Gatto NM, et al. - This follow up study was intended to assess if patients treated with Exubera (EXU; insulin human [rDNA origin], inhaled powder) in controlled clinical trials died due to incident primary lung cancer at a substantially higher rate vs patients treated with one of the other tested agents. This was a hybrid, randomized, controlled trial/cohort study involving candidates of 17 prior EXU clinical trials. Data revealed that the incidence density ratio was 2.8 for lung cancer-related mortality and 3.7 for incident primary lung cancer and the hazard ratio for all-cause mortality was 0.81. A greater risk of EXU-related lung cancer mortality cannot be excluded from these data. There was a minor absolute increase in risk of mortality related to lung cancer, if the risk is accurate. For all-cause mortality—the most reliably measured endpoint with the clearest interpretation—EXU users did not experience excess all-cause death rates (relative or absolute) over the study period vs users of other diabetes treatments.