Abstract
Objective: Hypertension guidelines issued in the last twenty years have consistently recommended use of a combination of two or more antihypertensive drugs to treat most hypertensive patients. Two-drug combinations have also been recommended as initial treatment. Aim of this study was to assess the use of antihypertensive combination treatment, both as the initial and as subsequent therapeutic step over a three-year treatment period, based on data from a large Italian population. Three temporal cohorts (2012, 2015, 2018) were identified to determine whether mono versus combination treatment strategies had changed over the years. Design and method: The residents of the Lombardy Region (Italy), aged > 40 years, who were newly treated with antihypertensive drugs during 2012, 2015 and 2018 were identified through the regional healthcare utilization database. The drug treatment strategy (monotherapy and combination of two, three and > 3 antihypertensive drugs) was assessed at treatment initiation, and after 6 months, 1, 2, and 3 years of treatment. Data were also analysed after stratification for demographic and clinical categories, i.e. sex, age, signs of cardiovascular disease, co-treatments, and clinical status. Results: About one-hundred thousand patients were identified for each cohort. About four out of ten patients were aged > 65 years, half of them were women, one in four patients was prescribed > 5 co-medications, and one in 6 patients had a poor clinical status. In the 2012 cohort, monotherapy was the most common initial treatment strategy (74%), followed by two-drug single-pill combination (17%), two-drug free combination (6%), and combination of > 3 drugs (3%). There were no significant differences between the 2012, 2015 and 2018 cohorts, and among strata of age, sex, clinical status, co-treatments, number of co-medications and evidence of cardiovascular disease. Use of two and three or more antihypertensive drugs increased during follow-up and reached about 32% (two drugs) and 11% (> 2 drugs) of the patients after 3 years from treatment initiation. Among patients prescribed a two-drug combination, the single-pill was the most common approach, whereas the use of the three-drug single-pill combination was extremely rare. There were no substantial differences in the use of combination treatment between the three cohorts and the results were similar in all demographic and clinical categories. Conclusions: In a real-life setting, use of antihypertensive drug combinations is low at treatment initiation and inferior to use of monotherapy during chronic treatment Contrary to guidelines recommendations, antihypertensive combination treatment did not show any noticeable increase over the years.
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