Endokrynologia Polska · 2021
Quality of life in patients with acromegaly receiving lanreotide autogel: a real-world observational study.
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Bolanowski Marek, Hubalewska-Dydejczyk Alicja, Kos-Kudła Beata, Ruchała Marek, Witek Przemysław, Zgliczyński Wojciech, Houchard Aude, Bartmańska Marta
Аннотация
INTRODUCTION: Patients with acromegaly have substantially reduced quality of life (QoL). This study evaluated QoL in patients with acromegaly treated with lanreotide autogel.
MATERIAL AND METHODS: This was a prospective, non-interventional, observational, multi-centre study conducted in Poland (NCT02396966). We included patients with acromegaly, who received treatment with lanreotide autogel 120mg for ≥ 3 months and < 3 years. Patients were assessed approximately every 4-5months for twoyears (six visits). QoL was measured with the Acromegaly Quality of Life Questionnaire (AcroQoL).
RESULTS: Of 152 patients enrolled from November 2014 to May 2018 in 37 centres, 24 were excluded due to major protocol deviations. The results are reported for the study population (n = 128). At baseline, the median [95% confidence interval (CI)] time from diagnosis was 3.3 (2.8, 4.2)years, and the median time since lanreotide initiation was 13.4 (9.9, 17.3) months. Symptoms of acromegaly were present at baseline in 86% of patients (headache, 57%; sweating, 58%; joint symptoms, 64%); symptoms remained unchanged at two years in 82% of patients. At baseline, 27% of patients had hormonal control (growth hormone < 2.5 μg/L and insulin-like growth factor-1 within the normal range); hormonal control status did not change during the study period in over 81% of patients. At baseline, 88% of patients were either very satisfied or satisfied with treatment; treatment satisfaction was unchanged in 62% of patients over the study period. Mean (95% CI) AcroQoL scores at baseline were as follows: total, 50.3 (47.3, 53.3); physical dimension, 48.8 (45.2, 52.4); psychological dimension, 51.3 (48.2, 54.4); appearance subdimension, 40.7 (37.5, 43.8); and personal relations subdimension, 62.5 (58.8, 66.2). The psychological appearance subscore improved by 3.8 points (1.2, 6.5) over the two years; scores in the remaining dimensions and subdimensions did not change substantially. The total AcroQoL score remained unchanged over the twoyears, regardless of prior acromegaly treatment, surgery or radiotherapy, hormonal control, or lanreotide dosing interval. No new safety findings were identified.
CONCLUSIONS: AcroQoL total scores and physical and psychological subscores remained stable but impaired among patients with long-lasting acromegaly treated with lanreotide autogel for two years. The psychological appearance subdimension improved numerically.
MATERIAL AND METHODS: This was a prospective, non-interventional, observational, multi-centre study conducted in Poland (NCT02396966). We included patients with acromegaly, who received treatment with lanreotide autogel 120mg for ≥ 3 months and < 3 years. Patients were assessed approximately every 4-5months for twoyears (six visits). QoL was measured with the Acromegaly Quality of Life Questionnaire (AcroQoL).
RESULTS: Of 152 patients enrolled from November 2014 to May 2018 in 37 centres, 24 were excluded due to major protocol deviations. The results are reported for the study population (n = 128). At baseline, the median [95% confidence interval (CI)] time from diagnosis was 3.3 (2.8, 4.2)years, and the median time since lanreotide initiation was 13.4 (9.9, 17.3) months. Symptoms of acromegaly were present at baseline in 86% of patients (headache, 57%; sweating, 58%; joint symptoms, 64%); symptoms remained unchanged at two years in 82% of patients. At baseline, 27% of patients had hormonal control (growth hormone < 2.5 μg/L and insulin-like growth factor-1 within the normal range); hormonal control status did not change during the study period in over 81% of patients. At baseline, 88% of patients were either very satisfied or satisfied with treatment; treatment satisfaction was unchanged in 62% of patients over the study period. Mean (95% CI) AcroQoL scores at baseline were as follows: total, 50.3 (47.3, 53.3); physical dimension, 48.8 (45.2, 52.4); psychological dimension, 51.3 (48.2, 54.4); appearance subdimension, 40.7 (37.5, 43.8); and personal relations subdimension, 62.5 (58.8, 66.2). The psychological appearance subscore improved by 3.8 points (1.2, 6.5) over the two years; scores in the remaining dimensions and subdimensions did not change substantially. The total AcroQoL score remained unchanged over the twoyears, regardless of prior acromegaly treatment, surgery or radiotherapy, hormonal control, or lanreotide dosing interval. No new safety findings were identified.
CONCLUSIONS: AcroQoL total scores and physical and psychological subscores remained stable but impaired among patients with long-lasting acromegaly treated with lanreotide autogel for two years. The psychological appearance subdimension improved numerically.