20 Years Results by HBP and DBP in Patients With Type 2 Diabetes Mellitus After Following-up

Microalbuminuria and clinical albuminuria were defined as urinary albumin excretion rate 30 mg/g creatinine and 300 mg/g creatinine, respectively (6).

CBP was measured once in each clinic visit. HBP was measured every day in the morning within 10 minutes after awakening in the sitting position, but HBP value assessed for this study used the value measured once in the same morning at each clinic visit.

Clinic hypertension (CH) and morning hypertension (MH) were defined as systolic BP (SBP) 130 mmHg and/or diastolic BP (DBP) 85 mmHg; clinic normotension (CN) and morning normotension (MN) were defined as SBP <130 mmHg and DBP <85 mmHg, respectively. .

Microvascular complications included nephropathy, neuropathy, and retinopathy. Severity of nephropathy was determined based on albuminuria using four categories: normal, 0 points; microalbuminuria, 1 point; clinical albuminuria, 2 points; and dialysis, 3 points. Severity of neuropathy was categorized as normal, 0 points; chronic sensorimotor distal symmetric polyneuropathy and/or cardiac autonomic neuropathy, 1 point. Severity of retinopathy was determined using four categories: normal, 0 points; simple, 1 point; pre-proliferative, 2 points; and proliferative, 3 points. Development of new, worsened, or improved microangiopathy was defined according to a change of at least one step from baseline.

Macrovascular complications included coronary heart disease, cerebrovascular disease and peripheral artery obstruction. Severity of macrovascular events was categorized using two categories: normal, 0 points; and coronary heart disease, cerebrovascular disease, or peripheral artery obstruction, 1 point (3). New, worsened (recurrent), or improved events were defined based on clinical manifestations and treatment throughout the study.

For ethical reasons, patients were treated with various anti-hypertensive, anti-diabetic, anti-dyslipidemia, anti-hypercoagulation and other agents during course of the study by their own doctors.

Outcome results considered only the first event in each subject (3). Primary end-point was death from any cause (3). Secondary end-points were new, worsened, or improved microvascular and macrovascular events (3).

1. Risk factor assessment for outcomes. Risk factors at end-point in ? participants related to each outcome were determined, and therapy which was added to baseline therapy used for each disease in patients with MH was recorded at base- and end-points (3). The 6-month interval minimizes bias due to the fall or rise in the HBP or CBP measurement (10).

Statistical analysis.

1. Baseline. All results are presented as means ± SD. Mean values were compared using the paired or unpaired student t test. To compare the prevalence of micro- and macrovascular complications or medical treatment in patients with and without HT on basis of HBP or CBP (3), Fisher's exact test with two-tailed P values was used, and then hazard ratio and 95% confidence intervals were calculatein.

End-points and outcome measures. Differences in outcomes for each end-point of death, and micro- and macrovascular complications between patients with HT and NT on basis of HBP or CBP at base- and end-points in the home or in the clinic, respectively, were assessed using Kaplan-Meier survival curves and then compared by hazard rate using the log-rank test.

Risk factor assessment for outcomes. Risk factors determined to be statistically related to outcomes were assessed by Cox proportional hazard analysis.

Analysis was performed using the Prism version software (GraphPad Software, CA, USA) and the Statistical Package for the Bioscience (ComWorks Co,Tokyo,Japan). Two-tailed values of P<0.05 were considered statistically significant.