Objectives: To investigate the therapeutic efficacy and safety of Amlodipine alone or in combination with terazosin for the presence of lower urinary tract symptoms (LUTS) and hypertension. LUTS and hypertension often coexist in elderly men. Methods: A total of 355 patients with Stage 1 or 2 hypertension and LUTS (as defined by an International Prostate Symptom Score of ≥10) were randomly assigned to receive 2 mg of terazosin (n = 117), 5 mg of Amlodipine (n = 119), or 5 mg of Amlodipine plus 2 mg of terazosin (n = 119) once daily for a total of 28 days. The primary outcomes were a reduction in the total and subscores of the International Prostate Symptom Score and blood pressure. Analyses were performed by intention to treat. This trial is registered with ClinicalTrials.gov (No. NCT00693199). Results: At day 28 of the trial, the Amlodipine plus terazosin group demonstrated comparable efficacy in lowering the total International Prostate Symptom Score and significant improvement in the presence of overactive bladder compared with the terazosin group (P < .05) and significant improvement in quality of life compared with the Amlodipine group (P < .05). The Amlodipine plus terazosin group also achieved the greatest blood pressure control compared with either the terazosin group (P < .01) or Amlodipine group (P < .05). All 3 treatment regimens were well tolerated by the study patients. Conclusions: The results of this 4-week, double-blind, randomized trial have demonstrated that in Chinese male hypertensive patients with LUTS, low-dose Amlodipine plus terazosin therapy appears to be a safe and effective combination therapy to control both conditions, especially for those with predominant overactive bladder symptoms.
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