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Relationship between pain relief and improvements in patient function/quality of life in patients with painful diabetic peripheral neuropathy or postherpetic neuralgia treated with pregabalin.
Clin Ther. 2013 May; 35(5):612-23.CT

Abstract

BACKGROUND

In patients with chronic pain due to diabetic peripheral neuropathy (DPN) or postherpetic neuralgia (PHN), pregabalin treatment results in pain relief and improved patient function/quality of life (QoL). Few studies, however, have examined the exact relationship between pain relief and improvements in patient function/QoL. It is unclear, for example, whether pregabalin has a direct independent effect on patient function/QoL or whether improvements in function/QoL are an indirect consequent of pain relief.

OBJECTIVES

To determine whether improvements in function/QoL in response to pregabalin treatment are related to the extent of pain relief in patients with neuropathic pain due to DPN or PHN and to determine whether pregabalin has a direct independent effect on patient function/QoL that is distinct from its effects on pain.

METHODS

Data from 11 randomized, double-blind, placebo-controlled trials of pregabalin for the treatment of DPN or PHN were pooled for this analysis. Changes in patient function/QoL scores were plotted according to the extent of pain relief to assess whether greater levels of pain relief were associated with greater improvement in function/QoL. A novel mediation analysis was used to asses to what extent the effects of pregabalin on function/QoL scores are a direct treatment effect as opposed to an indirect effect mediated through improvements in pain or sleep.

RESULTS

Moderate-to-substantial pain relief (a ≥30% decrease in pain) in response to pregabalin treatment was associated with significant (P < 0.05) improvements in 36-Item Short Form Health Survey (SF-36) scores (used to assess patient function/QoL). In many patients, greatest improvement in SF-36 scores was reported by patients achieving ≥50% decrease in pain. Analysis of Patient Global Impression of Change scores revealed a similar trend, where >80% of patients who achieved substantial pain relief also reported their status as much or very much improved. A substantial direct pregabalin treatment effect was evident for many SF-36 domains that could not be explained by pain relief or improvement in sleep.

CONCLUSIONS

In patients with chronic pain due to DPN or PHN, improvements in patient function/QoL in response to pregabalin treatment are correlated with the extent of pain relief. However, such improvements in function/QoL are not mediated entirely through pain relief but are the result of a combination of pregabalin's effects on pain and sleep disturbance and a direct effect on patient function itself.

Authors+Show Affiliations

Department of Internal Medicine, Eastern Virginia Medical School, Norfolk, VA, USA. VinikAI@evms.eduNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23541708

Citation

Vinik, Aaron, et al. "Relationship Between Pain Relief and Improvements in Patient Function/quality of Life in Patients With Painful Diabetic Peripheral Neuropathy or Postherpetic Neuralgia Treated With Pregabalin." Clinical Therapeutics, vol. 35, no. 5, 2013, pp. 612-23.
Vinik A, Emir B, Cheung R, et al. Relationship between pain relief and improvements in patient function/quality of life in patients with painful diabetic peripheral neuropathy or postherpetic neuralgia treated with pregabalin. Clin Ther. 2013;35(5):612-23.
Vinik, A., Emir, B., Cheung, R., & Whalen, E. (2013). Relationship between pain relief and improvements in patient function/quality of life in patients with painful diabetic peripheral neuropathy or postherpetic neuralgia treated with pregabalin. Clinical Therapeutics, 35(5), 612-23. https://doi.org/10.1016/j.clinthera.2013.03.008
Vinik A, et al. Relationship Between Pain Relief and Improvements in Patient Function/quality of Life in Patients With Painful Diabetic Peripheral Neuropathy or Postherpetic Neuralgia Treated With Pregabalin. Clin Ther. 2013;35(5):612-23. PubMed PMID: 23541708.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Relationship between pain relief and improvements in patient function/quality of life in patients with painful diabetic peripheral neuropathy or postherpetic neuralgia treated with pregabalin. AU - Vinik,Aaron, AU - Emir,Birol, AU - Cheung,Raymond, AU - Whalen,Ed, Y1 - 2013/03/28/ PY - 2012/12/11/received PY - 2013/02/20/revised PY - 2013/03/12/accepted PY - 2013/4/2/entrez PY - 2013/4/2/pubmed PY - 2014/1/1/medline SP - 612 EP - 23 JF - Clinical therapeutics JO - Clin Ther VL - 35 IS - 5 N2 - BACKGROUND: In patients with chronic pain due to diabetic peripheral neuropathy (DPN) or postherpetic neuralgia (PHN), pregabalin treatment results in pain relief and improved patient function/quality of life (QoL). Few studies, however, have examined the exact relationship between pain relief and improvements in patient function/QoL. It is unclear, for example, whether pregabalin has a direct independent effect on patient function/QoL or whether improvements in function/QoL are an indirect consequent of pain relief. OBJECTIVES: To determine whether improvements in function/QoL in response to pregabalin treatment are related to the extent of pain relief in patients with neuropathic pain due to DPN or PHN and to determine whether pregabalin has a direct independent effect on patient function/QoL that is distinct from its effects on pain. METHODS: Data from 11 randomized, double-blind, placebo-controlled trials of pregabalin for the treatment of DPN or PHN were pooled for this analysis. Changes in patient function/QoL scores were plotted according to the extent of pain relief to assess whether greater levels of pain relief were associated with greater improvement in function/QoL. A novel mediation analysis was used to asses to what extent the effects of pregabalin on function/QoL scores are a direct treatment effect as opposed to an indirect effect mediated through improvements in pain or sleep. RESULTS: Moderate-to-substantial pain relief (a ≥30% decrease in pain) in response to pregabalin treatment was associated with significant (P < 0.05) improvements in 36-Item Short Form Health Survey (SF-36) scores (used to assess patient function/QoL). In many patients, greatest improvement in SF-36 scores was reported by patients achieving ≥50% decrease in pain. Analysis of Patient Global Impression of Change scores revealed a similar trend, where >80% of patients who achieved substantial pain relief also reported their status as much or very much improved. A substantial direct pregabalin treatment effect was evident for many SF-36 domains that could not be explained by pain relief or improvement in sleep. CONCLUSIONS: In patients with chronic pain due to DPN or PHN, improvements in patient function/QoL in response to pregabalin treatment are correlated with the extent of pain relief. However, such improvements in function/QoL are not mediated entirely through pain relief but are the result of a combination of pregabalin's effects on pain and sleep disturbance and a direct effect on patient function itself. SN - 1879-114X UR - https://www.unboundmedicine.com/medline/citation/23541708/Relationship_between_pain_relief_and_improvements_in_patient_function/quality_of_life_in_patients_with_painful_diabetic_peripheral_neuropathy_or_postherpetic_neuralgia_treated_with_pregabalin_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0149-2918(13)00118-5 DB - PRIME DP - Unbound Medicine ER -