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Table 1 An overview of efficacy and safety outcome reporting of gout flare prophylaxis and therapy use (with and without renal function stratification)

From: Efficacy and safety of gout flare prophylaxis and therapy use in people with chronic kidney disease: a Gout, Hyperuricemia and Crystal-Associated Disease Network (G-CAN)-initiated literature review

First Author (Year)

(Trial Name)

Study Design

Number of participants by eGFR/CrCl at baseline (mL/min/1.73m2)

Total, n

Primary outcome data reporting

with stratified renal function = Yes

without stratified renal function = No

≥90

60-90

30-60

< 30

Efficacy

Safety

COLCHICINE

AHERN 1987 [9]

RCT (single- centre)

22

22

No

No

BORSTAD 2004 [10]

RCT (single-centre)

14

 

14

No

No

WORTMANN 2010 (FACT, APEX, CONFIRMS) [11]

Three RCTs (post-hoc analyses)

371(F); 541(A); 786(C)

295(F); 154(A); 402(C)

94(F); 154(A); 402(C)

 

760(F); 1072(A); 2269(C)

No

No

PASCART 2016 (GOSPEL 2) [12]

Cross-sectional study (post-hoc analysis)

158

59

45

2

264

No

No

SOLAK 2014 [13]

Case-control

   

1

1

No

No

HUNG 2005 [14]

Retrospective observational (single-centre)

29 (concomitant arm) vs 8 (sequential arm)

37

No

No

KWON 2017 [15]

Retrospective observational (single-centre)

36/188 (colchicine with statin arm) vs 41/486 (colchicine without statin arm)

77

No

No

AKAR 2001 [16]

Case report

   

1

1

No

No

AKDAG 2006 [17]

Case report

   

1

1

No

Yes

ALAYLI 2005 [18]

Case report

  

1

 

1

Yes

Yes

ALTIPARMAK 2002 [19]

Case series

   

1

1

No

No

ALTMAN 2007 [20]

Case report

  

1

 

1

No

Yes

BAKER 2004 [21]

Case report

  

1

 

1

No

No

BONNEL 2002 [22]

Case series

   

1

1

No

Yes

BOOMERSHINE 2002 [23]

Case report

   

1

1

No

No

BOUQUIÉ 2011 [24]

Case report

  

1

 

1

No

Yes

CHENG 2005 [25]

Case series

   

1

1

No

No

CHOI 1999 [26]

Case report

   

1

1

No

No

DIXON 2001 [27]

Case report

  

1

 

1

No

No

ELEFTHERIOU 2008 [28]

Case report

   

1

1

No

Yes

GARROUSTE 2012 [29]

Case report

   

1

1

No

Yes

HSU 2002 [30]

Case report

   

1

1

No

No

HUH 2013 [31]

Case report

  

1

 

1

No

Yes

JUSTINIANO 2007 [32]

Case report

  

1

 

1

No

Yes

KUBLER 2000 [33]

Case report

   

1

1

Yes

Yes

KUNCL 1987 [34]

Case series

12

12

No

No

LAI 2006 [35]

Case report

   

1

1

No

Yes

LEE 1997 [36]

Case report

  

1

 

1

No

Yes

LY 2007 [37]

Audit (single centre)

 

22

22

No

Yes

MARCINIAK 2016 [38]

Case report

  

1

 

1

No

No

MEDANI 2016 [39]

Case series

  

1

1

2

No

Yes

MONTSENY 1996 [40]

Case series

   

4

4

No

No

MORRIS 2003 [41]

Case series

   

1

1

No

No

MULLINS 2011 [42]

Audit (single centre)

4

7

16

10

37

No

No

NASHEL 1982 [43]

Case series

   

2

2

No

No

NEUSS 1986 [44]

Case report

   

1

1

Yes

Yes

ORTEL 1974 [45]

Case report

  

1

 

1

No

No

PATEL 2016 [46]

Case report

  

1

 

1

No

Yes

PETERSEL 2007 [47]

Audit (single centre)

38

38

No

No

RANA 1997 [48]

Case series

  

3

3

No

No

RIEGER 1990 [49]

Case report

   

1

1

No

Yes

RUTKOVE 1996 [50]

Case series

   

4

4

No

No

SU 2015 [51]

Case report

   

1

1

No

No

VAN DER VALDEN 2008 [52]

Case report

   

1

1

No

No

WILBUR 2004 [53]

Case series

  

1

1

2

Yes

Yes

WRIGHT 2017 [54]

Audit

128

128

No

No

YOON 2001 [55]

Case report

  

1

 

1

Yes

Yes

YU 2018 [56]

Audit

9

 

9

No

No

ZAGLER 2009 [57]

Case report

  

1

 

1

No

Yes

IL-1 INHIBITORS

SCHLESINGER 2011 [58]

Phase 2 RCT – an extension of a phase 2 RCT by So et al., 2010

(multi-centre)

95

 

95

No

No

SCHLESINGER 2012

(β-RELIEVED & β-RELIEVED-II) [59]

Two phase 3 RCTs, followed by extension studies for both trials (multi-centre)

 

123

59

 

182

No

No

SO 2007 [60]

Pilot, open-labelled study (single-centre)

2

5

2

1

10

No

No

SO 2010 [61]

Phase 2 RCT (multi-centre)

95

 

95

No

No

SUNKUREDDI 2011 [62]

Post-hoc analyses of the RCTs (β-RELIEVED & β-RELIEVED-II)

ACR abstract

 

188

188

No

No

SUNKUREDDI 2013 [63]

Post-hoc analyses of the RCTs (β-RELIEVED & β-RELIEVED-II)

EULAR abstract

 

65

65

No

No

SUNKUREDDI 2014 [64]

Post-hoc analysis of an RCT (multi-centre)

ACR abstract

  

24

24

No

No

TERKELTAUB 2009 [65]

Crossover trial (multi-centre)

2

 

2

No

No

TERKELTAUB 2012 [66]

Post-hoc analyses of RCTs (PRE-SURGE 1, PRE-SURGE 2 and RE-SURGE)

ACR abstract

 

624

103

 

727

No

No

ADLER 2017 [67]

Case report

   

1

1

Yes

No

AOUBA 2015 [68]

Case series (single-centre)

1

1

1

 

3

Yes

Yes

BARTOV 2013 [69]

Case report

   

1

1

Yes

Yes

CHEN 2010 [70]

Case series (single-centre)

 

2

5

3

10

No

No

DIREZ 2012 [71]

Case report

   

1

1

Yes

Yes

DONMEZ 2014 [72]

Case report

  

1

 

1

No

No

FUNCK-BRENTANO 2011 [73]

Case report

   

1

1

No

No

GHOSH 2013 [74]

Case series (single-centre)

  

5

5

No

No

GRATTON 2009 [75]

Case report

   

1

1

No

No

LOUSTAU 2018 [76]

Case series (multi-centre)

  

6

25

31

Yes

Yes

MAROTTO 2018 [77]

Case report

  

1

 

1

Yes

Yes

MCGONAGLE 2007 [78]

Case report

  

1

 

1

No

No

OTTAVIANI 2013 [79]

Case series (multi-centre)

  

40

40

No

No

PALMA 2016 [80]

Case series (single-centre)

ACR abstract

  

18

 

18

No

No

PEREZ-RUIZ 2013 [81]

Case series (single-centre)

EULAR abstract

2

 

6

 

8

Yes

Yes

SINGH 2009 [82]

Case report

  

1

 

1

No

No

TRAN 2011 [83]

Case series

  

1

 

1

Yes

No

NON-STEROIDAL ANTI-INFLAMMATORY DRUGS

KAHL 1989 [84]

Case series

  

1

1

2

Yes

Yes

MIKHNEVICH 2013 [85]

Case series

82

15

97

No

No

SCHLONDORFF 1993 [86]

Case report

 

1

  

1

Yes

Yes

ZAGLER 2009 [57]

Case report

  

1

 

1

Yes

Yes

GLUCOCORTICOIDS

SUNKUREDDI 2014 [64]

Post-hoc analysis of an RCT (multi-centre)

ACR abstract

  

24

24

No

No

BAJAJ 2004 [87]

Case series (single-centre)

4

2

4

10

No

No

FARGETTI 2012 [88]

Case report

  

1

 

1

No

No

HAUSCH 1991 [89]

Case report

  

1

 

1

No

No

HILL 2008 [90]

Case report

   

1

1

No

No

KARIMZADEH 2009 [91]

Case report

  

1

 

1

No

No

MAEKAWA 2014 [92]

Case report

   

1

1

No

No

RICHETTE 2006 [93]

Case report

   

1

1

No

No

SARMENTO 2009 [94]

Case report

  

1

 

1

No

No

TAUSCHE 2011 [95]

Case report

  

1

 

1

Yes

Yes

UDAYAKUMAR 2010 [96]

Case report

  

1

 

1

No

No

ZAGLER 2009 [57]

Case report

  

1

 

1

Yes

Yes

  1. ACR: American College of Rheumatology; APEX: Allopurinol- and Placebo-Controlled, Efficacy Study of Febuxostat; CONFIRMS: A Phase 3, Randomised, Multicenter, Double-Blind, Allopurinol-Controlled Study Assessing the Efficacy and Safety of Oral Febuxostat in Subjects With Gout; CrCl: creatinine clearance; eGFR: estimated glomerular filtration rate; EULAR: European League Against Rheumatism; FACT: Febuxostat Versus Allopurinol Control Trial in Subjects With Gout; GOSPEL 2: subgroup analysis of GOSPEL (goutte et observation des stratégies de prise en charge en médecine ambulatoire) survey; IL-1: interleukin-1; PRE-SURGE 1: Preventative Study Against Urate-Lowering Drug-Induced Gout Exacerbations 1; PRE-SURGE 2: Preventative Study Against Urate-Lowering Drug-Induced Gout Exacerbations; RCT: randomised controlled trial; RE-SURGE: Review of Safety Using Rilonacept in Preventing Gout Exacerbations; β-RELIEVED & β-RELIEVED-II: two phase three randomised studies (response in acute flare and in prevention of episodes of re-flare in gout)
  2. Rows set in italics include studies described in the supplementary materials
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Arthritis Research & Therapy

ISSN: 1478-6362

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