The Open Pain Journal, 2012, 5, 1-11 1 1876-3863/12 2012 Bentham Open Open Access Pregabalin in Neuropathic Pain Related to DPN, Cancer and Back Pain: Analysis of a 6-Week Observational Study Thomas R. Toelle 1 , Roxana Varvara 2, *, Meryem Nimour 2 , Birol Emir 3 and Matthias Brasser 4 1 Interdisciplinary Pain Clinic, Munich Technical University, Munich, Germany 2 Pfizer Ltd, Surrey, UK 3 Pfizer Inc, New York, NY, USA 4 Pfizer Pharma GmbH, Berlin, Germany Abstract: Background: Neuropathic pain is associated with many conditions. Pregabalin has demonstrated efficacy in randomized, controlled trials (RCTs) in peripheral and central neuropathic pain. Observational studies complement findings from RCTs by enabling an agent to be studied in real-world patients and circumstances. Methods: Patients with neuropathic pain were treated with pregabalin 150-600 mg/day in this 6 week observational study. Analyses of subsets of patients with painful diabetic peripheral neuropathy (DPN; n=4633), back pain with a neuropathic component (n=3800), and cancer-related neuropathic pain (n=345) were undertaken. Results: The mean pregabalin doses ranged from 219 to 250 mg/day across the disease groups. Mean baseline pain scores (6.4 to 7.0 across the three disease states) indicated patients had moderate to severe pain. Pregabalin was associated with a rapid and significant reduction in pain from week 1 to endpoint in all groups. Over 80% in each of the groups had a 30% pain reduction in their pain at 6 weeks, and over two-thirds had a 50% reduction. Pain-related sleep interference decreased rapidly and significantly. Most patients (87%) were either very satisfied or satisfied with the action of pregabalin. General well-being improved significantly over the 6 weeks. Pregabalin was generally well tolerated; the most common adverse event overall was dizziness (1.4%). Few patients (6.1%/group) discontinued due to adverse events. Conclusions: In neuropathic pain patients in day-to-day practice, pregabalin was associated with notable reductions in pain and sleep interference. The benefits of pregabalin were reflected in the high level of patient satisfaction and improvement in general well-being. Keywords: Pregabalin, Back pain, DPN, Cancer, Neuropathic pain, Observational. INTRODUCTION Neuropathic pain was initially defined as pain initiated or caused by a primary lesion or dysfunction in the nervous system [1]. More recently it has been proposed that neuro- pathic pain be defined as being pain arising as a direct consequence of a lesion or disease affecting the somatosensory system either at peripheral or central level [2]. It is estimated that as many as 7-8% of the European general population may experience neuropathic pain [3, 4]. Neuropathic pain is associated with many conditions including metabolic disorders such as diabetes, surgery, nerve entrapment, conditions causing central lesions such as stroke, and with infections, as in the case of post-herpetic neuralgia [5]. In conditions such as radiculopathy (sciatica) and cancer-related pain, the pain patients experience may have both neuropathic and nociceptive components, sometimes referred to as "mixed pain" [6-8]. Neuropathic *Address correspondence to this author at Pfizer Ltd, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS, UK; Tel: +44 (0) 1737 331 904; Fax: +44 (0) 1737 332 214; E-mail: [email protected] pain is debilitating, costly and does not respond to conventional analgesics [5]. Pregabalin 150-600 mg/day has been shown to be effective at relieving pain and reducing pain-related sleep interference in numerous well controlled trials of patients with painful diabetic peripheral neuropathy (DPN) [9] and post-herpetic neuralgia [10, 11], in a trial in post-traumatic peripheral neuropathic pain [12], and in a trial in central neuropathic pain associated with spinal cord injury [13]. In addition to improving pain-related sleep interference, pre- gabalin has also shown to improve composite indices of sleep disturbance in patients with neuropathic pain assessed using the Medical Outcomes Sleep Scale [12, 13]. Pregabalin is also effective in relieving pain associated with fibromyalgia [14], in the treatment of generalized anxiety disorder [15] and in partial onset seizures [16]. The efficacy of pregabalin across various diseases, including neuropathic pain, has been attributed to the modulation of neurotransmitter release from hyperexcited neurons via binding to the alpha-2-delta subunit, which modulates calcium influx into the pre-synaptic terminal [17, 18]. The effect of pregabalin in neuropathic pain is also
Pregabalin in Neuropathic Pain Related to DPN, Cancer and Back Pain: Analysis of a 6-Week Observational Study
May 23, 2023
Neuropathic pain was initially defined as pain initiated or caused by a primary lesion or dysfunction in the nervous system [1]. More recently it has been proposed that neuropathic pain be defined as being pain arising as a direct consequence of a lesion or disease affecting the somatosensory system either at peripheral or central level [2]. It is estimated that as many as 7-8% of the European general population may experience neuropathic pain [3, 4]. Neuropathic pain is associated with many conditions including metabolic disorders such as diabetes, surgery, nerve entrapment, conditions causing central lesions such as stroke, and with infections, as in the case of post-herpetic neuralgia
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