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Baseline diabetes as a way to predict CV outcomes in a lipid-modifying trial: a meta-analysis of 330,376 patients from 47 landmark studies.

Hermans MP, Bouenizabila E, Amoussou-Guenou DK, Ahn SA, Rousseau MF - Cardiovasc Diabetol (2015)

Bottom Line: Diabetes is a major cardiovascular risk factor.There were significant linear relationships between diabetes prevalence and both PO and CHD rates (%/year): y = 0.0299*x + 3.12 [PO] (p = 0.0128); and y = 0.0531*x + 1.54 [CHD] (p = 0.0094), baseline diabetes predicting PO rates between 3.12 %/year (no diabetic included) and 6.11 %/year (all patients diabetic); and CHD rates between 1.54 %/year (no diabetic) and 6.85 %/year (all patients diabetic).Absolute and relative CV risk associated with diabetes at inclusion can be readily predicted using linear equations relating diabetes prevalence to primary outcomes or CHD rates.

View Article: PubMed Central - PubMed

Affiliation: Division of Endocrinology & Nutrition, Cliniques universitaires St-Luc and Institut de Recherche Expérimentale et Clinique (IREC), Université catholique de Louvain, Brussels, Belgium. michel.hermans@uclouvain.be.

ABSTRACT

Background: Diabetes is a major cardiovascular risk factor. However, its influence on the rate of occurrence of cardiovascular (CV) events during a clinical trial that included a diabetes subgroup has not yet been quantified.

Aims: To establish equations relating baseline diabetes prevalence and incident CV events, based on comparator arms data of major lipid-modifying trials.

Methods: Meta-analysis of primary outcomes (PO) rates of key prospective trials, for which the baseline proportion of diabetics was reported, including studies having specifically reported CV outcomes within their diabetic subgroups.

Results: 47 studies, representing 330,376 patients (among whom 124,115 diabetics), were analyzed as regards the relationship between CV outcomes rates (including CHD) and the number of diabetics enrolled. Altogether, a total of 18,445 and 16,156 events occurred in the comparator and treatment arms, respectively. There were significant linear relationships between diabetes prevalence and both PO and CHD rates (%/year): y = 0.0299*x + 3.12 [PO] (p = 0.0128); and y = 0.0531*x + 1.54 [CHD] (p = 0.0094), baseline diabetes predicting PO rates between 3.12 %/year (no diabetic included) and 6.11 %/year (all patients diabetic); and CHD rates between 1.54 %/year (no diabetic) and 6.85 %/year (all patients diabetic). The slopes of the equations did not differ according to whether they were derived from primary or secondary prevention trials.

Conclusions: Absolute and relative CV risk associated with diabetes at inclusion can be readily predicted using linear equations relating diabetes prevalence to primary outcomes or CHD rates.

No MeSH data available.


Related in: MedlinePlus

Relationship between proportion of diabetic patients at inclusion (%) and primary outcome rates (%/year; left panels) or total coronary heart disease (CHD) events (%/year; right panels) in comparator arms (upper panels) and in treatment arms (lower panels) of 33 landmark trials that included a substantial minority of diabetics (ranging from 2 % to 44 %), representing a total of 259,151 patients. The graphs are based on data from the following trials: 4S; AFCAPS/TexCAPS; AIM-HIGH; ALERT; ALLHAT-LLT; Alpha-Omega; ASCOT-LLA; AURORA; BIP; CARE; CDP; dal-OUTCOMES; GISSI-Prevenzione; GREACE; HATS; HHS; HPS-MRC/BHF; HPS2-THRIVE; IDEAL; ILLUMINATE; JELIS; LEADER; LIPID; LIPS; MEGA; PERFORM; Post-CABG; PROSPER; SHARP; STABILITY; TNT; VA Cooperative Study; and VA-HIT. The open diamonds represent primary outcome rates and CHD events from the following diabetes substudies: 4S; ASCOT-LLA; AURORA; CARE; GREACE; HHS; HPS-MRC/BHF; TNT; and VA-HIT. See Table 1 for acronyms definition and trials’ references, and Table 2 and Table 4 for primary outcomes classification and description
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Fig1: Relationship between proportion of diabetic patients at inclusion (%) and primary outcome rates (%/year; left panels) or total coronary heart disease (CHD) events (%/year; right panels) in comparator arms (upper panels) and in treatment arms (lower panels) of 33 landmark trials that included a substantial minority of diabetics (ranging from 2 % to 44 %), representing a total of 259,151 patients. The graphs are based on data from the following trials: 4S; AFCAPS/TexCAPS; AIM-HIGH; ALERT; ALLHAT-LLT; Alpha-Omega; ASCOT-LLA; AURORA; BIP; CARE; CDP; dal-OUTCOMES; GISSI-Prevenzione; GREACE; HATS; HHS; HPS-MRC/BHF; HPS2-THRIVE; IDEAL; ILLUMINATE; JELIS; LEADER; LIPID; LIPS; MEGA; PERFORM; Post-CABG; PROSPER; SHARP; STABILITY; TNT; VA Cooperative Study; and VA-HIT. The open diamonds represent primary outcome rates and CHD events from the following diabetes substudies: 4S; ASCOT-LLA; AURORA; CARE; GREACE; HHS; HPS-MRC/BHF; TNT; and VA-HIT. See Table 1 for acronyms definition and trials’ references, and Table 2 and Table 4 for primary outcomes classification and description

Mentions: In addition to PO rates, which include de facto CHD, we also examined CHD rate as a separate outcome [Table 4 and Fig. 1left panels]. Rates of CHD were issued for 21 trials and DSS for comparator and treatment arms, and amounted to [%/year]: 11.1 and 7.2 [4S-DSS]; 1.3 and 0.9 [AFCAPS/TexCAPS]; 1.5 and 1.0 [ASCOT-LLA]; 5.1 and 4.9 [AURORA]; 5.8 and 5.4 [BIP]; 12.0 and 9.3 [CARE-DSS]; 4.9 and 4.5 [CDP (clofibrate)]; 4.9 and 4.1 [CDP (niacin)]; 2.4 and 1.7 [HPS - MRC/BHF]; 2.6 and 2.0 [HPS - MRC/BHF-DSS]; 1.4 and 1.3 [HPS2-THRIVE]; 5.0 and 4.2 [IDEAL]; 2.0 and 2.4 [ILLUMINATE]; 0.8 and 0.6 [JELIS]; 3.1 and 2.5 [LEADER]; 0.5 and 0.3 [MEGA]; 1.0 and 0.9 [SHARP]; 4.3 and 4.0 [STABILITY]; 1.7 and 1.4 [TNT]; 2.6 and 2.1 [TNT-DSS]; and 1.9 and 1.7 [VA Cooperative Study] (Fig. 1; right panels).Fig. 1


Baseline diabetes as a way to predict CV outcomes in a lipid-modifying trial: a meta-analysis of 330,376 patients from 47 landmark studies.

Hermans MP, Bouenizabila E, Amoussou-Guenou DK, Ahn SA, Rousseau MF - Cardiovasc Diabetol (2015)

Relationship between proportion of diabetic patients at inclusion (%) and primary outcome rates (%/year; left panels) or total coronary heart disease (CHD) events (%/year; right panels) in comparator arms (upper panels) and in treatment arms (lower panels) of 33 landmark trials that included a substantial minority of diabetics (ranging from 2 % to 44 %), representing a total of 259,151 patients. The graphs are based on data from the following trials: 4S; AFCAPS/TexCAPS; AIM-HIGH; ALERT; ALLHAT-LLT; Alpha-Omega; ASCOT-LLA; AURORA; BIP; CARE; CDP; dal-OUTCOMES; GISSI-Prevenzione; GREACE; HATS; HHS; HPS-MRC/BHF; HPS2-THRIVE; IDEAL; ILLUMINATE; JELIS; LEADER; LIPID; LIPS; MEGA; PERFORM; Post-CABG; PROSPER; SHARP; STABILITY; TNT; VA Cooperative Study; and VA-HIT. The open diamonds represent primary outcome rates and CHD events from the following diabetes substudies: 4S; ASCOT-LLA; AURORA; CARE; GREACE; HHS; HPS-MRC/BHF; TNT; and VA-HIT. See Table 1 for acronyms definition and trials’ references, and Table 2 and Table 4 for primary outcomes classification and description
© Copyright Policy - open-access
Related In: Results  -  Collection

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getmorefigures.php?uid=PMC4489105&req=5

Fig1: Relationship between proportion of diabetic patients at inclusion (%) and primary outcome rates (%/year; left panels) or total coronary heart disease (CHD) events (%/year; right panels) in comparator arms (upper panels) and in treatment arms (lower panels) of 33 landmark trials that included a substantial minority of diabetics (ranging from 2 % to 44 %), representing a total of 259,151 patients. The graphs are based on data from the following trials: 4S; AFCAPS/TexCAPS; AIM-HIGH; ALERT; ALLHAT-LLT; Alpha-Omega; ASCOT-LLA; AURORA; BIP; CARE; CDP; dal-OUTCOMES; GISSI-Prevenzione; GREACE; HATS; HHS; HPS-MRC/BHF; HPS2-THRIVE; IDEAL; ILLUMINATE; JELIS; LEADER; LIPID; LIPS; MEGA; PERFORM; Post-CABG; PROSPER; SHARP; STABILITY; TNT; VA Cooperative Study; and VA-HIT. The open diamonds represent primary outcome rates and CHD events from the following diabetes substudies: 4S; ASCOT-LLA; AURORA; CARE; GREACE; HHS; HPS-MRC/BHF; TNT; and VA-HIT. See Table 1 for acronyms definition and trials’ references, and Table 2 and Table 4 for primary outcomes classification and description
Mentions: In addition to PO rates, which include de facto CHD, we also examined CHD rate as a separate outcome [Table 4 and Fig. 1left panels]. Rates of CHD were issued for 21 trials and DSS for comparator and treatment arms, and amounted to [%/year]: 11.1 and 7.2 [4S-DSS]; 1.3 and 0.9 [AFCAPS/TexCAPS]; 1.5 and 1.0 [ASCOT-LLA]; 5.1 and 4.9 [AURORA]; 5.8 and 5.4 [BIP]; 12.0 and 9.3 [CARE-DSS]; 4.9 and 4.5 [CDP (clofibrate)]; 4.9 and 4.1 [CDP (niacin)]; 2.4 and 1.7 [HPS - MRC/BHF]; 2.6 and 2.0 [HPS - MRC/BHF-DSS]; 1.4 and 1.3 [HPS2-THRIVE]; 5.0 and 4.2 [IDEAL]; 2.0 and 2.4 [ILLUMINATE]; 0.8 and 0.6 [JELIS]; 3.1 and 2.5 [LEADER]; 0.5 and 0.3 [MEGA]; 1.0 and 0.9 [SHARP]; 4.3 and 4.0 [STABILITY]; 1.7 and 1.4 [TNT]; 2.6 and 2.1 [TNT-DSS]; and 1.9 and 1.7 [VA Cooperative Study] (Fig. 1; right panels).Fig. 1

Bottom Line: Diabetes is a major cardiovascular risk factor.There were significant linear relationships between diabetes prevalence and both PO and CHD rates (%/year): y = 0.0299*x + 3.12 [PO] (p = 0.0128); and y = 0.0531*x + 1.54 [CHD] (p = 0.0094), baseline diabetes predicting PO rates between 3.12 %/year (no diabetic included) and 6.11 %/year (all patients diabetic); and CHD rates between 1.54 %/year (no diabetic) and 6.85 %/year (all patients diabetic).Absolute and relative CV risk associated with diabetes at inclusion can be readily predicted using linear equations relating diabetes prevalence to primary outcomes or CHD rates.

View Article: PubMed Central - PubMed

Affiliation: Division of Endocrinology & Nutrition, Cliniques universitaires St-Luc and Institut de Recherche Expérimentale et Clinique (IREC), Université catholique de Louvain, Brussels, Belgium. michel.hermans@uclouvain.be.

ABSTRACT

Background: Diabetes is a major cardiovascular risk factor. However, its influence on the rate of occurrence of cardiovascular (CV) events during a clinical trial that included a diabetes subgroup has not yet been quantified.

Aims: To establish equations relating baseline diabetes prevalence and incident CV events, based on comparator arms data of major lipid-modifying trials.

Methods: Meta-analysis of primary outcomes (PO) rates of key prospective trials, for which the baseline proportion of diabetics was reported, including studies having specifically reported CV outcomes within their diabetic subgroups.

Results: 47 studies, representing 330,376 patients (among whom 124,115 diabetics), were analyzed as regards the relationship between CV outcomes rates (including CHD) and the number of diabetics enrolled. Altogether, a total of 18,445 and 16,156 events occurred in the comparator and treatment arms, respectively. There were significant linear relationships between diabetes prevalence and both PO and CHD rates (%/year): y = 0.0299*x + 3.12 [PO] (p = 0.0128); and y = 0.0531*x + 1.54 [CHD] (p = 0.0094), baseline diabetes predicting PO rates between 3.12 %/year (no diabetic included) and 6.11 %/year (all patients diabetic); and CHD rates between 1.54 %/year (no diabetic) and 6.85 %/year (all patients diabetic). The slopes of the equations did not differ according to whether they were derived from primary or secondary prevention trials.

Conclusions: Absolute and relative CV risk associated with diabetes at inclusion can be readily predicted using linear equations relating diabetes prevalence to primary outcomes or CHD rates.

No MeSH data available.


Related in: MedlinePlus