Medida de la calidad de vida mediante las láminas Coop-Wonca en una muestra de pacientes con fibromialgia tratadas con pregabalina

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Abstract

Objetivo: En el seguimiento de los enfermos de Fibromialgia interesa conocer los resultados obtenidos en medidas que reflejen la repercusión sobre la Calidad de Vida Relacionada con la Salud (CVRS) de los pacientes. Este interés aumenta cuando se utiliza un fármaco novedoso como es pregabalina, un anticonvulsivante de última generación, que se une a la subunidad a2-d de los canales del calcio. Utilizando como instrumento las láminas COOP-WONCA ( versión validada española de Nottingham Health Profile ) nos planteamos estudiar si pregabalina mejora la percepción de calidad de vida de un grupo de pacientes con Fibromialgia. Métodos: Este estudio comparó los resultados de las láminas Coop-Wonca sin pregabalina, con pregabalina a dosis de 300 y de 600 mg/día en un grupo de 16 pacientes con Fibromialgia. En todos los casos se mantuvieron sus tratamientos habituales. Resultados: No hubo diferencias estadísticamente significativas en los resultados de las láminas Coop-Wonca al añadir pregabalina a dosis de 300 mg/día y 600 mg/día ( p ‹ 0.05 ). Los efectos secundarios más frecuentes fueron mareo y aumento de peso. Conclusión: Las viñetas Coop-Wonca como instrumento de medida la calidad de vida relacionada con la salud no mostraron mejoría en nuestra muestra de 16 pacientes con FM cuando se añadió pregabalina al tratamiento. Creemos que se precisa un estudio más amplio con un número mayor de pacientes para extraer más conclusiones al respecto.

Translated abstract

Objective: About the evolution of patients with Fibromyalgia it is interesting to know the results of measures assesing of the health-related quality of life.The interest annhace with the use of a new drug, pregabalin, the lastest generation anti-convulsivant, a ligand of a2-d subunit of calcium chanels. Helped by the COOP-WONCA charts ( reliable Spanish version of Nottingham Health Profile) our aim is determine if pregabalin improve the health-related quality of life in a group of Fibromyalgia affected patients. Methods: This trial compared the results of Coop-Wonca charts without pregabalin, with dosis of 300 and 600 mg/day pregabalin in a group of 16 patients with Fibromyalgia. All patients were continuated with their medications. Results: Pregabalin at 300 and 600 mg/day did not significantly improvement in the results of Coop/Wonca charts (p ‹ 0.05). Dizziness and weight gain were the most frequent adverse events. Conclusion: The scale of health-related quality of life Coop/Wonca did not result in improvement in our group of 16 patientes with Fibromyalgia when pregabalin was add to the treatment. Further study with a large group of patients is necessary to draw more conclusions on this point.

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Pregabalin for the treatment of postherpetic neuralgia: a randomized, placebo-controlled trial.

Uma Sharma, E Garofalo, R Poole … (2003)

To evaluate the efficacy and safety of pregabalin in the treatment of postherpetic neuralgia (PHN). The authors conducted a multicenter, parallel-group, double-blind, placebo-controlled, 8-week, randomized clinical trial in PHN, defined as pain for 3 or more months following herpes zoster rash healing. Patients (n = 173) were randomized to treatment with pregabalin or placebo. Patients randomized to pregabalin received either 600 mg/day (creatinine clearance > 60 mL/min) or 300 mg/day (creatinine clearance 30 to 60 mL/min). The primary efficacy measure was the mean of the last seven daily pain ratings. Secondary endpoints included additional pain ratings, sleep interference, quality of life, mood, and patient and clinician ratings of global improvement. Pregabalin-treated patients had greater decreases in pain than patients treated with placebo (endpoint mean scores 3.60 vs 5.29, p = 0.0001). Pain was significantly reduced in the pregabalin-treated patients after the first full day of treatment and throughout the study, and significant improvement on the McGill Pain Questionnaire total, sensory, and affective pain scores was also found. The proportions of patients with >or=30% and >or=50% decreases in mean pain scores were greater in the pregabalin than in the placebo group (63% vs 25% and 50% vs 20%, p = 0.001). Sleep also improved in patients treated with pregabalin compared to placebo (p = 0.0001). Both patients and clinicians were more likely to report global improvement with pregabalin than placebo (p = 0.001). Given the maximal dosage studied, pregabalin had acceptable tolerability compared to placebo despite a greater incidence of side effects, which were generally mild to moderate in intensity. Treatment of PHN with pregabalin is safe, efficacious in relieving pain and sleep interference, and associated with greater global improvement than treatment with placebo.

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Efficacy of pregabalin in neuropathic pain evaluated in a 12-week, randomised, double-blind, multicentre, placebo-controlled trial of flexible- and fixed-dose regimens.

Krzysztof Strojek, Michael Balkenohl, Teresa Griesing … (2005)

Pregabalin binds with high affinity to the alpha2-delta subunit protein of voltage-gated calcium channels and, thereby, reduces release of excitatory neurotransmitters. This 12-week randomised, double-blind, multicentre, placebo-controlled, parallel-group study evaluated the efficacy and safety of pregabalin in patients with chronic postherpetic neuralgia (PHN) or painful diabetic peripheral neuropathy (DPN). Patients were randomised to placebo (n=65) or to one of two pregabalin regimens: a flexible schedule of 150, 300, 450, and 600 mg/day with weekly dose escalation based on patients' individual responses and tolerability (n=141) or a fixed schedule of 300 mg/day for 1 week followed by 600 mg/day for 11 weeks (n=132). Both flexible- and fixed-dose pregabalin significantly reduced endpoint mean pain score (primary outcome) versus placebo (P=0.002, P<0.001) and were significantly superior to placebo in improving pain-related sleep interference (P<0.001). The most common adverse events (AEs) for pregabalin-treated patients were dizziness, peripheral oedema, weight gain (not affecting diabetes control), and somnolence. These results are consistent with previous studies' demonstrating pregabalin's efficacy, tolerability, and safety for treatment of chronic neuropathic pain associated with DPN or PHN. Pregabalin dosing aimed at optimal balance of efficacy and tolerability provides significant pain relief and may reduce risks for AEs and therapy discontinuation.

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Pregabalin reduces pain and improves sleep and mood disturbances in patients with post-herpetic neuralgia: results of a randomised, placebo-controlled clinical trial.

Jonathan Cherry, Mark Versavel, Florence Jacquot … (2004)

This study was designed to assess the efficacy and safety of pregabalin-a novel alpha(2)-delta ligand with analgesic, anxiolytic, and anticonvulsant activity-for treating neuropathic pain in patients with post-herpetic neuralgia (PHN). Two hundred and thirty-eight patients were randomised into this multicentre, doubleblind, placebo-controlled trial to receive 150 (n=81), 300 mg/day (n=76) pregabalin, or placebo (n=81) for 8 weeks. Among the exclusion criteria was failure to respond to previous treatment for PHN with gabapentin at doses > or =1200 mg/day. Endpoint mean pain scores were significantly reduced in patients receiving 150 or 300 mg/day pregabalin compared with placebo. Efficacy was observed as early as week 1 and was maintained throughout the study. Significantly more patients in both pregabalin groups (150 mg, 26%; 300 mg, 28%) were responders (> or =50% decrease in mean pain score from baseline to endpoint) than in the placebo group (10%). Additionally, by week 1 and for the study's duration, 150 and 300 mg/day pregabalin significantly reduced weekly mean sleep interference scores. More pregabalin-treated patients than placebo-treated patients reported that they were 'much improved' or 'very much improved'. Health-related quality-of-life (HRQoL) measurements using the SF-36 Health Survey demonstrated improvement in the mental health domain for both pregabalin dosages, and bodily pain and vitality domains were improved in the 300 mg/day group. The most frequent adverse events were dizziness, somnolence, peripheral oedema, headache, and dry mouth. Pregabalin efficaciously treated the neuropathic pain of PHN. Additionally, pregabalin was associated with decreased sleep interference and significant improvements in HRQoL measures.