Asthma is one of the most common chronic diseases characterized by sex disparities. Gender bias is a well-documented issue detected in the design of published clinical trials (CTs). International guidelines encourage researchers to analyze clinical data by sex, gender, or both where appropriate. The objective of this work was to evaluate gender bias in the published CTs of biological agents for the treatment of severe asthma. A systematic review of randomized controlled CTs of the biological agents (omalizumab, benralizumab, reslizumab, mepolizumab or dupilumab) for the treatment of severe asthma was conducted. The literature search was performed using PubMed and EMBASE without language restrictions. This study followed the corresponding international recommendations. We identified a total of 426 articles, of which 37 were finally included. Women represented 60.4% of patients included. The mean percentage of women in these trials was 59.9%, ranged from 40.8% to 76.7%. The separate analysis by sex of the main variable was only performed in 5 of the 37 publications included, and none of the trials analyzed secondary variables by sex. Only 1 of the articles discussed the results separately by sex. No study included the concept of gender in the text or analyzed the results separately by gender. The proportion of women included in CTs was higher compared to publications of other disciplines, where women were under-represented. The analysis of the main and secondary variables by sex or gender, even the discussion separately by sex, was insufficient. This gives rise to potential gender bias in these CTs.
Migraine is considered one of the most disabling diseases. Currently, there are few studies on clinical migraine treatment based on sex-related differences, despite the important role of sex in migraine. Our aim was to evaluate gender bias in published clinical trials on monoclonal antibodies (erenumab, galcanezumab, fremanezumab and eptinezumab). We performed a systematic review of controlled clinical trials of erenumab, galcanezumab, fremanezumab and eptinezumab, searching the PubMed/MEDLINE database for articles published before December 2021. The search identified 760 articles, 25 of which met the inclusion criteria. Of all the patients included in these trials, 85.1% were women. Only one study had female lead authors. Two of the 25 studies included a sex-based analysis of the primary endpoint. None of the articles discussed the results separately for men and for women. The proportion of men recruited in trials is scarce and more studies are needed to guarantee the safety and tolerability of monoclonal antibodies used in male migraine. As observed in our study, despite the high number of women recruited, only 2 studies analysed the results separately by sex. Thus, a potential risk of gender bias was found in these clinical trials.
Introduction: Alectinib is a potent and selective orally active tyrosine kinase inhibitor used for anaplastic lymphoma kinase-positive non-small cell lung cancer, which has a better safety profile than other inhibitors of anaplastic lymphoma kinase. We report a case of a mixed pattern of acute interstitial nephritis and acute tubular necrosis proven by renal biopsy upon starting alectinib therapy. Case report: A 68-year-old man with diabetes, hypertension, and dyslipidaemia, diagnosed with anaplastic lymphoma kinase-positive non-small cell lung cancer stage IV, had 27 days previously started alectinib 600 mg twice daily. He presented at the emergency room due to vomiting, nausea, and more dyspnoea than usual. A high creatinine level and metabolic imbalances were detected in laboratory tests. Management and outcomes: After a diagnosis of acute renal failure, the patient was admitted to hospital. Nephrotoxic drugs were suspended, and haemodialysis was required. After dismissing other causes, a probable diagnosis of acute interstitial nephritis due to alectinib was established. Corticotherapy was initiated and renal function returned to baseline levels. Renal biopsy showed a mixed pattern of acute interstitial nephritis and acute tubular necrosis. The patient was discharged, and alectinib therapy was modified to lorlatinib. No polymorphisms were found in a pharmacogenetic test. After 10 months with lorlatinib, renal function remains stable. Discussion: The relationship between acute renal failure and alectinib initiation is considered probable in this patient. Although it is an adverse effect reported in less than 1% of cases, it would be advisable to monitor renal function in this kind of patient.
Purpose The aim of this work was to investigate the association between anticholinergic burden or anticholinergic drug use and xerostomia and/or xerophtalmia in elderly through a systematic review of the published literature. Methods A search was carried out in 3 databases (CINAHL, Embase and Pubmed). Studies conducted in people ≥65 years of age, who took anticholinergic medications, and measured the association between the anticholinergic burden or the use of these medications with the prevalence of xerostomia and / or xerophthalmia, published up to August 2022, were selected. Studies published in languages other than Spanish and/or English were excluded. Results One thousand two hundred eleven articles were identified, 10 were selected for this review: six cross-sectional studies, two cohorts, one case-control and one randomized controlled clinical trial. A total of 3535 patients included in the different studies were studied. The most used scales were the Anticholinergic Drug Scale (ADS) and the Anticholinergic Risk Scale (ARS). Four articles studied the relationship between the use of anticholinergic medication and the prevalence of xerostomia and / or xerophthalmia, finding a positive relationship with xerostomia in all of them. Another 6 measured the relationship between anticholinergic burden and xerostomia and / or xerophthalmia. Four found a positive relationship between anticholinergic burden and xerostomia and/or xerophthalmia. Conclusions Our findings suggest a clear relationship between the use of anticholinergic drugs or anticholinergic burden and the presence of xerostomia. This relationship was less conclusive in the case of xerophthalmia.
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