Influence of the number of daily pills and doses on adherence to antiretroviral treatment: a 7-year study.

WHAT IS KNOWN AND OBJECTIVE: Antiretroviral treatment (ART) is hampered by complicated regimens, high pill burden, drug-drug interactions, and frequent short- and long-term adverse effects, leading to decreased adherence. Over recent years, considerable effort has been directed at developing regimens that are less burdening. We undertook a 7-year retrospective study of the records of 264 HIV-infected subjects enrolled in a pharmaceutical care programme to document the progress made and to study the influence of the number of ART pills and doses on the level of treatment adherence. METHODS: Antiretroviral dispensing records were analysed for the number of pills and doses administered and the ART adherence rate estimated. RESULTS AND DISCUSSION: In 2005, the patients took a mean of 6·2 pills daily (CI 95%: 5·9-6·6), and 92·9% of them were on a twice-a-day (BID) dosage regimen. By 2012, the mean number of pills was reduced to 4·1 (CI 95%: 3·8-4·4), and only 50·9% were on a BID regimen. No statistically significant relation was observed between number of daily pills and doses and ART adherence reached by the patients in any of the analyses performed. WHAT IS NEW AND CONCLUSIONS: There has been a continuous reduction in the number of pills and doses of antiretrovirals taken by individual patients over the last 7 years due largely to the introduction of improved treatments and regimens. More daily pills or doses was not associated with worse ART adherence in our pharmaceutical care programme.

Pharmacogenetic analysis of SNPs in genes involved in the pharmacokinetics and response to lopinavir/ritonavir therapy.

Despite the known benefits and the experienced use of lopinavir/ritonavir (LPV/r) in the management of HIV infection, important interindividual variability in the pharmacokinetics (PKs) and the response to treatment with standard doses of this drug has been observed. Host genetic factors have been recently suggested as being responsible for part of this variability as they may affect the expression and functional activity of many proteins involved in the kinetic behavior, the immune recovery or the adverse effects related to LPV/r. Here, we present a genetic association study in 106 HIV-infected individuals collected over a period of 5 years with the aim of identifying and confirming single nucleotide polymorphisms (SNPs) with a significant influence on the PK parameters of LPV/r, the immunovirological response or toxicity derived from treatment with the studied drug. Genotyping was performed by MALDI-TOF and KASPar; LPV/r plasma concentrations were quantified using high-performance liquid chromatography with an ultraviolet detection system and the PK parameters were estimated using Bayesian algorithms. Genetic association analysis was performed with SPSS. The most significant associations were found between SNPs in the dopamine receptor D3 gene and the PK of LPV/r. Additionally, other suggestive relationships were established between genetic factors and the response during treatment with this drug. Thereby, identifying HIV-infected individuals who are at increased risk of achieve non-optimal LPV/r plasma concentrations with the emergence of toxicity, drug resistance or absence of clinical response could be helpful as a tool to optimize the LPV/r-based antiretroviral therapy.

[Biosimilars: assessment of efficacy, safety and cost]. / Biosimilares: balance de eficacia, seguridad y coste.

A biosimilar medicinal product is a successor to a biological medicinal product for which patent protection no longer applies. Manufactured by recombinant DNA technology (insertion of gene into the host cell to produce the protein). Comparable with the selected comparator, reference product, in terms of quality, safety and efficacy. The biosimilar product is usually approved for the same indications as the comparator reference product given that they share the same mode of actions.

Biosimilares: balance de eficacia, seguridad y coste / Biosimilars: assessment of efficacy, safety and cost

Un medicamento biosimilar es un producto biológico que sucede a un innovador una vez que su patente ha expirado. Se producen por tecnología del ADN recombinante (inserción de un gen en la célula huésped para producir la proteína). El biosimilar debe ser comparable con el innovador en términos de calidad, seguridad y eficacia. El biosimilar es autorizado con las mismas indicaciones que el innovador debido a que presentan el mismo mecanismo de acción (AU)

A biosimilar medicinal product is a successor to a biological medicinal product for which patent protection no longer applies. Manufactured by recombinant DNA technology (insertion of gene into the host cell to produce the protein). Comparable with the selected comparator, reference product, in terms of quality, safety and efficacy. The biosimilar product is usually approved for the same indications as the comparator reference product given that they share the same mode of actions (AU)

Documento de Consenso sobre el uso de factores estimuladores de colonias de granulocitos biosimilares para la corrección de la neutropenia asociada en pacientes con cáncer / No disponible

No disponible

[Prevalence and factors associated with preventable adverse drug events leading to hospital admission]. / Prevalencia y factores asociados a los acontecimientos adversos prevenibles por medicamentos que causan el ingreso hospitalario.

OBJECTIVE: To determine the prevalence of adverse drug events (ADEs) leading to hospital admission, and to assess those that were potentially preventable, identifying the drug classes involved, types of medication errors and the factors associated with the preventable ADEs. METHOD: An observational study, over a six-month period on ADEs that lead or contributed to hospital admissions, carried out in 6 medical units of a university hospital. RESULTS: A total of 259 ADEs were detected of which 159 (61.4%) were assessed to be potentially preventable. The overall prevalence of admissions directly due to ADEs was of 6.7% (177) and to preventable ADEs of 4.7% (125). In addition, 82 ADEs that contributed to hospital admission were detected. Risk factors for preventable ADEs were patient age of 65-74 (OR = 1.40) or = 75 years (OR = 2.70), self-medication (OR = 15.55), prescription in primary care (OR = 2,88) and the use of narrow therapeutic index drugs (OR = 2.40). The drug classes most frequently involved in preventable ADEs were NSAID and aspirin (32.5%), diuretics (15.3%), antihypertensives (9.1%) and digoxin (7.7%). Inadequate therapy monitoring (20.7%), prescription of an inappropriate drug (15.7%) or of an excessive dosage (12.0%), lack of preventive treatment (15.7%), non-adherence (10.6%) and inappropriate self-medication (10.1%) were the most commonly identified types of error. CONCLUSIONS: A high proportion (4.7%) of hospital admissions are caused by potentially preventable ADEs. Results obtained justified the need to adopt measures directed at improving surveillance and prescription quality, and educating patients in safe drug use, focusing especially on older patients and narrow therapeutic index drugs.

Prevalencia y factores asociados a los acontecimientos adversos prevenibles por medicamentos que causan el ingreso hospitalario / No disponible

Objetivo: Determinar la prevalencia de acontecimientosadversos por medicamentos (AAM) que causan el ingreso hospitalario,y evaluar los AAM prevenibles, identificando los medicamentosimplicados, los tipos de errores y los factores asociados asu aparición.Método: Estudio observacional de 6 meses, realizado en 6unidades médicas de un hospital universitario, sobre los AAM quemotivaron o contribuyeron al ingreso hospitalario.Resultados: Se detectaron un total de 259 AAM, de los que159 (61,4%) fueron potencialmente prevenibles. La prevalenciade ingresos causados directamente por AAM fue del 6,7% (177) ypor AAM prevenibles del 4,7% (125). Además, se detectaron 82AAM que contribuyeron al ingreso. Los factores de riesgo deAAM prevenibles fueron: edad 65-74 años (OR = 1,40) o ≥ 75años (OR = 2,70), automedicación (OR = 15,55), prescripción enatención primaria (OR = 2,88) y uso de medicamentos de margenterapéutico estrecho (OR = 2,40). Los medicamentos más frecuentementeimplicados en los AAM prevenibles fueron: AINE yaspirina (32,5%), diuréticos (15,3%), antihipertensivos (9,1%) ydigoxina (7,7%). Los principales tipos de errores identificados fueron:falta de seguimiento (20,7%), prescripción de medicamentoinapropiado (15,7%) o de dosis elevadas (12,0%), falta de tratamientopreventivo (15,7%), falta de adherencia (10,6%) y automedicacióninapropiada (10,1%).Conclusiones: Una elevada proporción (4,7%) de ingresoshospitalarios está motivada por AAM potencialmente prevenibles.Los resultados obtenidos apoyan la necesidad de adoptar medidasenfocadas a mejorar el seguimiento y la prescripción de los tratamientos,y a promover la educación sanitaria sobre medicamentos,dirigidas prioritariamente a los pacientes de edad avanzada ya los medicamentos de margen terapéutico estrecho

Objective: To determine the prevalence of adverse drugevents (ADEs) leading to hospital admission, and to assess thosethat were potentially preventable, identifying the drug classesinvolved, types of medication errors and the factors associatedwith the preventable ADEs.Method: An observational study, over a six-month period onADEs that lead or contributed to hospital admissions, carried outin 6 medical units of a university hospital.Results: A total of 259 ADEs were detected of which 159(61.4%) were assessed to be potentially preventable. The overallprevalence of admissions directly due to ADEs was of 6.7% (177)and to preventable ADEs of 4.7% (125). In addition, 82 ADEsthat contributed to hospital admission were detected. Risk factorsfor preventable ADEs were patient age of 65-74 (OR = 1.40) or≥ 75 years (OR = 2.70), self-medication (OR = 15.55), prescriptionin primary care (OR = 2,88) and the use of narrow therapeuticindex drugs (OR = 2.40). The drug classes most frequentlyinvolved in preventable ADEs were NSAID and aspirin (32.5%),diuretics (15.3%), antihypertensives (9.1%) and digoxin (7.7%).Inadequate therapy monitoring (20.7%), prescription of an inappropriatedrug (15.7%) or of an excessive dosage (12.0%), lack ofpreventive treatment (15.7%), non-adherence (10.6%) and inappropriateself-medication (10.1%) were the most commonly identifiedtypes of error. Conclusions: A high proportion (4.7%) of hospital admissionsare caused by potentially preventable ADEs. Resultsobtained justified the need to adopt measures directed at improvingsurveillance and prescription quality, and educating patients insafe drug use, focusing especially on older patients and narrowtherapeutic index drugs

[Antisense therapy in oncology: present situation]. / Terapia antisentido en oncología: situación actual.

The purpose of antisense therapy is to control the regulation of genes contributing to cancer progression while sparing normal cell growth, which represents a novel alternative with fewer side effects when compared to conventional chemotherapy. Antisense oligonucleotides control cell proliferation by specifically blocking the expression of selected genes, and hence they are being developed as molecular drugs with potential activity for cancer treatment. Extensive clinical information and a number of clinical trials show encouraging results. This review discusses the most significant aspects of this new therapeutic alternative in oncology. Clinical trials performed thus far have demonstrated their short- to mid-term efficacy and safety; however, long-term studies are needed to definitely define their clinical effectiveness and true toxic profile.

Terapia antisentido en oncología: situación actual / Antisense therapy in oncology: present situation

La finalidad de la terapia antisentido es controlar la regulaciónde los genes que contribuyen a la progresión del cáncer sin afectaral crecimiento de las células normales, por lo que representa unanueva alternativa con menos efectos secundarios que la quimioterapiaconvencional. Los oligonucleótidos antisentido controlan laproliferación celular al bloquear específicamente la expresión dedeterminados genes, por lo que se están desarrollando como fármacosmoleculares con potencial actividad en el tratamiento delcáncer. Se dispone de amplia información preclínica y de algunosensayos clínicos con resultados esperanzadores. En esta revisiónse recogen los aspectos más significativos de esta nueva alternativaterapéutica en oncología. Los ensayos clínicos realizados hastala fecha han puesto de manifiesto su eficacia y seguridad a corto ymedio plazo; sin embargo, son necesarios estudios a largo plazopara terminar de definir su efectividad clínica y su verdadero perfiltoxicológico

The purpose of antisense therapy is to control the regulation ofgenes contributing to cancer progression while sparing normalcell growth, which represents a novel alternative with fewer sideeffects when compared to conventional chemotherapy. Antisenseoligonucleotides control cell proliferation by specifically blockingthe expression of selected genes, and hence they are being developedas molecular drugs with potential activity for cancer treatment.Extensive clinical information and a number of clinical trialsshow encouraging results. This review discusses the most significantaspects of this new therapeutic alternative in oncology. Clinicaltrials performed thus far have demonstrated their short- tomid-term efficacy and safety; however, long-term studies areneeded to definitely define their clinical effectiveness and true toxicprofile

[Cost-utility analysis of relapsing-remitting multiple sclerosis treatment with azathioprine or interferon beta in Spain]. / Análisis coste-utilidad del tratamiento de la esclerosis múltiple remitente-recidivante con azatioprina o interferón beta en España.

AIM: To carry out a cost-utility analysis of the treatment of relapsing-remitting multiple sclerosis (RRMS) with azathioprine (Imurel) or beta interferon (all, Avonex, Rebif and Betaferon). MATERIAL AND METHODS: Pharmacoeconomic Markov model comparing 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 (euros in 2003) of a life treatment, considering a life expectancy of 53 years, would be 620,205, 1,047,836, 1,006,014, 1,161,638 and 968,157 euros with Imurel, all interferons, Avonex, Rebif and Betaferon, respectively. Therefore, the saving with Imurel would range between 327,000 and 520,000 euros approximately. The quality-adjusted life years (QALY) obtained with Imurel or interferons would be 10.08 and 9.30, respectively, with an average gain of 0.78 QALY per patient treated with Imurel. The sensitivity analyses confirmed the robustness of the base case. The cost of one additional QALY with interferons would range between 413,000 and 1,308,000 euros approximately in the hypothetical worst scenario for Imurel. CONCLUSIONS: For a typical patient with RRMS, treatment with Imurel would be more efficient than interferons and would dominate (would be more efficacious with lower costs) beta interferon.

Análisis coste-utilidad del tratamiento de la esclerosis múltiple remitente-recidivante con azatioprina o interferón beta en España / Cost-utility analysis of relapsing-remitting multiple sclerosis treatmetn with azathioprine or interferon beta in Spain

Aim. To carry out a cost-utility analysis of the treatment of relapsing-remitting multiple sclerosis (RRMS) with azathioprine (Imurel) or beta interferon (all, Avonex, Rebif and Betaferon). Material and methods. Pharmacoeconomic Markov model comparing 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 (euros in 2003) of a life treatment, considering a life expectancy of 53 years, would be 620,205, 1,047,836, 1,006,014, 1,161,638 and 968,157 euros with Imurel, all interferons, Avonex, Rebif and Betaferon, respectively. Therefore, the saving with Imurel would range between 327,000 and 520,000 euros approximately. The qualityadjusted life years (QALY) obtained with Imurel or interferons would be 10.08 and 9.30, respectively, with an average gain of 0.78 QALY per patient treated with Imurel. The sensitivity analyses confirmed the robustness of the base case. The cost of one additional QALY with interferons would range between 413,000 and 1,308,000 euros approximately in the hypothetical worst scenario for Imurel. Conclusions. For a typical patient with RRMS, treatment with Imurel would be more efficient than interferons and would dominate (would be more efficacious with lower costs) beta interferon (AU)

Objetivo. Realizar un análisis coste-utilidad del tratamiento de la esclerosis múltiple remitente-recidivante (EMRR) con azatioprina (Imurel) o los interferones beta (todos en conjunto, Avonex, Rebif y Betaferon). Material y métodos. Modelo farmacoeconómico de Markov que comparó los tratamientos mediante la simulación de la vida de una cohorte hipotética de mujeres de 30 años de edad, desde la perspectiva de la sociedad. Las probabilidades de transición, las utilidades, la utilización de recursos y los costes (directos e indirectos) se estimaron a partir de fuentes españolas y de la bibliografía. Se hicieron análisis de sensibilidad simples univariantes del caso básico. Resultados. En el caso básico del análisis, el coste medio por paciente (euros de 2003) de un tratamiento de por vida, considerando una esperanza de vida de 53 años, sería de 620.205, 1.047.836, 1.006.014, 1.161.638 y 968.157 euros con Imurel, todos los interferones, Avonex, Rebif y Betaferon, respectivamente. Por tanto, el ahorro con Imurel oscilaría entre 327.000 y 520.000 euros, aproximadamente. Los años de vida ajustados por calidad (AVAC) que se obtendrían con Imurel o los interferones serían 10,08 y 9,30, respectivamente, con una ganancia media de 0,78 AVAC por paciente tratado con Imurel. Los análisis de sensibilidad confirmaron la estabilidad del caso básico. El coste de obtener un AVAC adicional con los interferones oscilaría entre 413.000 y 1.308.000 euros, aproximadamente, en el caso hipotético de que se produjera el peor escenario posible para Imurel. Conclusiones. Para un paciente tipo con EMRR, el tratamiento con Imurel sería más eficiente que los interferones, a los que dominaría –Imurel sería más eficaz con costes inferiores a los de éstos (AU)

Seguridad de medicamentos. Prevención de errores de medicación / Drug safety. Preventing medication errors

No disponible

Abreviaturas, símbolos y expresiones de dosis asociados a errores de medicación / Drug safety. Error-prone abbreviations, symbols and dose designations

No disponible

Respuesta de los autores a la carta de Ahumada et al sobre el artículo "Análisis farmacoeconómico del tratamiento de la artritis reumatoide resistente a metotrexato con las combinaciones de leflunomida-metotrexato o infliximab-metotrexato" / Response to the letter of M. C. Ahumada et al, on the article "Pharmacoeconomic analysis of methotrexate-resistant rheumatoid arthritis with combinations of leflunomide-methotrexate or infliximab-methotrexate"

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Seguridad de Medicamentos. Prevención de errores de medicación / Drug safety. Preventing medication errors

No disponible