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      Gender differences in the adverse events’ profile registered in seven observational studies of a wide gender-medicine (MetaGeM) project: the MetaGeM safety analysis

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          MetaGeM is a wide gender-medicine project comprising post hoc and meta-analyses by gender of clinical outcomes, therapeutic approaches, and safety data from previously conducted observational studies to explore possible gender differences in real-life clinical settings. We report the results of the safety meta-analysis of seven MetaGeM studies, evaluating gender differences in adverse event (AE) incidence and severity.


          Data were collected between February 2002 and July 2013. Male and female patients were compared for the main safety variables, using Student’s t-test, χ 2 test, or Fisher’s exact test as appropriate. As supportive analysis, a logistic regression model was estimated to evaluate associations between gender and outcome.


          In total, 4,870 patients (46% females, 54% males) were included in the analysis; age was higher for females (mean ± standard deviation 61.2±18.3 years) than males (56.3±16.6 years). Overall, 264 AEs were reported (59.1% in males). There were no significant gender differences in the percentage of patients with at least one AE: 3.0% for females versus 3.9% for males, χ 2 test P>0.05. According to the logistic regression model results, no association between gender and AEs occurrence seems to exist. A statistically significant gender difference in the percentage of drug-related AEs emerged (37.6% in females vs 20.8% in males, χ 2 P=0.0039). Slightly significantly more AEs in females were addressed with treatment compared with males (78.1% vs 66.7%, χ 2 P=0.0485). Total serious AEs (SAEs) were 47 (72% in males). The frequency of patients with ≥1 SAE was 0.6% in females versus 1.2% in males ( χ 2 test P=0.0246).


          This safety analysis on a large sample of almost 5,000 patients with different diseases and treated with a wide range of different drugs provides a useful overview on possible gender differences in drug tolerability, which may be helpful in more accurately designing future clinical trials from a gender-specific perspective.

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          Sex differences in pharmacokinetics and pharmacodynamics.

          Significant differences that exist between the sexes affect the prevalence, incidence and severity of a broad range of diseases and conditions. Men and women also differ in their response to drug treatment. It is therefore essential to understand these reactions in order to appropriately conduct risk assessment and to design safe and effective treatments. Even from that modest perspective, how and when we use drugs can result in unwanted and unexpected outcomes. This review summarizes the sex-based differences that impact on pharmacokinetics, and includes a general comparison of clinical pharmacology as it applies to men, women and pregnant women. Sex-related or pregnancy-induced changes in drug absorption, distribution, metabolism and elimination, when significant, may guide changes in dosage regimen or therapeutic monitoring to increase its effectiveness or reduce potential toxicity. Given those parameters, and our knowledge of sex differences, we can derive essentially all factors necessary for therapeutic optimization. Since this is a rapidly evolving area, it is essential for the practitioner to review drug prescribing information and recent literature in order to fully understand the impact of these differences on clinical therapeutics.
            • Record: found
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            • Article: not found

            Trends in incidence of adult-onset psoriasis over three decades: a population-based study.

            Incidence studies of psoriasis are rare, mainly due to lack of established epidemiological criteria and the variable disease course. The objective of this study is to determine time trends in incidence and survival of psoriasis patients over three decades. We identified a population-based incidence cohort of 1633 subjects aged > or = 18 years first diagnosed with psoriasis between January 1, 1970 and January 1, 2000. The complete medical records for each potential psoriasis subject were reviewed and diagnosis was validated by either a confirmatory diagnosis in the medical record by a dermatologist or medical record review by a dermatologist. Age- and sex-specific incidence rates were calculated and were age- and sex-adjusted to the 2000 US white population. The overall age- and sex-adjusted annual incidence of psoriasis was 78.9 per 100,000 (95% confidence interval [CI]: 75.0-82.9). When psoriasis diagnosis was restricted to dermatologist-confirmed subjects, the incidence was 62.3 per 100,000 (95% CI: 58.8-65.8). Incidence of psoriasis increased significantly over time from 50.8 in the period 1970-1974 to reach 100.5 per 100,000 in the 1995-1999 time period (P = .001). Although the overall incidence was higher in males than in females (P = .003), incidence in females was highest in the sixth decade of life (90.7 per 100,000). Survival was similar to that found in the general population (P = .36). The study population was mostly white and limited to adult psoriasis patients. The annual incidence of psoriasis almost doubled between the 1970s and 2000. The reasons for this increase in incidence are currently unknown, but could include a variety of factors, including a true change in incidence or changes in the diagnosing patterns over time.
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              Trends in hospital admissions for adverse drug reactions in England: analysis of national hospital episode statistics 1998–2005

              Background Adverse drug reactions (ADRs) are a frequent cause of mortality and morbidity to patients worldwide, with great associated costs to the healthcare providers including the NHS in England. We examined trends in hospital admissions associated with adverse drug reaction in English hospitals and the accuracy of national reporting. Methods Data from the Hospital Episode Statistics database (collected by the Department of Health) was obtained and analysed for all English hospital episodes (1998–2005) using ICD-10 codes with a primary (codes including the words ('drug-induced' or 'due to') or secondary diagnosis of ADR (Y40–59). More detailed analysis was performed for the year 2004–2005 Results Between 1998 and 2005 there were 447 071 ADRs representing 0.50% of total hospital episodes and over this period the number of ADRs increased by 45%. All ADRs with an external code increased over this period. In 2005 the total number of episodes (all age groups) was 13,706,765 of which 76,692 (0.56%) were drug related. Systemic agents, which include anti-neoplastic drugs, were the most implicated class (15.7%), followed by analgesics (11.7%) and cardiovascular drugs (10.1%). There has been a 6 fold increase in nephropathy secondary to drugs and a 65% decline in drug induced extra-pyramidal side effects. 59% of cases involving adverse drug reactions involved patients above 60 years of age. Conclusion ADRs have major public health and economic implications. Our data suggest that national Hospital Episode Statistics in England have recognised limitations and that consequently, admissions associated with adverse drug reactions continue to be under-recorded. External causes of ADR have increased at a greater rate than the increase in total hospital admissions. Improved and more detailed reporting combined with educational interventions to improve the recording of ADRs are needed to accurately monitor the morbidity caused by ADRs and to meaningfully evaluate national initiatives to reduce adverse drug reactions.

                Author and article information

                Drug Des Devel Ther
                Drug Des Devel Ther
                Drug Design, Development and Therapy
                Drug Design, Development and Therapy
                Dove Medical Press
                13 September 2016
                : 10
                : 2917-2927
                [1 ]Patient Access, Novartis Farma S.p.A., Origgio, Varese
                [2 ]MediNeos Observational Research, Modena, Italy
                Author notes
                Correspondence: Emanuela Zagni, Novartis Farma, Largo Umberto Boccioni 1, 21040 Varese (VA), Italy, Tel +39 029 654 2305, Fax +39 059 848 305, Email medidata@ 123456medineos.com
                © 2016 Colombo et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                Original Research

                Pharmacology & Pharmaceutical medicine

                meta-analysis, gender, adverse events, safety, drugs


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