Treatment In Spain Research Articles

Cost-effectiveness of the combination therapy of dutasteride and tamsulosin in the treatment of benign prostatic hyperlasia in Spain

ObjectiveTo evaluate the incremental cost-effectiveness ratio (ICER) of the combination therapy with dutasteride and tamsulosin (DUT+TAM) as initiation treatment versus the most used drug in Spain, tamsulosin (TAM), in the treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH) with risk of progression. MethodsA semi-Markov model was developed using 4-year and 35-year time horizons and from the Spanish National Healthcare Service perspective. Data was obtained from the CombAT trial. Effectiveness was measured in terms of quality adjusted life years (QALYs). An experts’ panel defined healthcare resources and unitary costs were obtained from published Spanish sources. Pharmacologic cost is expressed in PTPWAT; in the case of TAM, the generic price is used; in the case of DUT+TAM the price of a fixed-dose combination is used. Costs are expressed in 2010 Euros. ResultsCombination therapy with DUT+TAM produces an incremental effectiveness of 0.06QALY at year 4 and 0.4QALY at year 35. DUT+TAM represents an incremental cost of €810.53 at 4 years and €3,443.62 at 35 years. Therefore, the ICER for DUT+TAM versus TAM is €14,023.32/QALY at year 4 and €8,750.15/QALY at year 35. ConclusionsInitiation treatment with DUT+TAM represents a cost-effective treatment versus TAM, the most used treatment in Spain, due to the fact the ICER is below the threshold that usually allows a technology to be considered as cost-effective.

Epidemiological description of the demographic and HIV disease characteristics of HIV patients who are in care but not on treatment in Spain

7‐11 November 2010, Tenth International Congress on Drug Therapy in HIV Infection, Glasgow, UK

Experiencia con la infusión continua de levodopa intraduodenal (Duodopa ®) en pacientes con enfermedad de Parkinson avanzada en un hospital de segundo nivel asistencial

Introduction Continuous levodopa delivery by enteral infusion (Duodopa ®) is an alternative to deep brain stimulation and subcutaneous apomorphine to control motor fluctuations and dyskinesias in advanced Parkinson's disease (PD). We report our experience with Duodopa ® therapy in 11 patients with advanced PD. Methods We retrospectively assessed clinical and quality of life changes in all patients with PD with severe motor fluctuations and dyskinesias who started continuous daily levodopa duodenal infusion through percutaneous endoscopic gastrostomy from September 2006 (Duodopa ® was approved for advanced PD treatment in Spain at that date) until April 2010 at the A. Marcide Hospital of Spain. Results Nine patients received Duodopa ® [62.7 ± 10.6 (44-74) years, 63.6% male)]. Pre-Duodopa ® clinical characteristics of patients were: disease duration 14.5 ± 8.9 (3-34) years, oral levodopa dose 918.2 ± 277.7 (450-1300) mg/day, and Hoehn and Yahr staging 3.7 ± 0.5 (3-4). Nine patients are still receiving Duodopa ®. Patients improved motor fluctuations (72.7% significant improvement), dyskinesia (55.5% significant improvement), daily off-time (90.9%) and daily duration dyskinesia (66.6%) after total infusion time of 170.5 months (3-31). The improvement in Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39) and Schwab&England Capacity for Daily Living Scale were 38.5 ± 19.8 and 24 ± 12.5 respectively ( P < 0.05). Equivalent daily dose of levodopa (April 2010) was 1683.4 ± 295.8 (1234-2216) mg/day. Conclusions Intraduodenal infusion of levodopa offers an important alternative in treating patients with advanced Parkinson disease.

Patient preferences for osteoporosis in Spain: a discrete choice experiment

In Spain, various treatments are available to prevent osteoporotic fractures. A discrete choice experiment (DCE) was used to investigate the importance of different treatment aspects and its influence on patients' preferences. All attributes included as type and place of drug administration as well as costs showed to be significant predictors of choice. Spanish osteoporosis patients have well-defined preferences and accept trade-offs among attributes. This study was designed to identify patient preferences for different aspects of osteoporosis treatments in Spain. Main attributes of severe osteoporosis treatments were determined by literature review and consultations with nurses. The discrete choice experiment included three attributes: type of drug administration, place of administration, plus a cost attribute in order to estimate willingness to pay for improvements in attribute levels. A pilot study with 50 patients was performed to identify the areas of misunderstanding. One hundred sixty-six patients with a diagnosis of osteoporosis and severe osteoporosis were presented with pairs of hypothetical treatment profiles with different type of administration levels, places of administration and costs. Questions to collect socio-demographic and disease-related treatment data were also included. Data were analysed using a random effects probit model. All attributes had the expected polarity and were significant predictors of choice. Patients were willing to pay 183 euro/month to have a subcutaneous injection once per day rather than an intravenous injection once per year. Patients with osteoporosis were willing to pay 121 euro/month to have medical support when administering the drug treatment at home rather than being admitted several hours to a hospital for drug administration. Spanish osteoporosis patients have well-defined preferences among treatment attributes and are willing to accept trade-offs among attributes. Participants indicated that they are willing to accept self medication with medical support rather than being hospitalised for several hours. The perspective of the patients should be taken into account when making treatment decisions.

P02 Risk factor and treatment contributions to the coronary heart disease mortality decline in a low risk Mediterranean population: Spain 1988–2005

BackgroundThe “Mediterranean Paradox” means that low risk countries such as Spain experience substantially less cardiovascular mortality than North Europe or the USA. Can cardiovascular mortality fall further?ObjectiveWe examined the extent...

Hemocromatosis neonatal: tratamiento con inmunoglobulinas en la gestación

Neonatal hemochromatosis is a severe neonatal liver disease with a high mortality and recurrence rate. In theory, it is a gestational alloimmune disease due to there being maternal antibodies against fetal hepatic metabolism. On the basis of this hypothesis, the administration of intravenous immunoglobulin has been reported as a succesful treatment during subsequent pregnancies. Here, we describe the first case of this treatment in Spain which confirms the data available in the literature.

The influence of warm versus cold climate on the effect of physiotherapy in multiple sclerosis

To compare the effect of inpatient physiotherapy in a warm versus cold climate in short- and long-term perspectives. Sixty multiple sclerosis (MS) patients with gait problems, without heat intolerance, were included in a randomized cross-over study of 4-week inpatient physiotherapy in warm (Spain) and cold (Norway) climate. The primary outcome, 6-min walk test (6MWT), and secondary physical performance and self-reported measures were scored at screening, baseline, after treatment and at 3 and 6 months of follow-up. Treatment effects were analysed by mixed models. After treatment, the mean walking distance had increased by 70 m in Spain and 49 m in Norway (P = 0.060). Improvement in favour of warm climate was demonstrated at 6 months of follow-up, 43 m (Spain) compared to 20 m (Norway) (P = 0.048). The patients reported less exertion after walking (6MWT) in favour of treatment in Spain at all time points (P < 0.05). No significant differences in change were detected for the other physical performance measures. Most self-reported measures showed more improvement after treatment in Spain, but these improvements were not sustained at follow-up. The results indicate that MS patients without heat intolerance have additional benefits from physiotherapy in a warm climate.

Characteristics of multiple sclerosis at onset and delay of diagnosis and treatment in Spain (The Novo Study)

Multiple sclerosis (MS) is a disease supposedly of autoimmune origin, with reactivity directed against myelin antigens. From the neuropathological point of view, MS produces inflammation, demyelination and axonal and neuronal degeneration. Inflammatory phenomena are predominant in the initial phase of the disease, followed later by neurodegenerative processes. Over the last decade, early treatment, during the most inflammatory phase of the disease, has been considered the best strategy to treat MS. Accordingly, we decided to determine the periods of delay between the first symptoms and the time to the first medical visit, the time to referral to a specialised MS unit, the delay in undertaking clinical and paraclinical tests, the diagnostic criteria used and the overall delay in diagnosis and treatment. The median time from onset of first symptoms to the first visit to a physician was 19.2 months, which represented the greatest delay. The median time between this initial medical consultation and the confirmation of the diagnosis by a specialised MS unit was 5.7 months, and the overall time from symptom onset to diagnosis was 24.9 months (2.08 years). The median time between onset of the first symptoms and the decision to give the first treatment was 2 years. The most important delay was that from symptom onset to the first medical visit, with the other delays being less. Thus, it is during this initial period that greater effort is required in order to reduce the time to diagnosis, by increasing awareness of the problem of MS among the general population and primary care physicians.

Experience with continuous levodopa enteral infusion (Duodopa ®)in patients with advanced Parkinson's disease in a secondary level hospital

Introduction Continuous levodopa delivery by enteral infusion (Duodopa ®) is an alternative to deep brain stimulation and subcutaneous apomorphine to control motor fluctuations and dyskinesias in advanced Parkinson's disease (PD). We report our experience with Duodopa ® therapy in 11 patients with advanced PD. Methods We retrospectively assessed clinical and quality of life changes in all patients with PD with severe motor fluctuations and dyskinesias who started continuous daily levodopa duodenal infusion through percutaneous endoscopic gastrostomy from September 2006 (Duodopa ® was approved for advanced PD treatment in Spain at that date) until April 2010 at the A. Marcide Hospital of Spain. Results Nine patients received Duodopa ® [62.7±10.6 (44–74) years, 63.6% male)]. Pre- Duodopa ® clinical characteristics of patients were: disease duration 14.5±8.9 (3–34) years, oral levodopa dose 918.2±277.7 (450–1300) mg/day, and Hoehn and Yahr staging 3.7±0.5 (3–4). Nine patients are still receiving Duodopa ®. Patients improved motor fluctuations (72.7% significant improvement), dyskinesia (55.5% significant improvement), daily off-time (90.9%) and daily duration dyskinesia (66.6%) after total infusion time of 170.5 months (3–31). The improvement in Parkinson's Disease Quality of Life Questionnaire-39 (PDQ-39) and Schwab&England Capacity for Daily Living Scale were 38.5±19.8 and 24±12.5 respectively (P<0.05). Equivalent daily dose of levodopa (April 2010) was 1683.4±295.8 (1234–2216) mg/day. Conclusions Intraduodenal infusion of levodopa offers an important alternative in treating patients with advanced Parkinson disease

Present situaltion of living-donor kidney transplantation in Spain and other countries: past, present and future of an excellent therapeutic option

Kidney transplantation from living donor is an established treatment in Spain since the 60s but has maintained a low level of activity until 2000, when the number of procedures and hospitals that perform this therapy experienced a gradual increase, reaching the highest figure in our history in 2009, with 235 living donor kidney transplants (which represents 10% of renal transplant activity). The reasons why living donor kidney transplantation is emerging in our country are diverse and can be focused in four main areas. 1) Better outcomes obtained when using living donors for kidney transplantation than those obtained with kidneys from deceased donors. Younger recipients with better HLA matching, the good health of the donor, the absence of any damages that occur in the kidney secondary to brain death, the small ischemic time and the possibility of preemptive transplantation can explain the best graft and patient survival. 2) The scarcity of sources: the relaxation of entry criteria on the waiting list implies an increasing challenge of the demand for transplant without the contribution of living donor kidney transplantation, especially in young recipients where the chances of obtaining an age-appropriate deceased donor are lower, due to the change in the profile of the deceased donor (increasingly older). 3) Improvement in the safety of the donor: the excellent evaluation and monitoring of donors (based on international standards) plus the use of less invasive surgical techniques are related to a low complication rate and to survival expectancies of living donors being similar to those of the general population. 4) Barriers overcome: The training effort by the transplant teams, hospital and regional coordinations, and the National Transplant Organization is giving excellent results, visible in the gradual increase in the number of hospitals with a program of living donor kidney transplantation and its activity. In addition, desensitization programs and the national cross-over kidney transplantation program have removed barriers to transplantation in cases of ABO incompatibility or positive crossmatch.

Suboxone® (Buprenorphine/Naloxone) as an Agonist Opioid Treatment in Spain: A Budgetary Impact Analysis

Objective: To evaluate the economic impact of buprenorphine/naloxone (B/N) as an agonist opioid treatment for opiate dependence. Methods: A budgetary impact analysis model was designed to calculate the annual costs (drugs and associated costs) to the Spanish National Healthcare System of methadone versus B/N. Data for the model were obtained from official databases and expert panel opinion. Results: It was estimated that 86,017 patients would be in an agonist opioid treatment program each of the 3 years of the study. No increase in the number of patients is expected with the introduction of B/N combination. The budgetary impact (drugs and associated costs) for agonist opiate treatment in the first year of the study would be 89.53 million EUR. In the first year of B/N use, the budgetary impact would rise by 4.39 million EUR (4.6% of the total impact), with an incremental cost of 0.79 million EUR (0.9% of the total impact). The budgetary increase would be 0.6% (0.48 million EUR increase) and 0.6% (0.49 million EUR increase) in the second and third years of use, respectively. The mean cost per patient in the first year with and without B/N would be EUR 1,050 and 1,041, respectively. The most influential variables in the sensitivity analysis were logistics and production costs of methadone and the percentage use of B/N. Conclusion: With an additional cost of only EUR 9 per patient, B/N is an efficient addition to the therapeutic arsenal in the drug treatment of opiate dependence, particularly when considering clinical aspects of novel pharmacotherapy.

P03-150 The implantation of assertive community treatment in Spain

Assertive Community Treatment (ACT) or Assertive outreach is not a treatment but a way of organising and delivering care via a specialised team to provide intensive, highly co-ordinated and flexible support and treatment for clients with longer term needs living in the community. to be effective, teams must deliver a mix of evidence based psychosocial intervention and intensive practical support from multi-skilled and multi-disciplinary practitioners. This lecture will focus on an overview of ACT development in Spain and a number of issues affecting the implementation of ACT services. the Assertive Community Treatment team of Avilés (Asturias, Spain) was the first ACT service-delivery model implemented in Spain. It started in 1999 as an effort to give an answer to the increasing needs of patients with the most severe and persistent mental illnesses and their families. Due to lack of previous community-based programs following ACT model in Spain, our development process and start-up procedure have guided a number of similar teams all over our country.

Long-term results of two consecutive trials in childhood acute lymphoblastic leukaemia performed by the Spanish Cooperative Group for Childhood Acute Lymphoblastic Leukemia Group (SHOP) from 1989 to 1998

The first multi-centric protocol for childhood acute lymphoblastic leukaemia (ALL) treatment in Spain started in 1989 and was conducted by the Spanish Pediatric Hematology and Oncology Societies. A total of 673 patients were included in two consecutive trials, SHOP-89 (1989-1993) and SHOP- 94 (1994-1998). Approximately 67% of the children diagnosed with ALL in Spain during this period were enrolled in these trials. The 250 eligible patients enrolled in the SHOP- 89 study were stratified to either a standard or a high-risk group. Therapy schedule was based on the central nervous system (CNS) therapy designed by St Jude CRH and the Children's Cancer Group, and the post-induction intensification developed by the BFM group. In the SHOP-94 study, a further high-risk group was included in the stratification of the 423 enrolled patients. The therapeutic protocol was characterised by intensification of systemic chemotherapy and the administration of cranial radiotherapy only to patients at high risk of relapse or with CNS involvement at diagnosis. Event-free survival (EFS) increased from 0.57+/- 0.03 at 15 years in SHOP-89, to 0.68+/-0.03 at 11 years in SHOP-94 (p=0.01). Relapse rate decreased from SHOP-89 to SHOP-94: 0.38 vs. 0.25 (p=0.01). CNS relapse rate was 9.1% in SHOP-89 and 4.6% in SHOP-94 (p=0.001). EFS in patients with T-immunophenotype was 0.40+/-0.08 in SHOP-89 and 0.44+/-0.06 in SHOP-94 (p=ns). Our therapeutic results evidence a significant improvement in EFS and systemic and CNS relapse rates among the two consecutive trials after modification of patient stratification and intensification of systemic chemotherapy.

Body physical changes in HIV patients under antiretroviral treatment in Spain

Methods The survey on BPCs consisted of two parallel questionnaires, for patient and physician. Ethics Committee approval was received and patient's informed consent was requested to participate. Estimating a 25% BPCs incidence (10% relative error) in the HIV+ Spanish population taking ART (>60,000 pts) and 20% surveys missing, a sample size of 1,020 pts was calculated for a multistage stratified sampling as follows: the 17 Autonomous Communities (ACs) were grouped in 12 strata and 102 physician-sites were allocated among stratum according to their weights [stratum sampling fraction 0.017 (0.014–0.026)]. In each centre, physician was selected by single random sampling, whereas the 10 patients to be surveyed were selected using systematic sampling with random start point from patients visiting the physician in January 2008. Results are shown as weighted rates based on the population per AC over the total surveyed sample (95% CI).

Transversal Study of Breast Cancer Treatment in Spain

ObjectivesThe study's objectives were to observe and describe chemotherapy treatment (CT) used in breast cancer (BC) patients in Spain and estimate its cost. MethodsMulti-centre and transversal study, which included consecutive BC patients treated with chemotherapy between 10 and 15 May 2004 in 110 centres throughout Spain. Information was gathered on the general characteristics of the centres, the patient data and the treatments administered. This information was collected prospectively based on the data available in the pharmacy service and/or the patient's clinical history. The following information was requested: demographic, clinical, CT administered during the week of the study, established guidelines, inclusion in clinical trials, and the direct costs of the medication. ResultsA total of 2134 patients were included (99.7% women) from 16 autonomous communities and the average age was 51.5. The majority of the treatments were administered in general hospitals (89.7%), public or public health partnership hospitals (91.5%), and level 3 specialist hospitals (64.5%). Among these patients, 120 (5.6%) received treatment as part of a clinical study. A total of 51% of patients received adjuvant or neoadjuvant treatment, mainly for stage IIA disease (28.7%). A total of 1011 patients presented metastatic disease (MD). The estimated average cost of chemotherapy treatment was %428.5 per cycle and the group of patients with MD incurred the greatest cost (%640.4 per cycle). ConclusionsThe results show the current situation of CT for BC in Spain and a great deal of variability is observed both in the use of drugs as well as in the associated costs.

Pharmacoeconomic Impact of the Sunitinib Adverse Events (AEs) Prophylaxis Treatment in Spain

Pharmacoeconomic Impact of the Sunitinib Adverse Events (AEs) Prophylaxis Treatment in Spain

Análisis de los estudios publicados sobre el incumplimiento terapéutico en el tratamiento de la hipertensión arterial en España entre los años 1984 y 2005

To analyse therapy non-compliance in hypertension treatment in Spain, after a review of studies published between 1984 and 2005. Systematic review. Data searches used Internet (Medline and Spanish index on doctoral these), a manual search of several Spanish journals, and bibliographic references to compliance from detected articles and through personal contact with experts. Descriptors used were: hypertension and patient compliance, compliance, adherence, patient drop-outs, treatment refusal, and their combinations. Studies conducted in Spain and published between 1984 and 2005 were included, along with original articles, congress abstracts or doctoral theses, which used as a method of measurement pill count or counting of spaces in electronic monitoring systems, and which defined as non-compliers patients with a compliance percentage <80% and >110%. The percentage of non-compliers was calculated, with 95% confidence intervals and weighted average of the percentage of non-compliers in each study. Twenty-six research studies published in Spain, excluding 2 analytical studies, were found. A total of 3553 patients with hypertension were included, of which 32.53% were non-compliers (n= 1156; 95 CI, 29.83-35.23) and 67.47% were compliers (n=2397; 95% CI, 65.67-69.27). The weighted average of non-compliance was at 32.78%. The percentage of therapy non-compliance in the treatment of hypertension in Spain has fallen in recent years, although it continues to be high.

P-58: Reproductive tourism: Offspring’s rights

P-58: Reproductive tourism: Offspring’s rights

Treatment adequacy of anxiety and depressive disorders: Primary versus specialised care in Spain

Background Literature suggests that a high proportion of the population with mental disorders remains either untreated or poorly treated. This study aimed to describe the adequacy of treatment for Anxiety and Depressive disorders in Spain, how this differs between providers (primary versus specialised care) and which factors are associated with appropriate care. Method Data were derived from the Spanish sample ( N = 5473) of the European Study of the Epidemiology of Mental Disorders (ESEMeD), a cross sectional study in a representative sample of adults. The subsample analyzed was composed by the 133 subjects with a mental disorder in the year prior to the interview who received treatment. Treatment adequacy was evaluated in two different ways: (1) considering definitions of minimally adequate treatment evidence based guidelines and criteria used in other epidemiological studies; (2) considering experts rating of treatment appropriateness based on the information contained in the case vignettes created from the CIDI answers. Generalised Estimating Equation (GEE) models and simple logistic regression were conducted to assess the correlates of adequate treatment. Results Similar proportions of patients in specialty and general medical treatment received a minimally adequate treatment (31.8% and 30.5%, respectively). Associated factors to appropriateness were living in a large city, having a high educational level, and having a good self rated health state. Limitations Treatment adequacy was based on simple information and criteria. Conclusions Only one third of the mental health treatment in Spain met minimal adequacy criteria. More research is needed in order to find out reasons for these low rates.

ABS75: Asthma treatment in Spain — Study in primary care and Pneumology Services

Asthma is a disease that can easily be controlled but it presents a high morbidity rate due to poor patient care. To find out about the quality of the care given to asthmatic patients in Spain, both in primary care and Pneumology Services, assessing how asthma and general morbidity are diagnosed and treated. Data were collected from 2346 asthmatic patients, chosen at random, seen in primary care and Pneumology Departments. The data were collected in two different periods: winter- spring and summer-autumn. There was a questionnaire for each center to record the techniques and the prevalence data; there was another questionnaire to record each patient's treatment and the morbidity data. The spirometry was performed at least once a year in 87.2% of the patients seen in primary care and 39.8% in Pneumology Services. Morbidity was high in both groups with more than two night time awakenings per month (25% in Pneumology versus 29% in Primary Care) and visits to the emergency services in the previous year (26% vs 21%). A high percentage of asthmatic patients were using both inhaled corticoids and long-acting b2- agonists (49.5% vs 32%). Thirty percent of the primary care patients could not be classified into any of the recommended treatments in international guidelines. In Spain, the asthma morbidity is high, despite the large use of drugs. Objective monitoring tests of lung function have been limited in primary care and there is room for improvement in the treatment provided. Conflict of interest and funding ASTRAZENECA Farmaceutica Spain, S.A. financed the logistic aspects of the study.