The efficacy and safety of the world's first bisoprolol transdermal patch (BTP) on the blood pressure and the glycemic control of patients with type 2 diabetes mellitus (T2DM) and hypertension is unknown. We investigated the effect of beta1-selective beta-blocker on office blood pressure and home morning blood pressure, following the effect of the glycemic and metabolic control in patients with T2DM and cardiovascular disease.Design and Method:
Twenty-five patients (mean age 68 ± 9 years, 10 males) with heart disease and stable T2DM (glycated hemoglobin level [HbA1c] of 8% or less, no urine sugar and no urine protein) without insulin therapy were administered once-daily BTP 4 mg at 9 p.m. and were followed up. The mean follow-up period was 85 days.Results:
In regards to office blood pressure, BTP significantly reduced the diastolic blood pressure (DBP) from 82 ± 8 mmHg to 77 ± 8 mmHg (P < 0.05) and pulse-rate (PT) from 68 ± 9 beats per minute to 56 ± 10 beats per minute (P < 0.01), respectively, although there was no significant change in systolic blood pressure (SBP): 145 ± 14 mmHg at baseline, 142 ± 11 mmHg at 85 days. For home morning blood pressure, SBP, DBP and PT achieved the target home blood pressure goal (SBP: 125 ± 11 mmHg, DBP: 72 ± 8 mmHg, PT: 56 ± 10 beats per minute) at the first week of the administration and were maintained (SBP: 124 ± 11 mmHg, DBP: 70 ± 10 mmHg, PT: 53 ± 6 beats per minute) at the fourth week. HbA1c (6.9 ± 0.6%) and body weight (BW) (66.0 ± 7.7 kg) at baseline were not altered during BTP therapy (HbA1c: 6.9 ± 0.6%, BW: 66.1 ± 8.0 kg at 85 days). Moreover, there was no variation in urine sugar and urine protein, and there was no occurrence of hypoglycemia or cardiac decompensation for the duration of this study.Conclusions:
The administration of BTP at bedtime controlled the office blood pressure and the home morning blood pressure effectively, without the adverse effect of T2DM control.