Patient inclusion criteria

Pharmacogenetics provides a rational framework to minimize the uncertainty in outcome of drug therapy and clinical trials and thereby should significantly reduce the risk of drug toxicity. The reader is referred to the Internet sources in Table 20.1 for more details on pharmacogenetics and drug development. Potential improvements in patient inclusion criteria will be addressed later in this chapter. 

In patients with nonischemic cardiomyopathy, NSVT does not seem to be predictive of SCD. In DEFINITE (28), which used NSVT as part of the selection process, the absolute mortality reduction was 6.2%. In SCD-HeFT (29) where NSVT was not an inclusion criterion, there was a similar reduction in mortality of 7.2%, implying that NSVT does not provide additional risk stratification beyond LVEF and HF class. In the... 

The opposite case, of over-selecting a patient population, has also been seen recently, and with another ERBB 1 inhibitor— the monoclonal antibody cetuximab. Initial studies were conducted in patients whose tumors had immunohistochemical evidence of EGER expression (25). This ultimately led to inclusion of this criterion in the drug label. It was subsequently found that benefit from cetuximab may also occur in the absence of ERBBl expression (26). 

This study involved 75 patients, 36 in the active group and 36 in the placebo group 3 patients were excluded because of insufficient data. The mean age of patients was 25 years. The study was conducted double-blind versus placebo for 2 years. The criterion for inclusion was rhinitis with or without asthma. The efficacy criteria were skin tests, a diary kept daily of symptoms and treatments, the assessment of nasal symptoms only, assessment of rhinitis using a visual analog scale by the patient and by the doctor, and assay of specific IgE and specific IgG4 versus mites. 

The stability identified in these patients was most likely due to excellent collateral circulation in these patients. Patients with excellent collateral circulation were selected through the inclusion criteria of the study. To be eligible for inclusion, patients had to be outside the therapeutic window for tPA, and not eligible for intra-arterial thrombolytic therapy. The other major criterion was that the patient had to have a large diffusion/perfusion mismatch. These two criteria resulted in the selection of patients with relatively... 

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