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Although a causal relationship cannot be definitively excluded, this imbalance may well be attributed to detection bias due to frequent urinalyses in dapagliflozin-treated patients experiencing urinary tract infections. As a precautionary measure, co-administration of dapagliflozin with pioglitazone is not currently recommended in Europe [European Medicines Agency, 2014a]. Dapagliflozin in special populations Renal impairment Dapagliflozin is not recommended for use in patients with moderate to severe renal impairment [estimated glomerular filtration rate (eGFR) Isotretinoin for dapagliflozin 10 mg) and an imbalance in incidence of bone fractures among the two groups (13 patients treated with dapagliflozin, n = 168 versus zero events in the placebo group, n = 84) after two years of treatment [Kohan et GDC-0068 ic50 al. 2014]. Elderly patients Glycemic efficacy of dapagliflozin in elderly subjects has been explored in a pooled analysis of 12 phase IIb/III studies. The effect of dapagliflozin on HbA1c was slightly attenuated in patients ?65 years of age compared with those INCB28060 nmr amongst elderly subjects, patients with moderate renal impairment or subjects treated with loop diuretics [European Medicines Agency, 2012]. Discontinuation of treatment with dapagliflozin is recommended for patients who develop volume depletion. Are the benefits worth the costs? T2DM is a chronic and costly disease with an increasing prevalence in both developed and developing countries. Therapeutic interventions that delay or prevent the development of its long-term complications could confer substantial cost savings to health systems worldwide, which are forced to allocate limited healthcare resources efficiently and evenly among the population [Oliver et al. 2004]. As a consequence, many countries have adopted the implementation of Health Technology Assessments (HTAs) and economic evaluations in the decision-making process for reimbursement of new health technologies [Oliver et al. 2004; Brennan et al. 2006].