Basel, 19 February 2003 - Cardiovascular disease is the leading cause of death for patients suffering from acromegaly, a rare hormonal disorder which leads to excess growth hormone (GH) secretion. In a study, recently published in Clinical Endocrinology (February 2003 Vol. 58, 169-176), Sandostatin® LAR® (octreotide acetate for injectable suspension) was shown to reverse acromegalic cardiomyopathy and related morbidity and mortality in young patients diagnosed with acromegaly. Globally, an estimated 244,000 people suffer from acromegaly.
An insidious disease, which can cause chronic disfiguring and enlargement of internal organs, acromegaly often remains undiagnosed for up to 15 years, and patients are diagnosed only after presenting for comorbid conditions such as hypertension or diabetes. Patients with acromegaly typically have higher glucose, glycosylated hemoglobin, insulin, LDL-cholesterol, and triglyceride levels as a result of their condition. Other complications associated with acromegaly include respiratory diseases, such as upper airway obstructions; and malignancies, such as colon cancer. Cardiac disease is the major cause of morbidity and mortality in patients with acromegaly, affecting approximately 80% of patients with the disease.
Researchers at "Federico II" University in Naples, Italy, set out to evaluate whether young acromegaly patients, with short disease duration, were more likely to experience reversal of their acromegalic cardiomyopathy when treated with Sandostatin LAR than older patients with longer disease duration. Acromegalic cardiomyopathy is a serious condition in which the heart muscle becomes damaged due to excessive growth, and cannot pump blood adequately.*
"The study indicates that reversal of acromegalic cardiomyopathy is achievable in young patients provided that an early diagnosis is made and a prompt and effective treatment, such as Sandostatin LAR, is started," said Annamaria Colao, MD, principal investigator of the published study and member of the faculty of the Department of Molecular and Clinical Endocrinology and Oncology, "Federico II" University, Naples, Italy.
Left ventricular mass (LVM) normalized in 100% of young patients
Patients with acromegaly typically have increased tissue mass in the left ventricle, causing systolic dysfunction and, ultimately, cardiovascular disease. In the open prospective study, 22 patients with active uncomplicated acromegaly (12 women, 10 men, age range 21- 57 years) received Sandostatin LAR dosed 20 mg or 30 mg every 28 days, for 12 months. Cardiac structure, by echocardiography, and left ventricular (LV) performance, by equilibrium radionuclide angiography, were investigated before and after treatment.
After 12 months, Sandostatin LAR normalized LVM in 100% of young (10 patients) and 50% of middle-aged patients (12 patients) (p<0.0001). The treatment also improved the left ventricular ejection fraction (LVEF) response at peak exercise in 80% of young and 50% of middle-aged patients. Exercise capacity and duration increased only in young patients (p=0.02).
Hormone Suppression May Successfully Reverse Cardiovascular Alterations
A second study, published in Journal of Clinical Endocrinology and Metabolism (July 2002, Vol. 87, No. 7 3097-3104), found that elevated levels of growth hormone (GH) and insulin growth factor-1 (IGF-1), as well as acromegaly, had a profound impact on cardiovascular risk parameters. The study demonstrated that patients with acromegaly, even in its early stages (<5 years), had increased cardiovascular risk parameters. However, GH/IGF-1 suppression by Sandostatin LAR successfully reversed cardiovascular alterations in approximately two thirds of the patients.
These two studies show that acromegalic patients treated with Sandostatin LAR achieved normalization of elevated hormone levels and reduction of ventricular mass, resulting in a decrease in morbidity and mortality rates among this patient population.
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 that reduces and normalizes levels of IGF-1 and growth hormone in the treatment of acromegaly. 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 (octreotide acetate) injection. In most countries in which it is approved, 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, gas, constipation, nausea, vomiting, pain at injection site, gallstone formation, and high or low blood sugar levels.
The foregoing release contains forward-looking statements that can be identified by terminology such as "offers hope," "may reverse," or similar expressions, or by express or implied discussions regarding potential additional revenues from sales of Sandostatin LAR. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Sandostatin LAR to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Sandostatin LAR will achieve any particular level of revenues. In particular, management's expectations regarding commercialization of Sandostatin LAR could be affected by, among other things, additional analysis of Sandostatin LAR clinical data; new clinical data; unexpected clinical trial results; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; and other risks and factors referred to in the Company's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated, or expected.
Novartis Oncology is a business unit within Novartis AG (NYSE: NVS), a world leader in pharmaceuticals and consumer health. In 2002, the Group's businesses achieved sales of CHF 32.4 billion (USD 20.9 billion) and a net income of CHF 7.3 billion (USD 4.7 billion). The Group invested approximately CHF 4.3 billion (USD 2.8 billion) in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 72,900 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
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*http://www.merck.com/pubs/mmanual_home/sec3/18.htm
Additional information can be found also at www.sandostatin.com and media materials at www.novartisoncologyvpo.com.
