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Two- vs. One-Drug Pharmacotherapy for Hypertension
Study Questions:
Does initial two-drug pharmacotherapy (compared to monotherapy) for hypertension result in improved cardiovascular outcomes?
Methods:
Using the healthcare utilization database of the Lombardy Region of Italy, the 44,534 residents of the region (age 40–80 years) who in 2010 started treatment with one antihypertensive drug (n = 37,078) or a two-drug fixed-dose combination (FDC; n = 7,456) were followed for 1 year after treatment initiation to compare the risk of hospitalization for cardiovascular disease associated with the two treatment strategies. To limit the confounding associated with nonrandomized between-group comparisons, data also were analyzed by: 1) matching the two groups by the high-dimensional propensity score (HDPS); and 2) comparing, in patients experiencing one or more cardiovascular events (n = 2,212), the cardiovascular event incidence during subperiods in which patients were prescribed mono- or FDC therapy (self-controlled case series design).
Results:
Compared to initial monotherapy, patients on initial FDC therapy had a reduced 1-year risk of hospitalization for any cardiovascular event (–21%, p < 0.01). This was the case also when groups were compared in the HDPS analysis (–15%, p < 0.05). Finally, in patients experiencing cardiovascular events, the event incidence was much less when, during 1 year of follow-up, they were treated with FDC therapy than monotherapy (–56%, p < 0.01). The reduced risk of hospitalization was always significant for ischemic heart disease and new-onset atrial fibrillation, and included hospitalization for cerebrovascular disease and heart failure when monotherapy and FDC therapy were compared within patients.
Conclusions:
A comparison of the incidence of early cardiovascular events during antihypertensive monotherapy and FDC shows that the latter strategy is associated with more effective cardiovascular protection. The authors concluded that these data support the use of a two-drug FDC strategy as initial therapy in the hypertensive population.
Perspective:
Initial two-drug combination therapy for hypertension lowers blood pressure more promptly, is associated with better blood pressure control at 1 year, and reduces therapeutic inertia (reluctance to move from monotherapy to more complex treatment even when blood pressure is not controlled). This study suggests that an initial two-drug fixed-dose combination strategy also leads to better cardiovascular protection. This observational study from a healthcare utilization database in Italy does not control for potential differences in adherence between groups; does not control for other clinical factors including cardiovascular risk factors, cholesterol, and blood glucose; and does not compare FDC with combination therapy using individual drugs. Pending validation in other populations, consideration for two-drug FDC may be reasonable among patients initiating treatment for hypertension.
Keywords: Antihypertensive Agents, Atrial Fibrillation, Blood Glucose, Blood Pressure, Cardiovascular Diseases, Cerebrovascular Disorders, Cholesterol, Coronary Artery Disease, Drug Therapy, Combination, Heart Failure, Hypertension, Myocardial Ischemia, Primary Prevention, Risk Factors
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