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Introduction: Eslicarbazepine acetate (ESL), together with carbamazepine and oxcarbazepine, belongs to the dibenzazepine family. According to the latest clinical practice guidelines, tricyclic antidepressants, dual antidepressants (venlafaxine, duloxetine), and some antiepileptics (gabapentin, pregabalin) are first-line drugs for neuropathic pain; tramadol, lidocaine 5% patches, and capsaicin 8% patches are considered second-line drugs; and strong opioids constitute a third line of treatment. Such other antiepileptics as lamotrigine and lacosamide are not authorised as treatments for neuropathic pain by the regulatory agencies, but are nonetheless prescribed off-label in routine clinical practice. Carbamazepine, on the other hand, is indicated for trigeminal and glossopharyngeal neuralgia., Development: We conducted a literature search to gather evidence on the use of ESL for neuropathic pain, headache, and cranial neuralgia., Conclusions: Evidence is insufficient to recommend ESL for neuropathic pain, headache, and cranial neuralgia. Most of the available evidence comes from open and observational studies with small sample sizes and no control group; however, their favourable results call for further studies on the usefulness of ESL for neuropathic pain, headache, and cranial neuralgia., (Copyright © 2017 The Authors. Publicado por Elsevier España, S.L.U. All rights reserved.)

Objective: The aim of this study was to determine the pattern of use of pregabalin and the appropriateness of treatment, so that interventions could be designed to improve various clinical approaches to the use of pregabalin to include unlicensed indications., Design: A descriptive, cross-sectional, multicenter study was performed between April 2014 and January 2015., Setting: Fifty-three primary health care centers covering 1,250,000 inhabitants., Subjects: A total of 10,155 patients with pregabalin prescriptions., Methods: Demographic (gender, age) and clinical (licensed indications for pregabalin, treatment duration, dosing schedule, diagnoses, kidney function, previous treatment with pregabalin, and additional drug treatment combined with pregabalin) variables obtained from health records were studied. The indicators were related to the daily dose of pregabalin, diagnoses, and treatment., Results: A total of 64.2% of patients treated with pregabalin were female (mean age = 62.3 years; SD = 15.2 years). Twenty-nine patients were younger than age 18 years. A total of 68.2% of patients were taking pregabalin for an appropriate indication, 45.2% were using pregabalin off-label for bone and joint pain, and 15.1% were using pregabalin for fibromyalgia. A total of 71.9% of patients started treatment with pregabalin without previously using firstline drugs, such as amitriptyline or gabapentin, and 66% of active treatments had been initiated during the year before the study. In 47% of patients with glomerular filtration rates lower than 15 mL/min, the dose exceeded the maximum., Conclusions: Our study reveals that pregabalin is used for unlicensed indications and often when firstline drugs have not been trialed and suggests that better routines in diagnosis and prescription may improve treatment outcomes. Our study also provides novel information about the use of doses of pregabalin that are higher than recommended for patients with renal impairment.

Context and Objective: To describe clinical and resource utilization patterns in patients with refractory neuropathic pain (NeP) who were prescribed pregabalin for the first time in routine medical practice in primary care settings., Methods: Post-hoc analysis of a 12-week prospective observational study including pregabalin naïve adult patients with refractory chronic NeP of at least 6-months duration. Self-reported pain intensity, disability, sleep disturbances, symptoms of anxiety and depression, disability, health-related quality of life (HRQoL), health care resource utilization, and corresponding costs were assessed in this post-hoc analysis., Results: One thousand three hundred fifty-four patients were enrolled in the study, and three treatment groups were identified: (1) 598 patients replaced prior pain treatments with pregabalin as monotherapy; (2) 589 added pregabalin to their existing pain treatments; and (3) 167 other pain treatments were prescribed according with physician routine medical practice. Statistically significant differences were reported at baseline for intensity of pain, patient disability, severity of depressive symptoms, and HRQoL (P < 0.01 in all cases). No statistically significant differences were reported among the three treatment groups for anxiety severity or sleep disturbances. Subjects who received add-on pregabalin had greater use of direct and indirect resources vs the other groups, resulting in significantly higher quarterly overall costs per patient: €2,397 (2,308), €2,470 (1,857), and €3,110 (2,496), respectively (P < 0.001)., Conclusion: These findings suggest that primary care physicians chose pregabalin as an option for treating refractory patients who tended to have much more severe NeP profiles, costing society more than when they chose other therapeutic strategies not including pregabalin., (Wiley Periodicals, Inc.)

Background and Objective: Patients from a previous study of neuropathic pain (NP) in the Spanish primary care setting still had symptoms despite treatment. Subsequently, patients were treated as prescribed by their physician and followed up for 3 months. Since pregabalin has been shown to be effective in NP, including refractory cases, the objective of this study was to assess the effectiveness of pregabalin therapy in patients with NP refractory to previous treatments., Methods: This was a post hoc analysis of pregabalin-naïve NP patients treated with pregabalin in a 3-month follow-up observational multicenter study to assess symptoms and satisfaction with treatment. Patients were evaluated with the Douleur Neuropathique en 4 questions (DN4), the Brief Pain Inventory (BPI) and the Treatment Satisfaction for Medication Questionnaire (SATMED-Q) overall satisfaction domain., Results: 1,670 patients (mean age 58 years, 59 % women), previously untreated or treated with ≥1 drug other than pregabalin, were treated with pregabalin (37 % on monotherapy). At 3 months, pain intensity and its interference with activities decreased by half (p < 0.0001), while the number of days with no or mild pain increased by a mean of 4.5 days (p < 0.0001). Treatment satisfaction increased twofold (p < 0.0001). Patients with a shorter history of pain and those with neuralgia and peripheral nerve compression syndrome (PCS) as etiologies had the highest proportion on monotherapy and showed the greatest improvements in pain-related parameters in their respective group categories., Conclusion: Treatment with pregabalin (as monotherapy or combination therapy) provides benefits in pain and treatment satisfaction in patients with NP, including refractory cases. Shorter disease progression and neuralgia and PCS etiologies are favorable factors for pregabalin treatment response.

Objective: The objective of this study was to estimate the cost-effectiveness of pregabalin vs usual care (UC) in outpatients with refractory neuropathic pain (NeP), treated according to routine medical practice in primary care settings in Spain., Methods: Patients were extracted from a 12-week noninterventional prospective study conducted to ascertain the costs of NeP. Pairs of pregabalin-naïve patients receiving UC or pregabalin, matched by age, gender, pain intensity, and refractory to previous treatment, were selected in a 1:1 ratio. Refractory was considered a patient with actual pain (scoring >40 in a 100 mm in a pain visual analog scale) after receiving a course of a standard analgesic, at its recommended doses. Perspectives of the Spanish National Healthcare System and society were included in the analysis. Effectiveness was expressed as quality-adjusted life-year (QALY) gain. Results of the cost-effectiveness analysis were expressed as an incremental cost per QALY (ICER) gained. Probabilistic sensitivity analysis using bootstrapping techniques was also carried out., Results: A total of 160 pairs were extracted. Compared with UC, pregabalin was associated with significantly higher QALY gain; 0.0374 ± 0.0367 vs 0.0224 ± 0.0313 (P < 0.001). Despite drug acquisition costs being higher for pregabalin (€251 ± 125 vs €104 ± 121; P < 0.001), total and health care costs incurred for pregabalin were similar in both groups; €1,335 ± 1,302 vs €1,387 ± 1,489 (P = 0.587) and €529 ± 438 vs €560 ± 672 (P = 0.628), respectively, yielding a dominant ICER for both total and health care costs in the base case scenario; 95% confidence intervals, respectively, dominant to €17,268, and dominant to €6,508. Sensitivity analysis confirmed results of the basecase scenario., Conclusion: This study showed that pregabalin may be cost-effective in the treatment of refractory NeP patients when compared with UC in routine medical practice in Spain., (Wiley Periodicals, Inc.)

Purpose: Neuropathic pain (NP) in cancer patients severely impacts quality of life. Radiotherapy (RT) may cause NP, and at the same time, cancer patients visit RT units for pain relief. NP prevalence at these sites and current analgesic treatment should be assessed to improve management., Methods and Materials: This epidemiological, prospective, multicenter study was undertaken to assess NP prevalence, according to Douleur Neuropathique 4 questions questtionaire (DN4) test results, and analgesic management in cancer pain patients visiting RT oncologic units. Secondary analyses assessed NP etiology and pain intensity (using the Brief Pain Inventory-Short Form) and impact (using the Hospital Anxiety and Depression Scale (HADS), Medical Outcomes Study [MOS] for Sleep, and the Health Survey Short Form-12)., Results: A total of 1,098 patients with any kind of pain were registered. NP prevalence was 31.1% (95% confidence interval, 28.4%--33.9%); 291 NP patients (mean age, 62.2 ±12.5 years and 57.7% men) were eligible for study; 49% of patients were overweight. The most frequent tumors were those of breast and lung, and stage IIIB was the most common cancer stage. The tumors caused 75% of NP cases. Anxiety, sleepiness, and depression were common. At 8 weeks, pain intensity and interference with daily activities decreased significantly for 50.8% of responders. Depression and anxiety (p < 0.0001) scores on the Physical Component Summary and Mental Component Summary measures (p < 0.0001) and all MOS-Sleep subscales, except for snoring, improved significantly. The percentage of satisfied patients increased from 13.8% to 87.4% (p < 0.0001) with the current analgesic treatment, which meant a 1.2- and 6-fold increase (p < 0.0001) in narcotic analgesics and anticonvulsants, respectively, compared to previous treatment., Conclusions: NP is highly prevalent at RT oncology units, with sleepiness, anxiety, and depression as frequent comorbidities. There is a need to improve management of NP with increased use of more specific NP-targeting drugs., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Background: Thirty percent to ninety percent of cancer patients suffer from pain, including neuropathic pain (NP), which results in great burden for cancer patients. Thus, it was of great interest to determine NP prevalence in cancer patients in Spain, to raise awareness of the condition, and aiming to improve management of cancer NP., Patients and Methods: A 1-month follow-up prospective epidemiological multicenter study was conducted to assess prevalence and management of NP in Spanish oncologic units. The first 10 cancer patients at each unit diagnosed with NP by the validated Douleur Neuropathique 4 questionnaire (DN4) were recruited., Results: Of 8615 screened patients, 2567 (30%) suffered from pain. From these, 33% had NP according to investigators and 19% according to DN4 test. Three hundred and sixty-six patients (mean age 62.6 years; 61.2% male) were recruited. Pain decrease at 1 month was greater in patients with metastases (P<0.01) and depended on treatment (P<0.05), with 'oxycodone' showing 50.4% pain relief., Conclusions: NP prevalence in cancer pain is 33%. DN4 reports only about half the cancer NP cases diagnosed by clinicians. Pharmaceutical treatment of cancer pain, including NP, has a greater effect in patients with metastases and seems to depend on the specific treatment used., (© The Author 2010. Published by Oxford University Press on behalf of the European Society for Medical Oncology.)

Objective: To analyze the incidence and characteristics of the first 1000 headaches in an outpatient clinic., Background: Headache is a common cause of medical consultation, both in primary care and in specialist neurology outpatient clinics. The International Classification of Headache Disorders, 2nd Edition (ICHD-II), enables headaches to be classified in a precise and reproducible manner., Methods: In January 2008, an outpatient headache clinic was set up in Hospital Clínico Universitario, a tertiary hospital in Valladolid, Spain. Headaches were classified prospectively in accordance with ICHD-II criteria. In each case we recorded age and sex, duration of headache, ancillary tests required, and previous symptomatic or prophylactic therapies., Results: In January 2010, the registry included 1000 headaches in 682 patients. The women/men ratio was 2.46/1 and the mean age of the patients was 43.19 ± 17.1 years (range: 14-94 years). Patients were referred from primary care (53.4%), general neurology clinics (36.6%), and other specialist clinics (9%). The headaches were grouped (ICHD-II classification) as follows: group 1 (Migraine), 51.4%; group 2 (Tension-type headache), 16%; group 3 (Trigeminal autonomic cephalalgias), 2.6%; group 4 (Other primary headaches) and group 13 (Cranial neuralgias), 3.4%. The diagnostic criteria of chronic migraine were satisfied in 8.5% of migraines. Regarding secondary headaches, 1.1% of all cases were included in group 5 (Headaches attributed to trauma) and 8.3% in group 8 (Headaches attributed to a substance or its withdrawal). Only 3.4% of headaches were classified in group 14 (Unspecified or not elsewhere classified), and 5.2% were included in the groups listed in the ICHD-II research appendix., Conclusion: This registry outlines the characteristics of patients seen in an outpatient headache clinic in a tertiary hospital; our results are similar to those previously reported for this type of outpatient clinic. Migraine was the most common diagnosis. Most headaches can be classified using ICHD-II criteria., (© 2011 American Headache Society.)

Background and Objective: Different studies have shown pain to be one of the most frequent causes of health-care resource utilization, and a major public health concern because of its social repercussions. In Spain there are no recent data on the prevalence and management of neuropathic pain in the general primary-care setting., Methods: This study aimed to gain epidemiological insight into neuropathic pain in the Spanish primary-care setting. This was a cross-sectional, one-day, multicentre, observational epidemiological study involving 623 primary-care physicians in Spain. Patients who experienced pain were classified into three groups: pure neuropathic pain, mixed neuropathic pain or nociceptive pain. Pain intensity was evaluated on a visual analogue scale (VAS), range 0-10. Information on the location, duration, aetiology and current treatment of pain was obtained, together with data on whether the patients were referred to specialized care and to which type of specialist., Results: In a single day, 23 529 patients received primary care, and of these, 7220 experienced pain (30.7% [95% CI 29.5, 31.7]). Patients with pure neuropathic pain comprised 11.8% (95% CI 10.5, 13.2) of the 3044 patients for whom pain was the reason for consultation and the type of pain was documented, patients with mixed neuropathic pain accounted for 13.4% (95% CI 12.0, 14.8) of this group, and patients with nociceptive pain for 74.9% (95% CI 73.1, 76.7). Patients with pure neuropathic pain mostly received exclusively pharmacological treatment (84.6% [95% CI 80.3, 89.0]), with antiepileptic drugs being the most widely used substances (52.5% [95% CI 47.3, 57.7]), followed by non-opioid analgesics (35.2% [95% CI 30.2, 40.1]) and NSAIDs (26.8% [95% CI 22.2, 31.4]). The mean duration of neuropathic pain was 11.7 +/- 23.3 months. The mean pain intensity on the VAS exceeded 6 in all groups. Over half of the patients were diagnosed in the primary-care centre, and a large proportion in turn were referred to a specialist, most frequently an orthopaedist., Conclusions: The results of the present study show the high prevalence of neuropathic pain at the primary-care level in Spain. In addition, the data presented here point to a need to improve the management of outpatients with neuropathic pain in the Spanish primary-care setting, particularly in relation to the higher than recommended use of NSAIDs (which are not indicated for neuropathic pain) and the lower than recommended use of antiepileptic drugs with an analgesic indication for pain with a neuropathic component.

Although ganglioside administration has been suspected as being responsible for Guillain-Barré syndrome (GBS) and peripheral neuropathies in some patients, current epidemiological, experimental, and clinical data do not support such an association. In Spain, a total of 17 cases of suspected GBS and neuropathy had been reported to the National Drug Surveillance System as of April 15, 1992. No definite relationship between ganglioside administration and the illness in these cases could be established after careful review of available data.