The primary aim of this study, the largest European, single evaluation, observational trial to date, was to evaluate the impact of acromegaly on health-related quality of life (HRQoL) in patients with biochemically documented active disease, receiving Sandostatin® LAR® at a dose prescribed by their physician for at least 3 months. Secondary objectives were to investigate the relationships between HRQoL and subpopulations based on exploratory variables [age, gender, education, growth hormone (GH) and insulin-like growth factor (IGF-1)] and to compare the results of the Acromegaly Quality-of-Life questionnaire (ACROQOL) and SF-36. The study was approved by Health Authorities and/or local Ethics Committees, according to local regulations. Patients were invited to participate in the study when they attended a scheduled visit. GH and IGF-1 levels were to be measured within two months of completion of the questionnaires.
A total of 817 patients (55% female, mean age 51±14 years) were recruited in England, France, Germany, Greece, Italy, Portugal, Spain and Turkey. Patients had a diagnosis of acromegaly for an average of 8 years, and had been treated with Sandostatin® LAR® for an average of 3.4 years (range 0.318 years) at a median dose of 30 mg (range 1060 mg). Basal GH and IGF-1 mean levels were 4.2 and 345 ng/ml respectively. Both the ACROQOL and SF-36 recorded poorer HRQoL with advancing age and increasing number of comorbidities. The correlation between the ACROQOL and the SF-36 was good (P<0.001) and overall results suggest that ACROQOL may be more sensitive to the psychological impact of acromegaly than to the physical impact. While some cultural differences were found across the SF-36 domains, the results with the ACROQOL were consistent across all countries, confirming the ACROQOL to be a valid and sensitive tool for measuring the impact of acromegaly on HRQoL.