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Table 3 Study design of economic evaluations on ACEIs and ARBs

From: Economic evaluations of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers in type 2 diabetic nephropathy: a systematic review

Study, country/region Source of effectiveness data Intervention group Control group Decision model type Time horizon (years) Evaluation type
ACEIs       
Golan et al. 1999 US [33] UERNN, LEAPP and EADN trial ‘Treat all’ strategya (1) Screen for MiAb; Markov model with 5 states 10 CEA & CUA (Life-years & QALYs)
(2) Screen for gross proteinuriac.
Sakthong et al. 2001 Thailand [34] LEAN trial and the opinion of nephrologists Enalapril at the dose of 10 mg/day Placebo Markov model with 4 stages 25 CEA (Life years)
Rosen et al. 2005 US [35] UERNN, EADN, LEAN, H-MH studies and HOPE trial Medicare first-dollar coverage of ACEIs Year 2005’s Medicare practice Markov model adding a cardiovascular events component. lifetime CEA & CUA (Life-years & QALYs)
Campbell et al. 2007 US [36] UERNN, EADN, H-MH studies and IRMA-2 trial ACEI therapy in normoalbuminimuric, microalbuminuric, and macroalbuminuric patients No ACEI initiation in patients Markov model 8 CEA (CVD event avoided, life saved, dialysis prevented, composite endpoint avoided)
Adarkwah et al. 2010 Germany [37] EADN and two meta-analyses ‘Treat all’ strategya (1) Screen for MiAb; Markov model with 5 states 50 CUA (QALY)
(2) Screen for MaAc;
(3) no-screening and no-treatment alternative.
Adarkwah et al. 2011 Netherlands [38] EADN and two meta-analyses ‘Treat all’ strategya (1) Screen for MiAb; Markov model with 5 states 50 CUA (QALY)
(2) Screen for MaAc.
ARBs       
Losartan       
Herman et al. 2003 US [39] RENAAL trial Losartan Placebod A regression-based method 3.5 / 4 CEA (Number of ESRD days)
Souchet et al. 2003 France [40] RENAAL trial Losartan (initial daily dosing of losartan was 50 mg, with the possibility of titration to 100 mg/day) Placebod A regression-based method 3.5 / 4 CEA (Number of ESRD days)
Burgess et al. 2004 Canada [41] RENAAL trial Losartan Placebod A regression-based method 3.5 / 4 CEA (Number of ESRD days)
Szucs et al. 2004 Switzerland [42] RENAAL trial Losartan (initial daily dosing of losartan was 50 mg, with the possibility of titration to 100 mg/day) Placebod A regression-based method 3.5 / 4 CEA (Number of ESRD days)
Seng et al. 2005 Hong Kong [32] (only data of Hong Kong were included) RENAAL trial Losartan Placebod A regression-based method 3.5 CEA (Number of ESRD days)
Arredondo et al. 2005 Mexico [43]] RENAAL trial Losartan Placebod A variation of the cumulative incidence competing risk method / Weibull model 25 (life time) CEA (Cumulative incidence of ESRD, life expectancy)
Vora et al. 2005 UK [44] RENAAL trial Losartan (50–100 mg QD) Conventional antihypertensive treatmentd (excluding ACEIs or angiotensin II antagonists) Weibull model life time CEA (Cumulative incidence of ESRD, life expectancy)
Carides et al. 2006 US [45] RENAAL trial Losartan Placebod A cumulative incidence competing risk method / Weibull model 25 (life time) CEA (Cumulative incidence of ESRD, life expectancy)
Stafylas et al. 2007 Greece [46] RENAAL trial Losartan (50–100 mg QD) Placebod Markov model with 6 states 3.5/4 CEA (Number of ESRD days)
de Portu et al. 2011 Italy, France, Germany, Switzerland, US [47] RENAAL trial Losartan Standard cared Standard methods by comparing the economic outcomes deriving from additional losartan to standard care vs standard care alone 3.4 CEA (Number of ESRD days)
Irbesartan       
Rodby RA et al. 2003 US [48] IDNT trial Irbesartan titrated from 75 to 300 mg/day (1) ‘Control’d; Markov model with 5 stages 25 CEA (Life expectancy)
(2) Amlodipine titrated from 2.5 to 10 mg/day.
Palmer AJ et al. 2003 Belgium, France [49] IDNT trial Irbesartan titrated from 75 to 300 mg/day (1) ‘Control’d; Markov model with 5 stages 25 CEA (Life expectancy)
(2) Amlodipine titrated from 2.5 to 10 mg/day.
Coyle D et al. 2004 Canada [50] IDNT trial Irbessartan (1) Amlodipine; Markov model with 5 stages 25 CEA (Life expectancy)
(2) Standard cared
Palmer AJ et al. 2004 UK [51] IDNT trial Irbesartan 300 mg per day (1) ‘Control’d; Markov model with 5 stages 25 CEA (Life expectancy)
(2) Amlodipine 10 mg per day.
Palmer AJ et al. 2004 US [52] IRMA-2 study and IDNT ‘Early irbesartan’e (1) ‘Control’d; Markov model with 7 stages 25 CEA (Years free of ESRD, cumulative incidence ESRD, life expectancy)
(2) ‘Late irbesartan’f
Palmer AJ et al. 2005 Spain [53] IRMA-2 study and IDNT ‘Early irbesartan’e Standard antihypertensive medicationsd Markov model with 7 stages 25 CEA (Years free of ESRD, cumulative incidence ESRD, life expectancy)
Palmer AJ et al. 2006 Switzerland [54] IRMA-2 study and IDNT ‘Early irbesartan’e Conventional antihypertensive treatmentd initiated when patients had developed MiA. Markov model with 7 stages 25 CEA (Years free of ESRD, cumulative incidence of ESRD, life expectancy)
Palmer AJ et al. 2006 France [55] IRMA-2 study and IDNT ‘Early irbesartan’e (1) ‘Control’d; Markov model with 7 stages 25 CEA & CUA (Years free of ESRD, life expectancy, QALY)
(2) ‘Late irbesartan’f
Palmer AJ et al. 2007 Hungary [56] IRMA-2 study and IDNT ‘Early irbesartan’e ‘Placebo’d: standard antihypertensive medications initiated when patients developed MiA. Markov model with 7 stages 25 CEA (Years free of ESRD, cumulative incidence ESRD, life expectancy)
Palmer AJ et al. 2007 UK [57] IRMA-2 study and IDNT trial ‘Early irbesartan’e (1) ‘Control’d; Markov model with 7 stages 25 CEA (Years free of ESRD, cumulative Incidence of ESRD, life expectancy)
(2) ‘Late irbesartan’f
Coyle D et al. 2007 Canada [58] IRMA-2 study and IDNT ‘Early irbesartan’e (1) ‘Late irbesartan’f; Markov model with 7 stages 25 CEA (Life expectancy)
(2) ‘Conventional’d
Yang W.C. et al. 2007 Taiwan [59] IRMA-2 study and IDNT ‘Early irbesartan’e (1) ‘Standard’d; Markov model with 7 stages 25 CEA (Life expectancy, number of years free of ESRD, cumulative incidence of ESRD)
(2) ‘Late irbesartan’f;
(3) ‘Late amlodipine’g
Annemans et al. 2008 China, Taiwan, Malaysia, Thailand, South Korea [60] IRMA-2 study and IDNT trial ‘Early irbesartan’e (1) ‘Standard’d; Markov model with 7 stages 25 CEA (Cumulative incidence of ESRD, number of days in dialysis, number of years free of ESRD, life expectancy)
(2) ‘Late irbesartan’f;
(3) ‘Late amlodipine’g
Valsartan       
Smith DG et al. 2004 US [61] MARVAL study Valsartan Amlodipine Markov model with 7 stages 8 CUA (Quality-adjusted survival)
  1. a: no screening was performed at all and patients started on ACEI therapy at the time of diagnosing type 2 diabetes.
  2. b: patients were screened for MiA once a year and ACEI treatment was started if the test result is positive.
  3. c: patients were screened for MaA once a year and ACEI treatment was started if the test result is positive.
  4. d: standard antihypertensive therapy alone, excluding the use of ACEIs, ARBs.
  5. e: standard antihypertensive therapy plus administration of irbesartan 300 mg/d at the onset of MiA.
  6. f: standard antihypertensive therapy plus administration of irbesartan 300 mg/d once the patients reach the advanced diabetic nephropathy stage.
  7. g: standard antihypertensive therapy plus administration of amlodipine titrated from 5 to 10 mg/d once the patients reach the advanced diabetic nephropathy stage.
  8. UERNN = Use of enalapril to attenuate decline in renal function in normotensive, normoalbuminuric patients with type 2 diabetes mellitus; LEAPP = Long-term stabilizing effect of angiotensin-converting enzyme inhibition on plasma creatinine and on proteinuria in normotensive type II diabetic patients; EADN = The effect of angiotensin-converting-enzyme inhibition on diabetic nephropathy; LEAN = Long-term renoprotective effect of angiotensin-converting enzyme inhibition in non-insulin-dependent diabetes mellitus; H-MH = Effects of ramipril on cardiovascular and microvascular outcomes in people with diabetes mellitus: results of the HOPE study and MICRO-HOPE substudy; HOPE = The Heart Outcomes Prevention Evaluation; RENAAL = The reduction of endpoints in non-insulin dependent diabetes mellitus with the angiotensin II antagonist losartan; IDNT = The irbesartan in diabetic nephropathy trial; IMRA-2 = The irbesartan in reduction of microalbuminuria-2; MARVAL = The microalbuminuria reduction with valsartan.
  9. CEA = cost-effectiveness analysis; CUA = cost-utility analysis.