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Background & Aims The Drug-Induced Liver Injury Network is conducting a prospective study of patients with DILI in the United States. We present characteristics and subgroup analyses from the first 1257 patients enrolled in the study. Methods In an observational longitudinal study, we began collecting data on eligible individuals with suspected DILI in 2004, following them for 6 months or longer. Subjects were evaluated systematically for other etiologies, causes, and severity of DILI. Results Among 1257 enrolled subjects with suspected DILI, the causality was assessed in 1091 patients, and 899 were considered to have definite, highly likely, or probable DILI. Ten percent of patients died or underwent liver transplantation, and 17% had chronic liver injury. In the 89 patients (10%) with pre-existing liver disease, DILI appeared to be more severe than in those without (difference not statistically significant; P = .09) and mortality was significantly higher (16% vs 5.2%; P 365 days were nitrofurantoin (25%) or minocycline (17%). There were no differences in outcomes of patients with short vs long latency of DILI. Compared with individuals younger than 65 years, individuals 65 years or older (n = 149) were more likely to have cholestatic injury, although mortality and rate of liver transplantation did not differ. Nine patients (1%) had concomitant severe skin reactions; implicated agents were lamotrigine, azithromycin, carbamazepine, moxifloxacin, cephalexin, diclofenac, and nitrofurantoin. Four of these patients died. Conclusions Mortality from DILI is significantly higher in individuals with pre-existing liver disease or concomitant severe skin reactions compared with patients without. Additional studies are needed to confirm the association between azithromycin and increased DILI in patients with chronic liver disease. Older age and short or long latencies are not associated with DILI mortality.

In the present study, the effects of temporomandibular joint (TMJ) repositioning by use of an acrylic appliance on maximum and submaximum physiologic and performance measures were evaluated in seven male and four female volunteers with documented TMJ malalignment. In an attempt to remove design inadequacies of previous research in this area, a double-blind strategy was utilized. Subjects were randomly assigned to each of four conditions: 1) normal, without a bite splint, 2) with a placebo splint with no occlusal contact so as to maintain normal jaw position, 3) with a splint that optimized jaw position, and 4) with a splint that magnified the subjects normal degree of malocclusion. Measurements were taken of visual reaction time and movement time, muscular strength of the grip, elbow flexors, and leg extensors, submaximal and maximal oxygen uptake, perceived exertion, anaerobic power output, and all-out working capacity in both arm and leg exercise on a cycle ergometer. Analysis of variance for repeated measures indicated that in no instance were the differences in mean scores on physiologic and performance measures with TMJ repositioning or placebo statistically significant when compared with the normal condition. This was the case for the group as a whole or when the five subjects with the greatest TMJ dysfunction were analyzed separately. These findings strongly support the contention that the beneficial effects of short-term TMJ repositioning on exercise performance noted in previous reports may be the result of inadequacies in research design and evaluation rather than the true effects of the bite splint.