Effects of Losartan and Amlodipine on Urinary Albumin Excretion and Ambulatory Blood Pressure in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy

Editor's comment: The editorial committee of Diabetes Care had some ethical concerns about potentially leaving patients for up to 24 weeks with blood pressure between 140/90 and 200/110 mmHg. After careful consideration, we decided to publish this article for the following reasons. First, the scientific information was considered valid and important. Second, the study was passed by the institutional review board (IRB) of the investigators. The study was passed by their institution at a time when perhaps ethical guidelines were not as stringent. Third, in response to queries by the editorial committee, the investigators pointed out that other hypertension studies initiated at around that time also had similar protocols. The editorial committee then dealt with the general issue of different criteria utilized by different IRBs around the world. Although the editorial committee will continue to be sensitive to decisions by various IRBs, investigators should realize that the more recent, stricter guidelines will also be considered by the editorial committee should ethical concerns be raised in the review process. OBJECTIVE:--Few studies have assessed whether 24-h blood pressure control induced by antihypertensive agents improves macroalbuminuria in hypertensive type 2 diabetic patients with overt nephropathy. We evaluated the effects of losartan and amlodipine on 24-h blood pressure, autonomic nervous activity, and albuminuria in these patients. RESEARCH DESIGN AND METHODS--In this open-label, parallel-prospective, randomized study, 44 patients were treated with losartan and 43 with amlodipine for a 12-week titration phase and a maintenance phase for a maximum of 12 weeks. Twenty-four-hour blood pressure and urinary albumin excretion were measured before and during treatment. Simultaneously, power spectral analysis of heart rate was performed to evaluate low frequency (LF) and high frequency (HF) components and LF-to-HF ratios as an index of sympathovagal balance. RESULTS:--Losartan decreased (P < 0.001) mean blood pressure from 162/91 to 150/82 mmHg during daytime and from 146/82 to 137/74 mmHg during nighttime (systolic/diastolic). Amlodipine also decreased (P < 0.001) blood pressure from 159/90 to 147/82 mmHg during daytime and from 143/81 to 131/72 mmHg during nighttime. LF and HF components and nighttime-to-daytime ratios for the LF-to-HF ratios did not differ during treatment in two groups, showing no changes in the diurnal autonomic nervous rhythm. Losar