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Title: Low Risk for Development of Cardiac Valve Regurgitation in Acromegalics Treated with Lanreotide and Octreotide: Presented at ENDO 2006

"Low Risk for Development of Cardiac Valve Regurgitation in Acromegalics Treated with Lanreotide and Octreotide: Presented at ENDO 2006"

By Maria Bishop BOSTON, MA -- June 30, 2006 -- The incidence of new or worsening cardiac valvular regurgitation was low in patients with acromegaly who were randomized to either of the somastatin analogue treatments lanreotide or octreotide in a comparison study, researchers noted here at the Endocrine Society's 88[^th Annual Meeting (ENDO 2006).

The study randomized patients with acromegaly at 33 European centers, 107 patients received any formulation lanreotide (94 previously treated, 13 de novo) and 116 patients given any formulation octreotide (101 previously treated, 17 de novo). All previously treated patients were matched for age, gender and geography, while de novo patients were included irrespective of matching.

The study's sole investigator, AnnaMaria Colao, MD, associate professor of endocrinology, department of molecular and clinical endocrinology and oncology, University Frederico II, Naples, Italy, found that mild or moderate regurgitation in any valve (mitral, tricuspid, aortic, pulmonic) was comparable in both drug cohorts at baseline (39% lanreotide and 37% octreotide) and at Month 12 (40% and 37%, respectively) for the intention-to-treat (ITT) matched population. Results on the risk of new or worsening regurgitation were similar.

Centralized, blinded echocardiography and electrocardiography (ECG) readings were performed at baseline, and at 6 and 12 months. Valvular regurgitation was classified as none, physiological/trace, mild, moderate or severe; any category increase was defined as worsening.

According to Dr. Colao, the study was undertaken based upon a query by the U.S. Food and Drug Administration. For the majority of patients, the severity of valvular regurgitation remained the same during the study. The number of patients who showed either worsening or improvement by 1 level was similar in both cohorts.

Acromegaly is a serious systemic condition that is caused in over 98% of cases by a benign tumor of the pituitary gland that secretes excessive growth hormone. The reduced life expectancy of acromegalics is particularly related to cardiovascular complications, as well as the high incidence of left ventricular hypertrophy and impaired ventricular function.

In this study, the cardiac-events profile was similar for both drugs; first-degree atrioventricular block and ventricular hypertrophy were the most frequent events.

The study was supported by Ipsen Ltd., Paris, France.

[Presentation title: Risk of Cardiac Valvular Regurgitation with Lanreotide Relative to Octreotide: a 12-Month, Multicentre, Prospective, Controlled, Observer-Blinded, Phase IV, Cohort Study in Patients With Acromegaly. Abstract 680]

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