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Selected AbstractsEfficacy and safety of ezetimibe co-administered with simvastatin in thiazolidinedione-treated type 2 diabetic patientsDIABETES OBESITY & METABOLISM, Issue 1 2005L. M. Gaudiani Aim:, In patients with type 2 diabetes mellitus (T2DM), combination therapy is usually required to optimize glucose metabolism as well as to help patients achieve aggressive targets for low-density lipoprotein cholesterol (LDL-C) and other lipid parameters associated with cardiovascular risk. The thiazolidinediones (TZDs) are increasingly being used for both their blood glucose-lowering properties and their modest beneficial effects on triglycerides (TG) and high-density lipoprotein cholesterol (HDL-C). Ezetimibe, an intestinal cholesterol absorption inhibitor, has a mechanism of action that differs from that of statins, which inhibit hepatic cholesterol synthesis. We compared the lipid-modifying efficacy and safety of adding ezetimibe to simvastatin, vs. doubling the dose of simvastatin, in TZD-treated T2DM patients. Methods:, This was a randomized, double-blind, parallel group, multicentre study in T2DM patients, 30,75 years of age, who had been on a stable dose of a TZD for at least 3 months and had LDL-C > 2.6 mmol/l (100 mg/dl) prior to study entry. Other antidiabetic medications were also allowed. Following 6 weeks of open-label simvastatin 20 mg/day, patients were randomized to the addition of either blinded ezetimibe 10 mg/day (n = 104) or an additional blinded simvastatin 20 mg/day (total simvastatin 40 mg/day; n = 110) for 24 weeks. Patients were stratified according to TZD type and dose (pioglitazone 15,30 vs. 45 mg/day; rosiglitazone 2,4 vs. 8 mg/day). Results:, LDL-C was reduced more (p < 0.001) by adding ezetimibe 10 mg to simvastatin 20 mg (,20.8%) than by doubling the dose of simvastatin to 40 mg (,0.3%). Ezetimibe plus simvastatin 20 mg also produced significant incremental reductions in non-HDL-C (p < 0.001), very low-density lipoprotein cholesterol (p < 0.05) and apolipoprotein B (p < 0.001) relative to simvastatin 40 mg. There were no differences between the groups with respect to changes in TG and HDL-C levels, and both treatments were well tolerated. Conclusions:, Co-administration of ezetimibe with simvastatin, a dual inhibition treatment strategy targeting both cholesterol synthesis and absorption, is well tolerated and provides greater LDL-C-lowering efficacy than increasing the dose of simvastatin in T2DM patients taking TZDs. [source] Delivery of care to diabetic patients with foot ulcers in daily practice: results of the Eurodiale Study, a prospective cohort studyDIABETIC MEDICINE, Issue 6 2008L. Prompers Abstract Aims To determine current management and to identify patient-related factors and barriers that influence management strategies in diabetic foot disease. Methods The Eurodiale Study is a prospective cohort study of 1232 consecutive individuals presenting with a new diabetic foot ulcer in 14 centres across Europe. We determined the use of management strategies: referral, use of offloading, vascular imaging and revascularization. Results Twenty-seven percent of the patients had been treated for > 3 months before referral to a foot clinic. This varied considerably between countries (6,55%). At study entry, 77% of the patients had no or inadequate offloading. During follow-up, casting was used in 35% (0,68%) of the plantar fore- or midfoot ulcers. Predictors of use of casting were male gender, large ulcer size and being employed. Vascular imaging was performed in 56% (14,86%) of patients with severe limb ischaemia; revascularization was performed in 43%. Predictors of use of vascular imaging were the presence of infection and ischaemic rest pain. Conclusion Treatment of many patients is not in line with current guidelines and there are large differences between countries and centres. Our data suggest that current guidelines are too general and that healthcare organizational barriers and personal beliefs result in underuse of recommended therapies. Action should be undertaken to overcome these barriers and to guarantee the delivery of optimal care for the many individuals with diabetic foot disease. [source] Withdrawal symptoms in abstinent methamphetamine-dependent subjectsADDICTION, Issue 10 2010Todd Zorick ABSTRACT Aims Withdrawal symptoms have been linked to a propensity for relapse to drug abuse. Inasmuch as this association applies to methamphetamine (MA) abuse, an understanding of the course of MA withdrawal symptoms may help to direct treatment for MA dependence. Previous studies of symptoms manifested during abstinence from MA have been limited in size and scope. We asked (i) whether debilitating psychological and/or physical symptoms appear during the first several weeks of MA abstinence, (ii) how craving for MA evolves and (iii) whether psychiatric symptoms (e.g. depression, psychosis) persist beyond a month of abstinence. Design A study of MA-dependent participants, who initiated and maintained abstinence from the drug for up to 5 weeks, compared to a matched healthy comparison group. Setting In-patient research hospital ward (MA-dependent subjects) and out-patient (comparison subjects). Participants Fifty-six MA-dependent and eighty-nine comparison subjects. Measurements Rater-assessed MA withdrawal questionnaire and self-report assessment of craving (MA-dependent subjects) and self-report assessment of psychiatric symptoms (both groups). Findings At study entry, MA-dependent subjects exhibited a wide range in severity of depressive symptoms, with the average score at a mild,moderate level of severity. Symptoms of psychosis were also prevalent. While depressive and psychotic symptoms largely resolved within a week of abstinence, craving did not decrease significantly from the time of initiating abstinence until the second week, and then continued at a reduced level to the fifth week. Conclusions Depressive and psychotic symptoms accompany acute withdrawal from methamphetamine but resolve within 1 week. Craving is also present and lasts at least 5 weeks. [source] A cohort study to examine whether time and risk preference is related to smoking cessation successADDICTION, Issue 6 2009Rei Goto ABSTRACT Aim To identify whether time and risk preference predicts relapse among smokers trying to quit. Design A cohort study of smokers who had recently started to quit. Time and risk preference parameters were estimated using a discrete choice experiment (DCE). Participants A total of 689 smokers who began quitting smoking within the previous month. Measurements Time discount rate, coefficient of risk-aversion measured at study entry and duration of smoking cessation measured for 6 months. Findings In the unadjusted model, Cox's proportional hazard regression showed that those with a high time discount rate were more likely to relapse [hazard ratio: 1.18, 95% confidence interval (CI): 1.11,1.25]. A high coefficient of risk-aversion reduced the hazard of relapse (0.96, 0.96,0.97). When adjusted for other predictors of relapse (age, gender, self-efficacy of quitting, health status, mood variation, past quitting experience, the use of nicotine replacement therapy, nicotine dependence), the hazard ratios of time discount rate and the coefficient of risk-aversion is 1.17 (95% CI: 1.10,1.24) and 0.98 (95% CI: 0.97,0.99), respectively. Conclusions Those who emphasize future rewards (time,patient preference) and those who give more importance to rewards that are certain (higher risk-aversion) were significantly more likely to continue to abstain from smoking. [source] Mixed cryoglobulinemia is associated with increased risk for death, or neoplasia in HIV-1 infectionEUROPEAN JOURNAL OF CLINICAL INVESTIGATION, Issue 12 2001T. Kordossis Backround Cryoglobulinemia has been reported in several chronic infectious and autoimmune diseases, and in patients with HIV-1 infection. Cryoglobulinemia associated with hepatitis C virus infection is considered a risk factor for the development of neoplasia, especially B-cell non-Hodgkin lymphoma. This study was undertaken to investigate whether the presence of circulating cryoglobulins is associated with survival or development of neoplastic disease in HIV-1 infection. Design We evaluated 87 unselected consecutive HIV-1 infected patients for the presence of cryoglobulinemia and they were prospectively followed up for a median of 34 months, with clinic visits at 4-month intervals. None of the patients had neoplasia at study entry. Time-to-event analysis for death, neoplasm and B-cell lymphoproliferative disorder were performed with Cox proportional hazards models. Results Mixed cryoglobulinemia (types II and III) was detected in 24 (28%) of the 87 patients. During the follow up, 12 patients died and 8 developed neoplastic disease. Multivariate analysis showed that circulating cryoglobulins were an independent predictor of death [relative risk (RR), 4·97; 95% confidence intervals (CI), 1·26,19·63] and development of neoplasia (RR, 5·18; 95% CI, 1·23,21·83). In addition, cryoglobulinemia reached borderline significance as a predictor of lymphoproliferative disorder of B-cell origin (P = 0·08; RR, 4·53; 95% CI, 0·83,24·75). Conclusions Our results suggest that cryoglobulinemia is associated with an increased risk for death, neoplasia or development of lymphoproliferative disorder of B-cell origin, in HIV-1 infected patients. [source] Topiramate as an Adjunctive Treatment in Migraine ProphylaxisHEADACHE, Issue 10 2003Héctor R. Martínez MD Background.,Anticonvulsants now are commonly used for headache prevention. Topiramate, one of the newer anticonvulsants, recently has been demonstrated to be effective as monotherapy for migraine prophylaxis. Objective.,To assess the efficacy, safety, and tolerability of topiramate as adjunctive prophylactic therapy for migraine. Material and Methods.,A prospective trial involving patients with more than 3 migraine attacks per month was performed. Patients continued their usual prophylactic treatment. Baseline analgesic use and frequency and duration of migraine attacks were recorded. A 4-point visual analog scale evaluated severity. Laboratory tests, electrocardiogram, and computed tomography or magnetic resonance imaging were performed before study entry. After informed consent was obtained, patients were instructed to take 25 mg of topiramate per day, with 25- to 50-mg weekly increments to a maximum of 100 mg per day. Safety was assessed at the first month; tolerability and efficacy were assessed every week for the first month and then every month for 3 months. Effectiveness was assessed by comparing baseline and on-treatment migraine status, and data were analyzed by the Fisher exact test. Results.,Twenty-five women and 11 men (mean age, 44 years) were evaluated. Existing prophylactic treatment was either propranolol or flunarizine (or both) in 80% of the patients. At 3 months of therapy with topiramate, headache frequency decreased from 17 to 3 episodes per month, headache duration from 559 to 32 minutes, and intensity from 9 to 1 by visual analog scale (P < .001). Improvement in frequency and severity of migraine was observed in 83% of patients. Slight or no changes in headache were observed in 6 patients. Tolerability was good in 30 patients. The most common side effects were acroparesthesias, weight loss, sleepiness, and headache worsening. No adverse interaction with propranolol or flunarizine was observed. Conclusions.,These results suggest that topiramate is efficacious and safe as an adjunctive treatment in patients with migraine whose prior response to prophylactic management has been less than satisfactory. [source] Usefulness of transient elastography for assessment of liver fibrosis in chronic hepatitis B: Regression of liver stiffness during entecavir therapyHEPATOLOGY RESEARCH, Issue 9 2010Masaru Enomoto Aim:, The usefulness of transient elastography remains to be validated in chronic hepatitis B, particularly as a tool for monitoring the degree of liver fibrosis during treatment. Methods:, The subjects were 50 patients with chronic hepatitis B virus infection. Liver biopsy was performed in 38 patients, and in 12 patients with platelet counts of 50 × 109/L or less, cirrhosis was clinically diagnosed on the basis of specific signs of portal hypertension. Liver stiffness was measured by transient elastography at baseline and after 12 months of treatment in 20 nucleos(t)ide-naïve patients who started entecavir within 3 months after study entry. Results:, Twenty (40%) patients were classified as F1, 10 (20%) as F2, 5 (10%) as F3, and 15 (30%) as F4 (cirrhosis). Median liver stiffness (interquartile range) was 7.0 kPa (5.6,9.4), 9.8 kPa (5.6,14.7), 9.8 kPa (7.6,12.9), and 17.3 kPa (8.2,27.6) in fibrosis stages F1 to F4, respectively. Liver stiffness significantly correlated with fibrosis stage (r = 0.46; P = 0.0014). Of the patients who started entecavir, median liver stiffness significantly decreased from 11.2 kPa (7.0,15.2) to 7.8 kPa (5.1,11.9; P = 0.0090) during 12 months of treatment. Median levels of amino-terminal peptide of type III procollagen and type IV collagen 7S domain in serum significantly decreased from 0.9 (0.6,1.3) to 0.6 (0.5,0.7) U/mL (P = 0.0010) and from 5.0 (4.4,6.7) to 3.9 (3.2,4.4) ng/mL (P = 0.015), respectively. Conclusion:, Liver stiffness measurement can be useful for monitoring regression of liver fibrosis during entecavir treatment in patients with chronic hepatitis B virus infection. [source] Predicting short-term disease progression among HIV-infected patients in Asia and the Pacific region: preliminary results from the TREAT Asia HIV Observational Database (TAHOD)HIV MEDICINE, Issue 3 2005J Zhou Objectives HIV disease progression has been well documented in Western populations. This study aimed to estimate the short-term risk of AIDS and death from the TREAT Asia HIV Observational Database (TAHOD), a prospective, multicentre cohort study in Asia and the Pacific region. Methods Prospective data were analysed to estimate short-term disease progression. Endpoints were defined as the time from study entry to diagnosis with AIDS or death. Antiretroviral treatment was fitted as a time-dependent variable. Predictors of disease progression were assessed using Cox proportional hazards models, and prognostic models were developed using Weibull models. Results A total of 1260 patients with prospective follow-up data contributed 477 person-years of follow-up, during which 18 patients died and 34 were diagnosed with AIDS, a combined rate of 10.1 per 100 person-years. Compared with patients receiving antiretroviral treatment, patients not on treatment had a higher rate of disease progression (17.6 vs. 8.1 per 100 person-years, respectively). Baseline CD4 count was the strongest predictor of disease progression. Prognostic models, using either a baseline CD4 count as the sole marker or markers including baseline haemoglobin, AIDS-related symptoms and previous or current antiretroviral treatment, were successful at identifying patients at high risk of short-term disease progression. Conclusions Similar to the situation in Western countries, baseline CD4 count was the strongest predictor of short-term disease progression. Prognostic models based on readily available clinical data and haemoglobin level should be useful in estimating short-term clinical risk in HIV-infected patients in Asia and the Pacific region. [source] Epstein-Barr virus infection and risk of lymphoma: Immunoblot analysis of antibody responses against EBV-related proteins in a large series of lymphoma subjects and matched controlsINTERNATIONAL JOURNAL OF CANCER, Issue 8 2007Silvia de Sanjosé Abstract Epstein-Barr Virus (EBV) is consistently associated with distinct lymphoproliferative malignancies and aberrant EBV antibody patterns are found in most EBV cancer patients. We evaluate the detection of an abnormal reactive serological pattern to EBV (ab_EBV) infection and the risk of lymphoma in a multicentric case,control study. Serum samples were collected at study entry from 1,085 incident lymphoma cases from Spain, France, Germany, Czech Republic, Italy and 1,153 age, sex and country matched controls. EBV immunoglobulin G (IgG) serostatus was evaluated through a peptide-based ELISA combining immunodominant epitopes of EBNA1 (BKRF1) and VCA-p18 (BFRF3). Further, immunoblot analysis was performed to evaluate distinct antibody diversity patterns to EBV early antigens (EA), besides EBNA1, VCA-p18, VCA-p40 (BdRF1) and Zebra (BZLF1). Patients with chronic active EBV infection and aberrant EBV activity were characterized as having an abnormal reactive pattern (ab_EBV). Ab_EBV was observed in 20.9% of 2,238 included subjects with an increased proportion of cases presenting ab_EBV as compared to the control population (23.9% vs. 18.0% p = 0.001). Ab_EBV positivity was a risk factor for all lymphomas combined (odds ratio [OR] = 1.42, 95% confidence interval [CI]=1.15,1.74), and specifically for chronic lymphocytic leukaemia (OR = 2.96, 95%CI = 2.22,3.95). Lower levels of ab_EBV were observed for follicular lymphoma (OR = 0.38, 95%CI = 0.15,0.98). EBV may be involved in a larger subset of lymphomas among clinically immunocompetent subjects than previously thought, probably explained by an underlying loss of immune control of EBV latent infection. Ab_EBV is a useful tool to explore EBV imbalances preceeding or paralleling possible EBV associated oncogenic events. © 2007 Wiley-Liss, Inc. [source] Worldwide-Schizophrenia Outpatient Health Outcomes (W-SOHO): baseline characteristics of pan-regional observational data from more than 17,000 patients,INTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 11 2009J. Karagianis Summary Objective:, To describe the Worldwide-Schizophrenia Outpatient Health Outcomes (W-SOHO) patient population at study entry, focusing on illness burden and prescribing practices across regions. Methods:, The SOHO study was a 3-year, prospective, observational study designed to assess costs and outcomes associated with antipsychotic use in outpatients initiating or changing antipsychotic (with an emphasis on olanzapine compared with other antipsychotics). SOHO was conducted in 10 European countries and 27 other countries as Intercontinental SOHO (IC-SOHO). Data from all countries have been pooled to produce the W-SOHO dataset. Main outcomes measures:, Clinical Global Impression-Schizophrenia (CGI-SCH) severity scores, psychotropic medication use, adverse events, social interaction, housing and employment status, self-perceived health state (EuroQoL EQ-5D scale and Visual Analogue Scale, EQ-VAS), and reasons for initiation/change of antipsychotic. Results:, The W-SOHO database comprises 17,384 patients from six regions; East Asia (n = 1223), Central and Eastern Europe (n = 2175), Northern Europe (n = 4291), Southern Europe (n = 5788), Latin America (n = 2566), North Africa and the Middle East (n = 1341). Overall, patients were 38 ± 13 years old (mean ± SD), moderately ill (mean CGI-SCH overall score of 4.4 ± 1.0) with a median duration of illness of 7 years (interquartile range 1,16 years); 43% were female, 10% were receiving antipsychotic medication for the first time. Adverse events were prevalent across all regions; on average, 50% (range 41,59%) of patients taking antipsychotics exhibited extrapyramidal symptoms at baseline, and 62% (34,67%) of patients reported sexual dysfunction in the previous month. On average, only 19% (16,23%) of patients were in paid employment and as many as 69% were living in dependent housing. Conclusions:, Despite inherent diversity in these patients and the health care systems supporting them, there are striking cross-regional similarities in baseline characteristics for most measures. Not all countries are represented; regional comparisons may not be valid outside of the countries studied. [source] Eating Disorder Examination-Questionnaire as a measure of change in patients with bulimia nervosaINTERNATIONAL JOURNAL OF EATING DISORDERS, Issue 2 2005Robyn Sysko MS Abstract Objective The current study evaluated the agreement between the Eating Disorder Examination and the Eating Disorder Examination-Questionnaire in assessing eating disorder pathology in a sample of women with bulimia nervosa. Method Patients with broadly defined bulimia nervosa were enrolled in a double-blind, placebo-controlled treatment study of fluoxetine, with and without guided self-help. The current study presents information from 50 patients with data from both the EDE and EDE-Q at study entry and treatment termination. Results The EDE and EDE-Q produced more similar scores for compensatory behaviors (vomiting/laxative use) than complex eating-disordered features (binge eating/importance of shape and weight) at the pretreatment and posttreatment assessments, and for change during the study. Discussion The EDE and EDE-Q are highly correlated for many of the behavioral and attitudinal features of bulimia nervosa. There is substantial variability in agreement for individual patients, but on average, the EDE and EDE-Q will yield similar assessments of eating disorder symptoms and change in symptoms over time. © 2005 by Wiley Periodicals, Inc. [source] Allostatic Load and Frailty in Older AdultsJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 9 2009Tara L. Gruenewald PhD OBJECTIVES: To examine the association between allostatic load (AL), an index of multisystem physiological dysregulation, and frailty development over a 3-year follow-up in a sample of older adults. DESIGN: Longitudinal cohort study. SETTING: Community. PARTICIPANTS: High-functioning men and women aged 70 to 79 at study entry. MEASUREMENTS: Multisystem physiological dysregulation, or AL, was assessed according to 13 biomarkers of cardiovascular, endocrine, immune, and metabolic function. An AL score was computed as the total number of biomarkers for which participant values fell into high-risk biomarker quartiles. Frailty status (not frail, intermediate frail, frail) was determined according to the total number of five indicators of frailty: weight loss, exhaustion, weak grip, slow gait, and low physical activity. The association between level of AL at baseline and frailty status 3 years later was examined using ordinal logistic regression in 803 participants not frail at baseline. RESULTS: In a multivariable model adjusting for sociodemographic, health, and behavioral characteristics, each 1-unit increase in AL at baseline was associated with a 10% greater likelihood of frailty at the 3-year follow-up (cumulative adjusted odds ratio=1.10, 95% confidence interval=1.03,1.19). CONCLUSION: These findings support the hypothesis that dysregulation across multiple physiological systems is associated with greater risk of frailty. Greater levels of multisystem physiological dysregulation may serve as a warning sign of frailty development in later life. [source] Role of the Clinical Breast Examination in Breast Cancer ScreeningJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 7 2001Does This Patient Have Breast Cancer? QUESTION: The authors, in an article for the JAMA section on the rational clinical examination, consider the evidence on whether and how to use clinical breast examination as a cancer screening technique. BACKGROUND: Breast cancer is a common disease, particularly in older women. The authors note that by age 70 the annual incidence of breast cancer is one in 200 women. Breast cancer survival is strongly influenced by the stage of the disease at the time of diagnosis. As a result, it is important to consider how best to screen for this disease. In recent years there has been considerable attention in the clinical literature and in the popular media paid to the screening strategies of breast self-examination and of screening mammography, but somewhat less to the potential role of the breast examination by the healthcare provider. In actual clinical practice, the same woman may be the recipient of any, none, or all of these screening modalities. The best way to combine these screening strategies, particularly in the case of the older woman, remains a subject of some uncertainty and controversy. DATA SOURCES: Data were obtained from a MEDLINE search of the English-language literature for 1966 through 1997 and additional articles as identified by the authors. STUDY SELECTION CRITERIA: In their evaluation of the effectiveness of clinical breast examination, the authors included both controlled trials and case-controlled studies in which clinical breast examination was used as a component of the screening. Study of breast examination technique considered both clinical studies and studies using silicone breast models. DATA EXTRACTION: The combined data from the trials included information on approximately 200,000 women who received a breast cancer screening intervention (mammography and/or clinical breast examination). However, none of the studies made the direct comparison of a group receiving clinical breast examination as a sole intervention with a control group that did not receive any screening. Data on the utility of clinical breast examination were partially derived from studies where that screening modality was used in combination with mammography. MAIN RESULTS: A number of trials of cancer screening have demonstrated a reduction in mortality from the use of mammography and clinical breast examination as combined screening strategies compared with no screening, with the inference that the reduction in mortality comes from the earlier detection of breast cancer. The percentage of the detected cancers that are detected in the trials by clinical breast examination despite having been missed on mammography varies across the trials from a low of 3% of the detected cancers to a high of 45%. It is speculative whether the marginal contribution of clinical breast examination to the mortality reduction in these screening trials corresponds to the percentage of cancers detected by clinical breast examination alone. In most of the clinical trials, the technique of breast examination reportedly was not well described. It is unclear therefore how much the technique of breast examination used varied within and among the clinical trials. Data from studies using examinations of breast models made of silicone demonstrated that test performance accuracy correlated with a lengthier breast examination, better breast examination technique, and perhaps with examiner experience. The report includes data from six comparator studies and from two demonstration projects. Of the six comparator studies, four compared a screened population with an unscreened population and two compared different intensities of screening strategies. None of the eight clinical trials was directed to a geriatric population and in fact older women were excluded by upper age entry criteria from the six comparator studies. (The upper age limit for study entry in the six comparator studies varied from 49 to 64.) CONCLUSION: The authors drew on the pooled results of these eight studies to conclude that clinical breast examination has a sensitivity of 54% (95% confidence interval, 48.3,59.8) and a specificity of 94% (95% confidence interval, 90.2,96.9). The authors conclude that screening clinical breast examination should be done for women age older than 40. [source] Cigarette Smoking and the Risk of Supraventricular and Ventricular Tachyarrhythmias in High-Risk Cardiac Patients with Implantable Cardioverter DefibrillatorsJOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 9 2006ILAN GOLDENBERG M.D. Introduction: Nicotine elevates serum catecholamine concentration and is therefore potentially arrhythmogenic. However, the effect of cigarette smoking on arrhythmic risk in coronary heart disease patients is not well established. Methods and Results: The risk of appropriate and inappropriate defibrillator therapy by smoking status was analyzed in 717 patients who received an implantable cardioverter defibrillator (ICD) in the Multicenter Automatic Defibrillator Implantation Trial-II. Compared with patients who had quit smoking before study entry (past smokers) and patients who had never smoked (never smokers), patients who continued smoking (current smokers) were significantly younger and generally had more favorable baseline clinical characteristics. Despite this, the adjusted hazard ratio (HR) for appropriate ICD therapy for fast ventricular tachycardia (at heart rates ,180 b.p.m) or ventricular fibrillation was highest among current smokers (HR = 2.11 [95% CI 1.11,3.99]) and intermediate among past smokers (HR = 1.57 [95% CI 0.95,2.58]), as compared with never smokers (P for trend = 0.02). Current smokers also exhibited a higher risk of inappropriate ICD shocks (HR = 2.93 [95% CI 1.30,6.63]) than past (HR = 1.91 [95% CI 0.97,3.77]) and never smokers (P for trend = 0.008). Conclusions: In patients with ischemic left ventricular dysfunction, continued cigarette smoking is associated with a significant increase in the risk of life-threatening ventricular tachyarrhythmias and inappropriate ICD shocks induced by rapid supraventricular arrhythmias. Our findings stress the importance of complete smoking cessation in this high-risk population. [source] Menopausal symptom perception and severity: results from a screening questionnaireJOURNAL OF CLINICAL NURSING, Issue 7 2008FAANP, Judith A Berg PhD Background., Although it is widely acknowledged women experience symptoms during their transition from reproductive to postreproductive stage, there is inconsistency as to the prevalence of symptoms as well as their severity ratings. Aim and objectives., The purpose of this study was to describe symptom perception and severity in mid-life women volunteering for an intervention study for menopause symptom management. Design., A cross-sectional descriptive design was used to provide data on presenting symptoms in a sample of women negotiating the menopausal transition. Methods., A community-based sample of Caucasian women aged 43,55 years was recruited from national nursing media, local media and a variety of local community sources. A screening questionnaire was administered to determine qualification for study entry based upon symptom severity scores from the questionnaire. This report includes results from the screening questionnaire. Results., One hundred and sixty-five women were screened to obtain 110 qualified participants with mean age of 49·3 SD 3·04 years who were 4·7 SD 7 months past their last menstrual period. Sleep difficulties, forgetfulness and irritability were perceived by the highest number of women while sleep difficulties, night sweats, irritability and forgetfulness were rated the most severe. Conclusions., Findings from this study expand understanding of the menopause symptom experience, because few reports include symptom severity reports. All aspects of the symptom experience are necessary to develop appropriate interventions and to evaluate them. Relevance to clinical practice., Providing education about menopause symptoms is central to nursing practice of mid-life women. Therefore, nurses must keep abreast of current knowledge to prepare women for their transition to postreproductive phase or to reassure women who are surprised to find hot flashes are not the only symptoms encountered. [source] Effect of cisapride on gastric emptying in premature infants with feed intoleranceJOURNAL OF PAEDIATRICS AND CHILD HEALTH, Issue 6 2001CP Barnett Objective: To assess the effect of cisapride on gastric emptying and gastro-oesophageal reflux (GOR) symptoms in preterm infants with feed intolerance. Methods: Sixteen preterm infants (gestational age 24,35 weeks) with feed intolerance were enrolled in the study. Infants were randomized to receive 7 days of cisapride 0.2 mg/kg four times a day, immediately followed by 7 days of placebo or vice versa. Gastric emptying was measured using the [13C]-octanoic acid breath test prior to study entry and repeated on day 5, 6 or 7 after randomization and 5, 6 or 7 days after crossover. The symptoms of GOR were monitored during the study period using a standardized reflux chart. Weight was recorded daily. Results: There was no change in gastric emptying in infants prescribed cisapride (gastric half-emptying time (t1/2) 31.9 ± 4.7 vs 34.2 ± 3.9 min for placebo vs cisapride, respectively; P = 0.65). Infants on cisapride had slower growth and there was no change in reflux symptoms. Conclusions: The use of cisapride in preterm infants with feed intolerance cannot be recommended. [source] Unmitigated Communion, Social Constraints, and Psychological Distress Among Women With Rheumatoid ArthritisJOURNAL OF PERSONALITY, Issue 1 2004Sharon Danoff-Burg This longitudinal study is the first to examine the influence of unmitigated communion on adaptation to a chronic illness that affects a much greater proportion of women to men. Women with rheumatoid arthritis completed measures of unmitigated communion, social constraints, and psychological distress at study entry and repeated the distress measure one year later. As expected, unmitigated communion was associated with psychological distress. Cross-sectional moderation analyses indicated that low social constraints buffered the negative effects of unmitigated communion. [source] Naltrexone Is Associated With Reduced Drinking by Alcohol Dependent Patients Receiving Antidepressants for Mood and Anxiety Symptoms: Results From VA Cooperative Study No. 425, "Naltrexone in the Treatment of Alcoholism"ALCOHOLISM, Issue 1 2008John H. Krystal Background:, It is not clear whether naltrexone is effective in reducing alcohol consumption among patients with clinically significant mood symptoms and whether naltrexone favorably interacts with antidepressant medications when they are co-prescribed. Methods:, This study reflects a secondary analysis of the first 13 weeks of VA CSP #425, a study that evaluated the efficacy of naltrexone 50 mg/d in 627 alcohol dependent military veterans receiving Twelve Step Facilitation therapy at 20 VA Medical Centers. This study included patients with comorbid mood and anxiety disorders, providing they did not need treatment for these comorbid conditions at the time of study entry. Sixty patients developed sufficiently severe mood symptoms while on study medication that they required antidepressant treatment. This analysis evaluated whether the efficacy of naltrexone and placebo was influenced by the prescription of antidepressant medications to some study patients for their mood and anxiety symptoms. Results:, In patients randomized to placebo (n = 209), prescription of antidepressants was associated with a significantly higher percentage of drinking days (lsmean = 24.4, se = 4.85 vs. lsmean = 12.9, se = 1.69, p = 0.02). Although the group of patients receiving naltrexone (n = 418) was larger than the group assigned to placebo, there were no significant differences in drinking-related outcomes in the groups who did or did not receive antidepressants (lsmean = 11.5, se = 1.18 vs. lsmean = 12.9, se = 1.69, p = 0.47). Among the group of patients receiving antidepressants, naltrexone prescription was associated with a reduction in the percent drinking days compared to placebo [lsmean = 10.1, se = 3.47 vs. lsmean = 24.4, se = 4.85, F(1,556) = 5.84, p = 0.02]. Conclusions:, Further investigation will be needed to determine whether naltrexone is efficacious among depressed alcohol dependent patients and whether naltrexone and antidepressant medications show interactive efficacy for treating alcohol dependence. [source] Effect of combined maternal and infant vitamin D supplementation on vitamin D status of exclusively breastfed infantsMATERNAL & CHILD NUTRITION, Issue 1 2009Hussein F. Saadi Abstract Severe vitamin D deficiency in mothers and their breastfed infants is a significant health problem in the Middle East. Supplementation of the breastfed infant alone with the recommended dose of vitamin D may be insufficient in high-risk population. We investigated the effect of combined maternal and infant vitamin D supplementation on vitamin D status of the breastfed infant. We examined also the effect of supplementation on vitamin D antirachitic activity of breast milk in a subset of mothers. Healthy breastfeeding mothers (n = 90) were randomly assigned to 2000 IU daily (group 1) or 60 000 IU monthly (group 2) of vitamin D2, and all their infants (n = 92) received 400 IU daily of vitamin D2 for 3 months. Most infants had vitamin D deficiency , 25-hydroxyvitamin D [25(OH)D] , 37.5 nmol L,1, at study entry. Serum 25(OH)D concentrations at 3 months increased significantly from baseline in infants of mothers in group 1 (13.9 ± 8.6 vs. 49.6 ± 18.5 nmol L,1, P < 0.0001) and group 2 (13.7 ± 12.1 vs. 44.6 ± 15.0 nmol L,1, P < 0.0001). Maternal and infant serum 25(OH)D concentrations correlated positively at baseline (r = 0.36, P = 0.01) and 3 months (r = 0.46, P = 0.002). Milk antirachitic activity increased from undetectable (<20 IU L,1) to a median of 50.9 IU L,1. In conclusion, combined maternal and infant vitamin D supplementation was associated with a threefold increase in infants' serum 25(OH)D concentrations and a 64% reduction in the prevalence of vitamin D deficiency without causing hypervitaminosis D. [source] Fluid challenge in patients at risk for fluid loading-induced pulmonary edemaACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 1 2004M. Matejovic Background:, This study evaluated the effects of protocol-guided fluid loading on extravascular lung water (EVLW) and hemodynamics in a group of patients at high risk for volume expansion-induced pulmonary and systemic edema. Methods:, Nine acutely admitted septic patients with acute lung injury (ALI) were prospectively studied. In addition to sepsis and ALI, the following criteria indicating increased risk for edema formation had to be fulfilled: increased vascular permeability defined as microalbuminuria greater than fivefold normal and hypoalbuminemia <30 g l,1. Two hundred-ml boluses of a 10% hydroxyethyl starch (HES) was titrated to obtain best filling pressure/stroke volume relation. Extravascular lung water and intrathoracic blood volume (ITBV) were measured using a transpulmonary double-indicator dilution technique. Baseline data were compared with data at the end of fluid loading and 3 h postchallenge. Results:, At study entry the mean EVLW was 13 ml kg,1, and the mean EVLW/ITBV ratio (indicator of pulmonary permeability) was 0.72 (normal range 0.20,0.30). To attain optimal preload/stroke volume relation 633 ± 240 ml of HES was needed. Fluid loading significantly increased preload (CVP, PAOP and ITBV), and stroke volume. Effective pulmonary capillary pressure (Pcap) rose only slightly. As a result, the Pcap,PAOP gradient decreased. Despite increased cardiac output, EVLW did not change by plasma expansion. Conclusion:, In this selected group of at-risk patients, the optimization of cardiac output guided by the concept of best individual filling pressure/stroke volume relationship did not worsen permeability pulmonary edema. [source] Apathy may herald cognitive decline and dementia in Parkinson's disease,MOVEMENT DISORDERS, Issue 16 2009Kathy Dujardin PhD Abstract Apathy is usually defined as a lack of motivation. It may occur as part of another disorder (notably depression and dementia) or as an isolated syndrome. In Parkinson's disease (PD), apathy is common and several studies have reported an association between this condition and more severe cognitive symptoms, such as executive dysfunction. However, this association has not been thoroughly investigated. The aim of this study (in nondepressed, nondemented PD patients) was to examine whether or not cognitive decline and/or dementia occurred more frequently in apathetic subjects than in nonapathetic subjects. Forty consecutive PD patients participated in the study (20 with apathy and 20 without). None of the subjects were either demented or depressed at the time of study entry. The patients' cognitive functions were extensively assessed twice: at study entry and after an 18-month follow-up period. At study entry, the apathetic PD patients had significantly lower global cognitive status and executive function scores than the nonapathetic subjects. After a median period of 18 months, the rate of conversion to dementia was found to be significantly higher in the apathetic group than in the nonapathetic group (8 of 20 and 1 of 20, respectively). Even in nondemented patients, the decrease over time in cognitive performance (mainly executive function but also memory impairment) was significantly greater in apathetic subjects than in nonapathetic subjects. These findings suggest that in nondemented, nondepressed PD patients, apathy may be a predictive factor for dementia and cognitive decline over time. © 2009 Movement Disorder Society [source] Ethnic Differences in Pain Among Outpatients with Terminal and End-Stage Chronic IllnessPAIN MEDICINE, Issue 3 2005Michael W. Rabow MD ABSTRACT Objective., To explore ethnic and country of origin differences in pain among outpatients with terminal and end-stage chronic illness. Design., Cohort study within a year-long trial of a palliative care consultation. Setting., Outpatient general medicine practice in an academic medical center. Patients., Ninety patients with advanced congestive heart failure, chronic obstructive pulmonary disease, or cancer, and with a prognosis between 1 and 5 years. Outcome Measures., Patients' report of pain using the Brief Pain Inventory and analgesic medications prescribed by primary care physicians. Differences in pain report and treatment were assessed at study entry, at 6 and 12 months. Results., The overall burden of pain was high. Patients of color reported more pain than white patients, including measures of least pain (P = 0.02), average pain (P = 0.05), and current pain (P = 0.03). No significant ethnic group differences in pain were found comparing Asian, black, and Latino patients. Although nearly all patients who were offered opioid analgesics reported using them, opioids were rarely prescribed to any patient. There were no differences in pain between patients born in the U.S. and immigrants. Conclusions., Pain is common among outpatients with both terminal and end-stage chronic illness. There do not appear to be any differences in pain with regard to country of origin, but patients of color report more pain than white patients. Patients of all ethnicities are inadequately treated for their pain, and further study is warranted to explore the relative patient and physician contributions to the finding of unequal symptom burden and inadequate treatment effort. [source] An open-label, phase 2 trial of denosumab in the treatment of relapsed or plateau-phase multiple myeloma,,AMERICAN JOURNAL OF HEMATOLOGY, Issue 10 2009Ravi Vij RANKL is a key mediator of osteoclast differentiation, activation, and survival. Preclinical data suggest that aberrant production and activation of osteoclasts may influence proliferation of multiple myeloma (MM) cells in the bone marrow. Reports have also shown that inhibiting RANKL may have a direct effect on RANK-expressing myeloma cells and a therapeutic role in treating the disease. In mouse myeloma models, inhibition of RANKL led to reduced serum paraprotein levels and tumor burden. Based on this hypothesis, this proof-of-concept, single-arm study investigated whether RANKL inhibition with denosumab could reduce serum M-protein levels in relapsed or plateau-phase myeloma subjects. All subjects received denosumab monthly, with loading doses on days 8 and 15 of month one, until disease progression or subject discontinuation. Results of this ongoing study demonstrated that no subjects in either cohort met the protocol-defined objective response criteria of complete response (CR) or partial response (PR), but that denosumab effectively inhibited the RANKL pathway regardless of previous exposure to bisphosphonates, as evidenced by suppressed levels of the bone turnover marker, serum C-terminal telopeptide of type 1 collagen (sCTx). Eleven (21%) subjects who relapsed within 3 months before study entry maintained stable disease for up to 16.5 months. Nineteen (46%) subjects with plateau-phase myeloma maintained stable disease for up to 18.3 months. The adverse event (AE) profile for denosumab and its dosing schedule in these populations was consistent with that for advanced cancer patients receiving systemic therapy. Additional controlled clinical studies of denosumab in subjects with both relapsed and plateau-phase MM are warranted. Am. J. Hematol. 2009. © 2009 Wiley-Liss, Inc. [source] Early treatment with l -thyroxine in children and adolescents with type 1 diabetes, positive thyroid antibodies, and thyroid gland enlargementPEDIATRIC DIABETES, Issue 4 2007Olga Kordonouri Aim:, To investigate whether early treatment with l -thyroxine may prevent deterioration of thyromegaly and progression to subclinical or clinical hypothyroidism in pediatric patients with type 1 diabetes, positive thyroid antibodies, and ultrasound abnormalities of the thyroid gland. Methods:, The development of thyroid gland volume and function in patients without l -thyroxine treatment (group A, n = 8) was assessed and compared with that in patients receiving l -thyroxine treatment (group B, n = 7) with median follow-up time of 2.0 yr (range 0.6,3.0 yr). Standard deviation score (SDS) of thyroid gland volume was calculated according to gender- and age-corresponding data. Results:, Median thyroid gland volume SDS at study entry was 4.8 (range 2.0-15.3) in group A and 5.6 (3.6,13.9) in group B. At follow-up, median thyroid volume SDS has increased by 0.8 (,3.9 to 6.0) at 1 yr and by 2.0 (,4.5 to 10.9) at 2 yr in group A but decreased significantly by ,3.4 (,10.0 to 0.4) and ,5.3 (,12.3 to ,1.7) in group B, respectively. The change of thyroid gland volume was significantly different between the two groups (p = .043 and .032, respectively). In group A, three of eight patients without therapy developed subclinical hypothyroidism with thyroid-stimulating hormone elevation. Conclusion:, These data demonstrate that treatment with l -thyroxine in patients with diabetes, positive thyroid antibodies, and elevated gland volume leads to a significant reduction of thyromegaly. Prospective randomized clinical trials are required to prove these preliminary findings. [source] Healthcare resource utilization during 1-year treatment with long-acting, injectable risperidone,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 11 2004A. Leal Abstract Background Schizophrenia is associated with disproportionately high costs, mainly due to hospitalization rates. This study assessed healthcare resource use in patients with schizophrenia and schizoaffective disorder during treatment with long-acting risperidone. Methods Patients (n,=,397 [inpatients, 24%; outpatients, 76%]) receiving stable doses of an antipsychotic for ,4 weeks were eligible to enter this 1-year, open-label study. Following a 2-week run-in period (oral risperidone 1,6 mg/day), patients received intramuscular long-acting risperidone (25 or 50 mg modal dose) every 2 weeks. Healthcare resource use in the previous 12 weeks was assessed at baseline and 12-weekly intervals. Results Patients needing hospitalization decreased significantly and continuously from 38% during the 12 weeks before study entry to 12% during the last 12 weeks. Mean hospitalization length during the study was 30.5 days (outpatients, 4.9 days; inpatients, 110 days). This included 28 patients (7%) who remained in hospital throughout the study. During treatment, 71% of those hospitalized at baseline were discharged. Partial hospitalization decreased significantly from 7% of patients during the 12 weeks before treatment to 3% during the last 12 weeks. Outpatient consultations also decreased significantly from 70% of patients to 30% in the first 12 weeks of treatment and remained stable thereafter. Only 9% of patients required an emergency room visit; mostly for non-psychiatric conditions. Conclusion Healthcare resource use is significantly reduced in patients with stable schizophrenia or schizoaffective disorder receiving long-acting risperidone. It is highly likely that these reductions will decrease healthcare costs in patients receiving long-acting risperidone. Copyright © 2004 John Wiley & Sons, Ltd. [source] Pharmacokinetics and efficacy of a direct switch from conventional depot to risperidone long-acting injection in Chinese patients with schizophrenic and schizoaffective disordersPSYCHIATRY AND CLINICAL NEUROSCIENCES, Issue 4 2009Ying-Ching Lai md Aims:, This 12-week open-label study was designed to investigate the pharmacokinetics and efficacy of a direct switch from a conventional depot to long-acting injectable risperidone in patients with schizophrenia and schizoaffective disorder. Methods:, Men or women from 18 to 65 years old with a diagnosis of schizophrenia or schizoaffective disorder were eligible for participation if they had been treated with conventional depot for at least 8 weeks before study entry. Intramuscular long-acting risperidone was administered starting from 25 mg, with the dose flexibly adjusted every two weeks for 12 weeks from week 4. Results:, Of the 25 patients enrolled in this study, 21 completed at least one post-baseline assessment and were thus included in the analysis. The mean serum concentration of risperidone plus 9-hydroxyrisperidone was 29.1 ng/mL at the 12th week after switching, with an average injection dose of 31.25 mg long-acting risperidone every two weeks. The levels of active moiety of risperidone seemed to be higher in Chinese patients compared to those in Caucasian patients. Positive and Negative Syndrome Scale total scores (from 67.5 to 56.4; P = 0.002), scores for negative symptoms (P = 0.006) and general symptoms (P = 0.001) were improved significantly 12 weeks after the switch. Mean Extrapyramidal Symptom Rating Scale scores were improved significantly from 20.1 to 5.5 (P < 0.001). Significantly decreased levels of cholesterol and triglyceride were found at the 12th week. The levels of fasting glucose, low-density lipoprotein, high-density lipoprotein and bodyweight remained unchanged. Conclusions:, These findings suggest that switching from conventional depot to long-acting risperidone is feasible with the advantage of symptom reduction and side-effect profile decrement. [source] Evaluation of the Fertility and Cancer Project (FCP) among young breast cancer survivorsPSYCHO-ONCOLOGY, Issue 10 2010Karen Meneses Abstract Objective: Fertility and childbearing issues are the major quality of life concerns among young breast cancer survivors. Practical approaches are needed to convey reproductive health information. The Fertility and Cancer Project (FCP) is a dedicated research project that provides online reproductive health and fertility education. We report FCP participants' (a) changes in mood and functioning and (b) changes in knowledge of fertility and cancer from baseline to 6-month follow-up. Methods: Participants completed five self-report baseline measures, accessed FCP content and participated in online discussions. At 6 months post FCP study entry, participants were asked to complete follow-up self-reports. Results: One hundred and six breast cancer survivors from 8 countries participated in the FCP. Mean age at diagnosis was 34.3 years; mean time since diagnosis was 22 months. Significant change was detected in improved physical functioning (p=0.019) and social functioning (p=0.02). Significant changes were also noted in improved fertility knowledge (p=0.011). Conclusion: Preliminary evidence shows that young breast cancer survivors derive improved mood and knowledge benefit from FCP participation. Internet-based approach may be a viable format for engaging this population of cancer survivors. Copyright © 2009 John Wiley & Sons, Ltd. [source] Smoking behavior of 226 patients with diagnosis of stage IIIA/IIIB non-small cell lung cancerPSYCHO-ONCOLOGY, Issue 6 2002Lisa Sanderson Cox There is limited research of smoking cessation following diagnosis of lung cancer. This prospective study assessed cigarette smoking behavior among 226 patients (142 males, 84 females) prior to, at the time of, and after the diagnosis of unresectable stage IIIA/IIIB non-small cell lung cancer and entry into a phase III trial examining combined thoracic radiation therapy and chemotherapy. Their mean ±S.D. age was 62.7±9.4 years and 95.6% were Caucasian. Of 215 patients with a history of cigarette smoking, 69% (148/215) stopped smoking prior to entry in the trial, 9% (20/215) stopped smoking at some point during the course of the trial, 11% (24/215) continued smoking throughout the trial, 7% (16/215) were smoking at baseline but did not report subsequent smoking status, and smoking status at study entry was missing for the remaining patients. The majority of lung cancer patients were able to stop smoking. A notable subset of patients continued smoking despite diagnosis of lung cancer, enrollment in a clinical trial, treatment-related toxicity, and encouragement from clinicians to stop smoking. Smoking cessation interventions are needed for lung cancer patients who continue to smoke. Copyright © 2002 John Wiley & Sons, Ltd. [source] ORIGINAL ARTICLE: Safety Analysis of the Diaphragm in Combination with Lubricant or Acidifying Microbicide Gels: Effects on Markers of Inflammation and Innate Immunity in Cervicovaginal FluidAMERICAN JOURNAL OF REPRODUCTIVE IMMUNOLOGY, Issue 2 2009Deborah J. Anderson Objective, Diaphragms are being considered for use with vaginal microbicide gels to provide enhanced protection against sexually transmitted pathogens. The purpose of this study was to determine whether use of a diaphragm with microbicide or placebo gel causes cervicovaginal inflammation or perturbations in cervicovaginal immune defense. Method of study, Eighty-one non-pregnant women were randomized into three groups and instructed to use Milex® (CooperSurgical, Inc., Trumbull, CT, USA)diaphragms overnight for 14 days in combination with one of the two acid-buffering microbicide gels [ACIDFORMÔ (Instead Inc., La Jolla, CA, USA) or BufferGelÔ (BG; ReProtect Inc., Baltimore, Maryland)] or placebo gel (K-Y Jelly®; Personal Products Inc., Raritan, NJ, USA). Cervicovaginal lavages (CVLs) were performed prior to study entry and on days 8 and 16. Nine soluble mediators of vaginal inflammation or immune defense were measured in CVLs by Bio-Plex or ELISA. Results, Use of diaphragms with placebo or microbicide gel was not associated with increased levels of inflammation markers. Concentrations of secretory leukocyte protease inhibitor (SLPI) were markedly reduced in the BG group. Conclusion, Daily use of a diaphragm with placebo or acidifying microbicide gel did not cause cervicovaginal inflammation. However, diaphragm/BG use was associated with markedly reduced levels of SLPI, an important mediator of innate immune defense. Further studies are warranted to establish the safety of diaphragm/microbicide gel combinations. [source] Risk factors and impact of recurrent lupus nephritis in patients with systemic lupus erythematosus undergoing renal transplantation: Data from a single US institutionARTHRITIS & RHEUMATISM, Issue 9 2009Paula I. Burgos Objective To determine the risk factors for recurrent lupus nephritis, allograft loss, and survival among patients with systemic lupus erythematosus (SLE) undergoing kidney transplantation. Methods The archival records of all kidney transplant recipients with a prior diagnosis of SLE (according to the American College of Rheumatology criteria) from June 1977 to June 2007 were reviewed. Patients who had died or lost the allograft within 90 days of engraftment were excluded. Time-to-event data were examined by univariable and multivariable Cox proportional hazards regression analyses. Results Two hundred twenty of nearly 7,000 renal transplantations were performed in 202 SLE patients during the 30-year interval. Of the 177 patients who met the criteria for study entry, the majority were women (80%) and African American (65%), the mean age was 35.6 years, and the mean disease duration was 11.2 years. Recurrent lupus nephritis was noted in 20 patients (11%), allograft loss in 69 patients (39%), and death in 36 patients (20%). African American ethnicity was found to be associated with a shorter time-to-event for recurrent lupus nephritis (hazard ratio [HR] 4.63, 95% confidence interval [95% CI] 1.29,16.65) and death (HR 2.47, 95% CI 0.91,6.71), although, with the latter, the association was not statistically significant. Recurrent lupus nephritis and chronic rejection of the kidney transplant were found to be risk factors for allograft loss (HR 2.48, 95% CI 1.09,5.60 and HR 2.72, 95% CI 1.55,4.78, respectively). In patients with recurrent lupus nephritis, the lesion in the engrafted kidney was predominantly mesangial, compared with a predominance of proliferative or membranous lesions in the native kidneys. Conclusion African American ethnicity was independently associated with recurrent lupus nephritis. Allograft loss was associated with chronic transplant rejection and recurrence of lupus nephritis. Recurrent lupus nephritis is infrequent and relatively benign, without influence on a patient's survival. [source] | |||||||||||||||||||||||||||||||