Acromegaly: A complex hormonal disorder

The cause and epidemiology of acromegaly

Acromegaly is a rare disorder caused by an adenoma on the pituitary gland that causes the hypersecretion of growth hormone (GH) into the bloodstream. In turn, GH stimulates the production of another hormone in the liver, insulin-like growth factor 1 (IGF-1).1

In the US, overall annual incidence rates were ~11 cases per million person-years (2008-2012), with an overall prevalence of ~78 cases per million each year. Given the rarity of acromegaly, combined with the slow onset of a variety of clinical features—including skeletal and soft tissue growth of the face, hands, and feet; severe sweating; arthritis; headaches; and in some patients, visual field loss—diagnosis may be delayed by 4 to 7 years, and in some cases, 10 or more years.2-4

In addition, as acromegaly is associated with a number of comorbidities, diagnosis and early treatment are important.5

Signs of acromegaly: Recognizing it can be difficult

The outward effects of acromegaly can happen so slowly even family members may not notice.

Common signs of acromegaly may include:

  • Enlarged tongue, lips, or nose
  • Enlarged hands and/or feet
  • Prognathism (enlarged lower jaw)
  • Headaches
  • Coarse, oily, thickened skin
  • Excessive sweating & body odor
  • Abnormal bone growth in the face
  • Sleep apnea (severe snoring)
  • Numerous skin tags
  • Aching joints
  • Fatigue
  • Increased chest size (barrel chest)

Diagnosing acromegaly

As stated earlier, due to its slow evolution, seemingly unrelated symptoms, and rarity in the population, recognizing and diagnosing acromegaly may take years. However, while the outward features of acromegaly may appear benign, the severity of its more systemic effects would suggest the need for a more rapid approach to confirming a diagnosis.5,6

An accurate diagnosis of acromegaly should include:

  • Clinical observation6
  • Systemic evaluation6
  • Biochemical screening of growth hormones
    • IGF-1, a marker of integrated GH secretion, whose levels are relatively stable and highly reliable7,8
    • GH, although not by using random levels, which can vary, but by conducting a glucose tolerance test to confirm hyperglycemia and discover a lack of suppression of GH to <1 ug/L7
  • Magnetic resonance imaging (MRI) to confirm the presence, size, location, and invasiveness of a pituitary tumor7

Therapies for treating acromegaly

Surgery, medical therapy, and radiotherapy have positives and negatives that should be considered carefully. Surgery is considered the mainstay of therapy for most patients, with medication reserved for patients with persistent excess GH secretion uncontrolled by surgery. However, in patients for whom surgery is not an option, medication may be primary therapy. Radiotherapy is currently considered a third line of treatment.4

The goal is to normalize excessive hormone secretion of GH and IGF-1, to reduce the clinical signs and symptoms of acromegaly, as well as to reduce the size of the tumor itself, to alleviate symptoms resulting from the tumor mass.9

Surgical removal or reduction of the tumor

The first line of therapy is usually transsphenoidal surgery (TSS) by an experienced neurosurgeon, especially for small tumors. The expertise of the surgeon is crucial to the outcome, with better results seen from dedicated pituitary surgeons, extending even to lower complications post surgery. However, overall cure rates remain low because patients with these tumors usually present at an incurable stage.4,9

Radiotherapy (RT)

RT may be used as adjunctive therapy after unsuccessful surgery, and while it can lower GH levels and normalize IGF-1 levels, the effects may take years to achieve. In addition, a common complication of RT is the development of new hypopituitarism.9

The success of current medical therapies for acromegaly has led physicians to reserve RT for patients who are resistant to or intolerant of these therapies or for controlling an expanding tumor mass despite surgery.9

Managing acromegaly with medication

Many patients with acromegaly—including some who have had surgery—need to take medication in order to achieve disease control. Currently, there are 3 types of medications used to treat acromegaly.4

  • Somatostatin analog (SSA)
  • Growth hormone receptor antagonist (GHRA)
  • Dopamine agonist (DA)



Important Safety Information and Indication


  • SOMATULINE DEPOT is contraindicated in patients with hypersensitivity to lanreotide. Allergic reactions (including angioedema and anaphylaxis) have been reported following administration of lanreotide.

Warnings and Precautions

  • Cholelithiasis and Gallbladder Sludge
    • SOMATULINE DEPOT may reduce gallbladder motility and lead to gallstone formation.
    • Periodic monitoring may be needed.
  • Hypoglycemia or Hyperglycemia
    • Pharmacological studies show that SOMATULINE DEPOT, like somatostatin and other somatostatin analogs, inhibits the secretion of insulin and glucagon. Patients treated with SOMATULINE DEPOT may experience hypoglycemia or hyperglycemia.
    • Blood glucose levels should be monitored when SOMATULINE DEPOT treatment is initiated, or when the dose is altered, and antidiabetic treatment should be adjusted accordingly.
  • Cardiovascular Abnormalities
    • SOMATULINE DEPOT may decrease heart rate. In cardiac studies with acromegalic patients, the most common cardiac adverse reactions were sinus bradycardia, bradycardia, and hypertension.
    • In patients without underlying cardiac disease, SOMATULINE DEPOT may lead to a decrease in heart rate without necessarily reaching the threshold of bradycardia. In patients suffering from cardiac disorders prior to treatment, sinus bradycardia may occur. Care should be taken when initiating treatment in patients with bradycardia.
  • Thyroid Function Abnormalities
    • Slight decreases in thyroid function have been seen during treatment with lanreotide in acromegalic patients.
    • Thyroid function tests are recommended where clinically appropriate.
  • Monitoring/Laboratory Tests: In acromegaly, serum GH and IGF-1 levels are useful markers of the disease and effectiveness of treatment.

Most Common Adverse Reactions

  • Adverse reactions occurring in greater than or equal to 9% of patients who received SOMATULINE DEPOT in the overall pooled safety studies in acromegaly were diarrhea (37%), cholelithiasis (20%), abdominal pain (19%), nausea (11%), and injection-site reactions (9%).

Drug Interactions: SOMATULINE DEPOT may decrease the absorption of cyclosporine (dosage adjustment may be needed); increase the absorption of bromocriptine; and require dosage adjustment for bradycardia-inducing drugs (e.g., beta-blockers).

Special Populations

  • Lactation: Advise women not to breastfeed during treatment and for 6 months after the last dose.
  • Moderate to Severe Renal and Hepatic Impairment: See full prescribing information for dosage adjustment in patients with acromegaly.


SOMATULINE® DEPOT (lanreotide) Injection is a somatostatin analog indicated for the long-term treatment of patients with acromegaly 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.

To report SUSPECTED ADVERSE REACTIONS, contact Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127 or FDA at 1-800-FDA-1088 or

Please click here for the full Prescribing Information and Patient Information.


  1. Melmed S, Fagin J. Acromegaly update—etiology, diagnosis and management. West J Med. 1987;146:328-336.
  2. Burton T, Le Nestour E, Neary M, Ludlam WH. Incidence and prevalence of acromegaly in a large US health plan database. Pituitary. 2016;19:262-267.
  3. Melmed S, Cook D, Schopohl J, et al. 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. Pituitary. 2010;13:18-28.
  4. Fleseriu M, Delashaw JB Jr, Cook DM. Acromegaly: a review of current medical therapy and new drugs on the horizon. Neurosurg Focus. 2010;29E15. doi: 10.3171/2010.7.FOCUS10154. Accessed: January 10, 2017.
  5. Katznelson L. Diagnosis and treatment of acromegaly. Growth Horm IGF Res. 2005;15 SupplA:S31-S35.
  6. Maugens TA, Coates ML. Diagnosis and treatment of acromegaly. Am Fam Physician. 1995;52:207-213.
  7. Katznelson L, Laws ER Jr, Melmed S, et al. Acromegaly: an endocine society clinical practice guideline. J Clin Endocrinol Metab. 2014;99:3933-3951.
  8. Marzullo P, Di Somma C, Pratt KL, et al. Usefulness of different biochemical markers of the insulin­-like growth factor (IGF) family in diagnosing growth hormone excess and deficiency in adults. J Clin Endocrinol Metab. 2001;86:3001-3008.
  9. Freda PU. How effective are current therapies for acromegaly? Growth Horm IGF Res. 2003;13(suppl A):S144-S151.

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SOMATULINE® DEPOT (lanreotide) Injection is a somatostatin analog indicated for the long-term treatment of patients with acromegaly 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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PRIOR TREATMENT STATUS (refers to medication only)

Study included a diverse range of patient types2

NOTE: Patients either were not candidates for surgery or had had surgery and required further control.

The procedure for injecting Somatuline® Depot (lanreotide) Injection used for treating acromegaly is explained in this illustration.

Device not shown at actual size

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