Background & Aims
The drug-induced liver injury network (DILIN) 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<.001). Azithromycin was the implicated agent in a higher proportion of patients with pre-existing liver disease compared to those without liver disease (6.7% vs. 1.5%, p=0.006). Forty-one cases with latency ≤ 7 days were caused predominantly by antimicrobial agents (71%). Two most common causes for 60 DILI cases with latency >365 days were nitrofurantoin (25%) or minocycline (17%). There were no differences in outcomes of patients with short vs long latency of DILI. Compared to individuals younger than 65 y, individuals 65 y 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.
Conclusion
Mortality from DILI is significantly higher in individuals with pre-existing liver disease or concomitant severe skin reactions compared to patients without. Further 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.
Determination of the restenosis rate after multilesion percutaneous transluminal coronary angioplasty is an important consideration in defining expanded indications for the procedure. Of 209 patients who underwent successful multilesion coronary angioplasty, 55 symptomatic and 74 asymptomatic patients were restudied an average of 7 +/- 4 months after dilation. The restenosis rate was 82% (45 of 55) in the symptomatic patients and 30% (22 of 74) in the asymptomatic patients (p less than 0.001). Only 4% of the asymptomatic patients had restenosis at more than one dilation site. When only patients who developed a restenosis were considered, the restenosis occurred at more than one dilation site in 47% (21 of 45) of the symptomatic group versus 14% (3 of 22) of the asymptomatic group (p less than 0.05). When all recurrent stenoses were examined, the severity of the luminal narrowing was greater than or equal to 70% in 64% (45 of 70) of the stenotic lesions in the symptomatic patients versus 31% (8 of 26) of the stenotic lesions in the asymptomatic patients (p less than 0.05). Proximal left anterior descending coronary artery disease, increased length of the stenotic narrowing, male gender and diabetes were associated with an increased incidence of restenosis by multivariate analysis. Patient-related variables were not predictive of multilesion restenosis. In conclusion, the majority of patients are clinically improved after multilesion coronary angioplasty. Recurrent symptoms after multilesion coronary angioplasty are frequently associated with multilesion restenosis and a more severe degree of restenotic narrowing. Restenosis at more than one dilation site is uncommon in the asymptomatic patient.(ABSTRACT TRUNCATED AT 250 WORDS)
The potential of repeat percutaneous transluminal coronary angioplasty as a mode of therapy for recurrence of stenosis after initially successful angioplasty was examined on the basis of data on all 514 patients with successful angioplasty at Emory University before April 1982. Recurrence was found in 171 (33%) of the 514 patients. Repeat angioplasty was attempted in 95 patients with a significantly higher primary success rate (97 versus 85%, p less than 0.001) and a lower complication rate (8 versus 15%, p less than 0.10) than those of initial angioplasty. Follow-up documentation was available in all 92 patients with successful repeat angioplasty. A second recurrence of stenosis was found in 26% (24 of 92). A third angioplasty was performed in seven patients; six procedures were successful and there have been no recurrences of stenosis. Repeat coronary angioplasty provides a means to treat recurrence of stenosis. It proved to be very successful and safe and yielded good long-term results. It also increased the percent of patients with documented lasting success after angioplasty from 63 to 78%.
Coronary dissection and total coronary occlusion leading to emergency coronary surgery are the most frequent complications of percutaneous transluminal coronary angioplasty (PTCA) and their occurrence usually is unpredictable. To identify angiographic characteristics of coronary stenoses that may affect the incidence of these complications, the diagnostic pre-PTCA coronary angiograms of 38 consecutive patients (group I) undergoing emergency coronary surgery for dissection or occlusion were reviewed and compared with the angiograms of a random sample of 38 patients (stratified for left anterior descending and right coronary arteries) from a group of 1151 who did not need emergency coronary surgery (group II). Stenosis morphology before angioplasty was considered "complicated" if at least one of the following criteria was present: irregular borders, intraluminal lucency, and localization of stenosis in curve or at bifurcation. Baseline characteristics, maximum inflation pressures, types of balloon catheters used, and routinely registered angiographic stenosis properties (severity, length, eccentricity, and calcification) were similar in both groups. Irregular borders before PTCA were present in 22 of 38 patients in group I
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