Wyniki fazy retrospektywnej badania obserwacyjnego Lanro-Study oceniającego zużycie zasobów ochrony zdrowia w populacji polskich pacjentów z akromegalią, leczonych preparatem Somatuline AUTOGEL

*Ewa Orlewska¹, Beata Kos-Kudła², Jerzy Sowiński³, Krzysztof Sworczak⁴, Wojciech Zgliczyński⁵, oraz Grupa Badaczy badania Lanro-Study: Elżbieta Andrysiak-Mamos⁶, Anna Babińska⁴, Agata Bałdys-Waligórska⁷, Elżbieta Bandurska-Stankiewicz⁸, Krzysztof Błaut⁴, Paweł Bolko⁹, Wanda Foltyn², Danuta Jakubczyk¹0, Aleksandra Jawiarczyk-Przybyłowska¹¹, Roman Junik¹², Olga Juraniec¹², Ewelina Lewkowicz⁷, Anna Lewczuk⁴, Beata Matyjaszek-Matuszek¹³, Krzysztof Michałek³, Sławomir Mucha¹⁴, Renata Orłowska-Florek¹⁵, Marta Peszel-Barlik¹⁶, Sławomir Pynka¹⁷, Violetta Rosiek², Marek Ruchała³, Joanna Rutkowska⁸, Julia Słyńko-Krzyżostaniak³, Agnieszka Stefańska⁷, Janusz Strzelczyk², Anhelli Syrenicz⁶, Małgorzata Trofimiuk-Müldner⁷, Joanna Waligórska-Stachura³, Ryszard Waśko³, Przemysław Witek¹⁸, Danuta Zalewska-Rydzkowska¹², Piotr Zdunowski⁵, Anna Zemczak²

Summary
Aim. To present the results of Lanro-Study retrospective phase.
Material and methods. Lanro-Study is a multicenter, non-interventional, observational study on resource utilization in the population of Polish acromegalic patients treated with Somatuline Autogel at 4 weeks or extended dosing interval. During the 12-month retrospective phase all routinely collected medical data (e.g. GH, IGF-1, glucose concentration, clinical symptoms), any changes in the treatment scheme and baseline information for economic evaluation have been evaluated. The end-points for the analysis were: mean serum GH and IGF-1 concentration at every time point, proportion of patients with clinical symptoms of acromegaly, proportion of patients treated with a given pharmaceutical in a given dosing interval, resource utilization per patient/year.
Results. 143 patients were included in the analysis (72% women, in 80% macroadenoma, 72% had undergone pituitary surgery). Mean GH and IGF-1 serum concentration decreased to 5.74 (SD 11.75) μg/l and 41.69 (268.05) μg/l during the treatment with lanreotide AUTOGEL. Most common clinical symptoms were mild/moderate headache (84% patients) and arthralgia (82% patients). During the retrospective phase changes in the treatment scheme have been reported in 54 (38%) patients. In the moment of enrollment in 43 (30%) patients lanreotide AUTOGEL 120 was administered every 4 weeks, in 100 (70%) patients – every 5-9 weeks. Patients were predominantly treated in out-patient setting (4.78 physician visit/patient/year), most common diagnostic examinations were magnetic resonance imaging of brain (0.57/patient/year) and diagnostic ultrasound of neck (0.55/patient/year), most common laboratory tests were IGF-1 (1.96/patient/year), GH (1.49/patient/year), glucose (0.91/patient/year), thyroid hormones (0.43-0.49/patient/year).
Conclusions. The results of the study provides evidence on the use of a drug in a realistic settings and can be utilized as a vehicle for addressing multiple post-approval objectives.

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