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- Arana, Alejandro, et al.
(författare)
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Long-Term Risk of Skin Cancer and Lymphoma in Users of Topical Tacrolimus and Pimecrolimus : Final Results from the Extension of the Cohort Study Protopic Joint European Longitudinal Lymphoma and Skin Cancer Evaluation (JOELLE)
- 2021
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Ingår i: Clinical Epidemiology. - : Dove Medical Press. - 1179-1349. ; 13, s. 1141-1153
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: Evidence is insufficient to infer whether topical calcineurin inhibitors (TCIs; tacrolimus and pimecrolimus) cause malignancy. The study objective was to estimate the long-term risk of skin cancer and lymphoma associated with topical TCI use in adults and children, separately.Patients and Methods: A cohort study in Denmark, Sweden, UK, and the Netherlands was conducted. Adjusted incidence rate ratios (IRRs) and 95% confidence intervals (CIs) were calculated for nonmelanoma skin cancer (NMSC), melanoma, cutaneous T-cell lymphoma (CTCL), non-Hodgkin lymphoma (NHL) excluding CTCL, and Hodgkin lymphoma (HL) in new users of TCIs versus users of moderate/high-potency topical corticosteroids.Results: The study included 126,908/61,841 adults and 32,605/27,961 children initiating treatment with tacrolimus/pimecrolimus, respectively. Follow-up was ≥10 years for 19% of adults and 32% of children. Incidence rate ratios and (95% confidence intervals) for tacrolimus versus corticosteroid users in adults were <1 for melanoma, non-Hodgkin lymphoma, and Hodgkin lymphoma; and 1.80 (1.25-2.58) for cutaneous T-cell lymphoma. For pimecrolimus, IRRs in adults were <1 for non-Hodgkin lymphoma, cutaneous T-cell lymphoma, and Hodgkin's lymphoma; and 1.21 (1.03-1.41) for melanoma; and 1.28 (1.20-1.35) for nonmelanoma skin cancer. In children, results were inconclusive due to few events. In adults, incidence rate ratios ≥5 years after first topical calcineurin inhibitor exposure were not higher than in overall analyses.Conclusion: Overall, we found little evidence associating use of topical calcineurin inhibitors with skin cancer and lymphoma; confounding by indication, surveillance bias, and reverse causation may have influenced these results. Even if causal, the public health impact of these excess risks would be low and confined to the first years of exposure.
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| 4. |
- Gutiérrez, Lia P, et al.
(författare)
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Registries as a tool in evidence-based medicine : example of KIMS (Pfizer International Metabolic Database)
- 2008
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Ingår i: Pharmacoepidemiology and Drug Safety. - : Wiley. - 1053-8569 .- 1099-1557. ; 17:1, s. 90-102
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Tidskriftsartikel (refereegranskat)abstract
- Purpose To evaluate the value of a registry, set in 'real-life practice', as a contribution to evidence-based medicine and to estimate the impact of information collected in such a registry, on the up to date knowledge in growth hormone (GH)-related disorders. Methods Analysis of data collected prospectively for a pharmacoepidemiological registry-KIMS (Pfizer International Metabolic Database)-in assessing long-term clinical and safety outcomes of GH treatment (Genotropin (R)) in patients with GH deficiency. The study was based on 11374 treated (40000 patient-years of observation) and 263 untreated adult GH deficient patients from 30 countries, in whom background characteristics, clinical values such as lipids and body composition, quality of life (QoL) and GH dosage as well as safety profile were evaluated. Citation analysis for the published papers was also performed. Results The study depicts the clinical picture of adult patients with GH deficiency managed in current clinical settings. It confirms the features previously detected such as increased cardiovascular risk, mostly dyslipidemia and abnormal body composition as well as impaired QoL. There was considerable heterogeneity of conditions resulting in GH deficiency. The large database also enabled study of rare causes of the condition. The 31 out of 36 KIMS papers were cited 544 times, in 125 different journals. Conclusions These findings and the further insight into the response to GH replacement therapy show that the registry methodology is valuable for filling the gaps of information in evidence-based medicine that cannot be addressed by clinical trials.
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