RESUMO
OBJECTIVE: To carry out a cost-utility analysis of the treatment of relapsing-remitting multiple sclerosis (RRMS) with glatiramer acetate (copaxone) or interferon beta (all, avonex, rebif and betaferon). METHODS: A pharmacoeconomic Markov model was used to compare treatment options by simulating the life of a hypothetical cohort of women aged 30, from the societal perspective. The transition probabilities, utilities, resource utilisation and costs (direct and indirect) were obtained from Spanish sources and from bibliography. Univariant sensitivity analyses of the base case were performed. RESULTS: In the base case analysis, the average cost per patient (euro in 2001) for a lifetime treatment, considering a life expectancy of 53 years, would be 1,243,906 euros (euro), 1,818,149 euros, 1,763,263 euros, 1,987,153 euros and 1,704,031 euros with copaxone, all interferons, avonex, rebif and betaferon, respectively. Therefore, the saving with copaxone would range between 460,000 and 737,000 euros approximately. The quality-adjusted life years (QALY) obtained with copaxone or interferons would be 10.977 and 6.917, respectively, with an average gain of 4.060 QALY patient with copaxone. The sensitivity analyses confirmed the robustness of the base case. The interferons would only be superior to copaxone in the unlikely hypothetical case that they delay the progression of the illness by 20% more than that actually observed in clinical trials. CONCLUSIONS: For a typical patient with RRMS, treatment with copaxone would be more efficient than interferons and would dominate (would be more efficacious with lower costs) interferon beta.
Assuntos
Imunossupressores/economia , Imunossupressores/uso terapêutico , Interferon Tipo I/economia , Interferon Tipo I/uso terapêutico , Esclerose Múltipla Recidivante-Remitente/economia , Esclerose Múltipla Recidivante-Remitente/terapia , Peptídeos/economia , Peptídeos/uso terapêutico , Adulto , Análise Custo-Benefício , Feminino , Acetato de Glatiramer , Humanos , Cadeias de Markov , Anos de Vida Ajustados por Qualidade de Vida , Proteínas RecombinantesRESUMO
OBJECTIVE: To evaluate the measurement properties of the Hypertension Quality of Life (HQALY) questionnaire, under normal clinical practice conditions, and the relationship between quality of life and clinical variables in patients with hypertension. DESIGN: Observational, prospective and multi-centred study. SETTING: 92 primary care centres in Spain. PARTICIPANTS: 269 patients, of both sexes and over 17, with hypertension, stratified by age (18-44, 45-64 and over 64), sex and organic complaint. 106 individuals over 17 with normal tension were chosen at random. INTERVENTIONS: Intensification of treatment in hypertense patients. MEASUREMENTS: Administration of the HQALY and the EuroQol-5D at every attendance (patients, basal and at a month; controls, basal). In addition, at the basal attendance social-demographic and clinical features were recorded, and at the attendance at a month the clinical features and changes in health status. MAIN RESULTS: Mean time of administration was 28 (23) minutes. VALIDITY: factor analysis showed two dimensions, state of mind and somatic manifestations, which correlated most closely with the dimensions of anxiety/depression (0.64) and pain/discomfort (0.55) on the EQ-5D, respectively. HQALY scores were higher (worse quality of life) in patients than in controls without hypertension (p < 0.01). Reliability: intraclass correlation coefficient was 0.88 in state of mind and 0.76 in somatic manifestations. Cronbach's alpha was 0.96 and 0.89, respectively. Sensitivity: the "size of the effect" at a month from starting treatment for hypertension was 0.40. Hypertension for over 10 years, more organs affected, gravity and morbid obesity were associated with worse quality of life, especially in the state-of-mind dimension. Cardiac frequency correlated closer with state of mind than somatic manifestations. CONCLUSIONS: The HQALY is the first specific hypertension questionnaire developed in Spain which has been shown valid, reliable and sensitive to changes. However, the number of items on it must be reduced for routine use in clinical practice.
Assuntos
Hipertensão , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Inquéritos e Questionários , Adolescente , Adulto , Idoso , Estudos de Casos e Controles , Feminino , Nível de Saúde , Humanos , Hipertensão/complicações , Hipertensão/psicologia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Fatores Sexuais , EspanhaRESUMO
Objetivo. Evaluar las propiedades de medición del cuestionario de calidad de vida en hipertensión arterial (CHAL), en condiciones de práctica clínica habitual, así como la relación existente entre calidad de vida y variables clínicas en pacientes con HTA. Diseño. Estudio observacional, prospectivo y multicéntrico. Emplazamiento. Noventa y dos centros de atención primaria de España. Participantes. Doscientos sesenta y nueve hipertensos de ambos sexos, mayores de 17 años, estratificados según edad (18-44, 45-64 y más de 64 años), sexo y afectación orgánica. Ciento seis individuos normotensos mayores de 17 años, seleccionados de forma aleatoria. Intervenciones. Intensificación del tratamiento en los pacientes hipertensos. Mediciones. Administración del CHAL y el EuroQol-5D en todas las visitas (pacientes: basal y al mes; controles: basal). Adicionalmente, se registraron en la visita basal las características sociodemográficas y clínicas, y en la visita al mes las características clínicas y los cambios en el estado de salud. Resultados principales. El tiempo medio (DE) de administración fue de 28 (23) minutos. Validez: el análisis factorial mostró dos dimensiones: estado de ánimo (EA) y manifestaciones somáticas (MS) que presentaron una correlación máxima con las dimensiones de ansiedad/depresión (0,64) y dolor/malestar (0,55) del EQ-5D, respectivamente. Las puntuaciones del CHAL fueron superiores (peor CV) en pacientes que en controles sin HTA (p < 0,01). Fiabilidad: el coeficiente de correlación intraclase fue de 0,88 en EA y de 0,76 en MS; el alfa de Cronbach de 0,96 y 0,89, respectivamente. Sensibilidad: el 'tamaño del efecto' al mes de iniciar el tratamiento antihipertensivo fue de 0,40. La HTA de más de 10 años, mayor afectación orgánica, gravedad y obesidad mórbida se asociaron a una peor calidad de vida, especialmente en la dimensión de EA. La frecuencia cardíaca se correlacionó más con el EA que con las MS. Conclusiones. El CHAL es el primer cuestionario específico para la HTA desarrollado en España que ha mostrado ser válido, fiable y sensible a los cambios. Sin embargo, debe reducirse el número de ítems para su uso rutinario en la práctica clínica (AU)