LONGITUDINAL PATIENT-REPORTED OUTCOMES (PRO) IN SUBJECTS WITH REFRACTORY PAIN ASSOCIATED TO TRIGEMINAL NEURALGIA- A POST-HOC ANALYSIS OF A 12-WEEK PROSPECTIVE STUDY IN PRIMARY CARE SETTING (PCS) UNDER ROUTINE MEDICAL PRACTICE
Author(s)
María Teresa Saldaña, MD, --1, Concepción Pérez, MD, Anaesthesits2, Ana Navarro, MD, ------3, Silvia Martínez, MD, Statistician4, Javier Rejas, MD, Outcomes Research Manager51Primary Care Centre “Raíces”, Castrillón, Asturias, Spain; 2 Hospital University La Princesa, Madrid, Spain; 3 Primary Care Centre “Puerta del Ángel”, Madrid, Spain; 4 European Biometrics Institute, Barcelona, Spain; 5 Pfizer Spain, Madrid, Spain
OBJECTIVES: To analyze longitudinal PRO measurements evolution after treating refractory pain due to Trigeminal Neuralgia in Primary Care Setting (PCS) during 12-weeks under routine medical practice. METHODS: Sub-analysis of a sample of patients above 18 years, with 6-month chronic pain due to trigeminal neuralgia refractory to, at least, one previous analgesic [previous mean (SD) number of drugs was 2.2 (1.2), with a 36.3% on one-drug only], included in a prospective, naturalistic, 12-weeks two-visit study on refractory peripheral Neuropathic pain. PRO measurements included pain severity by McGill-pain scale (included 50%-reduction responder rate and days with no/mild pain), anxiety and depression symptoms (HAD scale), sleep disturbances (MOS-sleep), disability (Sheehan scale), and quality-adjusted-life-year (QALY) gain (EQ-5D). Paired non-parametric and t-tests were applied. RESULTS: Ninety-one [62.2% women, 57.7 (13.9) years] patients were analyzed: 45% switched to pregabalin as a monotherapy, 37% received pregabalin as add-on therapy, and in 18% previous treatment was replaced by a regimen not including pregabalin. After 12 weeks of therapy, significant reduction in last-week mean pain severity [-35.0 (23.9) mm, p<0.0001, 53.9% responders] and percentage of subjects declaring the pain as severe or worst from 60.5% to 10.5% (p<0.0001), was accompanied by reductions in total disability score [-8.2 (6.0) pts, p<0.0001], depression symptoms score [-3.8 (4.2) pts, p<0.0001], anxiety symptoms score [-3.4 (3.3) pts, p<0.0001], and summary-index sleep problems scoring [-16.5 (18.4), p<0.0001], while treatment increased the quarterly mean number of days with no/mild pain [+32.3 (28.9) days, p<0.0001], the average number of sleeping-hours per night [+0.8 (1.3), p<0.0001], and produced a QALY gain of 0.0317 (0.0385). CONCLUSION: A therapy mix of painful trigeminal neuralgia mostly based on pregabalin (82% of cases) was associated with a significant longitudinal improvement in patient-reported-outcomes including severity of pain, symptoms of depression and anxiety, disability, sleep disturbance and quality-adjusted-life-year gain.
Conference/Value in Health Info
2007-10, ISPOR Europe 2007, Dublin, Ireland
Value in Health, Vol. 10, No. 6 (November/December 2007)
Code
PND38
Topic
Economic Evaluation, Methodological & Statistical Research, Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes, PRO & Related Methods, Work & Home Productivity - Indirect Costs
Disease
Neurological Disorders
Explore Related HEOR by Topic