Clinical outcomes utilizing

Shaw LJ, Berman DS, Maron DJ, et al. Optimal medical therapy with or without percutaneous coronary intervention to reduce ischemic burden results from the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial nuclear substudy. Circulation 2008 Mar 11 117(10) 1283-91. 

Lev MH, Segal AZ, Farkas J, Hossain ST, Putman C, Hunter GJ, Budzik R, Harris GJ, Buonanno FS, Ezzeddine MA, Chang Y, Koroshetz WJ, Gonzalez RG, Schwamm LH. Utility of perfusion-weighted CT imaging in acute middle cerebral artery stroke treated with intra-arterial thrombolysis prediction of final infarct volume and clinical outcome. Stroke 2001 32 2021-2028. 

Table 12.1 summarizes five major types of pharmacoeconomic evaluations cost-consequence, cost-benefit, cost-effectiveness, cost-minimization, and cost-utility (Drummond et al., 1997 Kielhorn and Graf von der Schulenburg, 2000). In a cost-consequence analysis, a comprehensive list of relevant costs and outcomes (consequences) of alternative therapeutic approaches are presented in tabular form. Costs and outcomes are typically organized according to their relationship to cost (direct and indirect), quality of life, patient preferences, and clinical outcomes (see taxonomy below). No attempt is made to combine the costs and outcomes into an economic ratio, and the interpretation of the analysis is left in large part to the reader. 

The value of PET for predicting clinical outcomes is complex, since the relevant end points include LV function, symptoms, reduced hospitalizations, and mortality. The utility of PET for assessing viability will vary for each of these endpoints. Most studies on changes in LV function as related to myocardial viability imaging have been performed in patients with moderately impaired systolic performance without quantifying the size of the viable myocardium or scar. In these studies the positive predictive accuracy decreases significantly in patients with more severe LV dysfunction (LVEF <30-35%) [110]. In patients with severe LV dysfunction, quantification of the amount of viable myocardium as more than 31% of the left ventricle accurately predicts improvement in LVEF after revascularization [111, 112]. 

When several outcomes result from a medical intervention (e.g., the prevention of both death and disability), cost-effectiveness analysis may consider the outcomes together only if a common measure of outcome can be developed. Frequently, analysts combine different categories of clinical outcomes according to their desirability, assigning a weighted utility, or value, to the overall treatment outcome. A utility weight is a measure of the patient s preferences for his or her health state or for the outcome of an intervention. The comparison of costs and utilities sometimes is referred to as cost-utility analysis,... 

Numerous prospective and retrospective clinical studies have evaluated and compared the utility of measurements of cTnl and cTnT for risk stratification or clinical outcomes assessment of patients with ACS with possible myocardial... 

As an example of establishing a concentration-response relationship in Phase 2 studies, Pillai and his colleagues utilized a kinetics of drug action model and simulation to recommend a novel intermittent oral and rv ibandronate regimen for the treatment of osteoporosis. The model characterized the relationship between an ibandronate dose and the change of pCTX, a sensitive biomarker of bone turnover, as a PD response, and adequately described the time-course of pCTX change. In that paper, utility of biomarkers was demonstrated when clinical outcome is slow to come. ° ... 

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