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Fischer-Betz R.,Heinrich Heine University Dusseldorf | Specker C.,Heinrich Heine University Dusseldorf | Brinks R.,Institute of Biometry and Epidemiology | Aringer M.,TU Dresden | Schneider M.,Heinrich Heine University Dusseldorf
Rheumatology (United Kingdom) | Year: 2013

Objective. MMF is teratogenic and needs to be replaced before pregnancy. This change may lead to flares. Our aim was to determine the risk of renal flares in women with LN who switched treatment from MMF to AZA before conception and to evaluate the outcome of their pregnancies. Methods. Medical records of women with LN counselled for pregnancy wish were reviewed. Women receiving treatment with either MMF or AZA (control group), with inactive lupus (SLEDAI≤44) and quiescent LN (serum creatinine <1.5 mg/dl, inactive sediment and proteinuria <1 g/24 h for the preceding 6 months) were eligible for this study. Results. We identified 54 women [23 treated with MMF (group 1) and 31 treated with AZA (group 2)]. MMF dosage was tapered and subsequently transferred to AZA, which was maintained throughout pregnancy. Three (13%) patients (group 1) vs none (group 2) developed a renal flare 3-6 months after transitioning from MMF to AZA (P = 0.14) before pregnancy ensued. The only parameter with a significant difference in those with flare compared with those without was younger age (median 27 vs 30 years; P = 0.03). Risk for adverse outcome within 48 pregnancies (pre-eclampsia 9%, preterm delivery 20.5%) increased with every milligramme of prednisone dosage [odds ratio (OR) 2.03] and every single unit of SLEDAI score (OR 3.92). Renal flares occurred post-partum in two women. No patient developed worsening of renal function. Conclusion. Replacing MMF with AZA in patients with quiescent LN for pregnancy planning rarely leads to renal flares. Pregnancy outcome was favourable. © The Author 2013. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. Source

Muhlenbruch K.,German Institute of Human Nutrition | Muhlenbruch K.,German Center for Diabetes Research | Ludwig T.,Helmholtz Center Munich | Ludwig T.,German Center for Diabetes Research | And 15 more authors.
Diabetes Research and Clinical Practice | Year: 2014

Aims: Several published diabetes prediction models include information about family history of diabetes. The aim of this study was to extend the previously developed German Diabetes Risk Score (GDRS) with family history of diabetes and to validate the updated GDRS in the Multinational MONItoring of trends and determinants in CArdiovascular Diseases (MONICA)/German Cooperative Health Research in the Region of Augsburg (KORA) study. Methods: We used data from the European Prospective Investigation into Cancer and Nutrition (EPIC)-Potsdam study for extending the GDRS, including 21,846 participants. Within 5 years of follow-up 492 participants developed diabetes. The definition of family history included information about the father, the mother and/or sibling/s. Model extension was evaluated by discrimination and reclassification. We updated the calculation of the score and absolute risks. External validation was performed in the MONICA/KORA study comprising 11,940 participants with 315 incident cases after 5 years of follow-up. Results: The basic ROC-AUC of 0.856 (95%-CI: 0.842-0.870) was improved by 0.007 (0.003-0.011) when parent and sibling history was included in the GDRS. The net reclassification improvement was 0.110 (0.072-0.149), respectively. For the updated score we demonstrated good calibration across all tenths of risk. In MONICA/KORA, the ROC-AUC was 0.837 (0.819-0.855); regarding calibration we saw slight overestimation of absolute risks. Conclusions: Inclusion of the number of diabetes-affected parents and sibling history improved the prediction of type 2 diabetes. Therefore, we updated the GDRS algorithm accordingly. Validation in another German cohort study showed good discrimination and acceptable calibration for the vast majority of individuals. © 2014 Elsevier Ireland Ltd. Source

Schleich C.,Heinrich Heine University Dusseldorf | Buchbender C.,Heinrich Heine University Dusseldorf | Sewerin P.,Heinrich Heine University Dusseldorf | Miese F.,Heinrich Heine University Dusseldorf | And 5 more authors.
Clinical and Experimental Rheumatology | Year: 2015

Objective: The objective of this study was to evaluate a simplified version of the Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) reduced to five joints of the hand (RAMRIS5). Methods: 94 patients with rheumatoid arthritis (62 female; age 59±12 years, range 25-83 years; disease duration 60±90 months (median: 22 months, first quartile: 7 months, third quartile: 66 months) from the REMISSION PLUS study cohort who had complete files on C-reactive protein (CRP) levels and Disease Activity Score of 28 joints (DAS28) and complete MRI of the clinical dominant hand at baseline and after one year under anti-rheumatic therapy (follow-up time 12.5±1.1 months) in a dedicated extremity MRI scanner at 0.2T were included in this retrospective study. Results: There was a strong correlation between RAMRIS5 and the RAMRIS sum-score for all patients (r=0.87, p<0.001) at baseline and follow-up (r=0.87, p<0.001). Among the subscores there was a significant correlation between RAMRIS5 and RAMRIS-MCP (baseline: r=0.66, p<0.001; follow-up: r=0.74, p<0.001) as well as between RAMRIS5 and RAMRIS-wrist (baseline: r=0.72, p<0.001, follow-up: r=0.69, p<0.001) at baseline and follow-up. Conclusion: RAMRIS5, a modified shorter RAMRIS score based on five joints of the hand is a viable tool for semi-quantitative assessment of joint damage in RA. This abbreviated score might reduce the time needed for image analysis in MRI-controlled studies in RA and might facilitate the use of MRI in studies on therapy response assessment in RA. © Clinical and Experimental Rheumatology 2015. Source

Fischer-Betz R.,Heinrich Heine University Dusseldorf | Chehab G.,Heinrich Heine University Dusseldorf | Sander O.,Heinrich Heine University Dusseldorf | Vordenbaumen S.,Heinrich Heine University Dusseldorf | And 3 more authors.
Journal of Rheumatology | Year: 2012

Objective. Intravenous cyclophosphamide (IV CYC) in combination with high doses of cortico - steroids is considered the "gold standard" of therapy for lupus nephritis (LN). However, the optimal dose of corticosteroids needed has not been defined. We evaluated the efficacy of a monotherapy with IV CYC in patients with a first episode of LN (duration ≤ 6 months). Methods. Forty patients with LN received IV CYC (12 pulses). Prednisone alone was administered and dose-adjusted to control extrarenal manifestations. Response after 24 months was defined as normalization of creatinine level, inactive urinary sediment, and proteinuria ≤ 0.2 g/day [complete response (CR)] or ≤ 0.5 g/day [partial response (PR)]. Results. CR was achieved in 25 (62.5%) and PR in 8 (20%) patients. Mean starting dose of prednisone was 23.9 ± 23.8 mg/day. In a posthoc analysis, we separately analyzed patients initially treated with prednisone doses ≥ 20 mg/day (Group A, n = 19) or < 20 mg/day (Group B, n = 21). CR was achieved in 52.6% (Group A) versus 71.4% (Group B; p = 0.37); and PR in 26.3% versus 14.3%, respectively (p = 0.58). During longterm followup (10.4 ± 3.1 yrs), 37.8% experienced a renal flare. Thirty patients (81%) still have normal renal function. Renal outcome was irrespective of initial prednisone doses (p = 0.46, Pearson chi-square test of independence). Conclusion. Our rates of CR and PR and longterm outcomes were comparable with rates after treatment with a combination of IV CYC with high doses of corticosteroids. These data warrant randomized controlled trials evaluating different doses of corticosteroids in LN. The Journal of Rheumatology Copyright © 2012. All rights reserved. Source

Schadewaldt P.,Institute of Clinical Biochemistry and Pathobiochemistry | Schadewaldt P.,Institute For Klinische Biochemie And Pathobiochemie | Nowotny B.,Institute of Clinical Diabetology | Strassburger K.,Institute of Biometry and Epidemiology | And 3 more authors.
American Journal of Clinical Nutrition | Year: 2013

Background: Indirect calorimetry (IC) with metabolic monitors is widely used for noninvasive assessment of energy expenditure and macronutrient oxidation in health and disease. Objective: To overcome deficiencies in validity and reliability of metabolic monitors, we established a procedure that allowed correction for monitor-specific deviations. Design: Randomized comparative IC (canopy mode) with the Deltatrac MBM-100 (Datex) and Vmax Encore 29n (SensorMedix) was performed in postabsorptive (overnight fast >8 h) healthy subjects (n = 40). In vitro validation was performed by simulation of oxygen consumption (VO2) and carbon dioxide output (VCO2) rates by using mass-flow regulators and pure gases. A simulation-based postcalorimetric calibration of cart readouts [individual calibration control evaluation (ICcE)] was established in adults (n = 24). Results: The comparison of carefully calibrated monitors showed marked differences in VCO2 and VO2 (P < 0.01) and derived metabolic variables [resting energy expenditure (REE), respiratory quotient (RQ), glucose/carbohydrate oxidation (Gox), and fat oxidation (Fox); P < 0.001]. Correlations appeared to be acceptable for breath gas rates and REE (R2 ~ 0.9) but were unacceptable for RQ (R2 = 0.3), Gox, and Fox (R2 = 0.2). In vitro simulation experiments showed monitor-dependent interferences for VCO2 and VO2 as follows: 1) within series, nonlinear and variable deviations of monitor readouts at different exchange rates; 2) between series, differences and unsteady variability; and 3) differences in individual monitor characteristics (eg, rate dependence, stability, imprecision). The introduction of the postcalorimetric recalibration by ICcE resulted in an adjustment of gas exchange rates and the derived metabolic variables with reasonable correlations (R2 > 0.9). Conclusions: Differential, metabolic, monitor-specific deviations are the primary determinants for lack of accuracy, comparability, and transferability of results. This problem can be overcome by the present postcalorimetric ICcE procedure. Copyright © 2013 American Society for Nutrition. Source

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