Understanding the impact of pain response on changes in function, quality of life, and sleep interference in patients with painful diabetic peripheral neuropathy and post-herpetic neuralgia treated with pregabalin

Abstract

Treatment of peripheral neuropathic pain conditions can benefit from further understanding of the impact of pain response on activities of daily living and sleep. This study explores relationships between changes in diabetic peripheral neuropathy (DPN) and post herpetic neuropathy (PHN) pain, and changes from baseline to endpoint with pregabalin treatment on an 11-point pain numeric rating scale, Patient Global Impression of Change (PGIC), 36-Item Short Form Health Survey (SF-36), Medical Outcomes Study (MOS) Sleep scale, and Daily Sleep Interference (DSI) scale, an 11-point numeric rating scale using a daily diary. Data from 10 double-blind, placebo-controlled trials of pregabalin monotherapy (5-13 weeks) for painful DPN and PHN were pooled for this analysis. Percentage of pain reduction was assessed as: substantial improvement - ≥50% pain reduction; moderate - 30% to <50%; minimal - 15% to <30%; marginal - 0% to <15%. 54% of patients treated with pregabalin had moderate or substantial pain improvement vs. 31% of patients on placebo. In patients with substantial pain improvement, 80% reported “very much improved” or “much improved” on the PGIC, compared with 47% with moderate pain reduction, 31% with minimal pain reduction, and 10% with marginal pain reduction. Greater pain improvement was associated with higher scores on the SF-36 Social and Physical Function subscales. Sleep interference measured by the DSI decreased with increased pain response from baseline to endpoint: 4 points for patients with substantial pain improvement, 2.3 with moderate pain reduction, 1.7 with minimal reduction, and 0.9 for marginal reduction. Sleep problems as measured by the MOS overall sleep problem index and MOS sleep disturbance scale similarly decreased with increased pain response. Measurement of sleep disturbance improved to normal range for patients with substantial pain improvement. Greater pain reduction was associated with overall improvement in patients' function, quality of life, and sleep. (Supported by Pfizer Inc.) Treatment of peripheral neuropathic pain conditions can benefit from further understanding of the impact of pain response on activities of daily living and sleep. This study explores relationships between changes in diabetic peripheral neuropathy (DPN) and post herpetic neuropathy (PHN) pain, and changes from baseline to endpoint with pregabalin treatment on an 11-point pain numeric rating scale, Patient Global Impression of Change (PGIC), 36-Item Short Form Health Survey (SF-36), Medical Outcomes Study (MOS) Sleep scale, and Daily Sleep Interference (DSI) scale, an 11-point numeric rating scale using a daily diary. Data from 10 double-blind, placebo-controlled trials of pregabalin monotherapy (5-13 weeks) for painful DPN and PHN were pooled for this analysis. Percentage of pain reduction was assessed as: substantial improvement - ≥50% pain reduction; moderate - 30% to <50%; minimal - 15% to <30%; marginal - 0% to <15%. 54% of patients treated with pregabalin had moderate or substantial pain improvement vs. 31% of patients on placebo. In patients with substantial pain improvement, 80% reported “very much improved” or “much improved” on the PGIC, compared with 47% with moderate pain reduction, 31% with minimal pain reduction, and 10% with marginal pain reduction. Greater pain improvement was associated with higher scores on the SF-36 Social and Physical Function subscales. Sleep interference measured by the DSI decreased with increased pain response from baseline to endpoint: 4 points for patients with substantial pain improvement, 2.3 with moderate pain reduction, 1.7 with minimal reduction, and 0.9 for marginal reduction. Sleep problems as measured by the MOS overall sleep problem index and MOS sleep disturbance scale similarly decreased with increased pain response. Measurement of sleep disturbance improved to normal range for patients with substantial pain improvement. Greater pain reduction was associated with overall improvement in patients' function, quality of life, and sleep. (Supported by Pfizer Inc.)