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Basic Information |
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Somatostatin
and Octreotide:
Proven control of growth hormone, IGF-I and gastrointestinal
hormone
Octreotide is a synthetic form of the brain hormone somatostatin.
The slow-release form of octreotide, Sandostatin® LAR®, controls
growth hormone (GH) and insulin-like growth factor I (IGF-I) and
reduces the size of tumours to help control symptoms of acromegaly.
In patients with gastro-entero-pancreatic neuroendocrine (GEP
NE) tumours or carcinoid tumours, Sandostatin® LAR® controls symptoms
by regulating gastrointestinal hormone secretion.
The indications for Sandostatin® LAR® are:
Acromegaly
Patients with acromegaly who are adequately controlled on subcutaneous
(SC) Sandostatin®, and in whom surgery or radiation therapy is
inappropriate or ineffective (or not yet fully effective).
Symptoms of GEP
NE tumours
Patients with functional GEP NE tumours in whom symptoms are adequately
controlled on SC Sandostatin®. This includes patients with carcinoid
tumours or other types of GEP NE tumours (NB Not all tumour types
are approved in all countries):
- Vasoactive intestinal peptide tumours (VIPomas)
- Glucagonomas
- Gastrinomas (Zollinger-Ellison syndrome)
- Insulinomas-for pre-operative control of hypoglycemia as well
as maintenance therapy
- GRFomas
Most adverse events for Sandostatin® LAR®-including pain on injection-are mild-to-moderate and short-term. In addition, there is no need for monthly blood tests to monitor liver enzymes during post-treatment. |
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Slow-release octreotide: Sandostatin® LAR®
Sandostatin® LAR® maintains all of the clinical and pharmacological characteristics of the immediate-release dosage form (SC Sandostatin® Injection), with the added feature of slow release of octreotide from the site of injection, reducing the need for frequent administration. This slow release occurs as the polymer containing octreotide acetate biodegrades, primarily through hydrolysis.
With its slow release pharmacokinetic profile
compared to Sandostatin® Injection, Sandostatin® LAR® can be administered
once a month instead of 3 times a day, which
may lead to enhanced patient compliance.
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Working at the tumour site
Proven efficacy to control the "Critical
4" in acromegaly Sandostatin® LAR® is an established first-line
medical therapy that meets all 4 goals in treating
acromegaly. It works at the site of the tumour and binds to
the somatostatin receptors subtype-2 (sst-2 receptor) and subtype-5
(sst-5 receptor)* to reduce GH and IGF-I levels within normal ranges
in most patients.5 Sandostatin® LAR® also has been reported
to cause tumour shrinkage in most patients, and maintains long-term
hormonal suppression6 to stop hormone hypersecretion
where it starts. Sandostatin® LAR® is reported to significantly
reduce heart rate, normalizes left ventricular mass, improves left
ventricular ejection fraction, and increases exercise capacity and
duration.7
*80% of GEP NE tumours express SST-2, and 77% express sst-5.8
Potent sst activation in GEP NE tumours
Sandostatin® LAR® offers proven efficacy to control debilitating
symptoms of GEP
NE tumours. It works at the site of the tumour, binding to
SST-2 and SST-5 receptors to regulate gastrointestinal hormone
secretion and has been reported to affect tumour growth-providing
better disease control for patients.9-11
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Benefits
of Sandostatin® LAR®
In treating acromegaly:
Octreotide vs. lanreotide
ST·E·L·LAR® (STudy comparing the Efficacy of Lanreotide SR and octreotide
LAR® in patients with acromegaly) is the largest published study
to directly compare Sandostatin® LAR® and lanreotide SR in patients
with acromegaly. (Lanreotide is another type of somatostatin analogue,
and is available as an extended-release aqueous solution and a long-acting
microparticle formulation12).
The ST·E·L·LAR® trial was a prospective, open, controlled study
of 125 patients from France, Spain, and Germany. All patients
were switched from pre-trial lanreotide SR-at either day 1 or
month 4 of the study-to 20 mg per month of Sandostatin® LAR® for
at least 3 months. Results of the study showed:
| Switching to Sandostatin® LAR® resulted in significantly more patients with normal mean GH:
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- 69% of patients treated with Sandostatin® LAR® achieved
GH < 2.5 µg/L compared with 54% of patients treated with lanreotide
SR.13
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- 35% of patients treated with Sandostatin®
LAR® achieved GH levels <1 µg/L, compared with only 14%
of patients treated with lanreotide SR.14
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Switching to Sandostatin® LAR® resulted in significantly more
patients with normalized IGF-I levels: |
- 65% of patients achieved normalized IGF-I concentrations,
compared with 48% of patients treated with lanreotide SR.15
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Once-a-month therapy with Sandostatin® LAR® offered patients
a more convenient dosing schedule than the every- 10-to-14-day-schedule
offered by lanreotide SR.
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A meta-analysis of published clinical studies designed to establish
the efficacy of Sandostatin® LAR® and lanreotide AR in providing
biochemical control and tumor shrinkage in patients with acromegaly
showing the following14.
The meta-analysis included 44 clinical trials in which secondary
Sandostatin® LAR® or lanreotide SR had been administered to patients
for >= 3 months, or in which Sandostatin® LAR®, lanreotide
SR or Sandostatin® sc had been administered as a primary treatment
(no other prior therapy). The extent to which the treatments met
biochemical efficacy criteria was compared, as was their comparative
efficacy in shrinking pituitary tumours. The results showed:
- A significantly higher proportion of patients treated with
Sandostatin® LAR® than lanreotide
SR met criteria for efficacy based on GH and IGF-I levels (p=0.01
and p=0.0009, respectively).
- In patients given somatostatin analogs as secondary or primary
treatment, pituitary tumor shrinkage >10% occurred in a greater
proportion of Sandostatin® LAR® vs.
lanreotide-SR-treated patients (p<0.0001)
Octreotide vs. other drug therapies
Click
here
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In treating GEP NE tumours:
Octreotide vs. lanreotide
Click here |
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Sandostatin® LAR® Safety Information
In clinical studies, many patients on long-term treatment developed gallstones, although few patients required treatment. Patients may experience nausea, abdominal pain, gas, constipation, vomiting, pain on injection, and high or low blood sugar levels.
As an example of prescribing information for Sandostatin® LAR®, click here for the Novartis Core Labeling Text.
Please note that this information may not be consistent with that registered in your country. For detailed information, contact your local Novartis representative. The most commonly used trade name is Sandostatin® LAR®. Other trade names in certain countries are Sandostatin® LAR®-Monatsdepot®, Sandostatine LP® and Sandostatina LAR®
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