Evidence map›Paper›PMID 26396498›Full record

ArticleDrug design, development and therapy2015

Exposure-outcome analysis in depressed patients treated with paroxetine using population pharmacokinetics.

Jung-Ryul Kim, Hye In Woo, Mi-Ryung Chun, Shinn-Won Lim, Hae Deun Kim, Han Sung Na, Myeon Woo Chung, Woojae Myung, Soo-Youn Lee, Doh Kwan Kim

Abstract read
In one paragraph

Article in Drug design, development and therapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Jung-Ryul KimDepartment of Clinical Pharmacology and Therapeutics, Samsung Medical Center, Seoul, Republic of Korea.
Hye In WooDepartment of Laboratory Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Republic of Korea.
Mi-Ryung ChunDepartment of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Shinn-Won LimSamsung Advanced Institute for Health Sciences and Technology (SAIHST), Sungkyunkwan University, Seoul, Republic of Korea.
Hae Deun KimClinical Research Division, Toxicological Evaluation and Research Department, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Osong, Chungcheongbuk-do, Republic of Korea.
Han Sung NaClinical Research Division, Toxicological Evaluation and Research Department, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Osong, Chungcheongbuk-do, Republic of Korea.
Myeon Woo ChungClinical Research Division, Toxicological Evaluation and Research Department, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Osong, Chungcheongbuk-do, Republic of Korea.
Woojae MyungDepartment of Psychiatry, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Soo-Youn LeeDepartment of Clinical Pharmacology and Therapeutics, Samsung Medical Center, Seoul, Republic of Korea ; Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Doh Kwan KimDepartment of Psychiatry, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis study investigated population pharmacokinetics of paroxetine, and then performed an integrated analysis of exposure and clinical outcome using population pharmacokinetic parameter estimates in depressed patients treated with paroxetine. PATIENTS AND

methodsA total of 271 therapeutic drug monitoring (TDM) data were retrospectively collected from 127 psychiatric outpatients. A population nonlinear mixed-effects modeling approach was used to describe serum concentrations of paroxetine. For 83 patients with major depressive disorder, the treatment response rate and the incidence of adverse drug reaction (ADR) were characterized by logistic regression using daily dose or area under the concentration-time curve (AUC) estimated from the final model as a potential exposure predictor.

resultsOne compartment model was developed. The apparent clearance of paroxetine was affected by age as well as daily dose administered at steady-state. Overall treatment response rate was 72%, and the incidence of ADR was 30%. The logistic regression showed that exposure predictors were not associated with treatment response or ADR in the range of dose commonly used in routine practice. However, the incidence of ADR increased with the increase of daily dose or AUC for the patients with multiple concentrations.

conclusionIn depressed patients treated with paroxetine, TDM may be of limited value for individualization of treatment.

Indexed as

Models, BiologicalAdultAgedAged, 80 and overAntidepressive Agents, Second-GenerationArea Under CurveDose-Response Relationship, DrugDrug MonitoringFemaleHumansLogistic ModelsMajor Depressive DisorderMaleMetabolic Clearance RateMiddle AgedNonlinear DynamicsAntidepressive Agents, Second-GenerationParoxetineSelective Serotonin Reuptake Inhibitorsexposure–outcome relationshipNONMEMparoxetinepopulation pharmacokineticstherapeutic drug monitoring

Identifiers

PMID26396498
PMCPMC4577253

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.