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Summary
A double-blind comparator study was performed in 528 hypertensive patients [baseline sitting diastolic blood pressure (SitDBP) 95–114 mmHg]. The primary objective was to compare the incidence of drug-related cough in patients treated with enalapril and eprosartan. The secondary objective was to compare antihypertensive efficacy between treatments. This paper reports the results of a prespecified subgroup analysis performed in the 40 black patients recruited into the study. Eprosartan was titrated from 200 mg b.i.d. to 300 mg b.i.d. and enalapril from 5 mg o.d. to 20 mg o.d. over 12 weeks. Hydrochlorothiazide (HCTZ) 12.5–25 mg o.d. could be added where required to the treatment for the final six weeks of the titration phase if SitDBP ≥ 90 mmHg. Patients received the maximum titrated dosage during the maintenance phase. In the study overall, the incidence of cough at monotherapy endpoint was significantly higher in the enalapril-treated group than in the eprosartan-treated group (p = 0.018). This trend was reflected in the black subgroup but the numbers were too small to confirm significance. At study endpoint the mean change in SitDBP was-10.5 ± 1.9 mmHg and-9.6 ±2 AmmHg for eprosartan-treated and enalapril-treated patients, respectively. The mean change in SitSBP for eprosartan-treated black patients was -18.8 ±3.5mm Hg and for enalapril-treated patients was -10.5 ±3.7 mmHg. The black subpopulation mirrored the response of the study as a whole. Both treatments lowered BP with a further reduction evident following the addition of HCTZ at week 18.
In conclusion, eprosartan is effective and appears to be safe in black hypertensive patients. The combination of eprosartan and HCTZ was also well tolerated and provided additional efficacy in those patients not responding to eprosartan alone. The incidence of treatment- associated cough in the black subgroup was low, but there were no apparent differences between treatment groups.