Causality Assessment of Cutaneous Adverse Drug Reactions

Son, Young-Min; Lee, Jong-Rok; Roh, Joo‐Young

doi:10.5021/ad.2011.23.4.432

Cited by 18 publications

(19 citation statements)

References 18 publications

(28 reference statements)

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“…The Korean algorithm consists of 8 questions on adverse drug reactions, with scores of 9 or higher being "certain" for a reaction, 6 to 8 "probable/likely," and 3 to 5 "possible." 12 Seven of 8 patients in our study had "certain" reactions (all 7 had scores of 9), and 1 patient had a "probable/likely" reaction (score of 6).…”

Section: Figurementioning

confidence: 99%

“…Unfortunately, we found no comparative data in the medical literature. To provide an objective assessment of causality, we used the Korean algorithm 12 to further support our data ( Table 1). The Korean algorithm consists of 8 questions on adverse drug reactions, with scores of 9 or higher being "certain" for a reaction, 6 to 8 "probable/likely," and 3 to 5 "possible."…”

Section: Figurementioning

confidence: 99%

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Vasculitis Associated With Tumor Necrosis Factor-α Inhibitors

Sokumbi

Wetter

Makol

et al. 2012

Mayo Clinic Proceedings

163

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Objective: To describe the clinical characteristics, histopathologic features, and outcomes of patients in whom vasculitis developed in association with use of tumor necrosis factor-␣ (TNF-␣) inhibitors. Patients and Methods: This is a retrospective review of patients evaluated at Mayo Clinic, Rochester, Minnesota, from January 1, 1998, through March 31, 2011, with a diagnosis of vasculitis induced by anti-TNF-␣ therapy. Results: Of 8 patients with vasculitis associated with anti-TNF-␣ therapy (mean age, 48.5 years), 6 (75%) were female. Four (50%) had rheumatoid arthritis, 1 (13%) had Crohn disease, and 3 (38%) had ulcerative colitis. Five (63%) were treated with infliximab, 2 (25%) with etanercept, and 1 (13%) with adalimumab. The mean duration of treatment before development of vasculitis was 34.5 months. The skin was the predominant organ affected (5 patients [63%]), with the most common cutaneous lesion being palpable purpura (4 of 5 [80%]). Two organs involved in systemic vasculitis were the peripheral nervous system (4 patients [50%]) and kidney (1 patient [13%]). All cases of vasculitis were histopathologically confirmed. Seven of 8 patients improved with discontinuation of therapy (mean time to resolution, 6.9 months) and adjuvant treatment (all 8 received prednisone; another agent was also used in 7); rechallenge with anti-TNF-␣ therapy was not attempted in any patient. At last follow-up, no patients had experienced a recurrence of vasculitis after therapy discontinuation. Conclusion: Cutaneous small-vessel vasculitis was the most common finding, but systemic vasculitis, including peripheral nerve and renal vasculitis, was also frequently observed.

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Section: Figurementioning

confidence: 99%

Section: Figurementioning

confidence: 99%

Vasculitis Associated With Tumor Necrosis Factor-α Inhibitors

Sokumbi

Wetter

Makol

et al. 2012

Mayo Clinic Proceedings

163

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“…The presence of ADRs was established when the Naranjo's score was Ͼ1 (22). The use of Naranjo's algorithm is limited by the difference in the interpretation of some questions by different investigators (26,27). The WHO adverse reactions terminology (WHO-ART) was used to code and classify ADRs (28).…”

Section: Patients and Proceduresmentioning

confidence: 99%

A Clinical Adverse Drug Reaction Prediction Model for Patients with Chagas Disease Treated with Benznidazole

Silva

Mediano

Brasil

et al. 2014

Antimicrob Agents Chemother

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Benznidazole (BZN) is the main trypanocidal drug used to treat Chagas disease, and the evidence supporting the benefits of BZN use during the chronic phase of the disease will favor its use in millions of individuals. However, more than 30% of patients treated with BZN may suffer adverse drug reactions (ADRs), and the development of tools to identify those patients at risk is highly desirable. In the present study, we aimed to identify predictive factors for ADRs in Chagas disease patients treated with BZN. Among 195 patients included in the study, 48.7% experienced ADRs and 31.3% had ADRs that caused BZN treatment discontinuation. Overall ADRs and ADRs that caused BZN treatment discontinuation were more common among women and in those who graduated from elementary school. Overall ADRs were also less frequent among black individuals. Based on logistic regression analysis, female sex (odds ratio [OR], 2.9; 95% confidence interval [CI], 1.5 to 5.4), graduation from elementary school (OR, 2.0; 95% CI, 1.1 to 3.8), and white (OR, 5.0; 95% CI, 1.0 to 24.1) and mulatto (OR, 5.6; 95% CI, 1.1 to 28.7) races were considered to predict overall ADRs, and female sex (OR, 2.3; 95% CI, 1.2 to 4.3) was considered to predict ADRs that caused BZN treatment discontinuation. Graduation from elementary school also presented a tendency to predict ADRs that caused BZN treatment discontinuation (OR, 1.8; 95% CI, 0.9 to 3.6). The logistic regression (LR) models to predict ADRs to BZN described in this study may become important tools to minimize ADRs and improve patients' compliance and thus assist physicians treating patients with Chagas disease with BZN. E ven 100 years after it was first reported (1), Chagas disease remains a serious public health problem in Latin America, with a high social and economic burden (2, 3). Moreover, the prevalence of Chagas disease is increasing, mainly due to migration, in countries where it is not endemic, such as the United States and European countries (4-7).Benznidazole (BZN) is the main trypanocidal drug used to treat Chagas disease (8, 9), and the parasitological cure rate when patients are treated with BZN during the acute phase of the disease is almost 80% (10, 11). Although BZN effectiveness during the chronic phase of the disease remains uncertain (12)(13)(14), there is compelling evidence supporting the beneficial use of BZN even during the chronic phase of Chagas disease (13, 15), and some international guidelines are now advocating the use of BZN even among adults with chronic disease (16-18). However, adverse drug reactions (ADRs) occur in 30% to 87% of the patients treated with BZN (19-21), and 12% to 29% of patients fail to complete their full course of treatment (19-21). Therefore, the development of tools to identify patients with high probabilities of developing ADRs to BZN is highly desirable, as this strategy would improve compliance to BZN treatment and minimize complications (21,22).Logistic regression (LR) is a method often used to predict outcomes in health studies (23,24), and...

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“…This sub-analysis showed not only the differences and similarities but also the agreement and correlation between the evaluation systems compared with previous studies. 18,39,40 To find any relationship among the evaluation systems, additional studies to analyse the differences in the scoring systems might be needed in the future. This study has several limitations.…”

Section: Discussionmentioning

confidence: 99%