Adherence to Acromegaly Treatment and Analysis of the Related Factors-A Real-World Study in Bulgaria.

The purpose was to assess the level of medication adherence (MA) and related factors among individuals with acromegaly. The secondary goal was to assess the quality of life of patients and whether and how it correlates with the level of adherence. A prospective one-year study was conducted among patients with acromegaly diagnosed, treated, and monitored in the reference center for rare endocrine diseases in Bulgaria in 2021. Clinical data, patients reported outcomes, and health economics data were collected to define the predictors of non-adherence to medicines. Medication adherence level was assessed through a free Morisky-Green 4-item questionnaire. A total of 179 patients with acromegaly were observed. Approximately 62% were female, 50% were between 41 and 60 years, and the mean age at diagnosis was 40.4 years. The response rate to the questionnaires was 53% (n = 95; mean age 53.5 years, 73% female and 26% male). Patients with high levels of MA reported higher median values for the 36-Item Short Form Health Survey (SF-36) in comparison with those with low levels: 65.5 vs. 48.5 (p = 0.017). Similar results for EQ-5D-3L (3-level EuroQol 5D version) values and the level of MA were found: 0.656 vs. 0.796 (p = 0.0123). A low level of adherence was revealed in 34.7% of the patients, with no difference among different age groups. A significant positive determinant for adherence was years lived with acromegaly (OR = 5.625, 95% CI 1.7401-18.1832, p = 0.0039), as shorter duration was related to higher odds for high level of adherence. The current study demonstrates the importance of MA assessment for patients with acromegaly in Bulgaria. The medication adherence to the prescribed therapy among the observed group of patients with acromegaly varied as the percentage of adherent patients was around 65%. Still, there are low-adherent patients, and the responsible factors should be further investigated.

Do We Need a Specific Guideline for Assessment and Improvement of Acromegaly Patients Adherence?

Background: Adherence to therapy is one of the most important elements during the therapeutic process ensuring the predefined therapeutic outcomes. The aim is to analyze the need and importance of treatment adherence guideline for acromegaly patients and the possibilities for its development and implementation in Bulgaria. Methods: A set of methods was applied: (1) a literature review in the electronic database for identification of articles and guidelines related to adherence and acromegaly; (2) analysis of Bulgarian legislative documents; (3) a pilot study for assessment of the level of treatment adherence among hospitalized Bulgarian acromegaly patients in 2018; (4) a plan for development and implementation of specific guideline was created entitled BULMEDACRO - BULgarian guideline for MEdication aDherence assessment and improvement in ACROmegaly. Results: No specific guidelines for evaluation, monitoring, reporting and/or improving adherence in acromegaly patients has been found in the literature. Requirements for regular assessment of the level of adherence, application of appropriate methods for improvement and monitoring are not sufficiently formulated and mandatory. The pilot study confirmed that therapy adherence among Bulgarian patients with acromegaly is relatively high as almost 90% of patients report that they strictly comply with their prescribed treatment regimen. It is necessary, however, a specific guideline focused on the methods for assessment and improvement of adherence, in order to ensure monitoring and follow-up of acromegaly patients. Conclusions: Patients with acromegaly should be the focus of specially designed national programs, initiatives and/or guidelines for regular evaluation and improvement of the adherence level. Despite the difficulties and the lack of an adequate legal basis, successive steps initiated by different stakeholder are needed.

New Epidemiological, Clinical and Economic Data for Patients With Acromegaly in Bulgaria.

Background: Acromegaly and its comorbidities affect the patients' quality of life, each healthcare system and the society. This study aimed to evaluate clinical characteristics and treatment patterns and the economic burden of acromegaly. Materials and methods: All patients with acromegaly treated with expensive medicines and regularly followed up at the main expert clinical center for acromegaly in the country were included in this nationwide, retrospective, observational, population-based study. Patient characteristics, treatment patterns, healthcare resource use, and costs were assessed for 1-year period (01.01.2018-31.12.2018). Results were processed through statistical analysis using MedCalc software version 16.4.1. Results: A total of 191 acromegaly patients were observed. Approximately 67% were female, 45.5% were between 41 and 60 years and the mean age at diagnosis was 40.73 years. Surgical treatment was preferred as a first-line therapy among almost 89% of all diagnosed patients. The level of comorbidities was very high as more than 95% suffered from at least one concomitant disease. The most frequent comorbidities were other endocrine and metabolic diseases (96.7%), followed by cardiovascular diseases (70.7%). The most common first-line pharmacotherapy was long-acting somatostatin analogs (SSA) (38%) followed by dual combination SSA + pegvisomant (21%). The total economic burden of acromegaly was estimated to be 2,674,499.90 € in 2018 as the direct costs (medication costs, hospitalization costs covered by the patients and the National Health Insurance Fund) outnumbered indirect costs (loss of productivity due to hospitalization): 2,630,568.58 € vs. 43,931.32 €. The average annual per-patient direct and indirect costs were 14,002.62 €. Conclusions: The current study demonstrates a significant clinical and socio-economic burden of acromegaly in the country. Proper diagnosing and regular follow up of acromegaly patients in a specialized pituitary center ensure appropriate innovative pharmacotherapy with achievement of disease control.