Baseline Characteristics Of Subjects Research Articles

Evidence of uncoupling between renal dysfunction and injury in cardiorenal syndrome: insights from the BIONICS study.

ObjectiveThe objective of the study was to assess urinary biomarkers of renal injury for their individual or collective ability to predict Worsening renal function (WRF) in patients with acutely decompensated heart failure (ADHF).MethodsIn a prospective, blinded international study, 87 emergency department (ED) patients with ADHF were evaluated with biomarkers of cardiac stretch (B type natriuretic peptide [BNP] and its amino terminal equivalent [NT-proBNP], ST2), biomarkers of renal function (creatinine, estimated glomerular filtration rate [eGFR]) and biomarkers of renal injury (plasma neutrophil gelatinase associated lipocalin [pNGAL], urine kidney injury molecule-1 [KIM-1], urine N-acetyl-beta-D-glucosaminidase [NAG], urine Cystatin C, urine fibrinogen). The primary endpoint was WRF.Results26% developed WRF; baseline characteristics of subjects who developed WRF were generally comparable to those who did not. Biomarkers of renal function and urine biomarkers of renal injury were not correlated, while urine biomarkers of renal injury correlated between each other. Biomarker concentrations were similar between patients with and without WRF except for baseline BNP. Although plasma NGAL was associated with the combined endpoint, none of the biomarker showed predictive accuracy for WRF.ConclusionsIn ED patients with ADHF, urine biomarkers of renal injury did not predict WRF. Our data suggest that a weak association exists between renal dysfunction and renal injury in this setting (Clinicaltrials.gov NCT#0150153).

AT-43 * MULTI-CENTRE, RANDOMIZED, DOUBLE-BLIND PHASE II STUDY COMPARING CEDIRANIB (AZD2171) PLUS GEFITINIB (IRESSA, ZD1839) WITH CEDIRANIB PLUS PLACEBO IN SUBJECTS WITH RECURRENT/PROGRESSIVE GLIOBLASTOMA

BACKGROUND: The vascular endothelial growth factor receptor (VEGFR) 2 tyrosine kinase inhibitor cediranib failed to improve outcome in recurrent glioblastoma in a randomized phase III trial (Batchelor et al.). One resistance mechanism for cediranib is through up-regulation of epidermal growth factor receptor (EGFR). This study was designed to test if the efficacy of cediranib is improved with the addition of gefitinib (an EGFR inhibitor). METHODS: We planned to 1:1 randomize 112 subjects with recurrent/progressive glioblastoma to cediranib + gefitinib (C + G) or cediranib + placebo (C + P) (NCT01310855), with PFS as the primary endpoint. Secondary end-points: OS, radiographic response rate, PFS rate at 6 months, 12 months survival rate, steroid use, time to deterioration of neurological status, safety and tolerability. Recruitment was discontinued early following AstraZeneca's suspension of the cediranib programme. RESULTS: 38 subjects were randomized, the interim results on 34 subjects (17 in each arm) are currently available. 24 male and 10 female. Mean age 54 (range 30-71). KPS ≤80 (35%), >80 (65%). The base-line characteristics for subjects in the 2 arms of the study were well balanced. Median PFS (95% CI) C + G 4.0 mo (2.7, *n/c), C + P 4.1 mo (2.0, 7.3); 6 month PFS C + G 40%, C + P 26%; 12 month PFS n/c; C + G vs C + P HR = 0.49, 95% CI (0.22, 1.11, p = 0.15). OS (mo): Median C + G 7.7 (95% CI 3.8, n/c), C + P 5.5 (95% CI 2.5, 7.3); 12 month n/c; C + G vs C + P HR = 0.359, 95% CI (0.12, 1.1; p = 0.076). No safety concerns. CONCLUSIONS: These interim results demonstrate no difference in PFS, however there was a trend (p = 0.08) for improved OS with the combination. The final results of the study for all 38 subjects will be available. *n/c not calculable due to limited data at time of analysis

Is there a linear relationship between the dose of ruminant trans-fatty acids and cardiovascular risk markers in healthy subjects: results from a systematic review and meta-regression of randomised clinical trials.

The effects of ruminant (R) trans-fatty acids (TFA) on the risk of CVD are still under debate. It could be argued that the lack of the effect of R-TFA may be the result of the small amount of their intake. Taking into consideration the growing available data from intervention studies, we carried out a systematic review and meta-regression to assess the impact of R-TFA intake levels on changes in the total cholesterol: HDL-cholesterol (TC:HDL-C) ratio. A systematic review of the literature was conducted and thirteen randomised clinical trials were included, yielding a total of twenty-three independent experimental groups of subjects. A univariate random-effects meta-regression approach was used to quantify the relationship between the dose of R-TFA and changes in the TC:HDL-C ratio. To consider several potential modifiers such as subject and dietary characteristics, a multivariate regression analysis was performed. We found no relationship between R-TFA intake levels of up to 4.19% of daily energy intake (EI) and changes in cardiovascular risk factors such as TC:HDL-C and LDL-cholesterol (LDL-C):HDL-C ratios. In addition, a multivariate regression analysis that included other dietary variables, as well as subject baseline characteristics, confirmed that doses of R-TFA did not significantly influence the changes in the lipid ratio. Our findings showed that doses of R-TFA did not influence the changes in the ratios of plasma TC:HDL-C and LDL-C:HDL-C. These data suggest that TFA from natural sources, at least at the current levels of intake and up to 4.19% EI, have no adverse effects on these key CVD risk markers in healthy people.

Effectiveness of Switching from a DPP-4 Inhibitor to the Human GLP-1 Analogue Liraglutide in Patients with Type 2 Diabetes

Data from EVIDENCE, a post-marketing study in France were used to assess effectiveness of switching from a DPP-4 inhibitor (DPP-4i) to liraglutide in patients with T2D. EVIDENCE is a multicentre, observational, outpatient study requested by the French National Health Authority to evaluate efficacy and safety of liraglutide. It aims to determine the percentage still taking liraglutide and with A1c <7% after 2 years. Statistical analyses were: quantitative variables, via normality Kolmogorov-Smirnov test; comparisons of 2 dependent groups, via Wilcoxon signed rank test; paired qualitative variables, via McNemar test. Data were collected from 3152 subjects, of whom 1261 (40%) received DPP-4i prior to liraglutide; 1002 (32%) switched from DPP-4i to liraglutide at study start. Baseline characteristics of subjects who switched and were still on liraglutide at study end (n=624) are in Table 1 (above); reductions in A1c (–0.85%, p<0.0001), fasting plasma glucose (–0.28g/L, p<0.0001) and body weight (–3.60kg, p<0.0001) were significant. An increased percentage reached A1c <7% after switching to liraglutide (31.7% at study end vs. 9.7% at baseline; p<0.0001). Withdrawals (21.4% overall) were mostly due to gastrointestinal disorders at study start. Switching from a DPP-4i to liraglutide improved glycemic control and weight in this observational study. In a previous randomized trial, sitagliptin to liraglutide switch provided significant A1c (–0.5%; p<0.0001) and weight reductions (–2.5 kg; p<0.0001). The greater reductions in this observational study may reflect different baseline characteristics and concomitant diabetes medications. These data support the benefits of switching from a DPP-4i to a GLP-1 analogue. Table 1Baseline characteristics of subjects switching from a DPP-4i to liraglutide and still on liraglutide treatment at study end Baseline characteristics N 624 Age, years 58±10 Diabetes duration, years 9.2±5.8 A1c, % 8.4±1.4 Fasting plasma glucose, g/L 1.8±0.6 Body weight, kg 96±18 BMI, kg/m2 34±6 Proportion of patients with A1c <7% 9.7% Data are mean ± SD. Open table in a new tab Data are mean ± SD.

Primary care management of non-institutionalized elderly diabetic patients: The S.AGES cohort – Baseline data

AimS.AGES is a multicenter prospective cohort study of non-institutionalized patients aged 65 and over with atrial fibrillation, type 2 diabetes or chronic pain. Its objective is to describe the medical management in primary care. This article presents the baseline characteristics of subjects in the diabetes subcohort and compares the results to those from cohorts of older diabetic patients. MethodsFrom April 2009 to June 2011, 983 patients were included in the diabetes subcohort by 213 primary care providers. Demographic data, geriatric parameters and the history, characteristics and treatment of the diabetes were recorded at baseline. ResultsThe mean age was 76.7±5.9 years. Most patients were living independently, with no cognitive impairment and in relatively good health. The duration of diabetes was 11.3±8.7 years with average HbA1c of 6.9±1.0%. 20% of patients had macrovascular disease, 33% renal failure, 14.6% ocular complication and 7.1% neuropathy. The first-line antidiabetic treatment was metformin (61.2%) and 18% of patients had used insulin. Treatment intensified with the worsening of diabetic symptoms. When compared to those from French and North American cohorts, the results showed increased complications and use of insulin with age, disease duration and severity. ConclusionDue to the method of recruitment, S.AGES patients were generally healthy with well-controlled diabetes. However, the results were consistent with those from other cohorts. Three-year follow-up is expected to study the management of diabetic patients aged 65 and over in primary care.

AB0354 Cardiovascular Risk Factors in Rheumatoid Arthritis: Descriptive Study

BackgroundPatients with rheumatoid arthritis (RA) have an increased cardiovascular morbidity and mortality (CV) remains leading cause of death. The SCORE (Systematic Coronary Risk Evaluation) are tables that allow us estimate...

Combined effect of plant sterols and dietary fiber for the treatment of hypercholesterolemia.

Hypercholesterolemia is a major contributor for disease burden in both the developed and developing world and an important risk factor for cardiovascular diseases (CVD). Phytosterols (PhS) and dietary fiber (DF) act as low density lipoprotein cholesterol (LDL-C) lowering agents, offering an effective treatment against high blood cholesterol and CVD. The aim of this review was to consider clinical evidence that analyzed the combination of PhS and DF in a cereal carrier for lowering LDL-C. Electronic database searches were carried out to identify peer-reviewed journal articles, from which five intervention studies that combined both components in a cereal carrier were identified and included in the present review. LDL-C lowering effects varied widely among studies, due to large heterogeneity in study design, subject baseline characteristics, length of the interventions, PhS and DF dosage and type of DF used. In relation to a time of intake, three studies suggested a frequency or distribution of the product's consumption during the day, while two studies did not consider this factor. Overall, the selected studies found significant differences on LDL-C concentrations, although not all of them reached the expected outcomes. Future research should be conducted to explore the effect that different types of DF exert on LDL-C when combined with PhS, and to analyze the effect of the product's time of intake in order to suggest an optimal moment of the day for its consumption.

Mo1214 Long-Term Safety and Efficacy of Golimumab in Patients With Moderately to Severely Active Ulcerative Colitis: Results From the PURSUIT-SC Maintenance Study Extension

Mo1214 Long-Term Safety and Efficacy of Golimumab in Patients With Moderately to Severely Active Ulcerative Colitis: Results From the PURSUIT-SC Maintenance Study Extension

OP010 AlphaE integrin expression as a predictive biomarker for induction of clinical remission by etrolizumab: Analysis of a phase II trial in moderate-to-severely active ulcerative colitis

OP010 AlphaE integrin expression as a predictive biomarker for induction of clinical remission by etrolizumab: Analysis of a phase II trial in moderate-to-severely active ulcerative colitis

ASPIRATION PNEUMONIA IN PATIENTS WITH STROKE, NORTHEAST NIGERIA

Objectives: Aspiration pneumonia is a common complication in patients with stroke, having a negative influence on morbidity and mortality. This study sought to assess the frequency of aspiration pneumonia and the independent predictors for its development among Nigerian patients with stroke. Methods: Five hundred and twenty-four stroke patients were prospectively enrolled during the study period at the University of Maiduguri Teaching Hospital, Maiduguri, from January 2005 and May 2011. All patients who developed aspiration pneumonia during hospital stay and follow-up were recorded. A student’s t-test and a Pearson chi-square analysis was used to compare baseline characteristics of subjects who developed aspiration pneumonia and those who did not. A multiple logistic regression was used to assess the independent predictors of aspiration pneumonia. We also recorded the rate of deaths and duration hospital stay within this period. Results: Aspiration pneumonia occurred in 65 (12.4%) of our stroke patients, A univariate analysis showed that patients with aspiration pneumonia were older (P&lt;0.001), had a lower Glasgow coma score on presentation (P&lt;0.001), were more likely to have swallowing (P&lt;0.001) and speech problems (P=0.003). They were also more likely to have severe stroke (NIHSS, P&lt;0.001) and disability (mRDS, P&lt;0.001; Barthel’ ADL index, P&lt;0.001) both on admission and discharge. They had a higher 60 - day fatality (75.4% versus 9.4%; P&lt;0.001) and a lower duration of stay (25.3±17.5 versus 34.6±28.3; P=0.01). Factors associated with the development of aspiration pneumonia are; Age &gt; 60 years (OR, 2.3; 95% CI, 1.37 - 3.91; P=0.002); Initial GCS≤12 (OR, 4.5; 95% CI, 2.60 - 8.00; P&lt;0.001); dysphagia (OR, 12.1; 95% CI, 6.50 - 22.70; P&lt;0.001); dysphasia (OR, 2.2; 95% CI, 1.29 - 3.70; P=0.004); admission mRDS≥4 (OR, 4.1; 95% CI, 1.43 - 11.50; P=0.008); admission NIHSS≥11 (OR, 2.5; 95% CI, 1.34 - 4.66; P=0.004); admission Barthel’ ADL index &lt;30 (OR, 16.9; 95% CI , 4.07 - 70.29; P&lt;0.001). Conclusion: Aspiration pneumonia is a common complication in our stroke patients. Decline in consciousness, swallowing and speech difficulties, and severe strokes are associated with the development of aspiration pneumonia.

AB0261 Profile of an under-studied rheumatoid arthritis (RA) population: characteristics of patients with moderately active rheumatoid arthritis despite methotrexate use

BackgroundRA progression is difficult to predict and rheumatologists need to rely on a combination of subjective and objective measurements to assess RA disease activity and severity, as reliance on one...

Predictors of Successful Telephone Contact After Emergency Department-based Recruitment into a Multicenter Smoking Cessation Cohort Study.

IntroductionEmergency department (ED) studies often require follow-up with subjects to assess outcomes and adverse events. Our objective was to identify baseline subject characteristics associated with successful contact at 3 time points after the index ED visit within a sample of cigarette smokers.MethodsThis study is a secondary analysis of a prospective cohort. We recruited current adult smokers at 10 U.S. EDs and collected baseline demographics, smoking profile, substance abuse, health conditions, and contact information. Site investigators attempted contact at 2 weeks, 3 months, and 6 months to assess smoking prevalence and quit attempts. Subjects were paid $20 for successful follow-up at each time point. We analyzed data using logistic and Poisson regressions.ResultsOf 375 recruited subjects, 270 (72%) were contacted at 2 weeks, 245 (65%) at 3 months, and 217 (58%) at 6 months. Overall, 175 (47%) were contacted at 3 of 3, 71 (19%) at 2 of 3, 62 (17%) at 1 of 3, and 66 (18%) at 0 of 3 time points. At 6 months, predictors of successful contact were: older age (adjusted odds ratio [AOR] 1.2 [95%CI, 0.99–1.5] per ↑10 years); female sex (AOR 1.7 [95%CI, 1.04–2.8]); non-Hispanic black (AOR 2.3 [95%CI, 1.2–4.5]) vs Hispanic; private insurance (AOR 2.0 [95%CI, 1.03–3.8]) and Medicare (AOR 5.7 [95%CI, 1.5–22]) vs no insurance; and no recreational drug use (AOR 3.2 [95%CI; 1.6–6.3]). The characteristics independently predictive of the total number of successful contacts were: age (incidence rate ratio [IRR] 1.06 [95%CI, 1.00–1.13] per ↑10 years); female sex (IRR 1.18 [95%CI, 1.01–1.40]); and no recreational drug use (IRR 1.37 [95%CI, 1.07–1.74]). Variables related to smoking cessation (e.g., cigarette packs-years, readiness to quit smoking) and amount of contact information provided were not associated with successful contact.ConclusionSuccessful contact 2 weeks after the ED visit was 72% but decreased to 58% by 6 months, despite modest financial incentives. Older, female, and non-drug abusing participants were the most likely to be contacted. Strategies to optimize longitudinal follow-up rates, with limited sacrifice of generalizability, remain an important challenge for ED-based research. This is particularly true for studies on substance abusers and other difficult-to-reach populations.

Fever and laboratory profiles as predictors of serious bacterial infection in children

Background There is a debate on the use of high fever \\lith othermorbidities to predict serious bacterial infection (SBI). Bacterialinfection occurs in 3􀁉15% of children with fever of 2: 39°C.Various laboratory parameters including increased C􀁉reactiveprotein (CRP) levels, leukocyte counts, and absolute neutrophilcounts (AN C) have been studied for their usefulness in predictingthe occurrence of SBI, but with varied results. The ability todiscriminate whether a patient has a SBI can lead to improvedpatient management.Objective To evaluate fever of 2: 39°C, leukocyte counts of2: 15,000/mm3, ANC of 2: 1O,000/mm3 and CRP of 2: 10 mgiL aspredictors of SBI in children aged 1 month􀁉 18 years.Methods A case􀁉controlled study was conducted by collectingdata from medical records at Sanglah Hospital, Denpasar. Subjectsin the case group were diagnosed \\lith SBls (bacterial meningitis,bacterial pneumonia, bacteremia or sepsis, urinary tract infections,or bacterial gastroenteritis), and subjects in the control group nonserious bacterial infections (non􀁉SBI). Data was analyzed usingbivariate and multivariate methods \\lith 95% confidence intervalsand a statistical significance value ofP &lt;0.05.Results Sixty subjects were studied, \\lith 30 subjects in the casegroup and 30 in the control group. Baseline characteristics ofsubjects were similar between the two groups. Fever and CRP werepredictors ofSBI [OR8.71 (95% CI 1.61 t046.98), P 􀀁 0.009; andOR 6.20 (95% CI 1.58 to 24.24), P 􀀁 0.012, respectively].Conclusion Fever 2: 39°C and CRP 2: 10 mgiL were significantpredictors of serious bacterial infections in children. [Paediatrrndones, 2012;52:313-6].

A pilot, randomized, controlled clinical trial of lucinactant, a peptide-containing synthetic surfactant, in infants with acute hypoxemic respiratory failure

Inhibition of surfactant function and abnormal surfactant synthesis lead to surfactant dysfunction in children with acute hypoxemic respiratory failure. We evaluated whether intratracheal lucinactant, a synthetic, peptide-containing surfactant, was safe and well-tolerated in infants with acute hypoxemic respiratory failure, and assessed its effects on clinical outcomes. Infants ≤ 2 yrs of age with acute hypoxemic respiratory failure were enrolled in a phase II, double-blind, multinational, placebo-controlled randomized trial across 36 pediatric intensive care units. Infants requiring mechanical ventilation with persistent hypoxemia meeting acute lung injury criteria were randomized to receive intratracheal lucinactant (175 mg/kg) or air placebo. One retreatment was allowed 12-24 hrs after initial dosing if hypoxemia persisted. Peri-dosing tolerability of intratracheal lucinactant and adverse experiences were assessed. Mechanical ventilation duration was analyzed using analysis of variance. The Cochran-Mantel-Haenszel test was used for categorical variables.We enrolled 165 infants (84 lucinactant; 81 placebo) with acute hypoxemic respiratory failure. There were no significant differences in baseline subject characteristics, with the exception of a lower positive end-expiratory pressure and higher tidal volume in placebo subjects. The incidence of transient peri-dosing bradycardia and desaturation was significantly higher in the lucinactant treatment group. There were no statistical differences between groups for other adverse events or mortality. Oxygenation improved in infants randomized to receive lucinactant as indicated by fewer second treatments (67% lucinactant vs. 81% placebo, p = .02) and a trend in improvement in partial pressure of oxygen in arterial blood to fraction of inspired oxygen from eligibility to 48 hrs after dose (p = .06). There was no significant reduction in duration of mechanical ventilation with lucinactant (geometric least square means: 4.0 days lucinactant vs. 4.5 days placebo; p = .254). In a subset of infants (n = 22), the duration of mechanical ventilation in children with acute lung injury (partial pressure of oxygen in arterial blood to fraction of inspired oxygen >200) was significantly shorter with lucinactant (least square means: 2.4 days lucinactant vs. 4.3 days placebo; p = .006). In mechanically ventilated infants with acute hypoxemic respiratory failure, treatment with intratracheal lucinactant appeared to be generally safe. An improvement in oxygenation and a significantly reduced requirement for retreatment suggests that lucinactant might improve lung function in infants with acute hypoxemic respiratory failure.

Influence of Fundoplication on Remission and Recurrence of Intestinal Metaplasia after Ablation of Barrettʼs Esophagus

Purpose: Radiofrequency ablation (RFA) is an effective treatment for Barrett's dysplasia in conjunction with adequate acid reflux control. Fundoplication is a treatment option for persistent gastroesophageal reflux in spite of optimal pharmacotherapy. Our aim was to assess the effect of fundoplication in achieving complete remission of intestinal metaplasia (CRIM) and recurrence after successful RFA. Methods: We performed a retrospective cohort analysis of patients who underwent RFA for Barrett's dysplasia at a tertiary referral center from Jan. 2003 to Jun. 2012. All patients were on proton pump inhibitors following RFA. CRIM was defined as the absence of intestinal metaplasia (IM) in 2 consecutive endoscopies with biopsies. Recurrence was defined as the reappearance of IM with any grade of dysplasia after CRIM. Demographic and endoscopic factors associated with CRIM or recurrences were assessed by univariate and multivariate analyses. The effect of pre-RFA fundoplication to either time to CRIM or recurrence was assessed by Kaplan-Meier survival estimates. Results: A total of 206 patients were included in the analysis. There were 28 (13.6%) patients who had pre-RFA fundoplication. Patients were followed for 26.69 ±18.91 months after their first RFA session. Baseline characteristics are summarized in Table 1 which showed no significant difference between those with and without fundoplication. There was no association of fundoplication with either achieving CRIM (HR 0.93, 95% CI: 0.47-1.65) or recurrence (HR 0.99, 0.15-3.81) after controlling for age, number of RFA sessions, length of Barrett's esophagus (BE) segment and hiatal hernia in a multivariate Cox proportional hazards analysis. Figure 1 presents the Kaplan-Meier plot of patients with and without fundoplication in relation to CRIM. Time intervals for both CRIM (p=0.87) and recurrence (p=0.90) were not different between the two groups based on Mantel-Cox statistics.Table: Baseline characteristics of subjects with and without pre-RFA fundoplicationFigure: [62]Conclusion: In our cohort of patients, fundoplication was not associated with either time to CRIM or recurrence. Future studies with long term follow-up data and evidence of sufficient acid control, measured by pH impedance after fundoplication are needed to assess the effect of surgical reflux control on BE eradication following RFA. Disclosure: Dr. Wang - Consultant and research support from: Covidien (Barrx); Ninepoint Medical; CDX Diagnostics; Fujinon; Pinnacle Biologics; Ms. Lutzke - Research support: Covidien (Barrx); Fujinon; Ninepoint; Dr. Prasad Iyer - Research support: Takeda.

Clinical Characteristics of Exacerbations in Parkinson Disease

Episodes of subacute worsening of motor function occur commonly in Parkinson disease (PD), but there has been surprisingly little research about the clinical characteristics of these exacerbations in the outpatient setting. Retrospective study of an established cohort of 120 outpatients with PD. Primary outcome measures were the frequency, causes, and outcomes of motor exacerbations. Statistical analysis was performed to compare baseline characteristics of subjects with subsequent exacerbations versus without subsequent exacerbations. Over an 18-month period, 43 exacerbations occurred, affecting 30 of 120 subjects (25.0%). Infection was the single most frequent underlying cause, accounting for 11 of 43 (25.6%) exacerbations. Other common etiologies were anxiety (n=8), medication errors (n=6), poor adherence (n=6), medication side effects (n=3), and postoperative decline (n=3). Overall, 35 episodes (81.4%) were attributable to reversible or treatable causes. Most subjects recovered fully, but 10 (33.3%) experienced recurrent episodes, 5 (16.7%) suffered permanent decline, and 1 died. At baseline, subjects with exacerbations had a significantly longer median disease duration (7.8 vs. 5.7 y, P=0.003), lower Mini-Mental State Examination scores (27.0±3.3 vs. 28.6±1.6, P=0.02), higher modified Hoehn and Yahr scores (2.2±0.5 vs. 1.9±0.5, P=0.006), greater dopaminergic medication use (median, 750.0 vs. 395.0 levodopa equivalents; P=0.009), and a greater prevalence of motor complications (55.2% vs. 29.4%, P=0.01) than subjects without exacerbations. Exacerbations are common in PD, associated with more advanced disease, and usually attributable to treatable secondary causes such as intercurrent infection. Increased recognition of these underlying causes may help to decrease morbidity, reduce health care costs, and optimize quality of care in PD.

Baseline characteristics of subjects enrolled in the Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) trial

Secondary hyperparathyroidism (sHPT) and other abnormalities associated with chronic kidney disease-mineral bone disorder can contribute to dystrophic (including vascular) calcification. Dietary modification and variety of medications can be used to attenuate the severity of sHPT. However, it is unknown whether any of these approaches can reduce the high risks of death and cardiovascular disease in patients with end-stage renal disease. The Evaluation of Cinacalcet HCl Therapy to Lower Cardiovascular Events (EVOLVE) trial was designed to test the hypothesis that treatment with the calcimimetic agent cinacalcet compared with placebo (on a background of conventional therapy including phosphate binders +/- vitamin D sterols) reduces time to death or non-fatal cardiovascular events (specifically myocardial infarction, unstable angina, heart failure and peripheral arterial disease events) among patients on hemodialysis with sHPT. This report describes baseline characteristics of enrolled subjects with a focus on regional variation. There were 3883 subjects randomized from 22 countries, including the USA, Canada, Australia, three Latin American nations, Russia and 15 European nations. The burden of overt cardiovascular disease at baseline was high (e.g. myocardial infarction 12.4%, heart failure 23.3%). The median plasma parathyroid hormone concentration at baseline was 692 pg/mL (10%, 90% range, 363-1694 pg/mL). At baseline, 87.2% of subjects were prescribed phosphate binders and 57.5% were prescribed activated vitamin D derivatives. Demographic data, comorbid conditions and baseline laboratory data varied significantly across regions. EVOLVE enrolled 3883 subjects on hemodialysis with moderate to severe sHPT. Inclusion of subjects from multiple global regions with varying degrees of disease severity will enhance the external validity of the trial results.

690 Can baseline characteristics of subjects with overactive bladder predict responsiveness to antimuscarinic treatment

690 Can baseline characteristics of subjects with overactive bladder predict responsiveness to antimuscarinic treatment

Dosage of neuromuscular electrical stimulation: Is it a determinant of upper limb functional improvement in stroke patients?

To investigate the predictors related to upper extremity functional recovery, with special emphasis on neuromuscular electrical stimulation dose-response in patients after stroke. Ninety-five patients with stroke who received a 4-week neuromuscular electrical stimulation intervention. Prospective predictive analysis. The change score of the Action Research Arm Test (ARAT) was used as the main outcome. Baseline subject characteristics, stroke-related data, and intervention-related data were collected. Multiple linear regression analysis was applied to identify the potential predictors related to main outcome. The regression model revealed that the initial Fugl-Meyer upper limb score was the most important predictor for ARAT change score post-test, followed by time since stroke onset and location of stroke lesion. At 2-month follow-up, the neuromuscular electrical stimulation dosage became a significant determinant in addition to the above predictors. Initial motor severity and lesion location were the main predictors for upper limb functional improvement in stroke patients. Neuromuscular electrical stimulation dosage became a significant determinant for upper limb functional recovery after stroke at 2-month follow-up. More intensive neuromuscular electrical stimulation therapy during early rehabilitation is associated with better upper limb motor function recovery after stroke.

Thyroid function and bone mineral density among Indian subjects

Background:Thyroid hormones affect bone remodeling in patients with thyroid disease by acting directly or indirectly on bone cells. In view of limited information on correlation of thyroid function with bone mineral density (BMD) in euthyroid subjects, we undertook this study to evaluate the correlation between thyroid function with BMD in subjects with normal thyroid function and subclinical hypothyroidism.Material and Methods:A total of 1290 subjects included in this cross sectional study, were divided in Group-1 with normal thyroid function and Group-2 with subclinical hypothyroidism. Fasting blood samples were drawn for the estimation of serum 25(OH)D, intact parathyroid hormone, total and ionized calcium, inorganic phosphorus, and alkaline phosphatase. BMD at lumbar spine, femur, and forearm was measured.Results:BMD at all sites (radius, femur, and spine) were comparable in both groups. There was no difference in BMD when subjects were divided in tertiles of TSH in either group. In group-1, FT4 and TSH were positively associated with BMD at 33% radius whereas FT3 was negatively associated with BMD at femoral neck in multiple regression analysis after adjustment for age, sex, BMI, 25(OH)D and PTH levels. In group-2, there was no association observed between TSH and BMD at any site. Amongst all study subjects FT4 and FT3 were positively correlated with BMD at lumbar spine and radius respectively among all subjects.Conclusion:TSH does not affect BMD in euthyroid subjects and subjects with subclinical hypothyroidism. Thyroid hormones appear to have more pronounced positive effect on cortical than trabecular bone in euthyroid subjects.