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

Colombo, Delia; Zagni, Emanuela; Nica, Mihaela; Rizzoli, Sara; Ori, Alessandra; Bellia, Gilberto

doi:10.2147/dddt.s97088

Cited by 16 publications

(1 citation statement)

References 47 publications

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“…Sex-related physiological and hormonal differences that influence drug metabolism and disposition may be the reason for the observed higher incidence of AEs in women than men. Furthermore women are also more likely to pay attention to their health status and more often use medicines and therefore are more likely to report AEs compared to men [27].…”

Section: Discussionmentioning

confidence: 99%

Safety and Tolerability of Mass Diethylcarbamazine and Albendazole Administration for the Elimination of Lymphatic Filariasis in Kenya: An Active Surveillance Study

et al. 2021

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Preventive chemotherapy with diethylcarbamazine citrate (DEC) and albendazole (ALB) is the core intervention strategy to eliminate lymphatic filariasis (LF). We conducted a large-scale prospective active safety surveillance study to identify the incidence, type, severity, and risk factors for adverse events (AEs) following mass drug administration (MDA) of single-dose DEC and ALB in 10,010 participants from Kilifi County, Kenya. AEs were actively monitored and graded at 24 h, 48 h, and on day 7 Post-MDA. Out of 10,010 enrolled study participants, 1621 participants reported a total of 3102 AEs during a seven-day follow-up. The cumulative incidence of AEs was 16.2% (95% CI, 15.5–16.9%). The proportion of participants who experienced one, two, or ≥ three types of AEs was 9.2%, 4.6%, 2.4%, respectively. AEs were mild (87.3%), moderate (12.4%), and severe (0.3%) and resolved within 72 h. The five most common AEs were dizziness (5.9%), headache (5.6%), loss of appetite (3.3%), fever (2.9%), and drowsiness (2.6%). Older age, taking concurrent medications, ≥ three tablets of DEC, and type of meal taken before MDA were significant predictors of AEs. One in six participants experienced systemic mild-to-moderate severity grading and transient AEs. DEC and ALB co-administration for the elimination of LF is generally safe and well-tolerated.

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Section: Discussionmentioning

confidence: 99%

Safety and Tolerability of Mass Diethylcarbamazine and Albendazole Administration for the Elimination of Lymphatic Filariasis in Kenya: An Active Surveillance Study

et al. 2021

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Efficacy and safety of guanfacine extended‐release in Japanese adults with attention‐deficit/hyperactivity disorder: Exploratory post hoc subgroup analyses of a randomized, double‐blind, placebo‐controlled study

Naya

Sakai

Okutsu

et al. 2020

Neuropsychopharm Rep

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Aim Previously, we reported on the efficacy and safety of guanfacine extended‐release (GXR) in Japanese adults with attention‐deficit/hyperactivity disorder (ADHD) from a phase 3, double‐blind, placebo‐controlled, randomized trial. In this exploratory post hoc analysis, we assessed the efficacy and/or safety of GXR in the following subgroups: ADHD‐combined (ADHD‐C) and ADHD‐predominantly inattentive (ADHD‐I) subtypes, age (≥31, <31 years), sex (male, female), and body weight (≥50, <50 kg). Methods The primary efficacy endpoint was change from baseline in the Japanese version of the investigator‐rated ADHD‐Rating Scale‐IV (ADHD‐RS‐IV) with adult prompts (total scores) at week 10. Results The efficacy analysis population included 200 patients (GXR, 100; placebo, 100). ADHD‐RS‐IV total score effect sizes (GXR vs placebo) were similar across all subgroups (total population: 0.52, ADHD‐C: 0.51, ADHD‐I: 0.52, ≥31 years: 0.61, <31 years: 0.47, male: 0.50, female: 0.57). There were no major differences in the incidence/types of treatment‐emergent adverse events (TEAEs) across the subgroups. The incidence of significant TEAEs (34.3%, 10.6%) and TEAEs leading to discontinuation (34.3%, 12.1%) were approximately three times higher in females than males, respectively. The incidence of TEAEs in patients weighing <50 kg and ≥50 kg was 100% and 73.6% during dose optimization and 40% and 24.4% during the maintenance period, respectively. Conclusion Findings from this post hoc analysis in adults with ADHD support the efficacy and safety of GXR regardless of ADHD subtype, age, or sex and suggest that careful monitoring for TEAEs and GXR dose optimization is considered for all patients, as needed.

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Pharmacometrics in Precision Dosing

Ibarra

Lorier

Trocóniz

2021

The ADME Encyclopedia

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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

Cited by 16 publications

References 47 publications

Safety and Tolerability of Mass Diethylcarbamazine and Albendazole Administration for the Elimination of Lymphatic Filariasis in Kenya: An Active Surveillance Study

Safety and Tolerability of Mass Diethylcarbamazine and Albendazole Administration for the Elimination of Lymphatic Filariasis in Kenya: An Active Surveillance Study

Efficacy and safety of guanfacine extended‐release in Japanese adults with attention‐deficit/hyperactivity disorder: Exploratory post hoc subgroup analyses of a randomized, double‐blind, placebo‐controlled study

Pharmacometrics in Precision Dosing

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