The AACE guidelines (PDF 93KB) conclude that surgery remains the usual first course of therapy, particularly for patients with microadenomas or with symptoms requiring tumor decompression. Medical options include somatostatin analogues such as Sandostatin® LAR (octreotide acetate for injectable suspension) Depot, which control hypersecretion at the site of the tumor where hormone overproduction starts, and GH receptor antagonists (GHRAs), such as pegvisomant, which act peripherally. Sandostatin® LAR Depot is proven to shrink tumors in acromegaly. This guideline confirms that somatostatin analogues benefit patients with persistently nonsuppressible GH and high IGF-1 levels after a pituitary surgical procedure. The guidelines reserve radiotherapy for those patients whose hormone levels fail to normalize after medical therapy. Effective medical therapy provides clinicians with the ability to aggressively manage patients with persistently active acromegaly1.
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Surgery
Surgery is the first course of action recommended for most patients. The goal of surgery is to remove the tumor and normalize GH and IGF-1 levels. If successful, hormone control is reestablished. If not, medical therapy may be the next choice2-4.
| Surgery Advantages5 | Disadvantages5 |
|---|---|
| Possible cure if tumor is completely removed | Success depends on size and location of tumor |
| Possible GH and IGF-1 control, as well as symptom relief, even if resection is incomplete | Invasive procedure |
| May be surgical complications |
Medical Therapy
Somatostatin Analogues (SAs)
When patients have an inadequate response to surgery or if surgery is not an option, the mainstay for medical treatment is a class of drugs known as somatostatin analogues. Somatostatin analogues, including Sandostatin® and long-acting Sandostatin® LAR Depot, work directly at the site of the pituitary tumor by shutting off the hormones that cause the symptoms of acromegaly.
Sandostatin®* has been used in clinical practice for 20 years, with over 600,000 patient-years of experience and over 600 clinical trials6-8.† Sandostatin® LAR is the only somatostatin analogue proven to reduce tumor volume in patients with acromegaly. Somatostatin analogues may also be used instead of surgery in patients at risk for complications from anesthesia, patients with heart or lung complications, or patients whose tumors are large but not next to the optic nerve2,9-11.
*Combined use of immediate release Sandostatin® Injection and Sandostatin® LAR Depot for all approved indications.
†Includes both ongoing and completed trials for all approved indications.
|
Somatostatin Analogue Advantages5 |
Disadvantages11 |
|---|---|
| Control of hypersecretion at the site of the tumor where hormone overproduction starts | Patients may not tolerate possible side effects |
| Reduces GH and IGF-1 levels in the majority of patients | Ongoing cost |
| Improves symptoms | |
| Can be administered as once-a-month therapy | |
| Long-term safety profile |
GH Receptor Antagonists11
For select patients, GHRAs may be prescribed. These include patients in whom mainstay treatments such as surgery, somatostatin analogues, and dopamine agonists have proven ineffective or poorly tolerated, or those whose IGF-1 levels are extremely high.
| GHRA: Advantages5 | Disadvantages5 |
|---|---|
| Reduces IGF-1 levels | No long-term safety experience |
| Improves symptoms | |
| Does not control GH levels | |
| Ongoing cost | |
| Patients may not tolerate possible side effects |
Dopamine Agonists
Patients also may be prescribed drugs called dopamine agonists. These agents work on dopamine receptors to inhibit GH release from the tumor11.
|
Dopamine Agonist Advantages11 |
Disadvantages11 |
|---|---|
| Improves symptoms | Patients may not tolerate possible side effects |
| Tolerable by some patients who cannot tolerate other medical therapies | Ongoing cost |
Radiotherapy
Radiotherapy involves the use of radiation to kill rapidly growing tumor cells. After radiation, tumors typically stop growing and may even begin to shrink; however, elevated hormone levels fall much more slowly. Medical therapy with an SA is often needed to normalize hormone levels and control symptoms before radiation starts to work11.
| Radiotherapy Advantages11 | Disadvantages11 |
|---|---|
| Reduces GH and IGF-1 levels | Takes a long time to show effectiveness |
| Relatively few side effects | Potential for pituitary and optic nerve damage |
| One-time cost | Risk of secondary malignancy5 |
Important Safety Information
Carcinoid Syndrome:
Sandostatin® LAR Depot (octreotide acetate for injectable suspension) is indicated for long-term treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid tumors and for the long-term treatment of the profuse watery diarrhea associated with VIP-secreting tumors in patients in whom initial treatment with immediate release Sandostatin® (octreotide acetate) Injection has been shown to be effective and tolerated.
Important Safety Information:
As with immediate release Sandostatin® Injection, the most frequently reported drug-related adverse events were biliary disorders (62%), gastrointestinal disorders (14% to 38%), and injection-site pain (20% to 50%). Hypoglycemia (4%), hyperglycemia (27%), sinus bradycardia (19%), conduction abnormalities (9%), and arrhythmias (3%) have been reported.
The controlled clinical trials that support the marketing clearance for Sandostatin® LAR Depot did not include determination of effect on tumor size or rate of growth. Sandostatin® LAR Depot is not indicated for tumor shrinkage.
Acromegaly
Sandostatin® LAR Depot (octreotide acetate for injectable suspension) is indicated for long-term maintenance therapy in 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 GH and IGF-1 levels to normal.
Important Safety Information:
As with immediate release Sandostatin® Injection, the most frequently reported drug-related adverse events were biliary disorders (52%), gastrointestinal disorders (7% to 36%), and injection-site pain (2% to 11%). Hypoglycemia (2%), hyperglycemia (15%), and hypothyroidism (2%) have been reported. While not measured in acromegalic patients receiving Sandostatin® LAR Depot, ECG changes have been reported in patients receiving immediate release Sandostatin® Injection; the degree to which these abnormalities are related to octreotide acetate is not clear, as many acromegalics have cardiovascular disease. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
