FC 073REGIONAL EFFICACY AND SAFETY RESULTS OF ROXADUSTAT COMPARED WITH PLACEBO OR DARBEPOETIN ALFA IN NON-DIALYSIS-DEPENDENT (NDD) CHRONIC KIDNEY DISEASE (CKD) PATIENTS WITH ANAEMIA

Abstract Background and Aims Roxadustat regulates erythropoiesis and iron metabolism through hypoxia-inducible factor prolyl hydroxylase inhibition. This regional analysis evaluated efficacy and safety for roxadustat versus placebo/darbepoetin alfa (DA) in NDD CKD patients with anaemia. Method Results from three, double-blind phase 3 studies comparing roxadustat to placebo (ALPS, ANDES, OLYMPUS) in patients with anaemia and stage 3-5 NDD CKD were pooled and evaluated alongside results of an open-label study comparing roxadustat to DA (DOLOMITES) in the same population. Efficacy outcomes were compared in three regions (Europe, US, and other) in placebo-controlled studies (PCS) and two regions (Western Europe/Israel and Central/Eastern Europe) in the DA-controlled study (DCS). The primary efficacy endpoint in Europe was haemoglobin (Hb) response, defined as Hb ≥11.0 g/dL that changed from baseline (CFB) by ≥1.0 g/dL in patients with Hb >8.0 g/dL or as CFB ≥2.0 g/dL in patients with Hb ≤8.0 g/dL. The secondary efficacy endpoint was Hb CFB to Weeks 28-36 without rescue therapy (intravenous iron, red blood cell [RBC] transfusion, or erythropoiesis-stimulating agent [ESA] for PCS; RBC transfusion or ESA [roxadustat only] for DCS). Incidence of treatment-emergent adverse events (TEAEs) was summarised descriptively in two regions in PCS (Europe and non-Europe) and two regions in DCS (Western Europe/Israel and Central/Eastern Europe). Results A total of 4886 patients were randomised (2709 roxadustat; 1884 placebo; 293 DA). A significantly greater proportion of patients in all regions who received roxadustat had a Hb response without rescue therapy vs placebo (Europe: 77.9% vs 16.5%, difference of proportion [DOP] 61.4%, 95% CI: 56.5-66.2; US: 75.4% vs 8.3%, DOP 67.2%, 95% CI: 62.7-71.6; and other: 83.4% vs 5.5%, DOP 78.0%, 95% CI: 75.4-80.5) and a numerically greater proportion in both regions vs DA (Western Europe/Israel: 93.9% vs 83.5%, DOP 10.4%, 95% CI: 1.2-19.6; Central/Eastern Europe: 86.5% vs 75.4%, DOP 10.9%, 95% CI: 3.6-18.3). Mean Hb CFB was significantly greater with roxadustat vs placebo in Europe (2.01 vs 0.37 g/dL, LSMD 1.70, 95% CI: 1.55-1.84), US (1.80 vs 0.21 g/dL, LSMD 1.67, 95% CI: 1.53-1.82), and other (1.80 vs 0.06 g/dL, LSMD 1.77, 95% CI: 1.64-1.89) (all P<0.0001) and similar vs DA in Western Europe/Israel (1.64 vs 1.75 g/dL, LSMD -0.03, 95% CI: -0.30 to 0.23, P=0.80) and Central/Eastern Europe (1.94 vs 1.88 g/dL, LSMD 0.03, 95% CI: -0.14 to 0.21, P=0.72). The range in incidence for select TEAEs (arteriovenous fistula thrombosis, deep vein thrombosis, nausea, and seizure) was: 0.3-8.4% for roxadustat and 0.2-4.3% for placebo in Europe; 0.8-10.8% for roxadustat and 0.1-7.0% for placebo in non-Europe; 0-12.1% for roxadustat and 0-11.8% for DA in Western Europe/Israel; 0.4-6.3% for roxadustat and 0-3.4% for DA in Central/Eastern Europe. Conclusion In patients with anaemia and stage 3-5 NDD CKD, roxadustat was more effective than placebo for correcting Hb and generating Hb response without rescue therapy in Europe, the US, and other countries. It was similarly effective as DA for correcting Hb and generating a Hb response without rescue therapy in Western Europe/Israel and Central/Eastern Europe. The incidence of select TEAEs was comparable and relatively low in all regions.

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Coalition Governance in Western Europe

10.1093/oso/9780198868484.003.0001 ◽

2021 ◽

pp. 1-14

Author(s):

Torbjörn Bergman ◽

Bäck Hanna ◽

Hellström Johan

Keyword(s):

Life Cycle ◽

Eastern Europe ◽

Formation Process ◽

Western Europe ◽

Party Systems ◽

Final Phase ◽

Central Eastern Europe ◽

Three Stages ◽

Central Eastern ◽

Western European

This chapter describes the ambitions of the volume. First, we build on the lessons from earlier studies of governments in Western and Central Eastern Europe to deepen our understanding of the coalition life cycle, covering the three stages of a government’s ‘life’, beginning with the formation process, then turning to the governance stage, and lastly turning to the final phase when governments eventually terminate. Second, we seek to capture how recent changes in the Western European party systems, which are also described here, influence the various stages of the coalition life cycle. Third, we are in particular interested in how coalition partners cooperate and make policy once a government has formed, aiming to contribute to the growing literature on the topic of coalition governance. The chapter ends with a description of the content of the volume.

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The Coalition Life-cycle in Central Eastern Europe

Coalition Governance in Central Eastern Europe ◽

10.1093/oso/9780198844372.003.0013 ◽

2019 ◽

pp. 522-576

Author(s):

Torbjörn Bergman ◽

Gabriella Ilonszki ◽

Wolfgang C. Müller

Keyword(s):

Life Cycle ◽

Eastern Europe ◽

Party System ◽

Western Europe ◽

Initial Growth ◽

Central Eastern Europe ◽

Coalition Politics ◽

Central Eastern ◽

Number Of Parties ◽

Electoral Performance

This volume analyses the coalition life-cycle in ten countries in Central Eastern Europe, from pre-electoral alliances to government formation and portfolio distribution, to governing in coalitions, the events that eventually lead to a government termination, and electoral performance of coalition parties. This final chapter summarizes the main patterns of coalition politics and compares among the ten countries. In terms of the three models of coalition governance Hungary comes closest to the Dominant Prime Minister Model, Lithuania and Latvia approach the Ministerial Government Model, and Slovenia comes closest to the Coalition Compromise Model. The chapter also discusses how these findings contrast with the general patterns known from the literature on coalition politics in Western Europe. A few of the patterns of coalition politics are similar, including the relative frequency of different types of coalition governments and the increase and spread of the use of coalition governance mechanisms, such as written coalition contracts. Other features are more distinct: there have been fewer single-party governments and there is a stronger tendency to the Ministerial Government Model than in Western Europe. Over time, processes of learning and adjustment to coalition governance can be identified, however without a linear and general trend. Much of the change is rooted in party system changes, for instance the reversal of the initial growth of new political parties and the recent decline of the effective number of parties (ENP). While a less tangible result, the chapters also stress the role of personalities and animosities to impact coalition considerations.

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Migrant-averse Central-Eastern Europe will lose growth

Emerald Expert Briefings ◽

10.1108/oxan-db238341 ◽

2018 ◽

Keyword(s):

Eastern Europe ◽

Western Europe ◽

Lower Cost ◽

Population Ageing ◽

Content Type ◽

Central Eastern Europe ◽

Labour Costs ◽

Working Age ◽

Producer Prices ◽

Central Eastern

Subject Looming demographic decline in Central-Eastern Europe. Significance The populations of Central-Eastern Europe (CEE) are declining because of emigration and low birth rates, the region’s population being set to fall until 2050 by an average of 0.5% a year. With the working-age population falling even faster, the demographic crisis raises questions about the region’s growth model, which has relied heavily on integrating its pool of lower-cost labour into European supply chains. Impacts Internal imbalances will worsen, with less economically successful regions disproportionately affected, some facing severe depopulation. Population ageing could exacerbate CEE’s turn towards populism, particularly as its pensioners are often among the less well-off. Rising CEE labour costs will push up producer prices in Western Europe, many of whose manufacturers rely on CEE production or suppliers.

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Referenced but Not Linear?

East European Politics and Societies and Cultures ◽

10.1177/0888325416678657 ◽

2016 ◽

Vol 31 (1) ◽

pp. 179-200 ◽

Cited By ~ 1

Author(s):

Kacper Rekawek

Keyword(s):

Eastern Europe ◽

Western Europe ◽

Qualitative Data ◽

Threat Perception ◽

Eastern European ◽

Central Eastern Europe ◽

Central Eastern ◽

The Difference ◽

Copy And Paste ◽

Distinguishing Features

This article contextualizes the seemingly robust Central-Eastern European reactions to terrorist events in Western Europe, whilst examining the difference between how counterterrorism (CT) in Central-Eastern Europe looks in theory and how it works in practice. It constitutes the first comparative study, across eight case studies, focusing solely on CT-related issues of the post-2004 EU entrants, and one of the very first assessing CT developments in post-communist Europe available in English. The article addresses a serious gap in terrorism studies that are oriented towards works on terrorism or CT in Western Europe. It sets out five distinguishing features of CT routines in Central-Eastern Europe and consequently argues that Central-Eastern Europeans “reference” their CT arrangements from Western Europe in a copy and paste manner. Moreover, the Central-Eastern European CT, unlike that of their CT “referees” from Western Europe, is not linear in nature and does not stem from the local threat perception being filtered through CT legacies (developed norms, practices, and routines). By thematically analysing the haphazard manner in which the Central-Eastern Europeans develop their CT legacies, and depicting how eager they are in adopting the Western European rationale for countering a threat that is hardly present in their region, the article provides new empirical basis (derived from qualitative data, including sixty interviews with Central-Eastern European CT experts and officials) for a far-reaching argument about a West-East (old EU–new EU) divide on CT in Europe.

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FP399OBSERVATIONAL STUDY ON THE USE OF DARBEPOETIN ALFA (DA) IN HEMODIALYSIS PATIENTS IN CENTRAL EASTERN EUROPE

Nephrology Dialysis Transplantation ◽

10.1093/ndt/gfv176.23 ◽

2015 ◽

Vol 30 (suppl_3) ◽

pp. iii202-iii203

Author(s):

Tomasz Irzyniec ◽

Alena Parikova ◽

Alexander Selyutin ◽

Botond Csiky ◽

Jaroslav Rosenberger ◽

...

Keyword(s):

Eastern Europe ◽

Darbepoetin Alfa ◽

Hemodialysis Patients ◽

Central Eastern Europe ◽

Central Eastern

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Coalition Governance in Central Eastern Europe

10.1093/oso/9780198844372.001.0001 ◽

2019 ◽

Keyword(s):

Life Cycle ◽

Eastern Europe ◽

Western Europe ◽

Political Transformation ◽

Parliamentary Democracies ◽

Central Eastern Europe ◽

Coalition Politics ◽

Governance Systems ◽

Central Eastern ◽

Electoral Performance

Coalitions among political parties govern most of Europe’s parliamentary democracies. Traditionally, the study of coalition politics has been focused on Western Europe. Coalition governance in Central Eastern Europe brings the study of the full coalition life-cycle to a region that has undergone tremendous political transformation, but which has not been studied from this perspective. The volume covers Bulgaria, Estonia, the Czech Republic, Latvia, Lithuania, Hungary, Poland, Romania, Slovakia, and Slovenia. It provides information and analyses of the cycle, from pre-electoral alliances to coalition formation and portfolio distribution, governing in coalitions, the stages that eventually lead to a government termination, and the electoral performance of coalition parties. In Central Eastern Europe, few single-party cabinets form and there have been only a few early elections. The evidence provided shows that coalition partners in the region write formal agreements (coalition agreements) to an extent that is similar to the patterns that we find in Western Europe, but also that they adhere less closely to these contracts. While the research on Western Europe tends to stress that coalition partners emphasize coalition compromise and mutual supervision, there is more evidence of ‘ministerial government’ by individual ministers and ministries. There are also a few coalition governance systems that are heavily dominated by the prime minister. No previous study has covered the full coalition life-cycle in all of the ten countries with as much detail. Systematic information is presented in 10 figures and in more than one hundred tables.

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