- Hoerger T.J.
- Segel J.E.
- Zhang P.
- Sorensen S.W.
- Hoerger T.J.
- Segel J.E.
- Zhang P.
- Sorensen S.W.
- Sardar P.
- Udell J.A.
- Chatterjee S.
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Literature Search and Data Extraction
Simulation Using the BRAVO Diabetes Model
Model Specification and Regression Methods
γUS denotes the regional multiplier of the United States (the source region of the BRAVO model), and constitutes the baseline hazard of the BRAVO model. The relative bias when applying the BRAVO model on another region is
where γtarget denotes the regional multiplier of the target region.
where EUi, USi, Asiai, othersi denote proportions of study populations in each region for each study cohort, and γEU,γUS,γAsia and γothers are the corresponding regional multipliers. Equation 4 can be further written as
where εBRAVO denotes the error term of the BRAVO model. The term is the predicted hazard from the BRAVO model for cohort i, and hazardit is the observed hazard of the cohort i. Thus Equation 6 can be derived from Equation 5, assuming the hazard ratios were constant over time:
- Knopp R.H.
- d’Emden M.
- Smilde J.G.
- Pocock S.J.
|Trial acronym||Full name||Regions||Sample size||Follow-up years||Reference no.|
|LEADER||The Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results Trial||EU, US, Asia, Others||9340||3.8||21|
|CANVAS||The Canagliflozin Cardiovascular Assessment Study||EU, US, Others||10 142||4||22|
|EMPA-REG OUTCOME||The Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients–Removing Excess Glucose Study||EU, US, Asia, Others||7020||3.1||23|
|TIMI-53||The Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR)–Thrombolysis in Myocardial Infarction 53 trial||EU, US, Asia, Others||16 492||2.1||24|
|ADDITION-Europe||Anglo-Danish-Dutch Study of Intensive Treatment In People with Screen Detected Diabetes in Primary Care||EU||3057||5.3||25|
|ELIXA||The Evaluation of Lixisenatide in Acute Coronary Syndrome Trial||EU, US, Asia, Others||6068||2.1||26|
|PROactive||Prospective Pioglitazone Clinical Trial in Macrovascular Events||EU||5238||2.9||27|
|ROADMAP||Randomized Olmesartan and Diabetes Microalbuminuria Prevention Study||EU||4447||3.2||28|
|CARDS||Collaborative Atorvastatin Diabetes Study||EU||2838||3.9||29|
|Advance||The Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation Trial||EU, US, Asia, Others||11 140||5||30|
|RECORD||Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes||EU||4447||5.5||31|
|ASPEN||The Atorvastatin Study for Prevention of Coronary Heart Disease Endpoints in Non-Insulin-Dependent Diabetes Mellitus||EU, US, Asia, Others||2410||4||32|
|DIABHYCAR||Non-insulin-dependent Diabetes, Hypertension, Microalbuminuria or Proteinuria, Cardiovascular Events, and Ramipril Study||EU, Others||4912||4||33|
|TECOs||Trial Evaluating Cardiovascular Outcomes with Sitagliptin||EU, US, Asia, Others||14 671||3||34|
|FIELD||Fenofibrate Intervention and Event Lowering in Diabetes Study||EU, Others||9795||5||35|
|VADT||Veterans Affairs Diabetes Trial||US||1791||5.6||36|
|ORIGIN||The Outcome Reduction with an Initial Glargine Intervention Trial||EU, US, Others||12 537||6.2||37|
|ACCORD||The Action to Control Cardiovascular Risk in Diabetes Trial||US||10 251||3.5||38|
|Nonfatal MI||Stroke||CHF||Angina||Revascularization||All-cause Mortality|
|United States||1.64 (1.41–1.91)||3.60 (2.94–4.41)|
|Intercept||2.03 (1.70–2.42)||1.28 (1.05–1.55)||0.81 (0.68–0.96)||1.83 (1.60–2.08)|
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Conflict of interest: Hui Shao, Shuang Yang, Vivian Fonseca, Charles Stoecker, and Lizheng Shi have no conflicts of interest directly relevant to the content of this article.
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