Blood pressure and homocysteine-lowering effects of the amlodipine/folic acid combination in patients with hypertension and serum homocysteine concentration ≥10 μmol/l (H-type hypertension): a multicenter, randomized, double-blind, parallel-controlled clinical trial.
Jianping Li, Yan Zhang, Fangfang Fan et al.
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In 30 seconds
This multicenter, randomized, double-blind, parallel-controlled trial compared amlodipine alone with amlodipine plus either 0.4 mg or 0.8 mg folic acid in 540 adults with hypertension and serum homocysteine ≥10 μmol/l. At 8 weeks, the combined outcome of lowering both blood pressure and homocysteine was achieved more often with either combination than with amlodipine alone: 31.7% vs. 6.1% for 0.4 mg folic acid and 32.8% vs. 6.1% for 0.8 mg (both P < 0.001). Blood-pressure reduction and adverse events did not differ significantly among groups.
Key findings
- At 8 weeks, combined blood-pressure and homocysteine-lowering efficacy was 31.7% with 0.4 mg folic acid and 32.8% with 0.8 mg, versus 6.1% with amlodipine alone (both P < 0.001).
- Both folic-acid combination groups lowered homocysteine and raised folate levels more than amlodipine alone at 8 weeks.
- Blood-pressure lowering and adverse events did not differ significantly among the three treatment groups.
Why it matters
The trial separates the effects on blood pressure from those on homocysteine: adding folic acid improved the combined biochemical and blood-pressure outcome without a detectable difference in blood-pressure reduction itself. This provides evidence about an adjunctive approach for patients with hypertension and elevated homocysteine, while the study did not assess cardiovascular events such as stroke.
What to keep in mind
Follow-up was limited to 8 weeks, and the reported outcomes were blood pressure, homocysteine, folate, and adverse events rather than cardiovascular events.