Abstract

Objective: To evaluate and compare medication adherence, cardiovascular (CV) events and mortality incidence among 2 cohorts of patients treated with Perindopril/Amlodipine/Indapamide (PER/AML/IND) as a free or single-pill combination in a real-world setting in Italy. Design and method: Data were extracted from administrative databases of Italian Healthcare Entities. Adult patients treated with PER/AML/IND as single-pill or free combination (during the period 2010–2020) were included and categorized into 2 cohorts. The index date (ID) corresponded to the first prescription of a single-pill combination (single-pill cohort) or the first prescription of the 3 drugs simultaneously (within 30 days) (free cohort). Patients were characterized in the year prior to ID and followed up from ID to the end of data availability. Patients who died during the first 12-month period were excluded. Propensity score matching (PSM) was applied to minimize selection bias and to reduce potential imbalances between the two cohorts. Adherence was calculated as the proportion of days covered (PDC: PDC < 40% non-adherence; PDC = 40–79% partial adherence; PDC> = 80% adherence). Incidence of mortality and CV events was analyzed after the first year of follow-up and reported as event rate per 1,000-person/year. Results: The analysis included 37,365 patients (54.3% male) in the single-pill cohort and 6,105 (50.8% male) in the free cohort. The post-PSM cohorts were balanced for their characteristics and comprised 6,105 (free-cohort) and 12,105 (single-pill-cohort) patients. The adherence to medication (PDC > = 80%) was better in the single-pill cohort compared to the free cohort (59.9% vs 26.9% adherent patients, p < 0.001). Accordingly, there were more non-adherent patients in the free (54.0%) than in the single-pill (20.8%) cohort (p < 0.001), while similar values were observed for partial adherence (19%, both cohorts). The mortality rate was higher in the free-cohort versus single-pill-cohort patients (33.7 vs 29.9 per 1,000-person/year, p < 0.05). The same effect was reported for incidence of death and CV events as a composite endpoint: 139.0 (free-cohort) versus 105.8 (single-pill-cohort) per 1,000-person/year (p < 0.001). Conclusions: This real-world analysis among hypertensive patients showed that the treatment with PER/AML/IND as a single-pill, as opposed to free combination, could be associated with better medication adherence in the single-pill cohort at one year and with a lower incidence of cardiovascular events and mortality.

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