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Alejandro Arana

Publications and source records attributed to Alejandro Arana.

5 recordsLinked to original sources

Risk of lymphoma following exposure to calcineurin inhibitors and topical steroids in patients with atopic dermatitis.

Systemic use of immunosuppressant agents increases the risk of lymphoma in transplantation. We performed a nested case-control study in the PharMetrics database to evaluate the association between topical immunosuppressants and lymphoma in a cohort of patients with atopic dermatitis. We identified cases of lymphoma and randomly selected four controls for each case, matched by length of follow-up. We used conditional logistic regression to calculate odds ratio (OR) and 95% confidence intervals (CIs) of the association between topical immunosuppressants and lymphoma. Two hundred and ninety-four cases of lymphoma occurred in 293,253 patients, 81 in patients younger than 20 years. The adjusted analysis yielded the following OR (95%CI) for: severity (OR 2.4; 95% CI 1.5-3.8), oral steroids 1.5 (1.0-2.4), "super potent" topical steroids 1.2 (0.8-1.8) , "low potency" topical steroids OR 1.1 (0.7-1.6); pimecrolimus 0.8(0.4-1.6), tacrolimus OR 0.8 (0.4-1.7), and concomitant topical steroids, pimecrolimus, and tacrolimus 1.0 (0.3-4.1). We did not find an increased risk of lymphoma in patients treated with topical calcineurin inhibitors. It is difficult to disentangle the effects of severity of disease on outcome versus the true effects of drugs. However, in the adjusted analysis, severity of AD was the main factor associated with an increased risk of lymphoma.

Administration, Topical↗

Hepatic disorders in patients treated with COX-2 selective inhibitors or nonselective NSAIDs: a case/noncase analysis of spontaneous reports.

BACKGROUND: Hepatic adverse events associated with the use of nonaspirin drugs and NSAIDs are uncommon, but the widespread use of these drugs may impact public health. OBJECTIVE: We conducted a case/noncase analysis of spontaneous reports to compare the hepatic safety profile of cyclooxygenase (COX)-2 selective inhibitors with that of nonselective NSAIDs. METHODS: This case/noncase analysis was conducted using the US Food and Drug Administration Freedom of Information (FDA/FOI) database (through quarter 1, 2003) and the World Health Organization Uppsala Monitoring Centre (WHO/UMC) database (through quarter 3, 2003). Council for International Organizations of Medical Sciences and WHO Adverse Reaction Terminology preferred terms were used to classify hepatic disorders with broad and specific case definitions. After reports involving established hepatotoxic drugs (bromfenac, nimesulide, sulindac) were excluded, the proportion of reports (PRs) of each case definition was calculated for each NSAID. Crude and adjusted reporting odds ratios (RORs) were used to compare the overall proportions of hepatic disorders and hepatic failure of celecoxib and rofecoxib versus nonselective NSAIDs. RESULTS: A total of 158,539 and 185,253 reports of NSAIDs were identified in the FDA/FOI and WHO/UMC databases and 25% and 16%, respectively, involved other hepatotoxic drugs. The PRs of hepatic disorders for all COX-2 selective inhibitors and non-selective NSAIDs were 3.0% in the FDA/FOI database and 2.7% in the WHO/UMC database. In the FDA/FOI and WHO/UMC databases, respectively, mmesulide (16.7% and 14.4%), bromfenac (12.0% and 20.7%), diclofenac (8.1% and 4.7%), and sulindac (6.1 % and 9.9%) were reported to be associated with higher proportions of overall hepatic disorders compared with those of other NSAIDs. Crude and adjusted RORs for the prevalences of overall hepatic disorders and hepatic failure with celecoxib and rofecoxib versus the other NSAIDs were <1 (indicating that the proportion was not higher than that of the comparator) in both databases. The interpretation of the results was unchanged when bromfenac, nimesulide, and sulindac were excluded from the analysis. CONCLUSIONS: In this case/noncase analysis, bromfenac, nimesulide, sulindac, and diclofenac had higher proportions of reports of hepatic disorders compared with those of other NSAIDs in the FDA/FOI and WHO/UMC databases. The analysis did not raise a safety concern for celecoxib or rofecoxib versus NSAIDs for overall hepatic disorders and hepatic failure.

Anti-Inflammatory Agents, Non-Steroidal↗

An international survey of patients with thalassemia major and their views about sustaining life-long desferrioxamine use.

BACKGROUND: Management of thalassemia major requires patients to have life-long access to a treatment regimen of regular blood transfusions coupled with iron chelation therapy. The objective of this study was to investigate patients' reasons for missing iron chelation therapy with desferrioxamine, and the support to sustain life-long adherence to treatment. METHODS: From October 1999 to May 2000 a survey of patients with thalassemia major was conducted in ten countries: Cyprus, Egypt, Greece, Hong Kong, India, Iran, Italy, Jordan, Taiwan, and the United States. RESULTS: 1,888 questionnaires (65%) were returned. Most patients (1,573) used desferrioxamine, and 79% administered a dose at least 4 days a week. Inaccessibility of the drug was a common reason for missing a dose in India (51%), and in Iran (25%), whereas, in any other country, it was a reason for less than 17% of patients. Overall, 58% reported reasons for missing a dose related to their beliefs or feelings about the medication, and 42% drug-related side effects. CONCLUSION: Many patients miss doses of desferrioxamine and an opportunity remains to develop interventions that provide more support to sustain use of desferrioxamine.

Chelation Therapy↗

Impact of thalassemia major on patients and their families.

OBJECTIVE: To describe the burden of thalassemia major and its treatment, in terms of prevalence of iron-overload-related complications, direct and indirect costs, and the patient's physical and social well-being. METHODS: From October 1999 to May 2000 a survey of patients with thalassemia major was conducted in ten countries: Cyprus, Egypt, Greece, Hong Kong, India, Iran, Italy, Jordan, Taiwan, and the United States. RESULTS: 1,888 questionnaires (65%) were returned. The responses suggest that nowadays patients begin blood transfusions, and most use desferrioxamine (84.8%), but iron-related complications, including life-threatening ones such as heart disease, are still common. CONCLUSIONS: There remains a need to improve the management of thalassemia, as many patients with iron-related complications experience physical and social limitations.

Adolescent↗

Hormone therapy and cerebrovascular events: a population-based nested case-control study.

OBJECTIVE: The relationship between postmenopausal hormone therapy (HT) and cerebrovascular disease has been examined in several epidemiological studies and clinical trials with conflicting results. The authors aimed to evaluate the association between the use of HT and the incidence of first cerebrovascular event. DESIGN: The study cohort comprised 158,031 women 50 to 69 years old registered in the U.K. General Practice Research Database between 1991 and 1997. The authors conducted a nested case-control analysis using all 920 confirmed cases of cerebrovascular events identified during the follow-up (536 of transient ischemic attack [TIA]; 259 of ischemic stroke; 125 of hemorrhagic stroke) and 10,000 controls. RESULTS: The odds ratios of TIA, ischemic stroke, and hemorrhagic stroke among women currently using HT were 1.48 (95% CI, 1.17-1.87), 1.12 (95% CI, 0.78-1.59) and 1.21 (95% CI, 0.76-1.93), respectively, compared to never users. The overall risk estimate for having a cerebrovascular event was 1.34 (95% CI, 1.11-1.61). The risk of TIA was greater (1.96) among women using high doses of estrogen (95% CI, 1.34-2.87). CONCLUSION: Overall, a small increased risk of stroke associated with HT use of comparable magnitude to the one observed in recent clinical trials was found. The increased risk was more apparent for TIA than for stroke and was greater at higher doses.

Aged↗