OBJECTIVETo assess the antihypertensive effect and safety on medicine named 'Beijing Hypertensive No. 0' in a three-year treatment of primary hypertension.

METHODSA community-based intervention study was conducted. The antihypertensive effects and adverse events were observed.

RESULTS4000 patients with primary hypertension were randomly divided into two groups with 1529 patients treated with 'Beijing Hypertensive No. 0' and 976 patients treated with other antihypertensive drugs, among which 946 and 853 patients in the two groups completed the three-year study. After treatment, the systolic blood pressure decreased 13 mm Hg and 7 mm Hg while diastolic blood pressure decreased 8 mm Hg and 4 mm Hg in the 'No. 0' group and controlled group respectively. After three years of treatment, 90.0% and 79.5% in the 'No.0' group and in the control group had reached the BP 'fulfillment criteria', which were much higher than the baseline data. Side effects occurred in 33/1274 (2.6%) cases during three years' treatment with most commonly seen as dizziness, headache, palpitation and weakness. No serious adverse reactions occurred. There were some positive effects after treated by 'No. 0', including 0.13 mmol/L decrease of TC, 0.70 mmol/L decrease of LDL-C and an average 0.12 mmol/L increase of HDL-C. All of these changes were statistically significant. There were also opposite effects as 0.13 mmol/L increase of TG, 0.24 mmol/L increase of K+, and 0.88 mmol/L increase of Na+ on average, which were also statistically significant.

CONCLUSIONCompared with the conventional treatment, this treatment of 'Beijing Hypertensive No.0' was more convenient, safe and effective in treating mild to moderate primary hypertension in the community.

Aged ; Antihypertensive Agents ; adverse effects ; therapeutic use ; Female ; Follow-Up Studies ; Humans ; Hypertension ; drug therapy ; Male ; Safety