Women encounter ADRs more often than do men

Zopf, Y; Rabe, Christina; Neubert, Antje; Gaßmann, K-G; Rascher, Wolfgang; Hahn, Eckhart G.; Brune, Kay; Dormann, Harald

doi:10.1007/s00228-008-0494-6

Cited by 186 publications

(167 citation statements)

References 39 publications

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“…[30][31][32][33][34] The subgroup analyses of pooled data showed that the efficacy of suvorexant did not vary as a function of age or gender. With regard to safety, there was no evidence to suggest that any difference in AEs (total number and somnolence) between suvorexant and placebo was more marked in elderly than non-elderly patients.…”

Section: Discussionmentioning

confidence: 96%

Suvorexant in Patients with Insomnia: Pooled Analyses of Three-Month Data from Phase-3 Randomized Controlled Clinical Trials

Herring

Connor

Snyder

et al. 2016

Journal of Clinical Sleep Medicine

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Study Objectives: Suvorexant is an orexin receptor antagonist approved for treating insomnia at a maximum dose of 20 mg. Phase-3 trials evaluated two age-adjusted (non-elderly/elderly) dose-regimes of 40/30 mg and 20/15 mg with the primary focus on 40/30 mg. We report here results from pooled analyses of the 20/15 mg dose-regime, which was evaluated as a secondary objective in the trials. Methods: Prespecified analysis of pooled data from two identical randomized, double-blind, placebo-controlled, parallel-group, 3-month trials in non-elderly (18-64 years) and elderly (≥ 65 years) patients with insomnia. Patients were randomized to suvorexant 20/15 mg (non-elderly/elderly), suvorexant 40/30 mg (non-elderly/elderly), or placebo; by design, fewer patients were randomized to 20/15 mg. Efficacy was assessed by self-reported and polysomnography (PSG; subset of patients) sleep maintenance and onset endpoints. Results: Suvorexant 20/15 mg (N = 493 treated) was effective compared to placebo (N = 767 treated) on patient-reported and PSG sleep maintenance and onset endpoints at Night-1 (PSG endpoints) / Week-1 (subjective endpoints), Month-1 and Month-3, except for effects on PSG sleep onset at Month-3. Suvorexant 20/15 mg was generally well tolerated, with 3% of patients discontinuing due to adverse events over 3 months vs. 5.2% on placebo. Somnolence was the most common adverse event (6.7% vs. 3.3% for placebo). There was no systematic evidence of rebound or withdrawal signs or symptoms when suvorexant was discontinued after 3 months of nightly use.

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Section: Discussionmentioning

confidence: 96%

Suvorexant in Patients with Insomnia: Pooled Analyses of Three-Month Data from Phase-3 Randomized Controlled Clinical Trials

Herring

Connor

Snyder

et al. 2016

Journal of Clinical Sleep Medicine

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“…20 The lower risk of error in women is a surprising finding, and is in contrast to findings suggesting that women are at greater risk of adverse drug events. 21 It is possible, however, that GPs are more cautious when prescribing for women, hence the lower risk of error.…”

Section: Comparison With Existing Literaturementioning

confidence: 99%

The prevalence and nature of prescribing and monitoring errors in English general practice: a retrospective case note review

Avery¹,

Ghaleb²,

Barber³

et al. 2013

Br J Gen Pract

114

103

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“…Few studies have addressed gender differences in the nocebo effect. Women experience adverse drug reactions more often than do men [53], and evidence suggests that women are more prone to experience nocebo effects [54]. In a study evaluating the SSRI fluoxetine, women reported slightly more nocebo effects than men (38.5% versus 30.1%, p , 0.01) [52].…”

Section: Gender Differences In Placebo and Nocebo Effectsmentioning

confidence: 99%

Lessons learned from placebo groups in antidepressant trials

Shedden-Mora

Nestoriuc

Rief

2011

Phil. Trans. R. Soc. B

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This comprehensive review provides an overview about placebo and nocebo phenomena in antidepressant trials. Improvements in the placebo groups may partly be explained through methodological issues such as natural course of depression and regression to the mean, but also fundamentally reflect investigators' and participants' expectations. A meta-analysis by our group of 96 randomized placebo-controlled trials showed large placebo responses to antidepressant medication. Moderator analyses revealed substantially larger placebo responses in observer ratings compared with self-report. Effect sizes in observer ratings showed strong increase with publication year while this effect was not found for patients' self-ratings. This reflects the strong influence of investigators' expectations. The analysis of 'nocebo effects', e.g. adverse effects in placebo groups of antidepressant trials also confirms the impact of expectations: nocebo symptoms reflected the typical side-effect patterns expected in the drug group, with higher symptoms rates in the placebo groups of tricyclic antidepressant trials compared with placebo groups of trials testing selective serotonin reuptake inhibitors. While the placebo response seems to be similar for women and men, gender differences were found for nocebo rates. In the conclusion, we discuss potential implications for clinical trial designs and argue for interventions aimed at optimizing positive expectations of treatment benefit while minimizing the impact of adverse effects.

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Women encounter ADRs more often than do men

Abstract: Our data confirm the higher risk of ADRs among female subjects compared with a male cohort. Several explanations were investigated. No single risk factor could be identified.

Cited by 186 publications

References 39 publications

Suvorexant in Patients with Insomnia: Pooled Analyses of Three-Month Data from Phase-3 Randomized Controlled Clinical Trials

Suvorexant in Patients with Insomnia: Pooled Analyses of Three-Month Data from Phase-3 Randomized Controlled Clinical Trials

The prevalence and nature of prescribing and monitoring errors in English general practice: a retrospective case note review

Lessons learned from placebo groups in antidepressant trials

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