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The Appropriate Blood Pressure Control in Diabetes (ABCD) Trial is a prospective randomized blinded clinical trial that compares the effects of intensive versus moderate blood pressure control on the incidence and progression of type 2 diabetic complications. The current article discusses the results of 5.3 years of follow-up of 470 patients with hypertension and evaluates the effects of intensive and moderate blood pressure therapy using nisoldipine versus enalapril as the initial antihypertensive medication for nephropathy, retinopathy, and neuropathy. The 470 hypertensive subjects, defined as having a baseline diastolic blood pressure of > or = 90 mmHg, were randomized to intensive blood pressure control (diastolic blood pressure goal of 75 mmHg) versus moderate blood pressure control (diastolic blood pressure goal of 80-89 mmHg). The mean blood pressure achieved was 132/78 mmHg in the intensive group and 138/86 mmHg in the moderate control group. During the 5-year follow-up period, no difference was observed between intensive versus moderate blood pressure control and those randomized to nisoldipine versus enalapril with regard to the change in creatinine clearance. After the first year of antihypertensive treatment, creatinine clearance stabilized in both the intensive and moderate blood pressure control groups in those patients with baseline normo- or microalbuminuria. In contrast, patients starting with overt albuminuria demonstrated a steady decline in creatinine clearance of 5-6 ml.min-1.1.73 m-2 per year throughout the follow-up period whether they were on intensive or moderate therapy. There was also no difference between the interventions with regard to individuals progressing from normoalbuminuria to microalbuminuria (25% intensive therapy vs. 18% moderate therapy, P = 0.20) or microalbuminuria to overt albuminuria (16% intensive therapy vs. 23% moderate therapy, P = 0.28). Intensive therapy demonstrated a lower overall incidence of deaths, 5.5 vs. 10.7%, P = 0.037. Over a 5-year follow-up period, there was no difference between the intensive and moderate groups with regard to the progression of diabetic retinopathy and neuropathy. In addition, the use of nisoldipine versus enalapril had no differential effect on diabetic retinopathy and neuropathy. Blood pressure control of 138/86 or 132/78 mmHg with either nisoldipine or enalapril as the initial antihypertensive medication appeared to stabilize renal function in hypertensive type 2 diabetic patients without overt albuminuria over a 5-year period. The more intensive blood pressure control decreased all-cause mortality.

Cardiovascular disease accounts for 40 percent of overall mortality in the United States 1 and is the leading cause of death among persons with non-insulin-dependent diabetes mellitus (NIDDM). 2 , 3 Strategies to reduce this risk include the appropriate treatment of hypertension. However, the choice of antihypertensive agents may also affect the risk of cardiovascular events. In this regard, the angiotensin-converting–enzyme (ACE) inhibitors have been demonstrated to increase survival after an acute myocardial infarction 4 – 6 and among patients with congestive heart failure. 7 – 9 Calcium-channel–blocking drugs are also indicated for the treatment of a variety of cardiovascular diseases, including angina pectoris, systemic and pulmonary . . .

BackgroundMost patients with diabetes do not meet all evidence-based goals of care, and many patients report poor communication and lack of involvement in decision-making during primary care visits.ObjectiveTo test the hypothesis that a “Pre-Visit Prioritization” secure email message could improve visit communication and glycemic control among patients with type 2 diabetes.DesignWe conducted a pragmatic, provider-randomized, multi-site clinical trial from March 2015 to October 2016 across 30 primary care practices within Kaiser Permanente Northern California (KPNC), a large integrated care delivery system.ParticipantsEligible patients had at least 1 year of KPNC membership, type 2 diabetes with most recently measured hemoglobin A1c (HbA1c) > = 8.0%, and were registered users of the KPNC online patient portal.InterventionsPatients in the intervention arm, upon booking an appointment, received a secure email through the KPNC online portal with a link to the EHR allowing them to submit their top one or two priorities prior to the visit. Control patients received usual care.Main MeasuresGlycemic control; change in HbA1c 6 and 12 months after the initial visit; patient-reported outcomes related to patient-provider communication and patient care experiences.Key ResultsDuring the study period, 1276 patients had at least one eligible visit. In post-visit surveys (n = 457), more intervention arm patients reported preparing questions for their visit (72% vs 63%, p = 0.048) and being given treatment choices to consider (81% vs 73%, p = 0.041). Patients in both arms had similar reductions in HbA1c over the 12-month study period (0.56% ± 1.45%), with no significant differences between arms.ConclusionsA “light touch” email-based pre-visit intervention resulted in improved measures of visit interaction but did not significantly improve glycemic control relative to usual care. Improving diabetes clinical outcomes through more effective primary care visits may require more intensive approaches to patient visit preparation.Trial RegistryNCT02375932

Effects of aggressive blood pressure control in normotensive type 2 diabetic patients on albuminuria, retinopathy and strokes. Although several important studies have been performed in hypertensive type 2 diabetic patients, it is not known whether lowering blood pressure in normotensive (BP <140/90mm Hg) patients offers any beneficial results on vascular complications. The current study evaluated the effect of intensive versus moderate diastolic blood pressure (DBP) control on diabetic vascular complications in 480 normotensive type 2 diabetic patients. The current study was a prospective, randomized controlled trial in normotensive type 2 diabetic subjects. The subjects were randomized to intensive (10mm Hg below the baseline DBP) versus moderate (80 to 89mm Hg) DBP control. Patients in the moderate therapy group were given placebo, while the patients randomized to intensive therapy received either nisoldipine or enalapril in a blinded manner as the initial antihypertensive medication. The primary end point evaluated was the change in creatinine clearance with the secondary endpoints consisting of change in urinary albumin excretion, progression of retinopathy and neuropathy and the incidence of cardiovascular disease. The mean follow-up was 5.3 years. Mean BP in the intensive group was 128 ± 0.8/75 ± 0.3mm Hg versus 137 ± 0.7/81 ± 0.3mm Hg in the moderate group, P < 0.0001. Although no difference was demonstrated in creatinine clearance (P = 0.43), a lower percentage of patients in the intensive group progressed from normoalbuminuria to microalbuminuria (P = 0.012) and microalbuminuria to overt albuminuria (P = 0.028). The intensive BP control group also demonstrated less progression of diabetic retinopathy (P = 0.019) and a lower incidence of strokes (P = 0.03). The results were the same whether enalapril or nisoldipine was used as the initial antihypertensive agent. Over a five-year follow-up period, intensive (∼128/75mm Hg) BP control in normotensive type 2 diabetic patients: (1) slowed the progression to incipient and overt diabetic nephropathy; (2) decreased the progression of diabetic retinopathy; and (3) diminished the incidence of stroke.

Urinary albumin excretion as a predictor of diabetic retinopathy, neuropathy, and cardiovascular disease in NIDDM. S Savage , R O Estacio , B Jeffers and R W Schrier Department of Medicine, University of Colorado Health Sciences Center, Denver, USA. Abstract OBJECTIVE: The relationship between urinary albumin excretion (UAE) and diabetic complications in NIDDM has not been studied in a large American population. The demonstrated relationship between increased UAE and the development of retinopathy, nephropathy, and neuropathy in IDDM makes this an important issue to also be studied in NIDDM patients. RESEARCH DESIGN AND METHODS: A large population study of 947 NIDDM patients living predominantly in a metropolitan area was undertaken. Three categories of UAE, namely, normal albuminuria (< 20 micrograms/min), microalbuminuria (20-200 micrograms/min), and overt albuminuria (> 200 micrograms/min) were compared with 1) retinopathy as assessed by stereoscopic fundus photographs; 2) cardiovascular disease as assessed by a history of cardiac disease or stroke; ischemic changes on exercise treadmill testing; Q wave myocardial infarction; Estes, Sokolow, or Cornell criteria for left ventricular hypertrophy; positive Rose questionnaire for angina; and an abnormal Doppler exam for peripheral vascular disease; and 3) neuropathy as assessed by neurological symptom and disability scores, autonomic function testing, and quantitative sensory exams involving thermal and vibratory sensation. Selected patient characteristics were then evaluated to determine their effects on the presence of diabetic complications using univariate analyses. Multiple logistic regression analyses were then performed to determine the independent effect of UAE on these diabetic complications. RESULTS: chi 2 analyses revealed that UAE was significantly associated with the presence of retinopathy (P < 0.001), neuropathy (P < 0.001), and cardiovascular disease (P < 0.001). In the multiple logistic regression analyses, UAE had strong independent associations with retinopathy, neuropathy, and cardiovascular disease. CONCLUSIONS: Thus, increasing UAE in this large NIDDM population in the U.S. was associated with an increased prevalence of diabetic retinopathy, neuropathy, and cardiovascular disease. This suggests that UAE may be more than an indicator of renal disease in NIDDM patients and, in fact, may reflect a state of generalized vascular damage occurring throughout the body. Prospective studies in NIDDM patients are needed to determine the predictive effect of UAE and the effect of decreasing UAE on future diabetic micro- and macrovascular complications.

Progression of renal disease and cardiovascular complications in type II diabetes mellitus have been shown to correlate with control of blood glucose, lipids, blood pressure, and smoking. These factors, however, do not appear to totally explain these diabetic complications. Renal disease and cardiovascular complications in type II diabetes are associated with vascular abnormalities and fibrosis, both of which may occur with impaired fibrinolysis. A cross-sectional study was therefore performed in 107 type II diabetic patients recruited from the Denver Metropolitan Area to examine the effect of impaired fibrinolysis, as assessed by the ratio of plasminogen activator inhibitor (PAI-1) to tissue-type plasminogen activator (t-PA). With urinary albumin excretion (UAE) as a risk factor for both renal disease progression and cardiovascular complications, the patients were analyzed with respect to UAE less than and greater than 1 gm/day. The age, blood glucose, hemoglobin A1C, duration of diabetes, lipids, body mass index, and smoking were no different between the groups. As expected, the group with greater UAE had worse renal function, the serum creatinine (1.98±0.24 vs 1.21±0.05 mg/dl, P<0.001) and creatinine clearance (55.5±6.0 vs 76.8±2.7 ml/min, P<0.001) were significantly different. The type II diabetic patients with greater UAE exhibited significantly higher PAI-1/t-PA (2.43±0.26 vs 1.85±0.07, P<0.03). The past history of cardiac complications was also higher (87.5 vs 72.3%, P<0.07) in the diabetic patients with more impaired fibrinolysis and greater UAE. Thus a prospective, randomized clinical trial in type II diabetes with PAI-1 inhibitors is needed.

Diabetes is the most common cause of renal failure in the United States, and data regarding the effects of aggressive blood pressure (BP) therapy in normotensive patients with type 2 diabetes are inadequate. A total of 129 type 2 diabetic patients with a BP of <140/80 to 90 mm Hg without overt albuminuria were randomized to either intensive BP control (diastolic BP goal 75 mm Hg) using an angiotensin II receptor blocker, valsartan, versus moderate BP control (diastolic BP 80 to 90 mm Hg with placebo initially) to evaluate the effect on the change in urinary albumin excretion (UAE) from baseline. The mean entrance BP was 126 ± 8.8/84 ± 2.4 mm Hg. The mean follow-up period was 1.9 ± 1.0 years. During the follow-up period, the mean BP was 118 ± 10.9/75 ± 5.7 for the intensive v 124 10.9/80 6.5 mm Hg for the moderate BP groups ( P < .001). No difference was observed in change in creatinine clearance or serum creatinine from baseline between the two groups. An analysis of covariance model for change in log (UAE + 1), adjusting for age, HBA 1c, duration of diabetes, baseline log (UAE + 1), sex, and ethnicity resulted in a significant treatment difference at 2 years ( P = .007) with intensive BP control reducing log (UAE+1) compared with moderate BP control. Intensive BP control with valsartan to <120/80 mm Hg in normotensive patients with type 2 diabetes and normo- or microalbuminuria significantly decreased the progression of UAE and in some cases caused regression of UAE.

To the Editor: In 1998 we presented data from the Appropriate Blood Pressure Control in Diabetes (ABCD) trial on the effect of nisoldipine as compared with enalapril on cardiovascular outcomes after five years of follow-up in 470 patients with hypertension and type 2 diabetes. 1 The nisoldipine therapy was terminated in the cohort with hypertension on July 14, 1997, as recommended by the study's data and safety monitoring committee. At that time, there had been 25 myocardial infarctions in the nisoldipine group, as compared with 5 myocardial infarctions in the enalapril group, resulting in an unadjusted risk ratio of 5.5 (95 . . .

The association between diabetic complications and exercise capacity in NIDDM patients. R O Estacio , J G Regensteiner , E E Wolfel , B Jeffers , M Dickenson and R W Schrier Department of Medicine, Denver Health and University of Colorado Health Sciences Center, Colorado 80262, USA. Abstract OBJECTIVE: Exercise capacity has been used as a noninvasive parameter for predicting cardiovascular events. It has been demonstrated previously in NIDDM patients that several risk factors (i.e., obesity, smoking, hypertension, and African-American race) are associated with an impaired exercise capacity. We studied 265 male and 154 female NIDDM patients who underwent graded exercise testing with expired gas analyses to determine the possible influences of diabetic neuropathy, nephropathy, and retinopathy on exercise capacity. RESEARCH DESIGN AND METHODS: Univariate and multiple linear regression analyses were performed to determine the relationship between diabetic neuropathy, urinary albumin excretion (UAE), and retinopathy with respect to peak oxygen consumption (VO2). Neuropathy was assessed by neurological symptom and disability scores, autonomic function testing, and quantitative sensory exams involving thermal and vibratory sensation. Three categories of UAE were used: normal albuminuria (< 20 micrograms/min), microalbuminuria (20-200 micrograms/min), and overt albuminuria (> 200 micrograms/min). Retinopathy was assessed by stereoscopic fundus photographs. Multiple linear regression analyses were then performed controlling for age, sex, length of diagnosed diabetes, duration of hypertension, race and ethnicity, GHb, BMI, and smoking to determine whether there was an independent effect of these diabetic complications on exercise capacity. RESULTS: Univariate analyses revealed that the presence of diabetic retinopathy (P = 0.03), neuropathy (P = 0.002), microalbuminuria (P = 0.04), and overt albuminuria (P = 0.06) were associated with a lower peak VO2. Multiple linear regression analyses were performed to determine independent relationships with peak VO2. The results revealed that increasing retinopathy stage (Parameter estimate [PE] = -0.59 +/- 0.3 ml.kg-1.min-1; P = 0.026) and increasing UAE stage (PE = -0.62 +/- 0.3 ml.kg-1.min-1; P = 0.04) were associated with a decrease in peak VO2. CONCLUSIONS: In the present study of NIDDM subjects, a significant independent association was demonstrated between diabetic nephropathy and retinopathy with exercise capacity. These results were obtained controlling for age, sex, length of diagnosed diabetes, hypertension, race, and BMI. Thus the findings in this large NIDDM population without a history of coronary artery disease indicate a potential pathogenic relationship between microvascular disease and exercise capacity.

To assess the prevalence of sex work and its associations with substance use among female bar/spa workers in the Philippines (N = 498), workers from 54 bar or spa venues in Metro Manila (2009-2010) were surveyed on demographics, drug/alcohol use, abuse history, and sex work. Their median age was 23 years and 35% engaged in sex work. Sex work was independently associated with methamphetamine use (19% vs 4%; adjusted odds ratio [AOR] =2.9,95% confidence interval [CI] = 1.3-6.2), alcohol use with patrons (49% vs. 27%;AOR = 1.9, 95% CI = 1.1-3.4), and alcohol intoxication during sex (50% vs. 24%; AOR = 2.0, 95% CI = 1.2-3.5), but inversely associated with daily alcohol use (13% vs. 16%;AOR = 0.2, 95% CI = 0.1-0.5).Additional significant covariates included sexual abuse history, younger age, and not having a higher education. Findings suggest that interventions with sex workers in bars and spas should focus on methamphetamine use, alcohol use contexts, and violence victimization, to better meet the needs of this population.