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        Comparative Performance of the Reverse Algorithm Using Architect Syphilis TP Versus the Traditional Algorithm Using Rapid Plasma Reagin in Florida’s Public Health Testing Population

        Yolanda R. Totten,Bonnie M. Hardy,Berry Bennett,Marie-Claire Rowlinson,,Susanne Crowe, 대한진단검사의학회 2019 Annals of Laboratory Medicine Vol.39 No.4

        In Florida, where syphilis is a reportable disease, the number of primary and secondary (P&S) syphilis cases has increased from 3,266 in 2008–2010 to 5,340 in 2013–2015, a 63% increase. The objective of this study was to compare the performance and sensitivity of the syphilis reverse algorithm with the traditional algorithm for detecting P&S (infectious) syphilis cases. Clinical specimens from individuals who self-referred for syphilis testing at public health clinics were processed using the traditional algorithm (non-treponemal rapid plasma reagin (RPR) test followed by a confirmatory treponemal (EIA) test) and then further tested with the Architect Syphilis TP (ASTP) immunoassay (Abbott Diagnostics, Chicago, IL, USA) or by RPR confirmation, if needed (reverse algorithm). Of 1,079 specimens, 59 were positive for syphilis. The sensitivity of the reverse algorithm was 98.3% (58/59) and of the traditional algorithm was 72.9% (43/59). Based on clinical evidence, of the 16 traditional algorithm-negative but reverse algorithm-positive cases, 68.8% (11/16) were classified as missed P&S infections (treatment naïve) and 31.2% (5/16) were classified as missed past syphilis (latent or infections with documented linkage to care). The reverse algorithm enables the detection of additional P&S syphilis cases missed by our current traditional algorithm.

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        Efficacy and safety of empagliflozin in patients with type 2 diabetes from Asian countries: pooled data from four phase III trials

        Yoon, Kun‐,Ho,Nishimura, Rimei,Lee, Jisoo,Crowe, Susanne,Salsali, Afshin,Hach, Thomas,Woerle, Hans J. Blackwell Publishing Ltd 2016 DIABETES OBESITY AND METABOLISM Vol.18 No.10

        <P>We investigated the efficacy and safety of empagliflozin over 24 weeks in Asian patients with type 2 diabetes (T2DM) using pooled data from four phase III trials. In these trials, patients were randomized to receive empagliflozin 10 mg, empagliflozin 25 mg or placebo as monotherapy or add‐on to metformin, metformin plus sulphonylurea or pioglitazone ± metformin. In total, 1326 patients from Asia received ≥1 dose of study drug. At week 24, adjusted mean differences versus placebo in change from baseline in glycated haemoglobin (HbA1c) were −0.66% [95% confidence interval (CI) −0.76, −0.56] and −0.73% (95% CI −0.83, −0.64) and in weight were −1.6 kg (95% CI −1.9, −1.3) and −1.8 kg (95% CI −2.1, −1.5) with empagliflozin 10 and 25 mg, respectively (all p < 0.001). Empagliflozin significantly reduced systolic and diastolic blood pressure. The proportion of patients reporting ≥1 adverse event was similar across treatment groups, but events consistent with genital infection were more common in patients treated with empagliflozin 10 mg (3.4%) or 25 mg (2.3%) than placebo (0.9%). Thus in Asian patients with T2DM, empagliflozin reduced HbA1c, weight and blood pressure, and was well tolerated.</P>

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