Melatonin reduces night blood pressure in patients with nocturnal hypertension

Purpose

Nocturnal hypertension is associated with a high risk of morbidity and mortality. A blunted nocturnal surge in melatonin excretion has been described in nondipping hypertensive patients. We therefore studied the potency of melatonin to reduce nighttime blood pressure (BP) in treated hypertensive patients with nocturnal hypertension.

Patients and Methods

Thirty-eight treated hypertensive patients (22 males, mean age 64 ± 11 years) with confirmed nocturnal hypertension (mean nighttime systolic BP >125 mm Hg), according to repeated 24-hour ambulatory blood pressure monitoring (ABPM), were randomized in a double-blind fashion to receive either controlled release (CR)-melatonin 2 mg or placebo 2 hours before bedtime for 4 weeks. A 24-hour ABPM was then performed.

Results

Melatonin treatment reduced nocturnal systolic BP significantly from 136 ± 9 to 130 ± 10 mm Hg (P = .011), and diastolic BP from 72 ± 11 to 69 ± 9 mm Hg (P = .002), whereas placebo had no effect on nocturnal BP. The reduction in nocturnal systolic BP was significantly greater with melatonin than with placebo (P = .01), and was most prominent between 2:00 am and 5:00 am (P = .002).

Conclusions

Evening CR-melatonin 2 mg treatment for 4 weeks significantly reduced nocturnal systolic BP in patients with nocturnal hypertension. Thus, an addition of melatonin 2 mg at night to stable antihypertensive treatment may improve nocturnal BP control in treated patients with nocturnal hypertension.     

Les réponses sympathiques dans l’hypertension artérielle essentielle

High blood pressure (BP) is a major cause of cardiovascular disease and primary hypertension is a frequent pathological condition. Sympathetic hyperactivity may be involved in primary hypertension. The purpose of this study was mainly to evaluate sympathetic activity when performing cardiovascular autonomic profile examination in patients with primary hypertension in comparison with normotensive subjects.

Patients and methods

This prospective study included one group of hypertensive patients (n = 120, mean age 54 years) compared with a control group (n = 120, mean age 52 years) of normotensive subjects. Autonomic tests included deep-breathing (DB), hand-grip (HG) and echostress test (ES). Comparison tests between the two groups, similar in age, were expressed as mean ± SE and made using the t Student test, p < 0.05 was considered significant.

Results

Alpha-adrenergic sympathetic response using ES method produced a BP response of 20,0% ± 9,8 in hypertensive patients group and 15,2% ± 8,6 in the control group (p < 0.001). Alpha-adrenergic sympathetic response using three minutes HG test was of 16,7% ± 7,5 in hypertensive patients group and 13,3% ± 6,5 in the control group (p < 0.001). Vagal stimulation in hypertensive group after DB showed that electrocardiographic: ECG (EKG) waves R (RR) interval variation was of 30,2% ± 8,1 meanwhile in the control group this RR variation was of 46,1% ± 21,1 p < 0.001, and the one of HG of 15 seconds was 17,6% ± 10,2 versus 32,5% ± 12,7 p < 0.001.

Conclusion

Hypertensive patients had a significantly higher sympathetic response to central and peripheral stimulations and a significantly lower parasympathetic response when compared to normotensive controls.     

Effects of normal blood pressure, prehypertension, and hypertension on autonomic nervous system function

Background

Autonomic nervous system plays an important role in blood pressure (BP) regulation, and large proportion of patients with hypertension have increased sympathetic and decreased parasympathetic activity. Heart rate recovery (HRR) is a simple non-invasive measurement for investigating autonomic nervous system influence on the cardiovascular system; however, this methodology has not been used to evaluate autonomic nervous system in subjects with prehypertension (PHT). Accordingly, the present study was designed to evaluate HRR in subjects with PHT.

Methods and results

We measured HRR of 91 subjects with PHT, 44 patients with hypertension, and 53 normotensive healthy volunteers. HRR was significantly lower in the HT and PHT groups as compared to the control group (24.4 ± 5.7, 26.0 ± 8.4, 30.0 ± 8.7; hypertension, PHT, and control groups, respectively), but it did not significantly differ between HT and PHT groups. HRR was significantly and inversely correlated with age, systolic and diastolic BP, fasting and postprandial glucose level, waist circumference, total cholesterol, LDL cholesterol and non-HDL cholesterol, whereas exercise duration and METs were positively correlated with HRR. In multivariable analysis, we found that systolic BP, postprandial glucose level and exercise duration were independent predictors of lower HRR.

Conclusions

HRR, a non-invasive measurement analyzing the dysfunction in autonomic nervous system, was reduced in subjects with PHT as compared to normotensives, and the subjects with PHT had HRR as lower as patients with HT did. Our findings are supportive for the hypothesis that autonomic dysregulation is present in an early stage of essential hypertension.     

Relation of flow-mediated dilation to global arterial load: Impact of hypertension and additional cardiovascular risk factors

Background

Endothelial dysfunction may be related to increased left ventricular (LV) mass due to an association between endothelial dysfunction with increased arterial load. Therefore, we evaluated whether brachial artery flow-mediated dilation (FMD) is related to global arterial load.

Methods

Pulse pressure/stroke index (PP/SVi, global arterial stiffness, prognostically validated), stroke volume/PP (SV/PP, global arterial compliance), and % of the predicted SV/PP by heart rate, age and body weight (confounder-adjusted global compliance, prognostically validated) were used as LV geometry-related indices of global arterial load.

Results

Compared to normotensive participants (NT, n = 50), those with hypertension (HTN, n = 51) had lower FMD (8.3% ± 5.4 vs. 12.8% ± 6.5), higher PP/SVi (1.24 ± 0.34 vs. 1.04 ± 0.28 mm Hg m²/ml), higher LV mass and higher relative wall thickness (all p < 0.01); in contrast, SV/PP and % of predicted SV/PP did not differ between NT and HTN (all p > 0.1). Impaired FMD was 3-4-fold more prevalent than LV hypertrophy or increased arterial load both in NT and in HTN. Within NT and HTN separately, PP/SVi, SV/PP and % of predicted SV/PP were comparable among tertiles of FMD. Only in NT, lower FMD was associated with higher peak exercise systolic BP (p < 0.05). In multivariable regression models, FMD was not associated with indices of arterial load independently (all p > 0.1).

Conclusions

In young-to-middle-age subjects with cardiovascular risk factors, impaired FMD is more prevalent than traditional preclinical manifestation of cardiovascular disease, and may exist independent to increased arterial load. Thus, endothelial dysfunction assessment may refine cardiovascular risk profile and risk-reduction strategies based on detection of traditional target organ damage.     

Rehabilitation: Periodic somatosensory stimulation increases arterial baroreflex sensitivity in chronic heart failure patients

Background

One of the beneficial effects of exercise training in chronic heart failure (CHF) is an improvement in baroreflex sensitivity (BRS), a prognostic index in CHF. In our hypothesis-generating study we propose that at least part of this effect is mediated by neural afferent information, and more specifically, by exercise-induced somatosensory nerve traffic.

Objective

To compare the effects of periodic electrical somatosensory stimulation on BRS in patients with CHF with the effects of exercise training and with usual care.

Methods

We compared in stable CHF patients the effect of transcutaneous electrical nerve stimulation (TENS, N = 23, LVEF 30 ± 9%) with the effects of bicycle exercise training (EXTR, N = 20, LVEF 32 ± 7%). To mimic exercise-associated somatosensory ergoreceptor stimulation, we applied periodic (2/s, marching pace) burst TENS to both feet. TENS and EXTR sessions were held during two successive days.

Results

BRS, measured prior to the first intervention session and one day after the second intervention session, increased by 28% from 3.07 ± 2.06 to 4.24 ± 2.61 ms/mm Hg in the TENS group, but did not change in the EXTR group (baseline: 3.37 ± 2.53 ms/mm Hg; effect: 3.26 ± 2.54 ms/mm Hg) (P(TENS vs EXTR) = 0.02). Heart rate and systolic blood pressure did not change in either group.

Conclusions

We demonstrated that periodic somatosensory input alone is sufficient and efficient in increasing BRS in CHF patients. This concept constitutes a basis for studies towards more effective exercise training regimens in the diseased/impaired, in whom training aimed at BRS improvement should possibly focus more on the somatosensory aspect.     

Sub-clinical organ damage in hypertension and obesity

Background

The development of sub-clinical organ damage precedes and predicts the occurrence of cardiovascular (CV) events in hypertensive as well as in obese patients.

Aim and methods

We investigated the prevalence and clinical correlates of organ damage (OD), namely carotid atherosclerosis (US scan) and urine albumin to creatinine ratio (three non-consecutive first morning samples) in a group of 164 obese patients and in an age- and gender-matched group of non-obese hypertensive patients.

Results

There was a significantly greater prevalence and severity of OD in obese patients as compared to non-obese hypertensive patients. In particular obese patients more frequently had microalbuminuria (16 vs7%, χ² 5.8, P = 0.0157) and carotid abnormalities (53 vs 10%, χ² 69.5, P < 0.0001) as well as higher urinary albumin excretion rate (−0.05 ± 0.52 vs −0.28 ± 0.43log ACR, P < 0.0001) and carotid intima-media thickness (0.955 ± 0.224 vs 0.681 ± 0.171, <0.0001). Notably, the coexistence of hypertension and obesity did not entail a greater prevalence and severity of OD. Moreover, after adjusting for potentially confounding factors including blood pressure levels, diagnosis of diabetes, and lipid profile, morbidly obese patients showed a 5-fold, and 22-fold higher risk of having microalbuminuria, and carotid atherosclerosis, respectively.

Conclusions

Sub-clinical OD is highly prevalent in obese patients, even in the absence of high blood pressure. Hypertension and obesity seem to exert an independent, possibly non-additive role on the occurrence of organ damage.     

Impairment of autonomic reactivity is a feature of heart failure whether or not the left ventricular ejection fraction is normal

Background

Autonomic dysfunction (AD) is associated with morbidity and mortality in patients with systolic heart failure (SHF). The extent of AD when LV ejection fraction is preserved (HF-NEF), is unclear. Our objectives were: 1) quantitative assessment of autonomic function in SHF and HF-NEF; and 2) exploration of relationships among AD, symptoms and cardiac function.

Methods

This was an observational study of patients newly referred from primary care with a heart failure diagnosis; 21 SHF, 20 HF-NEF patients and 21 normal subjects were recruited. All subjects underwent clinical evaluation, 6-minute walk test (6MWT), Minnesota Questionnaire (MLWHFQ) and echocardiography. Autonomic assessment included haemodynamic responses to standing, deep breathing and handgrip. Concomitant blood pressure variability (BPV) and heart rate variability (HRV) parameters were also derived.

Results

There were significant differences in all haemodynamic responses between SHF, HF-NEF and normal. Log transformed (ln) low frequency spectral component of BPV was lower in SHF (4.1 ± 0.3) than HF-NEF (4.2 ± 0.4) and normal (4.4 ± 0.1; p = 0.001 SHF vs HF-NEF and vs normal). Ln LF/HF was greater in normal than HF-NEF and SHF (1.5 ± 0.7 vs 0.9 ± 1.0 vs 0.6 ± 0.6; p = 0.003). Autonomic modulations correlated negatively with severity of heart failure.

Conclusions

Autonomic responses in heart failure were blunted and the attenuation of responses correlated strongly with symptomatic and functional markers of disease severity. Autonomic dysfunction is a feature of the heart failure syndrome but is not dependent on ejection fraction.     

Event-free survival in adults with heart failure who engage in self-care management

Background

Self-care management in heart failure (HF) involves decision-making to evaluate, and actions to ameliorate symptoms when they occur. This study sought to compare the risks of all-cause mortality, hospitalization, or emergency-room admission among HF patients who practice above-average self-care management, those who practice below-average self-care management, and those who are symptom-free.

Methods

A secondary analysis was conducted of data collected on 195 HF patients. A Cox proportional hazards model was used to examine the association between self-care management and event risk.

Results

The sample consisted of older (mean ± standard deviation = 61.3 ± 11 years), predominantly male (64.6%) adults, with an ejection fraction of 34.7% ± 15.3%; 60.1% fell within New York Heart Association class III or IV HF. During an average follow-up of 364 ± 288 days, 4 deaths, 82 hospitalizations, and 5 emergency-room visits occurred as first events. Controlling for 15 common confounders, those who engaged in above-average self-care management (hazard ratio, .44; 95% confidence interval, .22 to .88; P < .05) and those who were symptom-free (hazard ratio, 0.48; 95% confidence interval, .24 to .97; P < .05) ran a lower risk of an event during follow-up than those engaged in below-average self-care management.

Conclusion

Symptomatic HF patients who practice above-average self-care management have an event-free survival benefit similar to that of symptom-free HF patients.     

Prognosis of patients with haematological malignancies admitted to the intensive care unit: Sequential Organ Failure Assessment (SOFA) trend is a powerful predictor of mortality

Background

The prognosis of patients with haematological malignancies who are admitted to the ICU is generally poor. In order to optimize care, it is important to be able to determine which patients are most likely to benefit from continuation of treatment after ICU admission.

Methods

Data of 86 patients with a haematological malignancy consecutively admitted to the ICU of Maastricht University Medical Centre were examined in a retrospective cohort study in order to identify clinically useful prognostic parameters.

Results

ICU mortality was 56% and in-hospital mortality was 65%. Non-survivors had higher APACHE-II and SOFA scores compared with survivors (32 ± 8.0 versus 25 ± 6.5 and 11.5 ± 3.1 versus 8.5 ± 3.0, respectively). The mortality rate was significantly higher in patients with an increasing SOFA score (≥ 2 points) compared with patients with an unchanged or decreasing SOFA score (72% versus 58% and 21%, respectively). Mortality was also higher in patients requiring invasive mechanical ventilation or inotropic/vasopressor therapy.

Conclusion

The mortality rate among patients with haematological malignancies who are admitted to the ICU is high and mainly associated with the severity of illness, as reflected by more severe and worsening organ failure and a need for mechanical ventilation or inotropic/vasopressor therapy. Several factors appear to be associated with a poor outcome, but no absolute predictors of mortality could be identified, although the results suggest that changes in the SOFA score during the stay in the ICU can be helpful in the decision making about the continuation or discontinuation of treatment.     

Replacement therapy for iron deficiency improves exercise capacity and quality of life in patients with cyanotic congenital heart disease and/or the Eisenmenger syndrome

Introduction

Iron deficiency is common in cyanotic congenital heart disease (CHD) and results in reduced exercise tolerance. Currently, iron replacement is advocated with limited evidence in cyanotic CHD. We investigated the safety and efficacy of iron replacement therapy in this population.

Methods

Twenty-five iron-deficient cyanotic CHD patients were prospectively studied between August 2008 and January 2009. Oral ferrous fumarate was titrated to a maximum dose of 200 mg thrice-daily. The CAMPHOR QoL questionnaire, 6 minute walk test (6MWT) and cardiopulmonary exercise testing were conducted at baseline and after 3 months of treatment.

Results

Mean age was 39.9 ± 10.9 years, 80% females. Fourteen had Eisenmenger syndrome, 6 complex cyanotic disease and 5 Fontan circulation. There were no adverse effects necessitating termination of treatment. After 3 months of treatment, hemoglobin (19.0 ± 2.9 g/dL to 20.4 ± 2.7 g/dL, p < 0.001), ferritin (13.3 ± 4.7 μg/L to 54.1 ± 24.2 μg/L, p < 0.001) and transferrin saturation (17.8 ± 9.6% to 34.8 ± 23.4%, p < 0.001) significantly increased. Significant improvements were also detected in the total CAMPHOR score (20.7 ± 10.9 to 16.2 ± 10.4, p = 0.001) and 6MWT distance (371.7 ± 84.7 m to 402.8.0 ± 74.9 m, p = 0.001). Peak VO₂ remained unchanged (40.7 ± 9.2% to 43.8 ± 12.4% of predicted, p = 0.15).

Conclusion

Three months of iron replacement therapy in iron-deficient cyanotic CHD patients was safe and resulted in significant improvement in exercise tolerance and quality of life. Identification of iron deficiency and appropriate replacement should be advocated in these patients.     

Approche multifactorielle et typologique du concept de fragilité chez les patients hypertendus non contrôlés. Enquête Eclat

Objective

The aim of the Eclat survey was to evaluate the frequency of frailty in uncontrolled hypertensives and to individualize different frailty profiles.

Patients and methods

This was an observational, prospective, longitudinal survey conducted in the cohort of uncontrolled hypertensive patients aged 55 years or more. Morbid events having occurred between two visits at a 6-month interval were reported. Patients with at least one event were considered to be frail. Predictive factors of at least one event were identified (logistic regression). The analysis was completed by a typological analysis (principal components analysis and clustering).

Results

At least one event occurred in 211 (9%) of 2306 patients (males 55%, 67 ± 9 years old, blood pressure [BP] = 160 ± 11/93 ± 8 mmHg, diabetes 23%): cardiovascular (1.7%), gerontological (5.5%), onset of diabetes (1.3%), worsening of renal impact (2%). Three frailty profiles were identified: patients at low risk (n = 1507, event rate = 6%), with neither cardiovascular risk factors nor target organ damage; patients at moderate risk (n = 335, event rate = 12%) with numerous risk factors but no target organ damage and patients at high risk (n = 243, event rate = 23%), the older ones, in bad general condition, with target organ damage, sensorial deficits and cognitive disorders. In a population of uncontrolled hypertensives aged 55 years or more, 9% could be considered as frailty.

Conclusion

Therapeutic measures might be adapted according to the frailty profile of the patient. With respect to treatment management, healthcare behaviour could differ depending on these frailty profiles.     

High-risk diabetic nephropathy patients: the outcome of evidence-based clinical practice in an outpatient clinic

Objective

A retrospective audit to assess the impact of a combined diabetes-renal consultant clinic over 10 years, on slowing the progression of diabetic nephropathy, using recognised markers of renal disease progression, including creatinine clearance and proteinuria.

Methods

44 high-risk patients with diabetic nephropathy defined as having significant proteinuria (an elevated albumin creatinine ratio greater than 30 mg/mmol), and hypertension, a progressive rise in plasma creatinine or other evidence of diabetic microvascular disease or macrovascular disease, were identified. Sufficient follow up was defined as at least two data sets over a 12-month period prior to referral to the combined clinic, and at least 18 months of combined clinic follow up thereafter.

Results

In this high risk group, GFR was falling at an average of 7.97 m/min/year (95% CI 9.83-6.10 ml/min/year) at the time of referral and following clinic intervention this was significantly reduced to 3.17 ml/min/year (95% CI 4.47-1.87 ml/min/year) over the duration of follow up. Blood pressure, glycaemic control and lipid status remained stable and close to current recommended guidelines.

Conclusions

A combined diabetes-renal consultant clinic is an effective intervention to improve the outcome of high-risk diabetics with progressive diabetic nephropathy.     

Alternative approach for selected severe pulmonary hypertension of congenital heart defect without initial correction — Palliative surgical treatment

Objectives

Uncorrected congenital heart defects (CHD) with severe pulmonary hypertension (sPH, systolic pulmonary artery > 70% of systolic pressure) are usually considered inoperable. We are curious to know if some selected patients might benefit from palliative operation for those sPH with uncorrected CHD.

Methods

Adults or adolescents with sPH associated with ventricular septal defect (VSD) with/without great artery anomalies were selected for pulmonary artery banding (PAB) to reduce sPH. The target pulmonary pressure was less than half of the systolic blood pressure after arch or great arteries reconstruction. Repeated catheterization was performed to evaluate the feasibility of defect closure.

Results

Consecutively, 8 patients (age 26 ± 9 years) received PAB as a palliative procedure in the past 8 years without mortality. The pre-PAB systolic pulmonary pressure was 119 ± 9 mmHg. Additional PAB had been applied in 4 of them. All patients showed significant improvement in function class (III to I or II). The mean post-PAB pulmonary pressure decreased significantly (77.5 ± 9.2 mmHg to 42.0 ± 9.0 mmHg) and 6-minute walk test was also found to have great improvement (270 ± 86 m to 414 ± 49 m), but the saturation at rest did not show a difference. Three of them received corrective surgery to close defects over 3-5 years.

Conclusion

For some selected adult sPH with uncorrected CHD, PAB can work as a palliative procedure to improve their functional class and even provide a chance of total repair.     

Pacemaker stress echocardiography predicts cardiac events in patients with permanent pacemaker

Purpose

Noninvasive pacemaker stress echocardiography is a newly introduced method for the diagnosis of coronary artery disease in patients with a permanent pacemaker. The prognostic value of pacemaker stress echocardiography has not been studied.

Subjects and methods

We studied 136 patients (mean age 64 ± 12 years) with a permanent pacemaker who underwent pacemaker stress echocardiography for evaluation of coronary artery disease. All patients underwent pacemaker stress echocardiography by external programming (pacing heart rate up to ischemia or target heart rate).

Results

Thirty-one patients (23%) had normal study results. Ischemia was detected in 75 patients (55%). During a mean follow-up of 3.5 ± 2.4 years, 35 deaths (26%) (20 the result of cardiac causes) and 2 nonfatal myocardial infarctions (1%) occurred. The annual cardiac death rate was 1.3% in patients without ischemia and 4.6% in patients with ischemia (P = .01). The annual all-cause mortality rate was 3.1% in patients without ischemia and 7% in patients with ischemia (P = .004). The presence of ischemia during pacemaker stress echocardiography was the strongest independent predictor of cardiac death (hazard ratio 4.1, confidence interval 1.2-14.5) and all-cause mortality (hazard ratio 2.7, confidence interval 1.2-6.0) in a multivariable model.

Conclusion

Myocardial ischemia during pacemaker stress echocardiography is an independent predictor of cardiac death and all-cause mortality in patients with a permanent pacemaker.     

Reclassification of diabetes type in pediatric patients initially classified as type 2 diabetes mellitus: 15 years follow-up using routine data from the German/Austrian DPV database

Objective

To examine change of diagnosis in patients from the German/Austrian multicenter DPV (Diabetes Patienten Verlaufsdokumentation) database initially classified as type 2 diabetes.

Methods

Patients aged ≤20 years at onset, diagnosed between 1995 and 2010 were followed for at least 6 months. Chi-square/Wilcoxon tests were performed to compare patient groups according to diabetes type after reclassification.

Results

From 580 study patients, 60 (10.3%) were reclassified, on average 2.4 years after initial diagnosis as follows: 23 (38.3%) as type 1 diabetes; 9 (15%) as maturity onset diabetes of the young (MODY); 20 (33.3%) as “other specific diabetes forms” and 8 (13.3%) as “remission” of type 2 diabetes. Patients reclassified to type 1 were significantly younger (13.5 ± 2.9 versus 14.0 ± 2.6; p = 0.027) and more often β-cell antibody positive at disease onset (80.0% versus 31.2%; p = 0.002), while patients reclassified as MODY had significantly lower BMI-SDS values than 520 patients with confirmed type 2 diabetes (2.5 ± 1.1 versus 0.9 ± 1.1; p < 0.001). The latter were also considerably more obese than patients in “remission” and those reclassified to “other specific diabetes forms”.

Conclusion

About 10% of patients in the DPV database, initially diagnosed as type 2 diabetes, were retrospectively reclassified.     

A new telemonitoring system intended for chronic heart failure patients using mobile telephone technology — Feasibility study

Background

Remote monitoring is one modality of structured care in chronic heart failure. The purpose of this study was to evaluate the feasibility of a new wireless telemonitoring system via a mobile phone network.

Methods

Portable home devices for electrocardiogram, blood pressure, body weight and self-assessment measurements were connected (via Bluetooth®) to a personal digital assistant (PDA) that performs automated encrypted transmission via mobile phone. Two telemedical centres were set-up.

Results

30 healthy volunteers were enrolled and followed for 26 days. A total of 4002 single measurements were taken, 133 ± 37 per person. No data was lost or incorrectly allocated. 880 of 937 (94%) of the ECG recordings had sufficient diagnostic quality for rhythm analysis and single beat measurements. 50 continuous ECG-streams (312 min) without disruption were performed. Total system availability was 96.6%, including that of the mobile phone network.

Conclusions

Mobile phone technology is suitable for continuous and secure medical data transmission. To evaluate the clinical use in chronic heart failure patients, a large multicentre randomized controlled trial (ClinicalTrials.gov Identifier: NCT00543881) was started.     

Contribution of sudden cardiac death to total mortality in India - a population based study

Introduction

Epidemiology of sudden cardiac death (SCD) in India is understudied.

Methods

We assessed proportion of SCD among total mortality in a population in Southern India using a staged, questionnaire-based kindred-wide approach. Detailed questionnaires (DQs) were completed by medical trainees from 8 medical colleges. Preliminary questionnaires evaluated total deaths in the kindred of a respondent. Deaths due to obvious non-cardiac causes were excluded. DQs were completed for the remaining deaths and categorized using a three-member adjudication system.

Results

A total population of 22,724 was evaluated by 478 respondents, (278 M and 200 F). Out of a total of 2185 deaths, 1691 (77.4%) were recallable. A total of 173 (10.3%; 128 M and 45 F; mean age — 60.8 ± 14 years) deaths were adjudicated as SCD. Of these, 82 (47.3%) were ≤ 60 years of age. Prior MI, LV dysfunction and prior aborted SCD were found in 33.5%, 22.5% and 5.7% respectively. Coronary artery disease (CAD) was observed in 66 (38%) and acute myocardial infarction documented in 30 (17%). At least 1 of 3 CAD risk factors — hypertension, diabetes, or smoking was observed in 80.6%. Proportion of subjects with at least one risk factor for CAD were similar in the age groups above and below 50 years (67.6% vs. 81.7%, p = 0.065).

Conclusions

SCD contributed to 10.3% of overall mortality in this population from Southern India. On an average, SCD cases were 5-8 years younger compared to populations reported in the western hemisphere, with a high prevalence of major risk factors for CAD.     

Insulin glargine compared to NPH among insulin-naïve, U.S. inner city, ethnic minority type 2 diabetic patients

Aims

We compared basal regimens of glargine or NPH among insulin-naïve, U.S. inner city, ethnic minority type 2 diabetic patients who were sub-optimally controlled on maximally tolerated doses of combination oral agents.

Methods

Eighty-five subjects were randomized to 26 weeks of open-label, add-on therapy using single doses of bedtime NPH, bedtime glargine, or morning glargine; initially through an 8-week dose titration phase, followed by a 16-week maintenance phase during which insulin doses were adjusted only to avoid symptomatic hypoglycemia.

Results

All three groups were comparable at baseline (mean HbA_1c 9.3 ± 1.4%), and improved their HbA_1c (to 7.8 ± 1.3%), fasting, and pre-supper glucose readings, with no significant between-group differences. Weight gain was greater with either glargine regimen (+3.1 ± 4.1 kg and +1.7 ± 4.2 kg) compared to NPH (−0.2 ± 3.9 kg), despite comparable total insulin doses. Pre-supper hypoglycemia occurred more frequently with morning glargine, but nocturnal hypoglycemia and improvements in treatment satisfaction did not differ among groups.

Conclusions

Among inner city ethnic minority type 2 diabetic patients in the U.S., we found no differences in basal glycemic control or nocturnal hypoglycemia between glargine and NPH, although glargine precipitated greater weight gain.     

Serum visfatin is associated with type 2 diabetes mellitus independent of insulin resistance and obesity

Objective

The aim of this study was to evaluate the association of serum visfatin, adiponectin and leptin with 2 diabetes mellitus (T2DM) in the context of the role of obesity or insulin resistance, which is not well understood.

Methods

A total of 76 newly-diagnosed T2DM patients and 76 healthy control subjects, matched for age, body mass index (BMI) and sex ratio, were enrolled. Anthropometric parameters, glycemic and lipid profile, insulin resistance (measured by homeostasis model assessment of insulin resistance index [HOMA-IR]), leptin, adiponectin, and visfatin were assessed.

Results

On the contrary to adiponectin, serum leptin and visfatin levels were higher in T2DM patients compared with controls (10.07 ± 4.5, 15.87 ± 16.4, and 5.49 ± 2.4 vs. 12.22 ± 4.9 μg/ml, 8.5 ± 7.8 ng/ml and 3.58 ± 2.2 ng/ml, respectively, P < 0.01). Waist circumference and BMI were correlated with leptin and adiponectin but not with visfatin. Leptin, adiponectin and visfatin all were associated with T2DM following adjusting for obesity measures. After controlling for HOMA-IR, visfatin remained as an independent predictor of T2DM (odds ratio = 1.32, P < 0.05). In a multiple regression analysis to determine visfatin only triglycerides and fasting glucose remained in the model (P < 0.05).

Conclusion

Elevation of visfatin in T2DM is independent of obesity and insulin resistance and is mainly determined by fasting glucose and triglycerides.