@article{LocatelliSpasovskiDimkovicetal.2014,
  author    = {Locatelli, Francesco and Spasovski, Goce and Dimkovic, Nada and Wanner, Christoph and Dellanna, Frank and Pontoriero, Giuseppe},
  title     = {The effects of colestilan versus placebo and sevelamer in patients with CKD 5D and hyperphosphataemia: a 1-year prospective randomized study},
  series = {Nephrology Dialysis Transplantation},
  volume    = {29},
  journal   = {Nephrology Dialysis Transplantation},
  number    = {5},
  doi       = {10.1093/ndt/gft476},
  url       = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-121114},
  pages     = {1061-73},
  year      = {2014},
  abstract  = {BACKGROUND: This study compared the effects of short-term titrated colestilan (a novel non-absorbable, non-calcium, phosphate binder) with placebo, and evaluated the safety and efficacy of colestilan over 1 year compared with sevelamer, in patients with chronic kidney disease (CKD) 5D. METHODS: This prospective multicentre study comprised a 4-week phosphate binder washout period, a 16-week short-term, flexible-dose, treatment period (including a 4-week placebo-controlled withdrawal period) and a 40-week extension treatment phase. RESULTS: At Week 16 (the end of the 4-week placebo-controlled withdrawal period), serum phosphorus level was 0.43 mmol/L (1.32 mg/dL) lower with colestilan than placebo (P < 0.001; primary end point). Serum LDL-C level was also lower with colestilan than with placebo (P < 0.001). Both colestilan and sevelamer produced significant reductions from baseline in serum phosphorus levels (P < 0.001), maintained for 1 year, and the proportion of patients achieving target levels of ≤1.78 mmol/L (5.5 mg/dL) or ≤1.95 mmol/L (6.0 mg/dL) at study end were similar (65.3 and 73.3\%, respectively, for colestilan, and 66.9 and 77.4\%, respectively, for sevelamer). Serum calcium level remained stable in the colestilan group but tended to increase slightly in the sevelamer group (end-of-study increase of 0.035 mmol/L over baseline). Both binders produced similar reductions from baseline in LDL-C level (P < 0.001), and responder rates after 1 year, using a target of <1.83 mmol/L (70 mg/dL) or <2.59 mmol/L (100 mg/dL) were similar in both groups (50.7 and 85.3\% for colestilan and 54.0 and 80.6\% for sevelamer). Colestilan was generally well tolerated. CONCLUSIONS: Colestilan is effective and safe for the treatment of hyperphosphataemia in patients with CKD 5D, and affords similar long-term phosphorus and cholesterol reductions/responder rates to sevelamer.},
  language  = {en}
}
@article{ZinmanInzucchiLachinetal.2014,
  author    = {Zinman, Bernard and Inzucchi, Silvio E. and Lachin, John M. and Wanner, Christoph and Ferrari, Roberto and Fitchett, David and Bluhmki, Erich and Hantel, Stefan and Kempthorne-Rawson, Joan and Newman, Jennifer and Johansen, Odd Erik and Woerle, Hans-Juergen and Broedl, Uli C.},
  title     = {Rationale, design, and baseline characteristics of a randomized, placebo-controlled cardiovascular outcome trial of empagliflozin (EMPA-REG OUTCOME (TM))},
  series = {Cardiovascular Diabetology},
  volume    = {13},
  journal   = {Cardiovascular Diabetology},
  number    = {102},
  issn      = {1475-2840},
  doi       = {10.1186/1475-2840-13-102},
  url       = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-116036},
  year      = {2014},
  abstract  = {Background: Evidence concerning the importance of glucose lowering in the prevention of cardiovascular (CV) outcomes remains controversial. Given the multi-faceted pathogenesis of atherosclerosis in diabetes, it is likely that any intervention to mitigate this risk must address CV risk factors beyond glycemia alone. The SGLT-2 inhibitor empagliflozin improves glucose control, body weight and blood pressure when used as monotherapy or add-on to other antihyperglycemic agents in patients with type 2 diabetes. The aim of the ongoing EMPA-REG OUTCOME (TM) trial is to determine the long-term CV safety of empagliflozin, as well as investigating potential benefits on macro-/microvascular outcomes. Methods: Patients who were drug naive (HbA(1c) >= 7.0\% and <= 9.0\%), or on background glucose-lowering therapy (HbA(1c) >= 7.0\% and <= 10.0\%), and were at high risk of CV events, were randomized (1:1:1) and treated with empagliflozin 10 mg, empagliflozin 25 mg, or placebo (double blind, double dummy) superimposed upon the standard of care. The primary outcome is time to first occurrence of CV death, non-fatal myocardial infarction, or non-fatal stroke. CV events will be prospectively adjudicated by an independent Clinical Events Committee. The trial will continue until >= 691 confirmed primary outcome events have occurred, providing a power of 90\% to yield an upper limit of the adjusted 95\% CI for a hazard ratio of <1.3 with a one-sided a of 0.025, assuming equal risks between placebo and empagliflozin (both doses pooled). Hierarchical testing for superiority will follow for the primary outcome and key secondary outcomes (time to first occurrence of CV death, non-fatal myocardial infarction, non-fatal stroke or hospitalization for unstable angina pectoris) where non-inferiority is achieved. Results: Between Sept 2010 and April 2013, 592 clinical sites randomized and treated 7034 patients (41\% from Europe, 20\% from North America, and 19\% from Asia). At baseline, the mean age was 63 +/- 9 years, BMI 30.6 +/- 5.3 kg/m(2), HbA1c 8.1 +/- 0.8\%, and eGFR 74 +/- 21 ml/min/1.73 m(2). The study is expected to report in 2015. Discussion: EMPA REG OUTCOME (TM) will determine the CV safety of empagliflozin in a cohort of patients with type 2 diabetes and high CV risk, with the potential to show cardioprotection.},
  language  = {en}
}