Evidence map›Paper›PMID 27785733›Full record

SynthesisDrugs & aging2016

The Efficacy and Safety of the Fentanyl Iontophoretic Transdermal System (IONSYS

Eugene R Viscusi, Li Ding, Loretta M Itri

Abstract readMeta-Analysis
In one paragraph

Synthesis in Drugs & aging, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–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

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Review
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

3 authors.

Eugene R ViscusiThomas Jefferson University, 111 South 11th Street, Gibbon Building, Suite 8490, Philadelphia, PA, 19107, USA.
Li DingThe Medicines Company, 8 Sylvan Way, Parsippany, NJ, 07054, USA.
Loretta M ItriThe Medicines Company, 8 Sylvan Way, Parsippany, NJ, 07054, USA. loretta.itri@themedco.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesAcute postoperative pain management in the geriatric patient can be challenging, including their response to medications. The purpose of this analysis was to evaluate whether the efficacy and safety profile of fentanyl iontophoretic transdermal system (ITS) (IONSYS

methodsEfficacy and safety data from three randomized, double-blind, placebo-controlled trials and four randomized, open-label, active-comparator trials were utilized for this analysis. Efficacy was assessed via the patient global assessment (PGA) and the investigator global assessment (IGA) scales. The PGA and IGA are categorical 4-point scales (excellent, good, fair, or poor) with treatment success defined as excellent or good. Safety was evaluated via adverse events.

resultsA total of 1763 patients were assigned to the fentanyl ITS treatment group. Of the 1763 patients in the fentanyl ITS group, 499 patients were ≥65 years of age; 65.1% were 65-74 years of age, 31.7% were 75-84 years of age, and 3.2% were ≥85 years of age. In the fentanyl ITS treatment groups, there were no statistically significant differences between the non-geriatric and geriatric patients in terms of patients reporting success on the PGA at 24 h (80.0 vs. 83.0%, respectively; p = 0.3415). There were no statistically significant differences between the groups in success rates on the IGA at study discharge (82.8 vs. 87.5%, respectively; p = 0.1195). The safety profile was similar between the age groups.

conclusionsOverall, efficacy and safety of the fentanyl ITS were similar between the geriatric and non-geriatric patients.

Indexed as

AdultAnalgesia, Patient-ControlledAnalgesics, OpioidClinical Trials, Phase III as TopicDouble-Blind MethodFentanylHumansIontophoresisPain ManagementPain MeasurementPostoperative PainRandomized Controlled Trials as TopicTreatment OutcomeAnalgesics, OpioidFentanyl

Identifiers

PMID27785733
PMCPMC5122621

What OpenQuestion holds

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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.