Patient-reported Outcomes in Subjects with Neuropathic Pain Receiving Pregabalin: Evidence from Medical Practice in Primary Care Settings

Abstract

To evaluate the effect of pregabalin on different patient-reported outcomes in subjects with neuropathic pain treated under usual medical practice conditions in primary care settings. Secondary analysis of a 12-week, multicenter, naturalistic, and prospective study on 18 years of age or older patients of both genders with chronic pain (of at least 6 months) due to diabetic neuropathy, post-herpetic, or trigeminal neuralgia refractory to the previous analgesic treatment (at least one drug). Assessed at baseline and end of the study visits by the following questionnaires: Short Form McGill Pain Questionnaire, Sheehan Disability Inventory, Medical Outcomes Study Sleep Scale, Hospital Anxiety and Depression Scale, and EQ-5D. The analysis included 1,354 patients not previously exposed to pregabalin; 598 patients (44%) received monotherapy with pregabalin as a substitute of the previous treatment, in 589 patients (44%) pregabalin was added to the existing therapy, and the treatment schedule of the other 167 patients (12%) did not include pregabalin. After 12 weeks of treatment, significant improvements in all effectiveness assessments were observed in all of the three groups, these being significantly greater in the groups receiving pregabalin, with large effect sizes in most health outcome measures. Under usual medical practice conditions, patients with chronic pain of peripheral neuropathic origin receiving pregabalin both in monotherapy and as add-on therapy showed substantial improvements in severity of pain and in the spectrum of associated symptoms, such as sleep disturbances, mood disorders, disability, and health-related quality of life. Further clinical trials are needed to confirm these findings.