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.
Clinical Trials Related to Somatuline Depot (Lanreotide)
SOMATULINE Autogel 90 mg IN DUMPING SYNDROME [Recruiting]
Assessment of the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel [Completed]
The purpose of this study is to determine whether subjects with acromegaly (or their
partners) are able to self administer Somatuline Autogel at home.
A Pilot Study of Pre- and Post-operative Use of Somatuline Depot. [Recruiting]
If someone is diagnosed with a pituitary tumor that causes acromegaly (too much growth
hormone) the treatment is to have it surgically removed. This study has two phases.
The first phase provides medical treatment with a drug that will be provided for 3 months
before surgery to see if complications of surgery are reduced and to see whether or not
remission improves following surgery if you have this medical treatment. The drug
administered is approved by the FDA for long-term treatment of acromegaly. It is not
routinely administered before surgery, and is therefore experimental as used in this way.
All other procedures performed during this research are standard of care with the exception
of the 3 questionnaires to be completed at each visit.
The second phase of this study is from 3 months until 12 months after surgery and is only
for people who do not go into remission after the operation. This phase assesses the
possible remission of acromegaly after resuming the drug treatment for an additional 3 to 9
months. The drug will be prescribed by your physician as part of your regular medical care
and will not be included as part of the study. All other procedures performed during this
research are standard of care with the exception of the 3 questionnaires to be completed at
each visit.
The study lasts approximately 16 months - 3 month before surgery and 12 months after
surgery.
An Efficacy and Safety Study of Somatuline Depot (Lanreotide) Injection to Treat Carcinoid Syndrome [Active, not 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 [Active, not 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.
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 >>
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Page last updated: 2010-10-05
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