ECE2007 Poster Presentations (1) (659 abstracts)
OASIS: observational study on the international clinical practice for the treatment of recently diagnosed acromegalic patients
Lesly Portocarrero 1 , Güngör Akçay 2 , Hakim Bouterfa 3 , Davide Carvalho 4 , Yona Greenman 5 , Feng Gu 6 , Mirtha A Guitelman 7 , Sungwoon Kim 8 , Christine Kriesche 9 , Moises Mercado 10 , Chiung-Chi Shen 11 , Antonio Silva 3 , Cesar Varela 12 , Henri Wallaschofski 13 & Susan Webb 14
1National Institute of Neurology and Neurosurgery, Department of Endocrinology, Mexico City, Mexico; 2Ataturk University Hospital, Erzurum, Turkey; 3Novartis Pharma AG, Basel, Switzerland; 4Hospital de São João, Porto, Portugal; 5Tel Aviv Medical Center, Tel Aviv, Israel; 6Peking Union Medical College Hospital, Beijing, China; 7Department of Endocrinology, Hospital Carlos G. Durand, Buenos Aires, Argentina; 8Kyung Hee University, Seoul, Korea, South; 9Chemnitz, Germany; 10Endocrinology Service, Hospital de Especialidades, Centro Medico Nacional Siglo XXI, IMSS, Mexico City, Mexico; 11Taichung, Taiwan; 12Hospital Ramón y Cajal, Madrid, Spain; 13University of Greifswald, Greifswald, Germany; 14Hospital Sant Pau, Barcelona, Spain.
Background: There is significant interest in how the use of different treatment regimens (e.g. surgery, medical therapy) impacts the clinical course of Acromegaly. This study has been designed to better understand clinical decision making in the context of various treatment options.
Methods: OASIS is an international, observational study in recently diagnosed acromegalic patients. Ethical committee approval was obtained where applicable. Observations include biochemical control, acromegaly symptoms, tumor volume, safety and tolerability. Patient data are collected under normal practice conditions over a 12 months period.
Results: As of November 2006, 380 patients are enrolled from 103 centres in 21 countries. Baseline characteristics of the first 133 patients with available data are reported here. About half of the patients are female (56%), the majority (82%) are Caucasian, and the mean age is 48 years. Most patients (70%) have a diagnosis of macroadenoma. At baseline, 61% of patients had a planed treatment with Sandostatin LAR alone or combined with surgery. 39% of patients received other treatment options (e.g. surgery alone, radiotherapy or non- Sandostatin LAR medical therapy). The most common starting dose for Sandostatin LAR was 20 mg (74% of the patients treated with Sandostatin LAR). At baseline median levels of GH were 8.8 ng/mL in 58 patients treated with Sandostatin LAR (alone or in combination) and 12.8 ng/mL in 46 patients treated with other therapies. IGF-1 levels were 626 ng/mL in 56 patients with Sandostatin LAR and 713 ng/mL for patients with other therapies. At first quarter follow-up data were available for 35 patients with GH and for 27 patients with IGF-1 levels. The median values of GH showed a 40% decrease in the Sandostatin LAR group and 70% decrease in patients with other therapies. Similarly, IGF-I decreased by 22% and 40%, respectively.
Conclusions: These first data show a large proportion of patients treated with Sandostatin LAR as first treatment option. Observation of the treatment practice over the complete course of the study will provide a more complete picture of the treatment choice for these patients.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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