OBJECTIVE: To investigate the effect of baseline homocysteine (Hcy) level on the efficacy of enalapril maleate and folic acid tablet in lowering blood pressure and plasma Hcy in patients with mild or moderate essential hypertension. METHODS:456 patients with mild or moderate essential hypertension were from 7 hospitals in Southern and Northern China, 196 males and 260 females, aged 18-75, were randomly assigned to one of the 3 groups: Group 1 treated with enalapril 10 mg (n=153); Group 2 treated with enalapril maleate and folic acid tablet at the ratio of 10/0.4 (n=151); and Group 3 treated with enalapril maleate and folic acid tablet at the ratio of 10/0.8 (n=152). Blood pressure was measured every 2 weeks and plasma Hcy level was measured before the experiment, 4 weeks after the beginning of experiment, and by the end of experiment. RESULTS: Compared with the baseline levels, the blood pressures of the 3 groups were all well controlled (all P<0.01). There was no significant difference among the 3 groups in the efficacy in lowering blood pressure, even after stratification by the baseline Hcy level. 75% of all the subjects had elevated plasma Hcy level (>or=10 micromol/L). The blood pressure and Hcy lowering rates of the subjects with hyperhomocysteinemia in Groups 2 and 3 were 70.9% and 67.0% respectively, both significantly higher than that of Group 1 [45.6%, OR(95%CI): 3.0 (1.7-5.5), P=0.000 and OR=3.3 (1.8-5.9), P=0.000], and in lowering Hcy [OR(95%CI): 7.5 (2.6-21.2), P=0.000 and 3.5 (1.4-8.7), P=0.007] subjects with hyperhomocy steinemia. The Hcy lowering efficacy in the patients without hyperhomocysteinemia of Group 3 was significantly higher than that of Group 1 (P=0.016). CONCLUSION:Hyperhomocysteinemia is s extremely common in Chinese hypertensive patients. Enalapril maleate combine with folic acid tablet shows better efficacy in lowering either blood pressure or Hcy in hypertensive patients with hyperhomocysteinemia.
RCT Entities:
OBJECTIVE: To investigate the effect of baseline homocysteine (Hcy) level on the efficacy of enalapril maleate and folic acid tablet in lowering blood pressure and plasma Hcy in patients with mild or moderate essential hypertension. METHODS: 456 patients with mild or moderate essential hypertension were from 7 hospitals in Southern and Northern China, 196 males and 260 females, aged 18-75, were randomly assigned to one of the 3 groups: Group 1 treated with enalapril 10 mg (n=153); Group 2 treated with enalapril maleate and folic acid tablet at the ratio of 10/0.4 (n=151); and Group 3 treated with enalapril maleate and folic acid tablet at the ratio of 10/0.8 (n=152). Blood pressure was measured every 2 weeks and plasma Hcy level was measured before the experiment, 4 weeks after the beginning of experiment, and by the end of experiment. RESULTS: Compared with the baseline levels, the blood pressures of the 3 groups were all well controlled (all P<0.01). There was no significant difference among the 3 groups in the efficacy in lowering blood pressure, even after stratification by the baseline Hcy level. 75% of all the subjects had elevated plasma Hcy level (>or=10 micromol/L). The blood pressure and Hcy lowering rates of the subjects with hyperhomocysteinemia in Groups 2 and 3 were 70.9% and 67.0% respectively, both significantly higher than that of Group 1 [45.6%, OR(95%CI): 3.0 (1.7-5.5), P=0.000 and OR=3.3 (1.8-5.9), P=0.000], and in lowering Hcy [OR(95%CI): 7.5 (2.6-21.2), P=0.000 and 3.5 (1.4-8.7), P=0.007] subjects with hyperhomocy steinemia. The Hcy lowering efficacy in the patients without hyperhomocysteinemia of Group 3 was significantly higher than that of Group 1 (P=0.016). CONCLUSION:Hyperhomocysteinemia is s extremely common in Chinese hypertensivepatients. Enalapril maleate combine with folic acid tablet shows better efficacy in lowering either blood pressure or Hcy in hypertensivepatients with hyperhomocysteinemia.