Prevalence of the potential drug-drug interactions between pangenotypic direct-acting antivirals and the concomitant medications associated with patients with chronic hepatitis C virus infection in Spain. / Prevalencia de las potenciales interacciones medicamentosas entre los antivirales de acción directa pangenotípicos y la medicación concomitante asociada a los pacientes con infección del virus de la hepatitis C crónica en España.

OBJECTIVE: To determine the comorbidity and potential for drug-drug interactions (DDIs) among pangenotypic direct-acting-antivirals (pDAAs) and the concomitant medications associated with chronic hepatitis C (CHC) patients in routine clinical practice in Spain. METHODS: Retrospective observational study. Included patients were ≥18 years, diagnosed with CHC, on antiviral treatment and required medical attention during 2017. Two groups were differentiated according to age ranges (<50 and ≥50 years). The variables collected were: age, gender, general/specific comorbidity, concomitant medication and potential DDIs (www.hep-druginteractions.org). The pDAAs analysed were: a) Sofosbuvir/Velpatasvir (SOF/VEL), b) Glecaprevir/Pibrentasvir (GLE/PIB) and c) Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX). Bivariate statistical analysis, P<.05. RESULTS: 3,430 patients with a mean age of 56.9 years and 60.3% males were enrolled. The average Charlson index was 0.8. Age range distribution: 18-49 years (28.9%) and ≥50 years (71.1%). The average number of medications per patient/year was 3.1 (SD 2.6). The total percentage of potential DDIs was: 8.6% minor DDIs, 40.5% clinically significant DDIs and 10.0% contraindicated medication. These DDIs were greater in patients ≥50 years (8.6%, 43.8% and 12.4%, respectively, P<.001). For all ages, SOF/VEL showed a lower percentage of: minor interactions (1.3% vs. 6.6% and 5.9%, P<.001); clinically significant interactions (53.4%, vs. 77.4% and 66.3%, P<.001) and contraindicated medication (1.7% vs. 8.3% and 10.7%, P<.001) compared to GLE/PIB and SOF/VEL/VOX, respectively. CONCLUSIONS: Patients with CHC present high comorbidity and concomitant medication use, particularly elderly patients, thus implying a greater exposure to potential DDIs. Although the DDI rate was considerable with the three combinations analysed, SOF/VEL showed a lower number of clinically significant interactions.

Comorbidity, concomitant medication, use of resources and healthcare costs associated with chronic hepatitis C virus carriers in Spain. / Comorbilidad, medicación concomitante, uso de recursos y costes sanitarios asociados a los pacientes portadores del virus de la hepatitis C crónica en España.

OBJECTIVES: To assess the comorbidity, concomitant medications, healthcare resource use and healthcare costs of chronic hepatitis C virus patients in the Spanish population. PATIENTS AND METHODS: Retrospective, observational, non-interventional study. Patients included were≥18 years of age who accessed medical care between 2010-2013. Patients were divided into 2 groups based on the presence or absence of liver cirrhosis. The follow-up period was 12 months. Main assessment criteria included general comorbidity level (determined by the resource utilisation band score) and prevalence of specific comorbidities, concomitant medications, healthcare resource use and healthcare costs. Statistical analysis was performed using regression models and ANCOVA, P<.05. RESULTS: One thousand fifty-five patients were enrolled, the mean age was 57.9 years and 55.5% were male. A percentage of 43.5 of patients had a moderate level of comorbidity according to the resource utilisation band score. The mean time from diagnosis was 18.1 years and 7.5% of the patients died during the follow-up period. The most common comorbidities were dyslipidaemia (40.3%), hypertension (40.1%) and generalised pain (38.1%). Cirrhosis was associated with cardiovascular events (OR 3.8), organ failures (OR 2.2), alcoholism (OR 2.1), diabetes (OR 1.2) and age (OR 1.2); P<.05. The most commonly used medications were anti-infectives (67.8%) and nervous system medications (66.8%). The mean total cost per patient was 3,198€ (71.5% healthcare costs, 28.5% indirect/non-healthcare costs). In the corrected model, the total costs per patient-year were 2,211€ for those without cirrhosis and 7,641€ for patients with cirrhosis; P<.001. CONCLUSIONS: Chronic hepatitis C virus patients are associated with a high level of comorbidity and the use of concomitant medications, especially in patients with liver cirrhosis. Chronic hepatitis C virus infection represents a substantial economic burden on the Spanish National Health System.

Comorbidity and metabolic syndrome in patients with multiple sclerosis from Asturias and Catalonia, Spain.

BACKGROUND: The impact of comorbidity on multiple sclerosis (MS) is a new area of interest. Limited data on the risk factors of metabolic syndrome (MetS) is currently available. The aim of this study was to estimate the presence of comorbid conditions and MetS in a sample of adult patients with MS. METHODS: A retrospective, cohort study was conducted using electronic medical records from 19 primary care centres in Catalonia and Asturias, Spain. The number of chronic diseases (diagnoses), the Charlson Comorbidity Index and the individual Case-mix Index were used to assess general comorbidity variables. MetS was defined using the National Cholesterol Education Program Adult Treatment Panel III. Patients were distributed into two groups according to the Expanded Disability Status Scale (EDSS) score: 0-3.5 and 4-10. RESULTS: A total of 222 patients were studied (mean age = 45.5 (SD 12.5) years, 64.4% were female and 62.2% presented a diagnosis of relapsing-remitting MS). Mean EDSS score was 3.2 (SD 2.0). Depression (32.4%), dyslipidaemia (31.1%), hypertension (23.0%) and obesity (22.5%) were the most common comorbidities. Overall MetS prevalence was 31.1% (95% CI: 25.0-37.2%). Patients with an EDSS ≥ 4.0 showed a significantly higher number of comorbidities (OR=2.2; 95% CI: 1.7-3.0; p<0.001). CONCLUSION: MS patients had a high prevalence of MetS. Screening for comorbidity should be part of standard MS care. Further studies are necessary to confirm this association and the underlying mechanisms of MS and its comorbidities.

Impact on healthcare resource utilization of multiple sclerosis in Spain.

BACKGROUND: Multiple sclerosis (MS) is a chronic disease with a high socioeconomic impact. The aim of this study was to assess healthcare resources utilization and costs in a sample of patients with MS. METHODS: A retrospective, cohort study was conducted using electronic medical records from 19 primary care centres in Asturias and Catalonia, Spain. Adult patients diagnosed with MS were distributed into two groups according to the Expanded Disability Status Scale (EDSS) score: 0-3.5 (no-moderate disability) and 4-9.5 (severe disability). Healthcare (direct cost) and non-healthcare costs (work productivity losses) were analysed. An analysis of covariance (ANCOVA) was used for correction, p < 0.05. A multiple regression model was performed to obtain the variables associated with costs. RESULTS: A total of 222 patients were analyzed; mean (SD) age: 45.5 (12.5) years, 64.4% female, and 62.2% presented a diagnosis of relapsing-remitting MS. Median EDSS score was 2.5, with 68.5% of the patients with no to moderate disability. The mean annual cost per MS patient was €25,103. For no-moderate and severe disability, the ANCOVA-adjusted mean annual cost was €23,157 and €29,242, respectively (p = 0.013). Direct costs and MS disease-modifying therapy accounted for 39.4% and 31.7% of the total costs, respectively. The total costs were associated with number of relapses (ß = 0.135, p = 0.001), time since diagnosis (ß = 0.281, p = 0.023), and age (ß = 0.198, p = 0.037). CONCLUSIONS: Multiple sclerosis imposes a substantial economic burden on the Spanish National Health System, patients and society as a whole. Costs significantly correlated with disease progression.

[Clinical characteristics and treatment response in adult patients with non-Hodgkin's chronic lymphocytic leukemia (CLL)]. / Características clínicas y respuesta al tratamiento de pacientes adultos con leucemia linfática crónica (LLC) y linfoma no Hodgkin (LNH).

OBJECTIVE: To determine comorbidities, clinical characteristics, and treatment response in adult patients with chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma (DLBCL), and follicular lymphoma (FL). METHODS: The design was observational from reviewing the medical records of patients seen in outpatient and inpatient settings. It included ≥50 subjects who demanded attention during the period 2008-2012 and that met specific inclusion/exclusion criteria. The main measures were: comorbidity (population group), clinical stage, patient treatment, response to treatment, overall survival, progression-free survival, and mortality. STATISTICAL ANALYSIS: p<0.05. RESULTS: 270 patients (CLL=90, DLBCL=81, FL=99) were recruited, with a mean age of 72.5, 65.5, and 62.4 years, respectively. These groups of neoplasms, compared with the general population, showed a higher percentage of men (60.0, 56.8 and 52.6 vs. 46.2%) and morbidity (Charlson Comorbidity Index: 1.6, 1.5, 1.4 vs. 0.4, respectively; p<0.05). The administration of chemotherapy treatment was 28.9 vs. 86.4 and 90.9%, respectively (p<0.001). Overall survival at five years was 84.4, 45.0 and 68.5%, respectively (p=0.027), while mortality rates were 17.0 vs. 35.3 and 20.6%, respectively (p=0.041). Compared with other treatments, with administered rituximab the median progression-free survival was 6.8 vs. 4.2 years (p<0.001). These differences were maintained for the three neoplasms. CONCLUSIONS: Comorbidity associated with hematological malignancies is high. The chronic lymphocytic leukemia group showed increased survival with lower mortality rate. Rituximab showed a higher progression-free survival in these neoplasms.

Impact of negative symptoms on healthcare resource utilization and associated costs in adult outpatients with schizophrenia: a population-based study.

BACKGROUND: To evaluate the prevalence and impact of negative symptoms on healthcare resources utilization and costs in patients with schizophrenia. METHODS: A retrospective study was conducted using electronic medical records from the health provider BSA (Badalona, Spain). All adult outpatients with a diagnosis of schizophrenia were followed for 12 months. Two study groups were defined by the presence or absence of negative symptoms based on the PANSS Negative Symptoms Factor (N1-N4, N6, G7 and G16). Healthcare (direct cost) and non-healthcare costs (work productivity losses) were described. An ANCOVA model was used for correction, p < 0.05. RESULTS: One thousand one hundred and twenty patients were included in the study (mean age: 46.8 ± 13.8 years; male: 58.4%). One or more negative symptoms were present in 52.5% of patients (95% CI: 49.6-55.4%). The most frequent were passive/apathetic social withdrawal and emotional withdrawal (60.5% and 49.8%, respectively). Patients with negative symptoms showed a greater mean number of comorbid conditions and pharmacological treatments. The adjusted unit healthcare cost related to the presence/absence of negative symptoms was €2,190.80 and €1,787.60 and the healthcare cost was €2,085.00 and €1,659.10, respectively; (p < 0.001). Patients with negative symptoms used more healthcare resources, mainly derived from primary care. The presence of negative symptoms was associated with being male, dyslipidemia, obesity and arterial hypertension (OR = 1.7, 1.4, 1.4 and 1.2, respectively). CONCLUSIONS: Negative symptoms are highly prevalent in adult outpatients with schizophrenia with a relevant economic impact on the healthcare system.

Antimuscarinic persistence patterns in newly treated patients with overactive bladder: a retrospective comparative analysis.

INTRODUCTION AND HYPOTHESIS: Treatment persistence is low in patients with overactive bladder (OAB), but persistence may vary among antimuscarinic agents. This study compared treatment persistence in patients with OAB receiving fesoterodine, solifenacin, or tolterodine as their initial OAB prescription in a routine clinical practice setting. METHODS: This retrospective study used medical records from primary healthcare centers in three locations in Spain; records from patients aged ≥18 years with a diagnosis of OAB who initiated antimuscarinic treatment for OAB (fesoterodine, tolterodine, or solifenacin) were included. The first prescription of one of the OAB study medications was considered the index date; patients were followed for ≥52 weeks. Persistence was estimated using Kaplan-Meier curves and Cox proportional hazard regression models, adjusting for covariates. RESULTS: A total of 1,971 records of patients (58.3 % women; mean age 70.1 years) initiating treatment with fesoterodine (n = 302), solifenacin (n = 952), or tolterodine (n = 717) were included. Unadjusted mean (±SD) treatment duration was 31.5 ± 17.6 weeks for fesoterodine, 29.9 ± 21.4 for solifenacin and 29.0 ± 21.6 for tolterodine (p = 0.217). At week 52, 35.8 % of fesoterodine-treated patients remained on their initial therapy, versus 31.9 % of solifenacin-treated (hazard ratio [HR], 1.24; 95 % CI, 1.05-1.47; p = 0.011) and 30.9 % of tolterodine-treated (HR = 1.28; 95 % CI, 1.07-1.52; p = 0.006) patients. Findings were consistent when the definition for discontinuation was varied. CONCLUSIONS: Overall persistence at week 52 was low, but the cumulative probability of persisting with initial therapy was significantly higher for fesoterodine than for solifenacin or tolterodine in clinical practice in Spain.

The effect of quitting smoking on costs and healthcare utilization in patients with chronic obstructive pulmonary disease: a comparison of current smokers versus ex-smokers in routine clinical practice.

PURPOSE: Chronic obstructive pulmonary disease (COPD) is a prevalent condition mainly related to smoking, which is associated with a substantial economic burden. The purpose was to compare healthcare resource utilization and costs according to smoking status in patients with COPD in routine clinical practice. METHODS: A retrospective cohort nested case-control study was designed. The cohort was composed of male and female COPD outpatients, 40 years or older, covered by the Badalona Serveis Assistencials (a health provider) health plan. Cases were current smokers with COPD and controls (two per case) were former smokers with COPD (at least 12 months without smoking), matched for age, sex, duration of COPD, and burden of comorbidity. The index date was the last visit recorded in the database, and the analysis was performed retrospectively on healthcare resource utilization data for the 12 months before the index date. RESULTS: A total of 930 COPD records were analyzed: 310 current and 620 former smokers [mean age 69.4 years (84.6 % male)]. Cases had more exacerbations, physician visits of any type, and drug therapies related to COPD were more common. As a consequence, current smokers had higher average annual healthcare costs: €3,784 (1,888) versus €2,302 (2,451), p < 0.001. This difference persisted after adjusting for severity of COPD. CONCLUSIONS: Current smokers with COPD had significantly higher use of healthcare resources, mainly COPD drugs and physician visits, compared with former smokers who had abstained for at least 12 months. As a consequence, current smokers had higher healthcare costs to the National Health System in Spain than ex-smokers.

Effect of smoking status on healthcare costs and resource utilization in patients with type 2 diabetes in routine clinical practice: a retrospective nested case-control economic study.

AIM: To compare healthcare resource utilization and costs according to smoking status in patients with type 2 diabetes in clinical practice. METHODS: A retrospective cohort nested case-control study was designed. Cases were current smokers, while 2 types of controls (former smokers and never smokers) were matched (2 controls per case) for age, sex, duration of diabetes and burden of comorbidity using data from medical records. Noninstitutionalized diabetics of both genders, aged>18 years and seen consecutively over a 5-year period before the index date, were enrolled. Analysis compared healthcare resource utilization, loss of productivity due to sick leave and corresponding costs. RESULTS: In total, 2,490 medical records were analyzed, i.e. 498 cases, 996 former smokers and 996 never smokers. Mean age was 63.4 years (64.9% male). Smokers had higher glycosylated hemoglobin levels (7.4 vs. 7.2 and 7.2%, respectively; p=0.013) and a lower degree of metabolic control (49.2 vs. 54.7 and 55.8%; p=0.036). Smokers had higher average annual costs (EUR 3,583) than former smokers (EUR 2,885; p<0.001) and never smokers (EUR 2,183; p<0.001). CONCLUSIONS: Diabetic smoker patients had lower metabolic control, higher health resource utilization and more sick leave, resulting in higher healthcare costs and lost productivity compared with both former and never smoker diabetics.

Cost comparison of adding pregabalin or gabapentin for the first time to the therapy of patients with painful axial radiculopathy treated in Spain.

OBJECTIVES: This paper aims to compare the costs of initiating pregabalin or gabapentin in the therapeutic management of patients with painful axial radiculopathy in routine medical practice. METHODS: A retrospective claim database analysis was carried-out using medical records of patients of both gender aged >18 years with axial painful radiculopathy (ICD-9-CM codes: 353.0 [cervical], 353.3 [thoracic] or 353.1 [lumbar]) who initiated pregabalin or gabapentin therapy between 2006 and 2008. The economic evaluation included healthcare resource utilisation and corresponding costs from a third-payer perspective during 12 months post index date. Estimates of indirect costs due to sick leave were also computed. RESULTS: A total of 571 records were eligible for analysis: 375 (66%) treated with pregabalin and 193 (34%) gabapentin. Time since diagnosis, duration of treatment, prevalence of most co-morbidities and previous use of analgesics were comparable. However, concomitant use of analgesics was higher in the gabapentin cohort; 3.1 (1.7) vs. 2.8 (1.8); p<0.05, mainly due to greater use of opioids (31.1% vs. 21.2%; p<0.05) and non-narcotic drugs (63.7% vs. 52.1%; p<0.01). Adjusted total costs per patient were significantly lower in the pregabalin group; €2.472 (2.101-2.836) vs. €3.346 (2.866-3.825); p=0.005, due to lower absenteeism costs; €1.012 (658-1.365) vs. €1.595 (1.129-2.062); p=0.042, and lower adjusted healthcare costs; €1.460 (1.360-1.560) vs. €1.750 (1.618-1.882); p=0.001. CONCLUSIONS: In a population setting, pregabalin-treated patients with painful radiculopathies were considerably less costly for the healthcare payer than those treated with gabapentin in routine clinical practice. Patients treated with pregabalin had significantly fewer days of sick leave than gabapentin-treated patients.

Health economics perspective of fesoterodine, tolterodine or solifenacin as first-time therapy for overactive bladder syndrome in the primary care setting in Spain.

BACKGROUND: Overactive bladder (OAB) is associated with high healthcare costs, which may be partially driven by drug treatment. There is little comparative data on antimuscarinic drugs with respect to resource use and costs. This study was conducted to address this gap and the growing need for naturalistic studies comparing health economics outcomes in adult patients with OAB syndrome initiating treatment with different antimuscarinic drugs in a primary care setting in Spain. METHODS: Medical records from the databases of primary healthcare centres in three locations in Spain were assessed retrospectively. Men and women ≥18 years of age who initiated treatment with fesoterodine, tolterodine or solifenacin for OAB between 2008 and 2010 were followed for 52 weeks. Healthcare resource utilization and related costs in the Spanish National Health System were compared. Comparisons among drugs were made using multivariate general linear models adjusted for location, age, sex, time since diagnosis, Charlson comorbidity index, and medication possession ratio. RESULTS: A total of 1,971 medical records of patients (58.3% women; mean age, 70.1 [SD:10.6] years) initiating treatment with fesoterodine (n = 302), solifenacin (n = 952) or tolterodine (n = 717) were examined. Annual mean cost per patient was €1798 (95% CI: €1745; €1848). Adjusted mean (95% bootstrap CI) healthcare costs were significantly lower in patients receiving fesoterodine (€1639 [1542; 1725]) compared with solifenacin (€1780 [€1699; €1854], P = 0.022) or tolterodine (€1893 [€1815; €1969], P = 0.001). Cost differences occurred because of significantly fewer medical visits, and less use of absorbent products and OAB-related concomitant medication in the fesoterodine group. CONCLUSIONS: Compared with solifenacin and tolterodine, fesoterodine was a cost-saving therapy for treatment of OAB in the primary care setting in Spain.

Relationship between efficiency and clinical effectiveness indicators in an adjusted model of resource consumption: a cross-sectional study.

BACKGROUND: Adjusted clinical groups (ACG®) have been widely used to adjust resource distribution; however, the relationship with effectiveness has been questioned. The purpose of the study was to measure the relationship between efficiency assessed by ACG® and a clinical effectiveness indicator in adults attended in Primary Health Care Centres (PHCs). RESEARCH DESIGN: cross-sectional study. SUBJECTS: 196, 593 patients aged >14 years in 13 PHCs in Catalonia (Spain). MEASURES: Age, sex, PHC, basic care team (BCT), visits, episodes (diagnoses), and total direct costs of PHC care and co-morbidity as measured by ACG® indicators: Efficiency indices for costs, visits, and episodes (costs EI, visits EI, episodes EI); a complexity or risk index (RI); and effectiveness measured by a general synthetic index (SI). The relationship between EI, RI, and SI in each PHC and BCT was measured by multiple correlation coefficients (r). RESULTS: In total, 56 of the 106 defined ACG® were present in the study population, with five corresponding to 44.5% of the patients, 11 to 68.0% of patients, and 30 present in less than 0.5% of the sample. The RI in each PHC ranged from 0.9 to 1.1. Costs, visits, and episodes had similar trends for efficiency in six PHCs. There was moderate correlation between costs EI and visits EI (r = 0.59). SI correlation with episodes EI and costs EI was moderate (r = 0.48 and r = -0.34, respectively) and was r = -0.14 for visits EI. Correlation between RI and SI was r = 0.29. CONCLUSIONS: The Efficiency and Effectiveness ACG® indicators permit a comparison of primary care processes between PHCs. Acceptable correlation exists between effectiveness and indicators of efficiency in episodes and costs.

Retrospective epidemiological study for the characterization of community- acquired pneumonia and pneumococcal pneumonia in adults in a well-defined area of Badalona (Barcelona, Spain).

BACKGROUND: Community-acquired pneumonia (CAP) has large impact on direct healthcare costs, especially those derived from hospitalization. This study determines impact, clinical characteristics, outcome and economic consequences of CAP in the adult (≥18 years) population attended in 6 primary-care centers and 2 hospitals in Badalona (Spain) over a two-year period. METHODS: Medical records were identified by codes from the International Classification of Diseases in databases (January 1st 2008-December 31st 2009). RESULTS: A total of 581 patients with CAP (55.6% males, mean age 57.5 years) were identified. Prevalence: 0.64% (95% CI: 0.5%-0.7%); annual incidence: 3.0 cases/1,000 inhabitants (95% CI: 0.2-0.5). Up to 241 (41.5%) required hospitalization. Hospital admission was associated (p<0.002) with liver disease (OR=5.9), stroke (OR=3.6), dementia (OR=3.5), COPD (OR=2.9), diabetes mellitus (OR=1.9) and age (OR=1.1 per year). Length of stay (4.4±0.3 days) was associated with PSI score (ß=0.195), in turn associated with age (r=0.827) and Charlson index (r=0.497). Microbiological tests were performed in all inpatients but only in 35% outpatients. Among patients with microbiological tests, results were positive in 51.7%, and among them, S pneumoniae was identified in 57.5% cases. Time to recovery was 29.9±17.2 days. Up to 7.5% inpatients presented complications, 0.8% required ICU admission and 19.1% readmission. Inhospital mortality rate was 2.5%. Adjusted mean total cost was €2,332.4/inpatient and €698.6/outpatient (p<0.001). Patients with pneumococcal CAP (n=107) showed higher comorbidity and hospitalization (76.6%), higher PSI score, larger time to recovery and higher overall costs among inpatients. CONCLUSIONS: Strategies preventing CAP, thus reducing hospital admissions could likely produce substantial costs savings in addition to the reduction of CAP burden.

Assessment of pharmacological strategies for management of major depressive disorder and their costs after an inadequate response to first-line antidepressant treatment in primary care.

BACKGROUND: The aim of the study was to determine the most common treatment strategies and their costs for patients with an inadequate response to first-line antidepressant treatment (AD) in primary care. METHOD: A retrospective cohort study of medical records from six primary care centers was conducted. Adults with a major depressive disorder diagnosis, at least 8 weeks of AD treatment after the first prescription, and patient monitoring for 12 months were analyzed. Healthcare (direct cost) and non-healthcare costs (indirect costs; work productivity losses) were described. RESULTS: A total of 2,260 patients were studied. Forty-three percent of patients (N = 965) presented an inadequate response to treatment. Summarizing the different treatment approaches: 43.2% were switched to another AD, 15.5% were given an additional AD, AD dose was increased in 14.6%, and 26.7% remained with the same antidepressant agent. Healthcare/annual costs were 451.2 Euros for patients in remission vs. 826.1 Euros in those with inadequate response, and productivity losses were 991.4 versus 1,842.0 Euros, respectively (p < 0.001). CONCLUSION: Antidepressant switch was the most common therapeutic approach performed by general practitioners in naturalistic practice. A delay in treatment change when no remission occurs and a significant heterogeneity in management of these patients were also found.

[Costs and associated factors with optimal and suboptimal responses to the treatment of major depressive disorder]. / Costes y factores asociados a las respuestas óptima y subóptima al tratamiento del trastorno depresivo mayor en atención primaria.

OBJECTIVE: To evaluate the compliance, persistence and costs of the treatment of major depressive disorder (MDD) in the setting of Primary Care, placing emphasis on the different aspects of those patients with an initial suboptimal response to antidepressant treatment. DESIGN: A retrospective observational study using the population registers of Badalona Healthcare Services. The inclusion criteria consisted of; age ≥18 years, initial episode during 2008-2009, and to be on antidepressant treatment for at least 8 weeks after the first prescription. The follow-up was 12 months. Two study groups were formed, patients with suboptimal response, and remission. MAIN MEASUREMENTS: Sociodemographic data, compliance and adherence to treatment, health costs (direct and indirect). RESULTS: A total of 2,260 subjects were analysed (mean age 58.8 years, 74% women). Just under half (42.7%, 95% CI; 40.0-46.4%) had a suboptimal response to the treatment. These patients had a higher mean age, a higher proportion of women, and pensioners, as well as higher comorbidity, compared to the remission group. They also had poorer compliance percentages (65.1% vs. 67.7%) and treatment persistence at 12 months (31.8% vs. 53.2%), respectively, P<.001. The annual health costs were, 826.1€ for patients with a suboptimal response vs. 451.2€ in patients in remission; loss of productivity 1,842.0€ vs. 991.4€, respectively; P<.001. The factors associated to a suboptimal response were; lack of compliance (OR=1.7), years with the disorder (OR=1.2), age (OR=1.1) and presence of comorbidity (OR=1.1). CONCLUSIONS: The patients with an initial suboptimal response to antidepressant treatment had a higher comorbidity, lower therapeutic compliance, and incurred higher total costs, particularly in losses in work productivity.

[Comparison of three methods for measuring multiple morbidity according to the use of health resources in primary healthcare]. / Comparación entre tres métodos de medida de la multimorbilidad en función del uso de recursos sanitarios en atención primaria.

OBJECTIVE: To compare three methods of measuring multiple morbidity according to the use of health resources (cost of care) in primary healthcare (PHC). DESIGN: Retrospective study using computerized medical records. SETTING: Thirteen PHC teams in Catalonia (Spain). PARTICIPANTS: Assigned patients requiring care in 2008. MAIN MEASUREMENTS: The socio-demographic variables were co-morbidity and costs. Methods of comparison were: a) Combined Comorbidity Index (CCI): an index itself was developed from the scores of acute and chronic episodes, b) Charlson Index (ChI), and c) Adjusted Clinical Groups case-mix: resource use bands (RUB). The cost model was constructed by differentiating between fixed (operational) and variable costs. STATISTICAL ANALYSIS: 3 multiple lineal regression models were developed to assess the explanatory power of each measurement of co-morbidity which were compared from the determination coefficient (R(2)), p< .05. RESULTS: The study included 227,235 patients. The mean unit of cost was €654.2. The CCI explained an R(2)=50.4%, the ChI an R(2)=29.2% and BUR an R(2)=39.7% of the variability of the cost. The behaviour of the ICC is acceptable, albeit with low scores (1 to 3 points), showing inconclusive results. CONCLUSIONS: The CCI may be a simple method of predicting PHC costs in routine clinical practice. If confirmed, these results will allow improvements in the comparison of the case-mix.

[Study of patients with gout: clinical features in the last 2 years of monitoring]. / Estudio de pacientes con gota: características clínicas en los últimos 2 años de seguimiento.

OBJECTIVE: to analyze the clinical characteristics of gout patients with < 3 attacks and ≥ 3 acute attacks per year. METHODS: retrospective observational study carried out at 6-primary care (AP) and 2 hospitals. We included patient's ≥ 18 years during the years 2003-2007 inclusive. The study groups were: patients with 1-2 and ≥ 3 attacks/acute recurrences.The main variables: demographic, metabolic syndrome (MS), clinical features and treatment. STATISTICAL ANALYSIS: logistic regression model, p < 0.05. RESULTS: 3,130 patients were included. The mean age was 55.8 years and 81.1% were male:31.6% have ≥ 3 attacks per year. The prevalence of MS was 28.8% (CI: 27.2-30.4%) in patients with 1-2 attacks. Subjects with ≥ 3 acute attacks were associated with: MS (OR: 6.2; CI: 4.6-8.3; 65.8 vs. 11.8%), obesity (OR: 2.1; CI: 1.7-2.5;63.5 vs. 33.8%) and hypertension (OR: 1.6; CI: 1.3-1.9; 58.3 vs. 36.9%), p < 0.001; 58.4% continued to take allopurinol(50.3 vs. 62.2%; p < 0.001). CONCLUSIONS: patients with ≥ 3 attacks per year have a more severe disease with acute poly-articular, tophi and higher number of co-morbidities. It is important to control uric acid to reduce the recurrence of attacks in these patients.

[Abstinence rates with varenicline compared to bupropion and nicotine replacement therapy for quitting smoking in primary care]. / Tasas de abstinencia de vareniclina frente a bupropión y terapia sustitutiva con nicotina en la cesación del tabaco en atención primaria.

OBJECTIVE: The objective of this study was to estimate the continuous abstinence rates of varenicline, bupropion and nicotine replacement therapy (NRT) in smoking cessation in 2 Primary Care (PC) External Support Units. DESIGN: Observational, multicentre, longitudinal study using a retrospective review of medical records. SETTING: Six Primary Care Centres. PARTICIPANTS: Patients > 18 years, who began smoking cessation treatment between 1/01/2006 and 1/12/2008 with varenicline, bupropion or NRT were included in the analysis. CONTINUATION: Patient follow-up was conducted from time-baseline (day 1) and assessed at 6 and 12 months. MAIN VARIABLES: comorbidities, effectiveness (continuous abstinence) and pharmacological tolerability. STATISTICAL ANALYSIS: logistic regression models and Kaplan-Maier survival curves; P<.05. RESULTS: A total of 957 smokers treated with NRT (53.0%), bupropion (25.1%) and varenicline (21.9%) were included in the analysis. Mean age: 47.6 (11.3) years; 58.6% men. 32.0% of smokers attended due to physical dependence. Average duration of smoking: 19.5 (6.7) years. At 6 months, 61.2% (95% CI: 54.6-67.8%) of participants in the varenicline group continuously abstained from smoking compared with 56.9% (95% CI: 50.6-63.2%) in the bupropion group, and 52.3% (95% CI: 48.0-56.6%) in the NRT group; P=.003. At 12 months, the rate of continuous abstinence was 57.4% (95% CI: 50.7-64.1%) in the varenicline group compared with 52.9% (95% CI: 46.6-59.2%) in the bupropion group and 47.1% (95% CI: 42.8-51.4%) in the NRT group; P=.002. CONCLUSION: One year-follow up results suggest that varenicline is an appropriate alternative compared with bupropion and NRT on smoking cessation in the PC setting.

Clinical validity of a population database definition of remission in patients with major depression.

BACKGROUND: Major depression (MD) is one of the most frequent diagnoses in Primary Care. It is a disabling illness that increases the use of health resources. AIM: To describe the concordance between remission according to clinical assessment and remission obtained from the computerized prescription databases of patients with MD in a Spanish population. DESIGN: multicenter cross-sectional. The population under study was comprised of people from six primary care facilities, who had a MD episode between January 2003 and March 2007. A specialist in psychiatry assessed a random sample of patient histories and determined whether a certain patient was in remission according to clinical criteria (ICPC-2). Regarding the databases, patients were considered in remission when they did not need further prescriptions of AD for at least 6 months after completing treatment for a new episode. Validity indicators (sensitivity [S], specificity [Sp]) and clinical utility (positive and negative probability ratio [PPR] and [NPR]) were calculated. The concordance index was established using Cohen's kappa coefficient. Significance level was p < 0.05. RESULTS: 133 patient histories were reviewed. The kappa coefficient was 82.8% (confidence intervals [CI] were 95%: 73.1 - 92.6), PPR 9.8% and NPR 0.1%. Allocation discrepancies between both criteria were found in 11 patients. S was 92.5% (CI was 95%: 88.0 - 96.9%) and Sp was 90.6% (CI was 95%: 85.6 - 95.6%), p < 0.001. Reliability analysis: Cronbach's alpha: 90.6% (CI was 95%: 85.6 - 95.6%). CONCLUSIONS: Results show an acceptable level of concordance between remission obtained from the computerized databases and clinical criteria. The major discrepancies were found in diagnostic accuracy.