Navegando por Palavras-chave "isotretinoin side effects and adverse reactions related to medicines"

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    Isotretinoína oral para acne
    (Universidade Federal de São Paulo (UNIFESP), 2015-02-25) Costa, Caroline Sousa [UNIFESP]; Riera, Rachel Riera [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)
    Objectives: To assess the efficacy and safety of oral isotretinoin for acne vulgaris. Methods: Systematic review of the literature, conducted at Programa de Pós-Graduação em Saúde Baseada em Evidências, Universidade Federal de São Paulo (UNIFESP), and Brazilian Cochrane Centre. Search Methods: until September 30th 2014, we conducted searches in the following electronic databases: ?Cochrane Skin Group Specialised Register?; ?Cochrane Central Register of Controlled Trials (CENTRAL)?, The Cochrane Library, Issue 8, 2014; MEDLINE via OVID (since 1946); EMBASE via OVID (since 1974); PsycINFO via OVID (since 1806); LILACS (since 1982). In the databases MEDLINE and EMBASE, we conducted an additional specific search strategy for adverse effects. We also searched ongoing trials in the clinical trials register database. We conducted handsearches in the reference lists of relevant studies and in issues of the scientific journals ?Journal of Investigative Dermatology?, ?Archives of Dermatology?, and ?British Medical Dermatology?, in conference proceedings since 1975 until September 30th 2014. We contacted the pharmaceutical industry and field specialists to identify ongoing trials. Inclusion Criteria: Randomized Controlled Trials (RCTs) comparing oral isotretinoin with itself, placebo or any other active systemic treatment or topical, in patients with the clinical diagnosis of acne vulgaris; non-randomized clinical trials, cohort and case?control studies on serious adverse effects, depression or inflammatory intestinal disease due to oral isotretinoin use for acne. Data collection: Two authors, CSC and EB, independently selected the studies, assessed the methodological quality and extracted the data. A third author, RR, resolved divergences during the process. We contacted by electronic mail authors of included studies for additional information. We collected data of all adverse effects reported in the clinical trials. Results: We included 25 RCTs with parallel design involving 3.247 patients. All studies presented high or unclear risk of bias. The included RCTs compared oral isotretinoin with itself (in alternative dose schedules in comparison with the standard, in different pharmaceutical formulations from the original and in combination with topical agents), placebo and other six therapeutic active options against acne. For all comparisons, the quality of the body of evidence was considered low or very low along throughout different outcomes. Regarding the comparison with oral antibiotics associated to topical agent, the main comparison in the review, the inadequate data reports and the heterogeneity regarding the primary efficacy outcome measurement prevented pooling the results of the three RCTs restricted to severe to moderate acne in the meta-analysis. Based in only one of the RCTs (n = 49), oral isotretinoin was not significantly superior to oral tetracycline associated with topical adapalene regarding the percentage of patients who reached a full cleaning (or 100% of improvement) of inflammatory lesions after 24 weeks of use (RR (risk ratio) 4.17, (95% CI (confidence interval) 0.50 to 34.66) and those who kept no inflammatory lesions on the following 2 months after the end of the treatment (RR 11.44, 95% CI 0.67 to 196.30). Only one serious adverse effect was detected in the analysis of all 25 included RCTs: Stevens-Johnson syndrome in 1 patient that received oral isotretinoin in one of the three RTCs that assessed the main comparison. In the safety primary outcome meta-analysis for the main comparison, from the three RCTs (n = 403), oral isotretinoin was equal to oral antibiotics combined with topical drugs regarding the risk of developing a severe adverse effect (RD (risk difference) 0.00, 95% CI -0.01 to 0.02). With respect to the secondary outcomes of the main comparison: 1- oral isotretinoin was superior (RR 1.22, IC 95% 1.09 a 1.38) to systemic antibiotic associated with topical medications in one RCT (n = 266) and similar (RR 1.08, IC 95%, 0.97 a 1.20) to that association in another RCT (n = 85), regarding the improvement in acne severity assessed by the global physician? assessment at the end on the treatment; 2 ? based on the results from one RCT (n = 49), there was no difference between oral isotretinoin and oral antibiotics associated with topical agents regarding the mean scores obtained on the ?Dermatology Life Quality Index? (DLQI) after the end of 24 weeks of treatment (MD (mean difference) -0.12 score; 95% CI -0.83 to 0.60); 3 ? based on a meta-analysis of extracted data from two RCTs (n = 351), less serious adverse effects were more frequent due to oral isotretinoin (RR 1.69, 95% CI 1.42 to 2.00); 4 ? a meta-analysis from data of three RCTs (n = 403) did not show differences between oral isotretinoin and the combination of a systemic antibiotics with topical agents regarding the global rates of drop-outs (RR 0.68, 95% CI 0.43 to 1.06). Comparing different dosage schedules in one included RCT (n = 60), the daily use of oral isotretinoin in low or conventional dose, significantly reduced more the mean counts of inflammatory lesions after 24 weeks of treatment when compared to the intermittent schedule (MD 3.72 lesions; 95% CI 2.13 to 5.31) and (MD 3.87 lesions; CI 95% 2.31 to 5.43), respectively. The qualitative analysis of four non-randomized prospective studies (n = 643), resulted of additional search focused in severe and rare adverse effects, showed that there is no increase in risk of depression caused by the acne treatment with oral isotretinoin in comparison with other drug therapies. Oral isotretinoin decreased the depression incidence in comparison with topical medications in a nonrandomized clinical trial (n = 78). Three retrospective study (n = 58.163), all cross-over study designs, presented conflicting results regarding the higher risk of depressive outcomes with the use of oral isotretinoin for acne, if compared to therapy with other drugs. We considered the body of evidence from non-randomized studies, prospective and retrospectives, as very low quality. Still in the additional search for non-randomized studies, we did not find direct evidence (regarding the studied population) regarding the use of oral isotretinoin in acne vulgaris and the occurrence of inflammatory bowel disease. Conclusion: Due to considerable limitations of applicability and quality of evidence, it was not possible to draw a precise and definite conclusion regarding the superior efficacy of oral isotretinoin in relation to the association of oral antibiotics with topical medications in moderate to severe acne. The risk of severe adverse effects seem to be no different within interventions, but the less serious adverse effects significantly happen more within patients treated with oral isotretinoin. Regarding the different oral isotretinoin dose schedules, daily administration in low or standard dose seems to be more efficacious than the intermittent use; however, the low quality of the evidence makes it unlikely to draw a conclusion without uncertainties. The association of oral isotretinoin with severe depressive outcomes, when compared to other acne treatments, remains still little clear and unlikely, based in a body of evidence with serious limitations of design and quality.