Clinical efficacy of amlodipine and benazepril hydrochloride tablets in controlling morning blood pressure surge (MBPS) in patients with arteriosclerosis
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Objective: This prospective, randomized, open-label, parallel-group clinical trial aimed to rigorously evaluate the influence of amlodipine besylate and benazepril hydrochloride tablets on nocturnal blood pressure patterns and morning blood pressure surge in a cohort of patients diagnosed with primary hypertension. Methods: A total of 294 eligible patients with primary hypertension were randomly assigned to one of two treatment regimens: (1) Bisoprolol amlodipine tablets in the morning (Group A) or (2) Amlodipine besylate and benazepril hydrochloride tablets in the morning(Group B). After 24 weeks of intervention, the following parameters were meticulously compared between the two groups: office blood pressure, morning blood pressure surge, adverse events, 24-hour ambulatory blood pressure monitoring, and major adverse cardiovascular events (MACE). Additionally, the prognostic utility of morning blood pressure surge for predicting future MACE was explored. Results: A total of 113 and 112 patients in Groups A and B, respectively, successfully completed the 24-week study protocol. Both treatment regimens elicited statistically significant reductions in blood pressure; however, the decrease in diastolic blood pressure was markedly greater in Group B versus Group A (p<0.05). Analysis of the 24-hour ambulatory blood pressure monitoring data revealed an interesting pattern. After 24 weeks, no between-group differences were detected in the variation of daytime ambulatory blood pressure. In contrast, the reductions in nighttime ambulatory systolic and diastolic blood pressure were significantly more pronounced in Group B versus Group A (p<0.05). Furthermore, the morning systolic and diastolic blood pressures were notably higher in Group A versus Group B at the end of the study. Importantly, the magnitude of the morning blood pressure surge was significantly lower in Group B versus Group A (p<0.05). During the subsequent 12-month follow-up period, a total of 42 MACE were observed, with 26 events occurring in Group A and 16 in Group B. Receiver operating characteristic (ROC) curve analysis identified optimal cutoff values for predicting MACE of 27.5 mmHg for morning systolic blood pressure surge (AUC=0.698) and 24.5 mmHg for morning diastolic blood pressure surge (AUC=0.701). Conclusion: In this population of hypertensive patients, morning blood pressure surge demonstrates moderate prognostic value for future MACE. Importantly, the regimen of administering amlodipine besylate and benazepril hydrochloride tablets in the morning was found to be an effective strategy for improving nocturnal blood pressure, attenuating morning blood pressure surge, and conferring significant long-term cardiovascular benefits.