abstract
- INTRODUCTION: The aim of the study was to assess the effects on blood pressure (BP) levels and control rates in hypertensive subjects receiving trandolapril as monotherapy or as part of an antihypertensive regimen in everyday Canadian clinical practice. METHODS: The MAVIKtory study was a multicenter, single-arm observational study in 601 primary-care centers in Canada. Diabetic and nondiabetic subjects were included, who were treated with trandolapril for hypertension in accordance with usual practices and national guidelines. Subjects received trandolapril as a new prescription, alone, or in combination with prior therapy. Treatment regimens were at the discretions of the treating physicians. Subjects were followed for 6 months. The primary outcomes measures were the percentage of subjects reaching BP targets set by their physicians after 6 months of therapy, and the percentage of subjects reaching the guidelines targets (systolic blood pressure [SBP]/diastolic blood pressure [DBP] < 140/90 mm Hg) after 6 months as assessed by their physicians. Other outcomes were the percentage of diabetic subjects reaching BP targets, and tolerability. RESULTS: A total of 8787 subjects were enrolled and included in the intention-to-treat population. Starting doses of trandolapril were 1 or 2 mg in the majority of subjects and remained unchanged in 51.9% of the population at 6 months. The target of < 140/90 (< 130/80) mm Hg was reached by 67.3% of the population. The lower mean physician-set target of 133.4/83.3 mm Hg for nondiabetic subjects and 128.6/79.3 mm Hg for diabetic subjects was reached by 52.2%. Mean reductions from baseline to month 6 were 19.4 mm Hg (95% CI: [-19.9 to -19.0]) in SBP, and 10.1 mm Hg (95% CI: [-10.4 to -9.8]) in DBP. Cough was the most commonly reported adverse event, reported in 4.2% of all subjects. CONCLUSION: Trandolapril demonstrated a favorable safety and effectiveness profile. SBP reductions of approximately 20 mm Hg and control rates > 65% could be achieved over 6 months.