Comparative efficacy of two primary care interventions to assist withdrawal from long term benzodiazepine use: A protocol for a clustered, randomized clinical trial

<p>Abstract</p> <p>Background</p> <p>Although benzodiazepines are effective, long-term use is not recommended because of potential adverse effects; the risks of tolerance and dependence; and an increased risk of hip fractures, motor vehicle accidents, and memory impairment. The estimated prevalence of long-term benzodiazepine use in the general population is about 2,2 to 2,6%, is higher in women and increases steadily with age. Interventions performed by General Practitioners may help patients to discontinue long-term benzodiazepine use. We have designed a trial to evaluate the effectiveness and safety of two brief general practitioner-provided interventions, based on gradual dose reduction, and will compare the effectiveness of these interventions with that of routine clinical practice.</p> <p>Methods/Design</p> <p>In a three-arm cluster randomized controlled trial, general practitioners will be randomly allocated to: a) a group in which the first patient visit will feature a structured interview, followed by visits every 2-3 weeks to the end of dose reduction; b) a group in which the first patient visit will feature a structured interview plus delivery of written instructions to self-reduce benzodiazepine dose, or c) routine care. Using a computerized pharmaceutical prescription database, 495 patients, aged 18-80 years, taking benzodiazepine for at least 6 months, will be recruited in primary care health districts of three regions of Spain (the Balearic Islands, Catalonia, and Valencia). The primary outcome will be benzodiazepine use at 12 months. The secondary outcomes will include measurements of anxiety and depression symptoms, benzodiazepine dependence, quality of sleep, and alcohol consumption.</p> <p>Discussion</p> <p>Although some interventions have been shown to be effective in reducing benzodiazepine consumption by long-term users, the clinical relevance of such interventions is limited by their complexity. This randomized trial will compare the effectiveness and safety of two complex stepped care interventions with that of routine care in a study with sufficient statistical power to detect clinically relevant differences.</p> <p>Trial Registration</p> <p>Current Controlled Trials: <a href="http://www.controlled-trials.com/ISRCTN13024375">ISRCTN13024375</a></p

Evolución de la utilización de antidepresivos, ansiolíticos e hipnóticos en la Comunitat Valenciana. Período 2000-2010

ResumenObjetivoConocer la evolución de la utilización de antidepresivos (AD), ansiolíticos(A) e hipnóticos (H) en la Comunidad Valenciana (CV) entre los años 2000 y2010, su importe y el coste por dosis diaria definida (DDD).DiseñoEstudio observacional retrospectivo.EmplazamientoRecetas dispensadas cargo del sistema público de salud de la CV durante los años 2000 a 2010.MedicionesConsumo de los principios activos pertenecientes a los grupos terapéuticos N05B (A), N05C (H) y N06A (AD) obtenidos a partir de la base de datos de farmacia de la Agencia Valenciana de Salud medido en dosis habitante día.ResultadosDurante el período estudiado, el consumo de AD aumentó el 81,2% y el de A e H el 11,7%. Los inhibidores selectivos de la recaptación de serotonina fueron los AD más prescritos y los inhibidores de la recaptación de serotonina y noradrenalina los de mayor crecimiento (386,8%). Escitalopram aumentó el 1.013%. Lorazepam, alprazolam y diacepam, suman el 80,4% de los ansiolíticos prescritos, y lormetazepam y zolpidem el 88,7% de los hipnóticos. El importe de los AD aumentó el 78,2% y el de los A e H el 14,5%; el coste por DDD de ambos grupo descendió el 29%.ConclusionesLa utilización de AD en la CV ha experimentado un gran incremento entre 2000-2010, mientras que el de A e H ha sido moderado, aunque su consumo todavía está por encima del de AD. A pesar de la reducción en el coste de la DDD en ambos grupos, el importe global de la factura en antidepresivos en la CV sigue en aumento.AbstractObjectiveTo describe the evolution in the use of antidepressants (AD), anxiolytics (A) and hypnotics (H) in the Comunitat Valenciana (CV) between 2000 and 2010, their expenditure, and the cost of the defined daily dose (DDD).DesignRetrospective observational study.SettingPrescriptions covered by the health public service of the CV during the period 2000-2010.MeasurementsConsumption of the therapeutic groups N06A (antidepressants), N05B (anxiolytics) and N05C (hypnotics) from the pharmacy database of the public Valencian Health Agency measured in defined daily dose per 1.000 inhabitants.ResultsDuring the period of study the use of AD increased by 81.2% and A and H, 11.7%. Selective serotonin reuptake inhibitors were the most prescribed AD and Selective serotonin and norepinephrine reuptake inhibitors experienced the higher rise (386.8%). The increase of escitalopram was 1.013%. Lorazepam, alprazolam and diazepam, accounted for the 80.4% of the anxyolitics, and lormetazepam and zolpidem the 88.7% of the hypnotics. The expenditure rise of AD was by 78.2% and that of the A and H was 14.5%; the cost of the DDD of both decreased by 29%.ConclusionsAntidepressant utilization has experienced a remarkable rise between 2000 and 2010 while that of A and H has been mild even though they are still more consumed than AD. In spite of the reduction of the DDD cost in both therapeutic groups, the whole expenditure on AD in the CV is still growing

Efficacy of two interventions on the discontinuation of benzodiazepines in long-term users: 36-month follow-up of a cluster randomised trial in primary care

[eng] Background Primary care interventions that promote cessation of benzodiazepine (BZD) use in long-term users are effective at 1 year, but their efficacy at 3 years is uncertain. Aim To assess the 3-year efficacy of two primary care interventions delivered by GPs on cessation of BZD use in long-term users. Design and setting Multicentre, three-arm, cluster randomised, controlled trial, with random allocation at the GP level. Method Seventy-five GPs and 532 patients were randomly allocated to three groups: usual care (control), structured intervention with stepped-dose reduction and follow-up visits (SIF), or structured intervention with written stepped-dose reduction (SIW). The primary outcome was BZD use at 36 months. Results At 36 months, 66/168 patients (39.2%) in the SIW group, 79/191 patients (41.3%) in the SIF group, and 45/173 patients (26.0%) in the control group had discontinued BZD use. The relative risks (RR) adjusted by cluster were 1.51 (95% CI = 1.10 to 2.05; P = 0.009) in the SIW group and 1.59 (95% CI = 1.15 to 2.19; P = 0.005) in the SIF group. A total of 131/188 patients (69.7%) who successfully discontinued BZD use at 12 months remained abstinent at 36 months. The groups showed no significant differences in anxiety, depression, or sleep dissatisfaction at 36 months. Conclusion The interventions were effective on cessation of BZD use; most patients who discontinued at 12 months remained abstinent at 3 years. Discontinuation of BZD use did not have a significant effect on anxiety, depression, or sleep quality