Concepción Pérez

Validity and reliability of the Spanish version of the DN4 (Douleur Neuropathique 4 questions) questionnaire for differential diagnosis of pain syndromes associated to a neuropathic or somatic component.

BackgroundThis study assesses the validity and reliability of the Spanish version of DN4 questionnaire as a tool for differential diagnosis of pain syndromes associated to a neuropathic (NP) or somatic component (non-neuropathic pain, NNP).MethodsA study was conducted consisting of two phases: cultural adaptation into the Spanish language by means of conceptual equivalence, including forward and backward translations in duplicate and cognitive debriefing, and testing of psychometric properties in patients with NP (peripheral, central and mixed) and NNP. The analysis of psychometric properties included reliability (internal consistency, inter-rater agreement and test-retest reliability) and validity (ROC curve analysis, agreement with the reference diagnosis and determination of sensitivity, specificity, and positive and negative predictive values in different subsamples according to type of NP).ResultsA sample of 164 subjects (99 women, 60.4%; age: 60.4 ± 16.0 years), 94 (57.3%) with NP (36 with peripheral, 32 with central, and 26 with mixed pain) and 70 with NNP was enrolled. The questionnaire was reliable [Cronbachs alpha coefficient: 0.71, inter-rater agreement coefficient: 0.80 (0.71–0.89), and test-retest intra-class correlation coefficient: 0.95 (0.92–0.97)] and valid for a cut-off value ≥ 4 points, which was the best value to discriminate between NP and NNP subjects.DiscussionThis study, representing the first validation of the DN4 questionnaire into another language different than the original, not only supported its high discriminatory value for identification of neuropathic pain, but also provided supplemental psychometric validation (i.e. test-retest reliability, influence of educational level and pain intensity) and showed its validity in mixed pain syndromes.

Patient-reported outcomes in subjects with neuropathic pain receiving pregabalin: evidence from medical practice in primary care settings.

OBJECTIVE 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. PATIENTS AND METHODS 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). SUBJECTS 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. RESULTS 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. CONCLUSION 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.

Pregabalin and gabapentin in matched patients with peripheral neuropathic pain in routine medical practice in a primary care setting: Findings from a cost-consequences analysis in a nested case-control study

BACKGROUND Pregabalin and gabapentin are marketed to treat peripheral neuropathic pain, but head-to-head comparison is lacking. OBJECTIVES The aims of this work were to compare the effects of pregabalin and gabapentin on different patient-reported health outcomes and to analyze health care and nonhealth-care resource consumption and their related costs among patients treated for peripheral neuropathic pain in primary medical care. METHODS A cost-consequences comparison in subjects with refractory (suboptimal response to > or =1 previous analgesic treatment for >6 months) chronic peripheral neuropathic pain was carried out using data extracted from two 12-week, observational, prospective studies in primary medical care. Patients were eligible if they were aged > or =18 years, had a score of > or =4 on the Douleur Neuropathique 4 questionnaire, and were able to complete health questionnaires written in Spanish. A nested-paired case-control design was chosen to perform the comparison with 2 controls (pregabalin) per case (gabapentin) matched by age, sex, peripheral neuropathic pain condition, time since diagnosis, number of previous treatments, pain intensity, depressive and anxiety symptom scores, and health state. Adult subjects with refractory chronic pain because of diabetic neuropathy, postherpetic or trigeminal neuralgias, or cervical or lumbosacral radiculopathies were included. Epidemiologic statistical methods were applied for comparing health effects (pain intensity, sleep, anxiety and depressive symptoms, disability, and health state), resources utilization, and related cost variations after 12 weeks. Indirect costs were measured by means of lost-workday equivalent calculations multiplied by the mean national daily salary. RESULTS Analysis included 44 patients treated with gabapentin (cases) and 88 patients treated with pregabalin (controls) who were matched for age, sex, and other parameters. The mean (SD) gabapentin and pregabalin doses were 1263 (540) and 202 (119) mg/d, respectively. Although there was a greater reduction in last-week mean pain intensity with pregabalin (visual analog scale: 39.1 [22.5] vs 28.0 [22.2] mm; P = 0.008), as well as more patients with a > or =50% reduction in pain rate (60.9% vs 40.5%; P = 0.029), there were no significant differences between groups for sensory, affective, total, or present pain intensity. The significantly higher drug cost associated with pregabalin was offset by a greater reduction in productivity costs compared with gabapentin, yielding similar cost reduction (-euro1254 [1479] vs -euro1384 [2874], respectively; P = NS). CONCLUSION Pregabalin appeared to be associated with greater reduction in mean weekly intensity of pain, but there were no significant differences in cost.

A Cost-Consequences analysis of the effect of Pregabalin in the treatment of peripheral Neuropathic Pain in routine medical practice in Primary Care settings

BackgroundNeuropathic pain (NeP) is a common symptom of a group of a variety of conditions, including diabetic neuropathy, trigeminal neuralgia, or postherpetic neuralgia. Prevalence of NeP has been estimated to range between 5-7.5%, and produces up to 25% of pain clinics consultations. Due to its severity, chronic evolution, and associated co-morbidities, NeP has an important individual and social impact. The objective was to analyze the effect of pregabalin (PGB) on pain alleviation and longitudinal health and non-health resources utilization and derived costs in peripheral refractory NeP in routine medical practice in primary care settings (PCS) in Spain.MethodsSubjects from PCS were older than 18 years, with peripheral NeP (diabetic neuropathy, post-herpetic neuralgia or trigeminal neuralgia), refractory to at least one previous analgesic, and included in a prospective, real world, and 12-week two-visit cost-of-illness study. Measurement of resources utilization included both direct healthcare and indirect expenditures. Pain severity was measured by the Short Form-McGill Pain Questionnaire (SF-MPQ).ResultsOne-thousand-three-hundred-fifty-four PGB-naive patients [58.8% women, 59.5 (12.7) years old] were found eligible for this secondary analysis: 598 (44%) switched from previous therapy to PGB given in monotherapy (PGBm), 589 (44%) received PGB as add-on therapy (PGB add-on), and 167 (12%) patients changed previous treatments to others different than PGB (non-PGB). Reductions of pain severity were higher in both PGBm and PGB add-on groups (54% and 51%, respectively) than in non-PGB group (34%), p < 0.001. Incremental drug costs, particularly in PGB subgroups [€34.6 (80.3), €160.7 (123.9) and €154.5 (133.0), for non-PGB, PGBm and PGBadd-on, respectively (p < 0.001)], were off-set by higher significant reductions in all other components of health costs yielding to a greater total cost reductions: -€1,045.3 (1,989.6),-€1,312.9 (1,543.0), and -€1,565.5 (2,004.1), for the three groups respectively (p = 0.03).ConclusionIn Spanish primary care settings, PGB given either add-on or in monotherapy in routine medical practice was associated with pain alleviation leading to significant longitudinal reductions in resource use and total costs during the 12-week period of the study compared with non-PGB-therapy of patients with chronic NeP of peripheral origin. The use of non-appropriate analgesic therapies for neuropathic pain in a portion of subjects in non-PGB group could explain partially such findings.

Adaptación lingüística y validación al castellano de la escala LANSS (Leeds Assessment of Neuropathic Symptoms and Signs) para el diagnóstico diferencial del dolor neuropático

Fundamento y objetivo: Adaptacion linguistica y validacion al castellano de la escala LANSS (Leeds Assessment of Neuropathic Symptoms and Signs) para el diagnostico diferencial del dolor neuropatico. Material y metodo: Estudio transversal de validacion en 2 fases: a) adaptacion cultural al castellano mediante equivalencia conceptual con traduccion y retrotraduccion, por duplicado, y revision por panel de expertos, y b) estudio de validacion de la escala en pacientes con dolor neuropatico, nociceptivo y mixto, en el que se evaluaron las propiedades de fiabilidad (consistencia interna y acuerdo entre jueces, con coeficiente kappa y coeficiente de correlacion intraclase) y validez (analisis de curvas COR, concordancia con el diagnostico de referencia y determinacion de la sensibilidad, la especificidad y los valores predictivos positivo y negativo). Resultados: El estudio incluyo a 156 sujetos (90 mujeres; el 58,4%); 89 con dolor con un componente neuropatico (con una edad media [desviacion estandar] de 59,6 [19,4] anos, 22 de ellos con dolor mixto debido a radiculopatia) y 67 con dolor nociceptivo (de edad media, 66,6 [11,8] anos). El diagnostico del tipo de dolor se realizo por criterios clinicos habituales. Entrevistadores entrenados aplicaron la escala por duplicado y a ciegas sobre el diagnostico de referencia. La escala mostro buena fiabilidad (consistencia interna, * de Cronbach y coeficiente de Guttman de las 2 mitades entre 0,68 y 0,71; concordancia entre jueces, * = 0,70; y coeficientes de correlacion intraclase, 0,77 y 0,92) y validez para un punto de corte e 12 puntos, que fue el que mejor discrimino a los pacientes con dolor de componente neuropatico de aquellos con dolor nociceptivo; coeficiente * = 0,70 (intervalo de confianza [IC] del 95%, 0,59-0,81; p < 0,0001), area bajo la curva, 0,929 (p < 0,0001), especificidad del 89,4% (IC del 95%, 79,4%-95,6%) y valor predictivo positivo del 91,1% (IC del 95%, 82,6%-96,4%). Conclusiones: La version espanola de la escala LANSS es fiable y valida para el diagnostico diferencial de dolor neuropatico en Espana.

Prevalence and Characterization of Neuropathic Pain in a Primary-Care Setting in Spain

AbstractBackground 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. This study aimed to gain epidemiological insight into neuropathic pain in the Spanish primary-care setting. Methods: 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 anti-epileptic 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. Conclusion: 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.

Trigeminal neuralgia treated with pregabalin in family medicine settings: its effect on pain alleviation and cost reduction.

The purpose of this study is to analyze the effect of pregabalin (PGB) on pain alleviation, use of health care and non—health care resources, and associated costs in patients with trigeminal neuralgia under usual clinical practice in primary care settings. Sixty‐five PGB‐naïve patients receiving PGB as monotherapy (n = 36, 55%) or combined with other drugs (n = 29, 45%) fulfill criteria for inclusion in a secondary analysis from a 12‐week, multicenter, observational prospective study aimed to ascertain the cost of illness in subjects with neuropathic pain. Pain is evaluated using the Short Form McGill Pain Questionnaire. Use of health care and non—health care resources and lost workdays equivalents (LWDEs) are also recorded. PGB significantly reduces pain scores, use of health care resources (ancillary tests and unscheduled medical visits), and number of LWDEs. Additional cost of PGB treatment (+€174 ± 106) is broadly compensated for by a reduction in both health care costs (−€621 ± 1211, P < .001) and indirect costs (−€1210 ± 1141, P < .001). It is concluded that PGB as monotherapy or combined with other drugs is effective in pain management in patients with trigeminal neuralgia and reduces the cost of illness.

Pain alleviation and patient-reported health outcomes following switching to pregabalin in individuals with gabapentin-refractory neuropathic pain in routine medical practice.

AbstractBackground: It has been suggested that peripheral neuropathic pain (PNP) may affect up to 3% of the general population. PNP has a substantial negative impact on patient functioning and quality of life, including reduced productivity and increased consumption of healthcare resources. Objective: The objective of this study was to analyse changes in pain and patient-reported health outcomes following switching to pregabalin treatment in patients with gabapentin-refractory PNP as part of routine clinical practice in Spanish primary-care settings. Methods: This was an open-label, non-randomized, post hoc analysis of a 12-week, multicentre, non-interventional cost-of-illness study. The study involved primary-care physicians and was carried out between September 2005 and April 2006. Patients were aged at least 18 years and had chronic, treat-ment-refractory PNP. The analysis included all pregabalin-naïve patient switches that had previously shown an inadequate response to gabapentin. The following variables were assessed before and after pregabalin therapy: pain (Short-Form McGill Pain Questionnaire [SF-MPQ]), disability level (Sheehan Disability Scale [SDS]), symptoms of anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), self-perceived sleep quality and quantity (Medical Outcomes Study [MOS] Sleep Scale), and health-related quality of life (EuroQol [EQ] five-dimension [5D] questionnaire). Results: A total of 174 patients with an inadequate response to gabapentin switched to pregabalin at the beginning of the study. After 12 weeks of pregabalin therapy, alone or in combination with other analgesic drugs, significant and clinically relevant improvements were observed in pain severity [mean (SD) SF-MPQ change: −31.9 (22.1) points; 42.5% being responders (pain reduction ≥50%)], disability [SDS score: −7.5 (6.2) vs baseline], affective symptoms [HADS depression: −4.5 (3.9); HADS anxiety: −4.1 (3.7)], sleep [MOS summary index: −17.2 (16.6)], and health status [EQ-5D visual analogue scale (VAS): 27.3 (18.2)], with an overall gain of 0.040 (0.031) quality-adjusted life-years. Conclusion: These findings suggest that pregabalin could be a valid treatment alternative for the management of patients with gabapentin-refractory peripheral neuropathic pain in primary-care settings under real-life conditions of care. Our data show that patients who were switched to pregabalin, either as monotherapy or in combination with other analgesics, showed substantial and clinically relevant improvements in relieving pain and related symptoms.

A cost-consequences analysis of the effect of pregabalin in the treatment of painful radiculopathy under medical practice conditions in primary care settings.

Purpose:  To analyze the effect of pregabalin (PGB) on pain relief, longitudinal utilization of health and nonhealth resources and derived costs in patients with refractory painful radiculopathy under routine medical practice in primary care settings (PCS).

Analgesic efficacy of zoledronic acid and its effect on functional status of prostate cancer patients with metastasis

Objectives A multi-centered observational study evaluated the efficacy of zoledronic acid for improving pain and mobility, and preventing skeletal-related events (SRE) (fracture, spinal compression, pain-relieving radiotherapy), in patients with prostate cancer and bone metastasis. Materials and Methods Males (n = 218) with prostate cancer and bone metastasis undergoing oncologic therapy received zoledronic acid (4 mg iv/month) for 6 months. Parameters evaluated were: 1) pain and movement after 2 consecutive doses; 2) quality of life; 3) SRE incidence and time-to-appearance. Medication tolerance and treatment satisfaction were assessed using a questionnaire. Results A total of 170 that matched all the inclusion criteria (78%) out of 218 were evaluable for efficacy. There was a measurable statistically significant reduction in pain at rest and on movement as well as an improvement in the quality of life compared with baseline. Best results were obtained with early treatment. Overall incidence of bone events was 11.2%. Of the 212 patients (97.2%) evaluable for safety, 16% suffered adverse events and 66% expressed satisfaction with the treatment Discussion Zoledronic acid is effective for reducing pain, improving mobility, and increasing the quality of life in patients with prostate cancer with bone metastasis. Its easy administration and good tolerability make zoledronic acid one of the principal therapeutic tools in the management of patients with pain associated with bone metastasis from prostate cancer.