uu.seUppsala University Publications
Change search
CiteExportLink to record
Permanent link

Direct link
Cite
Citation style
  • apa
  • ieee
  • modern-language-association
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf
The utility/futility of medications for neuropathic pain: an observational study
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Family Medicine and Preventive Medicine.
AstraZeneca R&D, Molndal, Sweden.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health, Research group (Dept. of women´s and children´s health), Clinical Psychology in Healthcare.
Wasser Pain Management Ctr, Mount Sinai Hospital, Toronto, Canada.
Show others and affiliations
2019 (English)In: Scandinavian Journal of Pain, ISSN 1877-8860, E-ISSN 1877-8879, Vol. 19, no 2, p. 327-335Article in journal (Refereed) Published
Abstract [en]

Background and aims

The RELIEF (Real Life) study by AstraZeneca was designed as an observational study to validate a series of Patient Reported Outcome (PRO) questionnaires in a mixed population of subjects with neuropathic pain (NP) coming from diabetes, neurology and primary care clinics. This article is an analysis of a subset of the information to include the medications used and the effects of pharmacological treatment over 6 months. The RELIEF study was performed during 2010–2013.

Methods

Subjects were recruited from various specialty clinics and one general practice clinic across Canada. The subjects were followed for a total of 2 years with repeated documentation of their status using 10 PROs. A total of 210 of the recruited subjects were entered into the data base and analyzed. Of these, 123 had examination-verified painful diabetic neuropathy (PDN) and 87 had examination-verified post-traumatic neuropathy (PTN). To evaluate the responsiveness of the PROs to change, several time points were included and this study focusses primarily on the first 6 months. Subjects also maintained a diary to document all medications, both for pain and other medical conditions, including all doses, start dates and stop dates, that could be correlated to changes in the PRO parameters.

Results

RELIEF was successful in being able to correlate the validity of the PROs and this data was used for further AstraZeneca Phase 1, 2, and 3 clinical trials of NP. To our surprise, there was very little change in pain and low levels of patient satisfaction with treatment during the trial. Approximately 15% of the subjects reported improvement, 8% worsening of pain, the remainder reported pain unchanged despite the use of multiple medications at multiple doses, alone or in combination with frequent changes of medications and doses over the study. Those taking predominantly NSAIDs (COX-inhibitors) did no worse than those taking the standard recommended medications against NP.

Conclusions

Since this is a real-life study, it reflects the clinical utility of a variety of internationally recommended medications for the treatment of NP. In positive clinical trials of these medications in selected "ideal" subjects, the effects are not overwhelming – 30% are 50% improved on average. This study shows that in the real world the results are not nearly as positive and reflects information from non-published negative clinical trials.

Implications

We still do not have very successful medications for NP. Patients probably differ in many respects from those subjects in clinical trials. This is not to negate the use of recommended medications for NP but an indication that success rates of treatment are likely to be worse than the data coming from those trials published by the pharmaceutical industry.

Place, publisher, year, edition, pages
2019. Vol. 19, no 2, p. 327-335
Keywords [en]
neuropathic pain, real world, drug failure, diabetic neuropathy, posttraumatic neuropathy
National Category
Other Clinical Medicine
Identifiers
URN: urn:nbn:se:uu:diva-372254DOI: 10.1515/sjpain-2018-0317ISI: 000463370000012PubMedID: 30407914OAI: oai:DiVA.org:uu-372254DiVA, id: diva2:1275602
Funder
AstraZenecaAvailable from: 2019-01-07 Created: 2019-01-07 Last updated: 2019-04-25Bibliographically approved

Open Access in DiVA

fulltext(127 kB)0 downloads
File information
File name FULLTEXT01.pdfFile size 127 kBChecksum SHA-512
f6ed301e64c99f6d85949141ebf7503cfb5ec8f263b58016ad69a6a62c4c59b32e556ee8433df580e9a41098a85d26f2b0369076e45abdcf250d081d4e14ef26
Type fulltextMimetype application/pdf

Other links

Publisher's full textPubMed

Authority records BETA

Butler, StephenRing, LenaKarlsten, Rolf

Search in DiVA

By author/editor
Butler, StephenRing, LenaKarlsten, Rolf
By organisation
Family Medicine and Preventive MedicineClinical Psychology in HealthcareAnaesthesiology and Intensive Care
In the same journal
Scandinavian Journal of Pain
Other Clinical Medicine

Search outside of DiVA

GoogleGoogle Scholar
The number of downloads is the sum of all downloads of full texts. It may include eg previous versions that are now no longer available

doi
pubmed
urn-nbn

Altmetric score

doi
pubmed
urn-nbn
Total: 257 hits
CiteExportLink to record
Permanent link

Direct link
Cite
Citation style
  • apa
  • ieee
  • modern-language-association
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf