Efficacy and safety of caspofungin in obese patients.

ABSTRACT

Safety and efficacy outcomes were retrospectively compared for obese versus non-obese patients who received standard caspofungin doses for different clinical conditions in nine clinical trials within the Merck caspofungin database. Favorable outcomes were as defined in specific protocols. Safety was assessed based on drug-related adverse experiences (AEs). The proportion of obese patients in the esophageal candidiasis and invasive aspergillosis studies was lower than seen in the invasive candidiasis and empirical therapy studies. The proportions of patients with a favorable response were generally similar in non-obese and obese patients with invasive candidiasis (73% versus 77%) or patients receiving empirical therapy (33% versus 40%). The efficacy analysis in patients with invasive aspergillosis or esophageal candidiasis was limited due to the small number of obese patients. The proportion of favorable responses in these two infections was similar among normal/underweight patients as compared to obese/overweight patients, i.e., esophageal candidiasis 81% versus 88% and invasive aspergillosis 48% versus 44%, respectively. AEs related to caspofungin occurred in similar proportions with non-obese and obese patients across all and within the four clinical conditions. The proportion of obese patients with serious drug-related AEs (1%) or caspofungin discontinuations due to toxicity (5%) was low. In the post-hoc analysis, caspofungin appeared to be as efficacious and well-tolerated in obese patients as in non-obese patients.