Rondo Hatton, a famous sufferer of acromegaly whose face was distorted by the disorder.
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Acromegaly

Acromegaly (from Greek akros "high" and megalos "large" - extremities enlargement) is a hormonal disorder that results when the pituitary gland produces excess growth hormone (hGH). Most commonly it is a benign hGH producing tumor derived from a distinct type of cells (somatotrophs) and called pituitary adenoma. more...

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Acromegaly most commonly affects middle-aged adults and can result in serious illness and premature death. Because of its insidious onset and slow progression, the disease is hard to diagnose in the early stages and is frequently missed for many years.

Symptoms

Features that result from high level of hGH or expanding tumor include:

  • Soft tissue swelling of the hands and feet (early sign)
  • Brow and lower jaw protrusion (enlarging jaw and hat size)
  • Enlarging hands (ring size)
  • Enlarging feet (shoe size)
  • Arthritis and carpal tunnel syndrome
  • Teeth spacing increase
  • Heart failure (major medical problem)
  • Compression of the optic chiasm leading to loss of vision in the outer visual fields
  • Diabetes mellitus
  • Hypertension

Causes

Pituitary adenoma

In over 90 percent of acromegaly patients, the overproduction of GH is caused by a benign tumor of the pituitary gland, called an adenoma. These tumors produce excess GH and, as they expand, compress surrounding brain tissues, such as the optic nerves. This expansion causes the headaches and visual disturbances that are often symptoms of acromegaly. In addition, compression of the surrounding normal pituitary tissue can alter production of other hormones, leading to changes in menstruation and breast discharge in women and impotence in men.

There is a marked variation in rates of GH production and the aggressiveness of the tumor. Some adenomas grow slowly and symptoms of GH excess are often not noticed for many years. Other adenomas grow rapidly and invade surrounding brain areas or the sinuses, which are located near the pituitary. In general, younger patients tend to have more aggressive tumors.

Most pituitary tumors arise spontaneously and are not genetically inherited. Many pituitary tumors arise from a genetic alteration in a single pituitary cell which leads to increased cell division and tumor formation. This genetic change, or mutation, is not present at birth, but is acquired during life. The mutation occurs in a gene that regulates the transmission of chemical signals within pituitary cells; it permanently switches on the signal that tells the cell to divide and secrete GH. The events within the cell that cause disordered pituitary cell growth and GH oversecretion currently are the subject of intensive research.

Other tumors

In a few patients, acromegaly is caused not by pituitary tumors but by tumors of the pancreas, lungs, and adrenal glands. These tumors also lead to an excess of GH, either because they produce GH themselves or, more frequently, because they produce GHRH, the hormone that stimulates the pituitary to make GH. In these patients, the excess GHRH can be measured in the blood and establishes that the cause of the acromegaly is not due to a pituitary defect. When these non-pituitary tumors are surgically removed, GH levels fall and the symptoms of acromegaly improve.

Read more at Wikipedia.org


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Novartis Sandostatin Lar Approved In Japan For Acromegaly
From Worldwide Biotech, 6/1/04

Novartis, Basel, Switzerland, has announced that the Japanese health authority has approved Sandostatin LAR (octreotide acetate for injectable suspension) for the treatment of acromegaly and pituitary gigantism which is unresponsive to or unsuitable for surgery or other drug therapies, and for symptoms associated with gastrointestinal hormone secreting tumors (also known as gastroenteropancreatic (GEP) neuroendocrine tumors (NET), including carcinoid tumors, gastrinomas, and VIPomas (Vasoactive Intestinal Peptide- secreting tumors).

The approval from the Japanese Ministry of Health, Labor and Welfare was based on clinical data from studies conducted in Japan and Western countries, including the member states of the European Union and the United States, where Sandostatin LAR is approved already. Sandostatin LAR is approved in more than 70 countries.

"Sandostatin LAR is the standard around the world for these conditions and we're pleased that the health authorities in Japan have approved the drug so patients in Japan can now benefit from it," said David Epstein, president, Novartis Oncology.

Clinical Data

The data from two Japanese trials, one in acromegaly and pituitary gigantism and the other in carcinoid syndrome, were consistent with findings of the previous western Phase III studies that were the basis for approval in the U.S. and E.U. In the western Phase III acromegaly studies, data showed that Sandostatin LAR was effective in reducing GH levels to <2.5ng/mL as the therapeutic goal in 89 out of 128 patients (69.5%). In addition, IGF-1 level was normalized in 85 out of 128 patients (66.4%). The drug markedly reduced clinical symptoms of acromegaly including headache, fatigue, perspiration, arthralgia, parathesias and carpal tunnel syndrome.

In the western Phase III clinical trials for malignant carcinoid syndrome, data from 93 patients, in whom subcutaneous treatment with Sandostatin Injection had adequately controlled clinical symptoms, Sandostatin LAR was shown to be as efficacious as Sandostatin Injection in controlling clinical symptoms.

About Sandostatin LAR

Sandostatin LAR (octreotide acetate for injectable suspension), launched in most major countries in 1998 and in the US in 1999 is a convenient, once-monthly injection with a well-established safety profile for superior control of both GH and normalization of IGF-1. Sandostatin LAR is indicated for long-term maintenance therapy in acromegalic patients for whom medical therapy is appropriate and who have been shown to respond to and can tolerate Sandostatin(r) (octreotide acetate) injection.

In acromegaly, Sandostatin LAR targets the tumor to control in four critical areas: 1) the site of tumor where hypersecretion starts, 2) GH secretion, 3) IGF-1 production, and 4) symptoms including headache, fatigue, perspiration, arthralgia, parathesias and carpal tunnel syndrome. Sandostatin LAR is also indicated to control symptoms, such as severe diarrhea and flushing, of functional GEP tumors (e.g. metastatic carcinoid tumors and vasoactive intestinal peptide-secreting tumors (VIPomas)) in patients who have responded to and tolerated subcutaneous injections of Sandostatin.

Contraindications and adverse events

In clinical studies of acromegaly, some patients experienced diarrhea, abdominal pain, flatulence, constipation, nausea, vomiting, pain at injection site, slow or irregular heart rate, and high or low blood sugar levels. In studies of carcinoid syndrome, some patients experienced nausea, abdominal pain, headache, dizziness, fatigue, flatulence, vomiting, pain at injection site, and low blood sugar levels.

Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2003, the Group's businesses achieved sales of USD 24.9 billion and a net income of USD 5.0 billion. The Group invested approximately USD 3.8 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 78,500 people and operate in over 140 countries around the world.

For more information, visit http://www.novartis.com.

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COPYRIGHT 2004 Gale Group

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