Total mesorectal excision (TME) is a precise dissection of the rectum and all para-rectal lymph nodes within the mesorectal envelope. It is becoming universally recognized and accepted as the standard technique for surgical excision of rectum carcinomas. TME results in lowest rates of local recurrence, especially when combined with pre-operative chemo-radiotherapy.

Especially after pre-operative chemo-radiotherapy, the post-operative drainage may be important. The quick decrease of this drainage will enable the early mobilisation of the patient and may shorten the time of hospitalization. If this decrease in fluid production can be achieved, it will have a positive effect on the Quality of Life of the patient and will ensure health economic savings by reduction of hospitalization time and resources.

Somatostatin analogues have shown to be able to decrease the secretion of numerous types of bodily fluids.

The aim of this study is to investigate if lanreotide Autogel 120mg is capable to reduce the fluid discharge in patients that underwent a TME for rectumcarcinoma.

Lanreotide Autogel 120mg compared to placebo, administered post-surgery on the fluid discharge in the drain of the patient that underwent a total mesorectum excision (TME) for rectal carcinoma. Patient planned to have a TME will be asked to participate in the study. When they have provided written informed consent, they will be randomized 1: 1 to receive either placebo or lanreotide autogel 120mg. Drain fluid will be checked for hematocrit daily post-surgery. Once hematocrit levels of the drain fluid are <10%, study medication or placebo will be administered. After administration the volume of the drain fluid will be measured every 12 hours for at least 5 days. A sample of the drain fluid will be collected

every 24 hours for at least 5 days and frozen at - 70┬░C for total protein content, sodium and

chloride analysis afterwards. If the patient has a hematocrit >10% in his drain fluid for a period of 5 days, this patient can not be randomized.

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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: 2014-11-03

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