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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