A total of206 patients were enrolled in this study; 182 were ultimately randomized to active treatment and were eligible for evaluation. Twenty-eight of the patients randomized were not able to complete the study according to the protocol because they were ineligible, protocol violators or had early study termination by virtue of premature discontinuation related to an adverse experience or loss to follow-up. Patients in both treatment groups demonstrated no significant difference in characteristics for age, sex, race and vital signs as presented in Table 1. Vital sign changes for both patient groups are presented in Table 2. A significant reduction in mean systolic and diastolic blood pressure for the supine and both standing positions at 1 and 3 mins was demonstrated following study therapy. This mean change was evident at the end of the study compared with baseline. You can start online shopping right now – Buy Symbicort Online for more advantages.
TABLE 1 Patient demographics
|N (%)||Enalapril Mean SD||Range||Hydrochlorothiazide/amiloride N (%) Mean SD Range||P value|
|Male: Age (years)||41 (45.6%)||51.9||14.2||21.1-78.1||44 (47.8%)||54.4||12.5||30.4-78.2||0.39|
|Female: Age (years)||49 (54.4%)||52.1||12.3||23.7-74.3||48 (52.2%)||55.7||12.8||26.1-73.0||0.16|
|Total: Age (years)||90 (100%)||52.0||13.1||21.1-78.1||92 (100%)||55.1||12.6||26.1-78.2||0.11|
|Caucasian||84 (93.3%)||88 (95.7%)||0.72|
|Duration of disease (months)||70.9||75.7||87.1||88.6||0.20|
|Supine blood pressure (mmHg)|
|Pulse rate (beats/min)||77.9||8.1||80.0||9.0||0.09|
|Body weight (kg)||75.2||15.6||78.9||16.2||0.12|
TABLE 2 Treatment comparison of changes in vital signs
|Treatment||N||Mean||ChangeSD||P value||P value BT|
|Supine BP (mmHg)|
|HCTZ/A 92 Standing 0-1 min BP (mmHg)||-15.74||7.83||0.0001||0.41|
|HCTZ/A 92 Standing 3 min BP (mmHg)||-14.54||7.39||0.0001||0.25|
|Pulse rate (beats/min)|
BP Blood pressure; BT Between treatment; HCTZ/A Hydrochlorothiazide/amiloride.
Patients receiving hctz/ amiloride, versus those in the ena-lapril group, routinely tended to have greater mean reductions in systolic and diastolic blood pressure in the supine position and in both standing positions after 1 and 3 mins at weeks 8, 12 and exit. For systolic blood pressure, this between group mean difference at exit was approximately 5 mmHg greater for patients treated with hctz/ amiloride. This was statistically significant in the standing position after 1 min (P=0.02) and after 3 mins (P=0.009). There were no significant differences between groups regarding pulse rate or weight at study exit.