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Baseline Characteristics (baseline + characteristic)
Kinds of Baseline Characteristics Selected AbstractsBaseline Characteristics of Patients Randomized in the Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction (REVERSE) StudyCONGESTIVE HEART FAILURE, Issue 2 2008Cecilia Linde MD The Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction (REVERSE) study is a randomized controlled trial currently assessing the safety and efficacy of cardiac resynchronization therapy in patients with asymptomatic left ventricular (LV) dysfunction with previous symptoms of mild heart failure. This paper describes the baseline characteristics of randomized patients; 610 patients with New York Heart Association (NYHA) class II (82.3%) heart failure or asymptomatic (NYHA class I) LV dysfunction with previous symptoms (17.7%) were randomized in 73 centers. The mean age was 62.5±11.0 years, the mean LV ejection fraction was 26.7%±7.0%, and the mean LV end-diastolic diameter was 66.9±8.9 mm. A total of 97% of patients were taking angiotensin-converting enzyme inhibitors or angiotensin receptor blockers and 95.1% were taking ,-blockers, which were at the target dose in 35.1% of patients. Compared with previous randomized cardiac resynchronization therapy trials, REVERSE patients are on better pharmacologic treatment, are younger, and have a narrower QRS width despite similar LV dysfunction. [source] ORIGINAL RESEARCH,EJACULATORY DISORDERS: Baseline Characteristics and Treatment Outcomes for Men with Acquired or Lifelong Premature Ejaculation with Mild or No Erectile Dysfunction: Integrated Analyses of Two Phase 3 Dapoxetine TrialsTHE JOURNAL OF SEXUAL MEDICINE, Issue 6 2010Hartmut Porst MD ABSTRACT Introduction., Premature ejaculation (PE) is classified as an acquired or lifelong condition but data on baseline characteristics and response to treatment of men with acquired or lifelong PE and mild erectile dysfunction (ED) or normal erectile function (EF) is limited. Aim., To present integrated analyses of baseline characteristics and treatment outcomes from phase 3 dapoxetine trials in men with acquired or lifelong PE and mild or no ED. Methods., Data were analyzed from two randomized, double-blind, placebo-controlled, phase 3 clinical trials (International and Asia-Pacific) that evaluated efficacy and safety of dapoxetine (30 mg or 60 mg as needed [PRN]) in patients with PE. Men were ,18 years, in a stable monogamous relationship for ,6 months, met DSM-IV-TR criteria for PE for ,6 months, had an International Index of Erectile Function EF domain score ,21, and had an intravaginal ejaculatory latency time (IELT) ,2 minutes in ,75% of intercourse episodes. Main Outcome Measures., Demographics, sexual history, and PE symptomatology at baseline, and mean IELT and patient-reported outcomes (PROs) at study end (week 12), were analyzed for men with acquired or lifelong PE and mild or no ED (EF score 21,25 vs. ,26). Results., Baseline characteristics except duration of PE were similar in men with acquired and lifelong PE, with no other differentiating features by ED status. Dapoxetine treatment improved significantly mean IELT (arithmetic and geometric) and PRO responses (perceived control over ejaculation, satisfaction with sexual intercourse, ejaculation-related personal distress, and interpersonal difficulty) for acquired and lifelong subtypes, but presence of mild ED diminished PRO responsiveness in both subtypes, particularly those with lifelong PE. Conclusions., Baseline characteristics and treatment outcomes were generally similar in men with acquired and lifelong PE. The presence of mild ED appears to be associated with a more modest treatment response, irrespective of lifelong or acquired PE subtype. Porst H, McMahon CG, Althof SE, Sharlip I, Bull S, Aquilina JW, Tesfaye F, and Rivas DA. Baseline characteristics and treatment outcomes for men with acquired or lifelong premature ejaculation with mild or no erectile dysfunction: Integrated analyses of two phase 3 dapoxetine trials. J Sex Med 2010;7:2231,2242. [source] Randomized Nonblinded Comparison of Convalescence for 2 and 7 Days After Split-Thickness Skin Grafting to the Lower LegsDERMATOLOGIC SURGERY, Issue 4 2009BEN TALLON MBChB BACKGROUND There is an increasing expectation of shortened postoperative recovery times and a suggestion that shorter convalescence times may not compromise lower leg split-thickness skin graft results. OBJECTIVE To determine whether mobilization after 2 days of convalescence compromises graft survival or patient morbidity. METHODS AND MATERIALS A pilot study was initiated in which patients undergoing split-thickness skin grafting to the lower legs were randomized to 2 or the routine 7 days of convalescence. Baseline characteristics were determined, and patients were followed up in dressing clinics and with a standardized telephone interview. RESULTS There was no difference in baseline patient comorbidities and no significant difference in the number of grafts lost, the number of dressing clinics, bleeding, or wound infections. CONCLUSION The results suggest that 2 days of convalescence after split-thickness skin grafting to the lower legs may not compromise graft survival or increase patient morbidity. Further study with larger numbers is required to confirm this finding. [source] Outcomes for 236 patients from a 2-year early intervention in psychosis serviceACTA PSYCHIATRICA SCANDINAVICA, Issue 2 2009M. A. Turner Objective:, To examine: i) changes in key outcome measures over time in treatment in a representative first-episode psychosis treatment cohort and ii) baseline predictors of service disengagement. Method:, Baseline characteristics of 236 patients were examined for associations with outcomes over time using generalized estimating equation models. The data on disengagement were analysed using logistic regression. Results:, After controlling for admission scores, patients showed consistently improved outcomes while in treatment on functional recovery (unemployment, P < 0.01; HoNOS, P < 0.001; the Quality of Life Scale, P < 0.001; GAF, P < 0.05) but not symptomatology (as assessed by the PANSS and substance abuse). The 64 (33%) who disengaged were more likely to be unemployed (P < 0.01) and have higher HoNOS (P < 0.01) and GAF (P < 0.05) scores at baseline. Conclusion:, This evaluation has shown significant improvements in psychosocial functioning but not psychopathology during treatment at an Early Intervention for Psychosis Service. Despite attempts to retain patients, there is a high rate of treatment discontinuation. [source] The First-Episode Psychosis Outcome Study: premorbid and baseline characteristics of an epidemiological cohort of 661 first-episode psychosis patientsEARLY INTERVENTION IN PSYCHIATRY, Issue 2 2007Philippe Conus Abstract Aims:, Studies conducted in first-episode psychosis (FEP) samples avoid many biases. However, very few studies are based on epidemiological cohorts treated in specialized FEP services. The aim of this file audit study was to examine premorbid and baseline characteristics of a large epidemiological sample of FEP. Methods:, File audit study of all patients admitted to the Early Psychosis Prevention and Intervention Centre between 1998 and 2000 using a specialized questionnaire. Results:, There were 661 patient files included in the study. Premorbid evaluation revealed high rates of substance use disorder (74.1%), history of psychiatric disorder (47.5%), past traumatic events (82.7%) suicide attempts (14.3%) and family history of psychiatric illness (55.6%). Baseline characteristics revealed high intensity of illness (mean CGI 5.5), high prevalence of lack of insight (62%) and high rate of comorbidity (70%). Conclusion:, High rates of traumatic events or episodes of mental illness before treatment for FEP must be considered when designing treatment approaches because a too narrow focus on positive psychotic symptoms will inevitably lead to incomplete treatment. Additionally, early intervention programmes need sufficient range of resources to address the multiple challenges presented by FEP patients such as high severity of illness, comorbidities and functional impairment. Finally, observation of an important degree of functional impairment despite short duration of untreated psychosis suggests that while early detection of FEP is a necessary step in early intervention, it may not be sufficient to improve functional recovery in psychosis and that efforts aimed at identifying people during the prodromal phase of psychotic disorders should be pursued. [source] Comparison between different dialysate calcium concentrations in nocturnal hemodialysisHEMODIALYSIS INTERNATIONAL, Issue 2 2007Nigel D. TOUSSAINT Abstract Benefits of dialysate with greater calcium (Ca) concentration are reported in nocturnal hemodialysis (NHD) to prevent Ca depletion and subsequent hyperparathyroidism. Studies with patients dialyzing against 1.25 mmol/L Ca baths demonstrate increases in alkaline phosphatase (ALP) and parathyroid hormone (PTH) and increasing dialysate Ca subsequently corrects this problem. However, whether 1.5 or 1.75 mmol/L dialysate Ca is most appropriate for NHD is yet to be determined, and differences in the effect on mineral metabolism of daily vs. alternate daily NHD have also not been well defined. We retrospectively analyzed mineral metabolism in 48 patients, from 2 institutions (30 at Monash and 18 at Geelong), undergoing home NHD (8 hr/night, 3.5,6 nights/week) for a minimum of 6 months. Thirty-seven patients were dialyzed against 1.5 mmol/L Ca bath and 11 patients against 1.75 mmol/L. We divided patients into 4 groups, based on dialysate Ca and also on the hours per week of dialysis, <40 (1.5 mmol/L, n=29 and 1.75 mmol/L, n=8) or ,40 (n=4 and 7). We compared predialysis and postdialysis serum markers, time-averaged over a 6-month period, and the administration of calcitriol and Ca-based phosphate binders between 1.5 and 1.75 mmol/L Ca dialysate groups. Baseline characteristics between all groups were similar, with a slightly longer, but nonsignificant, duration of NHD in both 1.75 mmol/L dialysate groups compared with 1.5 mmol/L. The mean predialysis Ca, phosphate, and Ca × P were similar between the 1.5 and 1.75 mmol/L groups, regardless of NHD hr/week. Postdialysis Ca was significantly greater, with 1.75 vs. 1.5 mmol/L in those dialyzing <40 hr/week (2.64±0.19 vs. 2.50±0.12 mmol/L, p=0.046), but postdialysis Ca × P were similar (2.25±0.44 vs. 2.16±0.29 mmol2/L2, p=0.60). Parathyroid hormone was also lower with 1.75 vs. 1.5 mmol/L baths in the <40 hr/week groups (31.99±26.99 vs. 14.47±16.36 pmol/L, p=0.03), although this difference was not seen in those undertaking NHD ,40 hr/week. Hemoglobin, ALP, and albumin were all similar between groups. There was also no difference in vitamin D requirement when using 1.75 mmol/L compared with the 1.5 mmol/L dialysate. Multivariate analysis to determine independent predictors of postdialysis serum Ca showed a statistically significant positive association with predialysis Ca, dialysate Ca, and total NHD hr/week. An elevated dialysate Ca concentration is required in NHD to prevent osteopenia but differences in serum markers of mineral metabolism between 1.5 and 1.75 mmol/L Ca dialysate in NHD in our study were few. This was similar for patients undertaking NHD <40 or ,40hr/week, although differences in the frequency of NHD may also be as important as dialysate Ca with regard to serum Ca levels. With concerns that prolonged higher Ca levels contribute to increased cardiovascular mortality, the optimal Ca dialysate bath is still unknown and further studies addressing bone metabolism with larger NHD numbers are required. [source] Early on-treatment prediction of response to peginterferon alfa-2a for HBeAg-negative chronic hepatitis B using HBsAg and HBV DNA levels,HEPATOLOGY, Issue 2 2010Vincent Rijckborst Peginterferon alfa-2a results in a sustained response (SR) in a minority of patients with hepatitis B e antigen (HBeAg),negative chronic hepatitis B (CHB). This study investigated the role of early on-treatment serum hepatitis B surface antigen (HBsAg) levels in the prediction of SR in HBeAg-negative patients receiving peginterferon alfa-2a. HBsAg (Architect from Abbott) was quantified at the baseline and during treatment (weeks 4, 8, 12, 24, 36, and 48) and follow-up (weeks 60 and 72) in the sera from 107 patients who participated in an international multicenter trial (peginterferon alfa-2a, n = 53, versus peginterferon alfa-2a and ribavirin, n = 54). Overall, 24 patients (22%) achieved SR [serum hepatitis B virus (HBV) DNA level < 10,000 copies/mL and normal alanine aminotransferase levels at week 72]. Baseline characteristics were comparable between sustained responders and nonresponders. From week 8 onward, serum HBsAg levels markedly decreased in sustained responders, whereas only a modest decline was observed in nonresponders. However, HBsAg declines alone were of limited value in the prediction of SR [area under the receiver operating characteristic curve (AUC) at weeks 4, 8, and 12 = 0.59, 0.56, and 0.69, respectively]. Combining the declines in HBsAg and HBV DNA allowed the best prediction of SR (AUC at week 12 = 0.74). None of the 20 patients (20% of the study population) in whom a decrease in serum HBsAg levels was absent and whose HBV DNA levels declined less than 2 log copies/mL exhibited an SR (negative predictive value = 100%). Conclusion: At week 12 of peginterferon alfa-2a treatment for HBeAg-negative CHB, a solid stopping rule was established with a combination of declines in serum HBV DNA and HBsAg levels from the baseline. Quantitative serum HBsAg in combination with HBV DNA enables on-treatment adjustments of peginterferon therapy for HBeAg-negative CHB. (HEPATOLOGY 2010) [source] Statins may reduce episodes of exacerbation and the requirement for intubation in patients with COPD: evidence from a retrospective cohort studyINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 9 2008A. I. Blamoun Summary Introduction:, Statins have diverse anti-inflammatory effects in addition to their lipid-lowering ability. This study assesses the rate of chronic obstructive pulmonary disease (COPD) exacerbation and intubations in patients taking statins. Methods:, This is a retrospective cohort study of 185 patients with COPD exacerbation, with a 1-year follow-up. Outcomes examined were repeat hospitalisation and intubations for COPD exacerbation. Baseline characteristics for which the p-value was , 0.10 were considered as covariates for inclusion in a multivariate model. Results:, The statin group had fewer episodes of exacerbation and required intubation fewer times than the subjects not receiving statins (p < 0.0001 for both outcomes). Unadjusted odds ratios (OR) for no statin use vs. statin use were 9.54 (95% CI: 4.54,20.02) for exacerbation and 10.47 (CI: 4.56,24.01) for intubation. The OR, adjusted for the use of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (ORa), were 2.35 (CI: 1.01,5.50) for non-statin users exhibiting an exacerbation and 10.36 (CI: 2.77,38.76) for this group requiring intubation, compared with statin users. Similarly, ORa for long-acting ,2 agonists as a covariate were 3.01 (CI: 1.46,6.10) for exacerbation and 8.89 (CI: 3.67,21.32) for intubation. Time to outcome during the observation period was reduced by statins with the hazard ratio (HR) for exacerbation of 0.19 (CI: 0.06,0.14); HR for statins reducing intubation was 0.14 (95% CI: 0.10,0.30). Conclusions:, These data suggest that the use of statins may be associated with lower incidence of both exacerbations and intubations in patients with COPD. [source] Old Age and Outcome After Primary Angioplasty for Acute Myocardial InfarctionJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 5 2010Menko-Jan De Boer MD OBJECTIVES: To assess the influence of age as an independent factor determining the prognosis and outcome of patients with acute myocardial infarction (AMI) treated using primary percutaneous coronary intervention (PCI). DESIGN: A retrospective analysis from a dedicated database. SETTING: A high-volume interventional cardiology center in the Netherlands. PARTICIPANTS: Four thousand nine hundred thirty-three consecutive patients with AMI. MEASUREMENTS: Baseline characteristics and clinical outcomes after 30 days and 1 year were compared according to age categorized in three groups: younger than 65, 65 to 74, and 75 and older. A more-detailed analysis was performed with six age groups, from younger than 40 to 80 and older. RESULTS: Of the 4,933 consecutive patients with AMI treated with PCI between 1992 and 2004, 643 were aged 75 and older. Multivariate analysis revealed that patients aged 65 to 75 had a greater risk of 1-year mortality than those younger than 65 (adjusted odds ratio (AOR)=1.57, 95% confidence interval (CI)=1.15,2.16) and that those aged 75 and older had a greater risk of 1-year mortality than those younger than 65 (AOR=3.03, 95% CI=2.14,4.29). CONCLUSION: In this retrospective analysis, older age was independently associated with greater mortality after PCI for AMI. Patients aged 65 and older had a higher risk of mortality than younger patients, and those aged 75 and older had the highest risk of mortality. [source] Early and Late Results of Partial Left Ventriculectomy: Single Center Experience and Review of the LiteratureJOURNAL OF CARDIAC SURGERY, Issue 3 2003Raimondo Ascione M.D. Methods: From February 1996 to August 2001, 24 patients with dilated cardiomyopathy (DCM) (12 idiopathic, 12 ischemic) underwent PLV. Perioperative and follow-up data were prospectively entered into a database and analyzed. An observational analysis of the literature was carried out of all the published series of PLV reporting on ,15 patients. Results: In our series there were 22 males with amean age of 65 years (range 49 to73]). Of the 22, there were 3 (12.5%) in-hospital deaths. Mean duration of follow-up was 26 months (range 3 to 71) with 9 late deaths (38%), 6 in the idiopathic group. The five-year actuarial survival was 74% in the ischemic group and 33% in the idiopathic group. The observational analysis of literature included a total of 506 patients (425 males, age 50.2 ± 5.2 years)]. The etiology was idiopathic in 255 (50.4%), and ischemic in 89 (17.6%) patients. Baseline characteristics of the whole population include: ejection fraction 18.9 ± 3.9%, NYHA functional class 3.7 ± 0.2, and LVEDD of 7.7 ± 0.4 cm. Severe mitral regurgitation was present in 368 (72.7%) patients. There were 88 (17.4%) in-hospital deaths. Cause of death included 55 due to (62.5%) low cardiac output, 10 (11.3%) due to severe bleeding, 7 (7.95%) caused by malignant arrhythmias, 8 (9%) due to sepsis, and 5 (5.7%) as a result of stroke. Ten of the selected series (overall 386 patients) reported late outcome. There were 89 (22.9%) late deaths, 12 (13.5%) were not cardiac-related, 50 (56.2%) were due to recurrence of congestive heart failure (CHF), 20 (22.5%) caused by sudden arrhythmias, 5 (5.6%) due to infections, and 2 (2.2%) from strokes. Overall, there were 248 (64.2%) survivors, of whom 179 (72.17%) were reported to be in NYHA functional class I or II. All 10 papers reported one-year survival ranging from 50% to 85%. Seven reported a two-year survival of 45% to 72%, and 4 reported a three-year survival of 33% to 64%. Conclusions: Our results and the review of the literature seem to suggest a relatively high early mortality with satisfactory late results of PLV in patients with dilated cardiomyopathy.(J Card Surg 2003;18:190-196) [source] Multicenter, Prospective, Randomized Safety and Efficacy Study of a New Atrial-Based Managed Ventricular Pacing Mode (MVP) in Dual Chamber ICDsJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 8 2005MICHAEL O. SWEENEY M.D. Background: Ventricular desynchronization caused by right ventricular pacing may impair ventricular function and increase risk of heart failure (CHF), atrial fibrillation (AF), and death. Conventional DDD/R mode often results in high cumulative percentage ventricular pacing (Cum%VP). We hypothesized that a new managed ventricular pacing mode (MVP) would safely provide AAI/R pacing with ventricular monitoring and DDD/R during AV block (AVB) and reduce Cum%VP compared to DDD/R. Methods: MVP RAMware was downloaded in 181 patients with Marquis DR ICDs. Patients were initially randomized to either MVP or DDD/R for 1 month, then crossed over to the opposite mode for 1 month. ICD diagnostics were analyzed for cumulative percentage atrial pacing (Cum%AP), Cum%VP, and duration of DDD/R pacing for spontaneous AVB. Results: Baseline characteristics included age 66 ± 12 years, EF 36 ± 14%, and NYHA Class II,III 36%. Baseline PR interval was 190 ± 53 msec and programmed AV intervals (DDD/R) were 216 ± 50 (paced)/189 ± 53 (sensed) msec. Mean Cum%VP was significantly lower in MVP versus DDD/R (4.1 ± 16.3 vs 73.8 ± 32.5, P < 0.0001). The median absolute and relative reductions in Cum%VP during MVP were 85.0 and 99.9, respectively. Mean Cum%AP was not different between MVP versus DDD/R (48.7 ± 38.5 vs 47.3 ± 38.4, P = 0.83). During MVP overall time spent in AAI/R was 89.6% (intrinsic conduction), DDD/R 6.7% (intermittent AVB), and DDI/R 3.7% (AF). No adverse events were attributed to MVP. Conclusions: MVP safely achieves functional atrial pacing by limiting ventricular pacing to periods of intermittent AVB and AF in ICD patients, significantly reducing Cum%VP compared to DDD/R. MVP is a universal pacing mode that adapts to AVB and AF, providing both atrial pacing and ventricular pacing support when needed. [source] Influence of Gender on Arrhythmia Characteristics and Outcome in the Multicenter UnSustained Tachycardia TrialJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 9 2004ANDREA M. RUSSO M.D. Introduction: Previous studies have demonstrated gender differences in risk of sudden death in patients with ischemic heart disease. The Multicenter UnSustained Tachycardia Trial (MUSTT) evaluated the ability of therapy guided by electrophysiologic (EP) testing to reduce mortality in patients with coronary disease, ejection fraction ,40%, and spontaneous nonsustained ventricular tachycardia. Methods and Results: We analyzed the influence of gender on results of EP testing and outcome of patients enrolled in MUSTT. Women made up 14% of the overall MUSTT population and were less likely than men to have inducible sustained randomizable ventricular arrhythmias (24% vs 36%, P < 0.001). Baseline characteristics differed between men and women. In randomized patients, women were older, more likely to have had an infarction within 6 months, more likely to have a history of heart failure, and more likely to have recent angina prior to enrollment than men (P < 0.05). In the EP-guided therapy group, there was no difference in implantable cardioverter defibrillator implantation rate in men and women (45% vs 53%, P = 0.38). There also were no significant gender influences on risk of arrhythmic death or cardiac arrest (2-year event rate 9% in women and 12% in men, adjusted hazard ratio 0.88) or overall mortality (2-year event rate 32% in women vs 21% in men, adjusted hazard ratio 1.51). Conclusion: The outcome and benefit of EP-guided therapy in this trial did not appear to be influenced by gender. However, due to the small numbers of women in the trial, small differences in outcome may not be apparent. Plans for future primary prevention trials should include careful risk stratification of women who less often have inducible sustained ventricular arrhythmias and better left ventricular function despite more frequent heart failure. [source] Effectiveness of the Electronic Medical Record in Improving the Management of HypertensionJOURNAL OF CLINICAL HYPERTENSION, Issue 6 2002James W. Kinn MD Clinical studies suggest that hypertension is often undiagnosed, undertreated, and poorly controlled. In 1997, the authors developed a comprehensive electronic medical record that interfaces with physicians during each outpatient visit and provides real-time feedback about patient care management, including the management of hypertension. The purpose of this study was to determine whether this interactive electronic medical record results in better detection and control of hypertension. During a 12-month study period, consecutive outpatients (n=1076) were seen for routine follow-up; patient care documentation relied solely on the electronic medical record. Quality indicators for hypertension included: 1) documentation of the diagnosis of hypertension; 2) use of blood pressure-lowering drugs; and 3) successful blood pressure lowering to ,140/90 mm Hg. The authors compared the hypertension management of these patients to a control group of similar patients (n=723) with medical records consisting solely of traditional "pen and paper" charts. Baseline characteristics were similar between the two groups, including the prevalence of hypertension (73 % vs. 70%; p=NS). However, the electronic medical record resulted in higher documentation rates of hypertension (90% vs. 77%; p<0.001), greater use of antihypertensive therapy (94% vs. 90%; p<0.01), and more successful blood pressure lowering to ,140/90 mm Hg (54% vs. 28%; p<0.001). In conclusion, the electronic medical record with real-time feedback improves the physician's ability to detect, treat, and control hypertension. [source] A Comparison of Correlates of DSM-IV Alcohol Abuse or Dependence Among More Than 400 Sons of Alcoholics and ControlsALCOHOLISM, Issue 1 2001M. A. Schuckit Background: Alcohol dependence and abuse are defined as separate disorders. However, relatively few data are available about whether the same characteristics predict both syndromes. Methods: Complete data were available from the 15 year follow-up of 411 men who originally had been evaluated from a university population at about age 20. Both baseline data gathered prospectively and the retrospective ratings in six domains of life functioning were analyzed for their relationship to the development of alcohol abuse or dependence during the follow-up. Results: Baseline characteristics of a family history of substance use disorders, the quantity and frequency of drinking, the history of alcohol-related problems, and the level of response to alcohol all predicted future alcohol abuse or dependence, but only an alcoholic second-degree relative or a first-degree drug-dependent family member differentially predicted dependence. Logistic regression analyses revealed that similar baseline characteristics combined to predict dependence and, separately, abuse. When the domains of functioning during the 15 years were included, positive alcohol expectancies, poor coping mechanisms, low level of social support, and drinking in the environment contributed to both dependence and abuse, although the relationship was stronger for dependence. Conclusions: The predictors and correlates of alcohol abuse and dependence in this group of men were similar. Further research in additional populations and on other drugs is needed to determine if the two syndromes overlap sufficiently to be combined. [source] Complement component C3 allotypes and outcomes in liver transplantationLIVER TRANSPLANTATION, Issue 2 2010Navdeep Dhillon The complement system has been implicated in the pathogenesis of liver diseases. Human complement component C3 (C3) exists as 2 allotypes, fast (F) and slow (S). We conducted a study to address the influence of these alleles on ischemia-reperfusion (IR) injury and graft survival in liver transplant recipients. Four hundred thirty patients receiving liver transplants from 2000 to 2004 were included. C3 allotypes of 296 donor-recipient pairs were determined and correlated with clinical outcomes. Four groups were analyzed according to the C3 genotype: C3 SS donor and recipient, C3 FS or C3 FF donor and C3 SS recipient, C3 SS donor and C3 FS or C3 FF recipient, and C3 FS or C3 FF donor and recipient. Baseline characteristics of the 4 groups were similar. The mean follow-up time was 4.3 ± 2.2 years. The 4 groups had similar rates of IR injury (P = 0.16). The hazard ratios for liver allograft survival in the C3 SS donor and recipient group in comparison with the other 3 groups (C3 FS or C3 FF donor and C3 SS recipient, C3 SS donor and C3 FS or C3 FF recipient, and C3 FS or C3 FF donor and recipient) were not significantly different: 1.13 (P = 0.60), 0.99 (P = 0.97), and 1.02 (P = 0.95), respectively. In conclusion, donor and recipient C3 genotypes are not associated with liver transplantation outcomes. Liver Transpl 16:198,203, 2010. © 2010 AASLD. [source] Aprotinin in orthotopic liver transplantation: Evidence for a prohemostatic, but not a prothrombotic, effectLIVER TRANSPLANTATION, Issue 10 2001I. Quintus Molenaar Aprotinin reduces blood transfusion requirements in orthotopic liver transplantation (OLT). Concern has been voiced about the potential risk for thrombotic complications when aprotinin is used. The aim of this study is to evaluate the effects of aprotinin on the two components of the hemostatic system (coagulation and fibrinolysis) in patients undergoing OLT. As part of a larger, randomized, double-blind, placebo-controlled study, we compared coagulation (fibrinogen level, activated partial thromboplastin time [aPTT], prothrombin time, and platelet count) and fibrinolytic variables (tissue-type plasminogen activator [tPA] antigen and activity, plasminogen activator inhibitor activity, and D-dimer), as well as thromboelastography (reaction time [r], clot formation time, and maximum amplitude) in 27 patients administered either high-dose aprotinin (2 × 106 kallikrein inhibitor units [KIU] at induction, continuous infusion of 1 × 106 KIU/h, and 1 × 106 KIU before reperfusion; n = 10), regular-dose aprotinin (2 × 106 KIU at induction and continuous infusion of 0.5 × 106 KIU/h; n = 8), or placebo (n = 9) during OLT. Blood samples were drawn at seven standardized intraoperative times. Baseline characteristics were similar for the three groups. During the anhepatic and postreperfusion periods, fibrinolytic activity (plasma D-dimer and tPA antigen levels) was significantly lower in aprotinin-treated patients compared with the placebo group. Interestingly, coagulation times (aPTT and r) were significantly more prolonged in aprotinin-treated patients than the placebo group. No difference was seen in the incidence of perioperative thrombotic complications in the entire study population (n = 137). Aprotinin has an anticoagulant rather than a procoagulant effect. Its blood-sparing (prohemostatic) effect appears to be the overall result of a strong antifibrinolytic and a weaker anticoagulant effect. These findings argue against a prothrombotic effect of aprotinin in patients undergoing OLT. [source] Early Results of Photoselective Vaporization of the Prostate in Medical Control-failed PatientsLUTS, Issue 2 2009Shen Kuang CHANG Objectives: We present here our early results and learning curve for photoselective vaporization of the prostate (PVP) performed by an experienced urologist and we provide an analysis of the morbidity and early functional outcomes. Methods: Forty-four patients were selected, from May 2006 to January 2009, who had benign prostate hyperplasia (BPH) accompanied by lower urinary tract symptoms (LUTS). After undergoing PVP for BPH at our hospital, the patients were followed up for approximately 2 years. PVP was performed by the same experienced urologist using potassium-titanyl-phosphate (KTP) laser. Baseline characteristics, preoperative and perioperative data, and postoperative complications were evaluated. Regular outpatient department follow-up was conducted after patients were discharged from the hospital at 1, 4 and 12 weeks. Results: The mean age of the 44 patients was 71.6 years. The mean prostate volume was 47.52 mL. The mean PVP surgery time was 79.11 min. The mean urinary catheterization time was 23.41 h. Few complications arose after PVP, except that 47.7% of the patients developed pyuria after being discharged from hospital. The average hospital stay was 2.45 days. There were no significant differences in the efficiency of tissue vaporization among the patients. Conclusion: PVP for BPH has various advantages, including reducing postoperative complications. An experienced urologist can easily perform PVP. However, early results show no significant differences in the efficiency for the PVP technique. [source] (204) Rofecoxib Was More Effective than Codeine with Acetaminophen in the Treatment of Acute PainPAIN MEDICINE, Issue 3 2001David J. Chang Rofecoxib (VIOXX®) is a selective inhibitor of cyclo-oxygenase-2 and is indicated for the treatment of acute pain. Prior acute pain studies showed similar analgesic efficacy of rofecoxib 50 mg compared with analgesics doses of non-selective NSAIDs. We performed a randomized, double-blind trial to evaluate the efficacy and safety of rofecoxib, a standard fixed formulation of codeine with acetaminophen, and placebo in the treatment of acute pain. Three-hundred ninety-three patients with moderate or severe pain after surgical extraction of at least two 3rd molars were randomized to receive a single dose of rofecoxib 50 mg (n = 182), codeine 60 mg with acetaminophen 600 mg (n = 180), or placebo (n = 31). Efficacy was assessed at 11 pre-specified time points after dosing by pain relief and pain intensity scores. Patient global assessment of study medication was also performed. Baseline characteristics were similar among the groups. The mean age was 21 years; 69.0% were female; and 78.6% had a pain intensity score of "moderate." For the primary endpoint, total pain relief over 6 hours, rofecoxib was more effective than codeine/acetaminophen (p < 0.001) and placebo (p < 0.001). Proportion of patients who rated the study medication as good, very good, or excellent at 6 hours was 64.6% on rofecoxib, 36.4% on codeine/acetaminophen, and 10.3% on placebo (rofecoxib> codeine/acetaminophen; p < 0.001). The time to rescue medication was longer for rofecoxib compared to codeine/acetaminophen (p < 0.001). More patients on codeine/acetaminophen experienced clinical adverse events than rofecoxib (p < 0.05). Patients receiving codeine/acetaminophen versus rofecoxib had higher incidences of nausea (25.0% vs 6.0%; p < 0.001) and vomiting (18.3% vs 3.8%; p < 0.001). In this study, rofecoxib had superior efficacy and gastrointestinal safety compared to codeine/acetaminophen, which provides support for the use of rofecoxib as an alternative option to opioid analgesics in the treatment of acute post-surgical pain. [source] Cardiovascular and psychiatric risk profile and patterns of use in patients starting anti-obesity drugs,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 7 2009Marjolein J. C. Willemen PharmD Abstract Purpose Real-life experience with anti-obesity drugs has shown that psychiatric and cardiovascular diseases may be reported as adverse drug reactions. For adequate risk assessment of these drugs knowledge on baseline risks of patients starting anti-obesity drugs and insight in patterns of use is needed. The aim was to assess whether baseline characteristics of patients starting anti-obesity drugs differ from those not being prescribed these drugs, and to study patterns of anti-obesity drug use. Methods A population-based cohort study was conducted in the IPCI database (1995,2007). The index cohort comprised all persons who started an anti-obesity drug. The reference cohort comprised up to six randomly sampled patients from the same GP practice with same index date. Baseline characteristics were assessed for both cohorts. The index cohort was followed for 1 year to study patterns of drug use. Unconditional logistic regression was used to calculate crude odds ratios and 95% confidence intervals. Results The index and reference cohort comprised 1471 and 8736 persons, respectively. Both cardiovascular and psychiatric co-morbidities were more prevalent among starters compared to non-starters. 77.7% of the patients stopped using anti-obesity drugs within 90 days. Users of amphetamine-like drugs differed from patients using orlistat or sibutramine, whereas users of orlistat and sibutramine were highly comparable. Conclusions The increased prevalence of co-morbidities constitutes a baseline risk which may translate in higher occurrence of psychiatric and cardiovascular diseases during use of anti-obesity drugs, independent of the drugs. The limited period of use might reduce possible cardiovascular benefits of weight reduction induced by these drugs. Copyright © 2009 John Wiley & Sons, Ltd. [source] ORIGINAL RESEARCH,EJACULATORY DISORDERS: Baseline Characteristics and Treatment Outcomes for Men with Acquired or Lifelong Premature Ejaculation with Mild or No Erectile Dysfunction: Integrated Analyses of Two Phase 3 Dapoxetine TrialsTHE JOURNAL OF SEXUAL MEDICINE, Issue 6 2010Hartmut Porst MD ABSTRACT Introduction., Premature ejaculation (PE) is classified as an acquired or lifelong condition but data on baseline characteristics and response to treatment of men with acquired or lifelong PE and mild erectile dysfunction (ED) or normal erectile function (EF) is limited. Aim., To present integrated analyses of baseline characteristics and treatment outcomes from phase 3 dapoxetine trials in men with acquired or lifelong PE and mild or no ED. Methods., Data were analyzed from two randomized, double-blind, placebo-controlled, phase 3 clinical trials (International and Asia-Pacific) that evaluated efficacy and safety of dapoxetine (30 mg or 60 mg as needed [PRN]) in patients with PE. Men were ,18 years, in a stable monogamous relationship for ,6 months, met DSM-IV-TR criteria for PE for ,6 months, had an International Index of Erectile Function EF domain score ,21, and had an intravaginal ejaculatory latency time (IELT) ,2 minutes in ,75% of intercourse episodes. Main Outcome Measures., Demographics, sexual history, and PE symptomatology at baseline, and mean IELT and patient-reported outcomes (PROs) at study end (week 12), were analyzed for men with acquired or lifelong PE and mild or no ED (EF score 21,25 vs. ,26). Results., Baseline characteristics except duration of PE were similar in men with acquired and lifelong PE, with no other differentiating features by ED status. Dapoxetine treatment improved significantly mean IELT (arithmetic and geometric) and PRO responses (perceived control over ejaculation, satisfaction with sexual intercourse, ejaculation-related personal distress, and interpersonal difficulty) for acquired and lifelong subtypes, but presence of mild ED diminished PRO responsiveness in both subtypes, particularly those with lifelong PE. Conclusions., Baseline characteristics and treatment outcomes were generally similar in men with acquired and lifelong PE. The presence of mild ED appears to be associated with a more modest treatment response, irrespective of lifelong or acquired PE subtype. Porst H, McMahon CG, Althof SE, Sharlip I, Bull S, Aquilina JW, Tesfaye F, and Rivas DA. Baseline characteristics and treatment outcomes for men with acquired or lifelong premature ejaculation with mild or no erectile dysfunction: Integrated analyses of two phase 3 dapoxetine trials. J Sex Med 2010;7:2231,2242. [source] Resource Utilization of Living Donor Versus Deceased Donor Liver Transplantation Is Similar at an Experienced Transplant CenterAMERICAN JOURNAL OF TRANSPLANTATION, Issue 3 2009J. C. Lai Although living donor liver transplantation (LDLT) has been shown to decrease waiting-list mortality, little is known of its financial impact relative to deceased donor liver transplantation (DDLT). We performed a retrospective cohort study of the comprehensive resource utilization, using financial charges as a surrogate measure,from the pretransplant through the posttransplant periods,of 489 adult liver transplants (LDLT n = 86; DDLT n = 403) between January 1, 2000, through December 31, 2006, at a single center with substantial experience in LDLT. Baseline characteristics differed between LDLT versus DDLT with regards to age at transplantation (p = 0.02), male gender (p < 0.01), percentage Caucasians (p < 0.01) and transplant model for end-stage liver disease (MELD) score (p < 0.01). In univariate analysis, there was a trend toward decreased total transplant charges with LDLT (p = 0.06), despite increased surgical charges associated with LDLT (p < 0.01). After adjustment for the covariates that were associated with financial charges, there was no significant difference in total transplant charges (p = 0.82). MELD score at transplant was the strongest driver of resource utilization. We conclude that at an experienced transplant center, LDLT imposes a similar overall financial burden than DDLT, despite the increased complexity of living donor surgery and the addition of the costs of the living donor. We speculate that LDLT optimizes transplantation by transplanting healthier and younger recipients. [source] Management of nonresponse to rituximab in rheumatoid arthritis: Predictors and outcome of re-treatmentARTHRITIS & RHEUMATISM, Issue 5 2010E. M. Vital Objective A proportion of patients with rheumatoid arthritis (RA) have disease that fails to respond to an initial cycle of rituximab. Using highly sensitive flow cytometry (HSFC), it has been shown that most patients who do not exhibit a response, as measured using the European League Against Rheumatism (EULAR) criteria, have persistent circulating B cell levels at week 2 after initial treatment with rituximab. This study was undertaken to examine whether an additional cycle of rituximab would improve B cell depletion and clinical response in patients whose disease did not respond to the initial cycle. Methods Patients with RA (n = 158) were treated with a first cycle of rituximab (2 infusions of 1 gm each). Clinical responses were assessed using EULAR criteria, and patients were categorized as either first-cycle responders or first-cycle nonresponders. Baseline characteristics of first-cycle nonresponders (n = 38) and first-cycle responders (n = 65) with complete data were compared. First-cycle nonresponders (n = 25) were treated with a second cycle of rituximab at least 6 months after the first cycle. HSFC was performed at baseline, immediately prior to the second infusion (week 2), 1 month after the second infusion (week 6), and then every 3 months for each cycle of rituximab. Complete B cell depletion was defined as being <0.0001 × 109 cells/liter. Results At baseline, the number of preplasma cells was significantly higher in first-cycle nonresponders than in first-cycle responders (P = 0.003). Following the first infusion of the first cycle of rituximab, only 9% of first-cycle nonresponders (3 of 34) exhibited complete depletion of B-lineage cells, compared with 37% of first-cycle responders (22 of 59) (P = 0.007). Following the first infusion of the second cycle of rituximab, 38% of first-cycle nonresponders exhibited complete depletion. Twenty-six weeks after the second cycle, there was a significant improvement in the Disease Activity Score in 28 joints, with 72% of patients exhibiting a EULAR response. Conclusion RA patients whose disease did not respond to an initial cycle of rituximab have higher circulating preplasma cell numbers at baseline and incomplete depletion. Our findings indicate that an additional cycle of rituximab administered prior to total B cell repopulation enhances B cell depletion and clinical responses. [source] LY2439821, a humanized anti,interleukin-17 monoclonal antibody, in the treatment of patients with rheumatoid arthritis: A phase I randomized, double-blind, placebo-controlled, proof-of-concept studyARTHRITIS & RHEUMATISM, Issue 4 2010M. C. Genovese Objective We undertook this study to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of LY2439821, a humanized anti,interleukin-17 (anti,IL-17) monoclonal antibody, in a first in-human trial in rheumatoid arthritis (RA) patients taking oral disease-modifying antirheumatic drugs (DMARDs). Methods This randomized, double-blind, placebo-controlled study consisted of 2 parts. In part A, 20 patients received 1 intravenous (IV) dose of LY2439821 (0.06, 0.2, 0.6, or 2.0 mg/kg, escalating) or placebo followed by 8 weeks of evaluation. End points included safety, tolerability, and pharmacokinetics. In part B, 77 patients received 1 IV dose of LY2439821 (0.2, 0.6, or 2.0 mg/kg) or placebo every 2 weeks for a total of 5 doses, with a total evaluation period of 16 weeks. End points included safety, tolerability, pharmacokinetics/pharmacodynamics, and efficacy (Disease Activity Score in 28 joints [DAS28] and percentages of patients meeting American College of Rheumatology 20%, 50%, or 70% improvement criteria [achieving an ACR20, ACR50, or ACR70 response]). The primary efficacy end point was the DAS28 at week 10. Results Baseline characteristics were similar across all groups. Changes in the DAS28 were significantly greater in the 0.2 mg/kg, 2.0 mg/kg, and all-LY2439821,combined groups (,2.3, ,2.4, and ,2.3, respectively) than in the placebo group (,1.7) at week 10 (P , 0.05), and these differences were significant as early as week 1. Percentages of ACR20, ACR50, and ACR70 responses as well as improvements in the ACR core set of measures were greater in LY2439821-treated patients than in placebo-treated patients at multiple time points. There was no apparent dose-response relationship in treatment-emergent adverse events. Conclusion LY2439821 added to oral DMARDs improved signs and symptoms of RA, with no strong adverse safety signal noted. This first evaluation of LY2439821 supports neutralization of IL-17 as a potential novel goal for the treatment of RA. [source] Effect of hyaluronic acid in symptomatic hip osteoarthritis: A multicenter, randomized, placebo-controlled trial,ARTHRITIS & RHEUMATISM, Issue 3 2009Pascal Richette Objective To evaluate the efficacy and tolerability of a single intraarticular (IA) injection of hyaluronic acid (HA) for the treatment of hip osteoarthritis (OA). Methods A multicenter, randomized, parallel-group, placebo-controlled trial was conducted over 3 months. Patients (older than 30 years) with symptomatic hip OA (pain score of >40 mm on a visual analog scale [VAS]) and a Kellgren/Lawrence grade of 2 or 3 were randomly assigned to receive 1 fluoroscopically guided IA injection of HA (2.5 ml) or placebo (2.5 ml). Patients were followed up for 3 months. The main outcome measure was pain score on a VAS (100 mm) at month 3 compared with baseline. Secondary outcome measures were the proportion of responders defined by Osteoarthritis Research Society International criteria; Western Ontario and McMaster Universities Osteoarthritis Index subscores for pain, stiffness, and disability; and patient and physician global assessment. Randomization was computer generated. HA and placebo preparations were placed in numbered identical containers, and syringes were covered with masking tape. Physicians assessing outcomes were blinded with regard to group assignment. Results Eighty-five patients were randomized to the HA group (n = 42) or placebo group (n = 43). Baseline characteristics were similar between the 2 groups. At 3 months, the decrease in pain score did not differ between the HA and placebo groups in the intent-to-treat analysis (mean ± SD decrease 7.8 ± 24.9 mm with HA versus 9.1 ± 27.4 mm with placebo; P = 0.98). The responder rates were 33.3% and 32.6% in the HA and placebo groups, respectively (P = 0.94). Other secondary end points did not differ between the groups, nor did use of rescue medication or frequency of adverse events. Conclusion Our findings indicate that a single IA injection of HA is no more effective than placebo in treating the symptoms of hip OA. [source] Efficacy and safety of tacrolimus in patients with rheumatoid arthritis: A double-blind trialARTHRITIS & RHEUMATISM, Issue 12 2003David E. Yocum Objective To evaluate the efficacy and safety of tacrolimus as monotherapy in controlling the signs and symptoms of patients with rheumatoid arthritis (RA). Methods This was a 6-month, phase III, double-blind, multicenter study. Patients with active RA who had discontinued all disease-modifying antirheumatic drugs (DMARDs) for an appropriate washout period (at least 1 month) and who, after the washout period, had a stable joint count (at least 10 tender/painful joints and 7 swollen joints) were stratified according to DMARD intolerance or DMARD resistance, and randomized to receive a single daily oral dose of placebo, tacrolimus 2 mg, or tacrolimus 3 mg. Results A total of 464 patients received at least 1 dose of study drug. Baseline characteristics were similar among the 3 treatment groups. American College of Rheumatology 20% improvement (ACR20) success (defined as completion of 6 months of treatment and an ACR20 response at the month 6 visit) for the placebo, tacrolimus 2 mg, and tacrolimus 3 mg groups was 10.2%, 18.8% (P < 0.05 versus placebo), and 26.8% (P < 0.0005 versus placebo), respectively. At the end of treatment, the ACR20 and ACR50 response rates in the 3-mg group were 32.0% (P < 0.005 versus placebo) and 11.8% (P < 0.05 versus placebo), respectively. DMARD-intolerant patients had better ACR response rates than did DMARD-resistant patients. Although serum creatinine levels increased by ,40% from baseline at some time during the trial in 20% and 29% of patients receiving tacrolimus 2 mg/day and 3 mg/day, respectively, the serum creatinine level remained within the normal range throughout the trial in ,90% of patients. Conclusion Tacrolimus, at dosages of both 2 mg/day and 3 mg/day, is efficacious and safe as monotherapy for patients with active RA, but treatment with the 3-mg dose of tacrolimus resulted in generally better ACR response rates. [source] Venous rupture during percutaneous treatment of hemodialysis fistulas and grafts,CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 7 2009John A. Bittl MD Abstract Objectives: The aim of this study was to analyze the risk and consequences of venous rupture during angioplasty of malfunctioning hemodialysis grafts and fistulas. Background: Venous stenoses in the outflow limb of hemodialysis accesses often require ultra-high balloon pressure for optimal dilatation. Methods: Baseline characteristics and outcomes were analyzed for a consecutive series of patients treated between 1999 and 2008. Results: Venous rupture or perforation occurred in 11 of 1242 (0.9%) procedures. No patient with a rupture or perforation died or required emergency or urgent surgical repair. Two of 11 patients (18.2%) required transfusions, 8 of 11 patients (72.7%) required stenting, and 6 of 8 (75.0%) who needed stenting received covered stents to achieve hemostasis. Rupture led to access thrombosis within 30 days in 9 of 11 cases (82%). Multivariable logistical regression analysis suggested that using a balloon catheter more than 2 mm larger than the diameter of the hemodialysis access or using peripheral cutting balloons increased the risk of rupture or perforation. Conclusions: Rupture or perforation is a rare complication of treatment of malfunctioning hemodialysis grafts and fistulas. The complication may be managed with nonsurgical methods and might be avoided by optimal balloon selection and sizing. © 2009 Wiley-Liss, Inc. [source] Oral D-penicillamine for the prevention of retinopathy of prematurity in very low birth weight infants: a randomized, placebo-controlled trialACTA PAEDIATRICA, Issue 9 2010Manjari Tandon Abstract Purpose:, To compare prophylactic enteral D-penicillamine (DPA) with placebo for prevention of ,retinopathy of prematurity (ROP) or death' among very low birth weight (VLBW) infants. Methods:, This was a double-blind, single-centre, randomized, placebo-controlled trial with stratification (for birth weight <1250 and ,1250 g) and blocking. Inborn neonates with birth weight 750,1500 g, gestation ,32 weeks, age ,5 days, who tolerated feeds were eligible. Neonates with gastro-intestinal malformations, life-threatening malformations and necrotizing enterocolitis were excluded. Enrolled subjects were randomly allocated to receive oral DPA suspension at 100 mg/kg/dose 8 h for 3 days, followed by 50 mg/kg/day for another 11 days or placebo. The primary outcome was ,any ROP or death'. Secondary outcomes included any ROP, treatable ROP, adverse effects and feed intolerance. Results:, A total of 88 subjects were enrolled. Baseline characteristics were similar with the exception of multiple gestation. There were no significant differences in primary and secondary outcomes, even after adjusting for multiple gestation and on sub-group analysis. No adverse reaction was noted. Conclusion:, Prophylactic enterally administered DPA suspension in a dose 100 mg/kg/dose 8 h for 3 days, followed by 50 mg/kg once per day for next 11 days, does not prevent ,any stage ROP or death' or ,ROP requiring treatment' in VLBW infants. DPA is well tolerated and does not have any major short-term adverse effects. [source] Thymoglobulin induction and steroid avoidance in cardiac transplantation: results of a prospective, randomized, controlled studyCLINICAL TRANSPLANTATION, Issue 1 2008Mohamad H Yamani Abstract:, Background:, Chronic use of corticosteroids (CS) following transplantation is associated with significant long-term morbidities. Minimizing exposure to CS to improve long-term outcomes, without compromising allograft function, remains an important goal in transplantation. Objectives:, This single-center, prospective, randomized, open-label study was designed to evaluate the efficacy of Thymoglobulin® as part of a CS-sparing regimen in cardiac transplantation. Methods:, Thirty-two low-risk cardiac transplant patients were randomized in a 1:1 ratio to receive either a Thymoglobulin-based CS-avoidance regimen (CS-avoidance group; n = 16) or a long-term CS-based regimen with no antibody induction (control group; n = 16). Pulse CS therapy was used for the treatment of acute cellular rejection in both groups. Results:, Baseline characteristics were similar between groups. At one yr, there was no significant difference in the mean incidence of acute cellular rejection (,3A) episodes between the CS-avoidance and control groups, 0.81 ± 1.05 and 1.07 ± 1.03, respectively. Importantly, the CS-avoidance patients had significant improvement in muscle strength and less bone loss compared with the control patients during the first six months post-transplant. Conclusions:, CS-avoidance regimen with Thymoglobulin induction appeared to be safe and effective in cardiac transplantation. Further studies are required to demonstrate the long-term safety and benefits of such a regimen. [source] Baseline characteristics of participants in the oral health component of the Women's Interagency HIV StudyCOMMUNITY DENTISTRY AND ORAL EPIDEMIOLOGY, Issue 2 2004Roseann Mulligan Abstract ,,, Objectives:, This study described baseline sociodemographic and oral health characteristics of a subset of HIV sero-positive and sero-negative women who participated in the oral health component of the Women's Interagency HIV Study (WIHS). Methods: In 1995,96, 584 HIV sero-positive and 151 sero-negative women from five WIHS core sites were enrolled in the oral study. Data on oral mucosa, salivary glands, dentition and periodontium, along with demographics, socioeconomics, and behavioral characteristics, were used to characterize this population. Results:, Mean (SD) age was 37 (8) years for HIV sero-positive and 36 (8) years for sero-negative women; 27% of sero-positive women had CD4 counts ,200 and 34% had viral loads >50 000 copies/ml. Sero-positive and sero-negative women were similar demographically, as well as on plaque index, gingival bleeding, linear gingival banding, and numbers of DMF teeth and surfaces, but sero-positive women had more abnormal gingival papilla (P = 0.004) and fewer teeth (P = 0.01). Among sero-positive women, those with <200 CD4 counts had more DMF teeth (P = 0.007), and the number of DMF surfaces increased with decreasing CD4 counts (P = 0.04). Sero-positive women who fit the Center for Disease Control (CDC) AIDS criteria were also more likely to have more DMF teeth (P = 0.004), DMF surfaces (P = 0.003), and decayed and/or filled (DF) root surfaces (P = 0.0002) compared to sero-positive women without AIDS. Conclusions:, Dental and periodontal variables showed little difference between HIV sero-positive and sero-negative women. Among sero-positive women, there were significant differences in coronal and root caries by AIDS diagnostic criteria, but no periodontal indicators by either AIDS diagnostic criteria or CD4 status, were observed. [source] Statin Use Is Associated With Improved Survival in Patients With Advanced Heart Failure Receiving Resynchronization TherapyCONGESTIVE HEART FAILURE, Issue 4 2009Andrew D. Sumner MD It is unknown whether statin use improves survival in patients with advanced chronic heart failure (HF) receiving cardiac resynchronization therapy (CRT). The authors retrospectively assessed the effect of statin use on survival in patients with advanced chronic HF receiving CRT alone (CRT-P) or CRT with implantable cardioverter-defibrillator therapy (CRT-D) in 1520 patients with advanced chronic HF from the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) trial database. Six hundred three patients (40%) were taking statins at baseline. All-cause mortality was 18% in the statin group and 22% in the no statin group (hazard ratio [HR] 0.85; confidence interval (CI), 0.67,1.07; P=.15). In a multivariable analysis controlling for significant baseline characteristics and use of CRT-P/CRT-D, statin use was associated with a 23% relative risk reduction in mortality (HR, 0.77; CI, 0.61,0.97; P=.03). Statin use is associated with improved survival in patients with advanced chronic HF receiving CRT. No survival benefit was seen in patients receiving statins and optimal pharmacologic therapy without CRT. 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