Trial reportBritish journal of clinical pharmacology2004
Effect of age on the pharmacokinetics of duloxetine in women.
Trial report in British journal of clinical pharmacology, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 70 citations in OpenAlex.
- Population pharmacokinetics of orally administered duloxetine in patients: implications for dosing recommendation.Clinical pharmacokinetics · 2009Pooled it
- Serotonin and noradrenaline reuptake inhibitors (SNRI) for stress urinary incontinence in adults.The Cochrane database of systematic reviews · 2005Pooled it
- Effects of varying degrees of renal impairment on the pharmacokinetics of duloxetine: analysis of a single-dose phase I study and pooled steady-state data from phase II/III trials.Clinical pharmacokinetics · 2010Trial
- In vitro and in vivo evaluations of cytochrome P450 1A2 interactions with duloxetine.Clinical pharmacokinetics · 2008Trial
- Clinical pearls for the management of duloxetine patients with medical comorbidities.The mental health clinician · 2024Article
- Determination of Patient Adherence for Duloxetine in Urine.Journal of analytical toxicology · 2022Article
- Tolerability of duloxetine in elderly and in non-elderly adults: a protocol of a systematic review and individual participant data meta-analysis of randomized placebo-controlled trials.Systematic reviews · 2022Article
- Genotoxic and oxidative effect of duloxetine on mouse brain and liver tissues.Scientific reports · 2021Article
- Physiologically-Based Pharmacokinetic Modeling for the Prediction of CYP2D6-Mediated Gene-Drug-Drug Interactions.CPT: pharmacometrics & systems pharmacology · 2019Article
- [Urinary incontinence in the elderly: what can and should be done?].Der Urologe. Ausg. A · 2013Article
- Duloxetine: a review of its use in the management of major depressive disorder in older adults.Drugs & aging · 2013Review
- Duloxetine: clinical pharmacokinetics and drug interactions.Clinical pharmacokinetics · 2011Review
- Prediction of repeat-dose occupancy from single-dose data: characterisation of the relationship between plasma pharmacokinetics and brain target occupancy.Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism · 2011Article
- Profile of adverse events with duloxetine treatment: a pooled analysis of placebo-controlled studies.Drug safety · 2010Article
- Duloxetine in the treatment of generalized anxiety disorder.Neuropsychiatric disease and treatment · 2008Article
- [Expanding therapeutic reference ranges using dose-related reference ranges].Der Nervenarzt · 2008Article
- Duloxetine in the treatment of major depressive disorder.Neuropsychiatric disease and treatment · 2007Article
- Review
- Duloxetine in the treatment of stress urinary incontinence.Therapeutics and clinical risk management · 2005Article
- Duloxetine: in stress urinary incontinence.Drugs · 2004Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsThe effect of age on duloxetine pharmacokinetics was evaluated in healthy volunteers and in patients with urinary incontinence.
methodsTwenty-four healthy subjects (12 women 65-77 years, and 12 women 32-50 years) were given a single 40-mg oral dose of duloxetine in Study 1. Plasma concentration-time data were analysed by noncompartmental pharmacokinetic methods. Sparse plasma samples were obtained from patients with urinary incontinence treated in two phase II studies: 70 women (24-77 years) who received duloxetine 20 mg day(-1), 30 mg day(-1), or 40 mg day(-1) in Study 2A and 128 women (28-64 years) who received duloxetine 20 mg day(-1), 40 mg day(-1), or 80 mg day(-1) in Study 2B. Based upon the combined data, a model was developed to characterize population pharmacokinetics of duloxetine using the nonlinear mixed-effects modelling program (NONMEM).
resultsIn Study 1, the elderly (> or = 65 years) exhibited a statistically significant slower elimination rate constant lambdaz compared with younger subjects [elderly-younger difference = -0.022 h(-1)[95% confidence interval (CI) -0.036, -0.008]]. However, no statistically significant differences in either CL/F [elderly-younger difference = -17.4 l h(-1) (95% CI -41.1, 6.23)] or V/F [elderly-younger difference = 115.9 l (95% CI -168.6, 400.4)] were observed. The population pharmacokinetic analysis of Studies 2A and 2B revealed that the CL/F of duloxetine decreased with increasing age. Despite statistical significance, the age effect only accounted for 3% of the interindividual variability in CL/F and unexplained sources of the variation in clearance were still substantial (> 50%). Adverse events were generally mild to moderate, and the incidence of adverse events was generally similar in elderly and non-elderly participants in these studies.
conclusionsWhereas the results suggest that age has an effect on duloxetine pharmacokinetics, primarily reflected as a slower lambdaz in the elderly, the magnitude of mean changes in CL/F, or V/F was small relative to the large interindividual variation in pharmacokinetics. Elderly participants had a safety profile of duloxetine comparable to their younger counterparts. Specific dose recommendations for duloxetine in the elderly are not warranted.
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