Objective: To investigate the efficacy and safety of Enalapril-Folic acid tablets in lowering blood pressure and plasma homocysteine(Hcy) level.
Methods: A randomized, double blind, multicenter clinical trial was performed. Subjects with mild-moderate hypertension were randomly assigned to the following three groups: group 1, Enalapril 10.0 mg/d; group 2, Enalapril 10.0 mg+ Folic acid 0.4 mg/d; group 3, Enalapril 10.0 mg + Folic acid 0.8 mg/d. Blood pressure and plasma Hcy level were examined every two weeks, for a total period of 8 weeks.
Results: A total of 480 hypertensives were enrolled. All analyses were performed according to the intention to treat and included all randomized patients. Compared to group 1, both group 2 and group 3 had significantly higher effectiveness in lowering both blood pressure and plasma Hcy level, or in lowering either blood pressure or plasma Hcy level. The proportions of subjects showing obvious reduction in both blood pressure and plasma homocysteine level in group 1, group 2, group 3, were 4.6%, 13.2%, 17.1%, respectively; the proportions of subjects showing obvious reduction in either blood pressure or plasma homocysteine level in group 1, group 2, group 3, were 45.8%, 59.6%, and 65.1%, respectively; Effects on blood pressure, as well as the safety profile were not significantly different among the three regimens.
Conclusion: Enalapril-Folic acid tablets could be used to reduce both blood pressure and plasma Hcy level in mild to moderate hypertensive subjects.