Persistence, use of resources and costs in patients under migraine preventive treatment: the PERSEC study.

BACKGROUND: Migraine represents a serious burden for national health systems. However, preventive treatment is not optimally applied to reduce the severity and frequency of headache attacks and the related expenses. Our aim was to assess the persistence to traditional migraine prophylaxis available in Spain and its relationship with the healthcare resource use (HRU) and costs. METHODS: Retrospective observational study with retrospective cohort design of individuals with migraine treated with oral preventive medication for the first time from 01/01/2016 to 30/06/2018. One-year follow-up information was retrieved from the Big-Pac™ database. According to their one-year persistence to oral prophylaxis, two study groups were created and describe regarding HRU and healthcare direct and indirect costs using 95% confidence intervals (CI). The analysis of covariance (ANCOVA) was performed as a sensitivity analysis. Patients were considered persistent if they continued on preventive treatment until the end of the study or switched medications within 60 days or less since the last prescription. Non-persistent were those who permanently discontinued or re-initiated a treatment after 60 days. RESULTS: Seven thousand eight hundred sixty-six patients started preventive treatment (mean age (SD) 48.2 (14.8) and 80.4% women), of whom 2,545 (32.4%) were persistent for 6 months and 2,390 (30.4%) for 12 months. Most used first-line preventive treatments were antidepressants (3,642; 46.3%) followed by antiepileptics (1,738; 22.1%) and beta-blockers (1,399; 17.8%). The acute treatments prescribed concomitantly with preventives were NSAIDs (4,530; 57.6%), followed by triptans (2,217; 28.2%). First-time preventive treatment prescribers were mostly primary care physicians (6,044; 76.8%) followed by neurologists (1,221; 15.5%). Non-persistent patients required a higher number of primary care visits (mean difference (95%CI): 3.0 (2.6;3.4)) and days of sick leave (2.7 (0.8;4.5)) than the persistent ones. The mean annual expenditure was €622 (415; 829) higher in patients who not persisted on migraine prophylactic treatment. CONCLUSIONS: In this study, we observed a high discontinuation rate for migraine prophylaxis which is related to an increase in HRU and costs for non-persistent patients. These results suggest that the treatment adherence implies not only a clinical benefit but also a reduction in HRU and costs.

Concomitant use of direct-acting antivirals (DAA) and central nervous system drugs in patients with hepatitis C virus infection. / Uso concomitante de antivirales de acción directa (AAD) y fármacos con acción sobre el sistema nervioso central: Consideraciones en el perfil actual del paciente con hepatitis C.

Our objective was to determine potential drug interactions (DI) between pangenotypic direct-acting antivirals (pDAA) and concomitant central nervous system (CNS) medication in patients with chronic hepatitis C virus (HCV). Transversal design. Patients aged ≥ 18 years on treatment with pDAA during 2017 were included. The variables collected were comorbidity, concomitant CNS medication and potential DI. The pDAA analyzed were a) Sofosbuvir/Velpatasvir (SOF/VEL), b) Glecaprevir/Pibrentasvir (GLE/PIB) and c) Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX). Descriptive statistical analysis. We recruited 1,170 patients (mean age 60.1 years, 56.4% male). Mean concomitant drug use was 3.2 per patient/year. The percentages of potential / possible DI between the DAAs and the concomitant drugs on the CNS were: 2.7% contraindications, 11.3% significant and 4.2% weak. By pDAA, the percentages were: SOF/VEL (2.7%; 0.0%; 4.4%), GLE/GDP (2.7%; 26.5%; 1.6%) SOF/VEL/VOX (2.7%; 6.8%; 4.4%), respectively. Concomitant CNS medication was used in one third of HCV patients. It is important to select a pDAA with a low rate of potential DI to simplify treatment. SOF/VEL is a good alternative compared with the other pDAA studied, mainly due to the concomitant use of antipsychotics and analgesics.

El objetivo fue determinar las potenciales interacciones farmacológicas (IF) entre los antivirales de acción-directa pangenotípicos (AADp) y la medicación-concomitante sobre el sistema nervioso central (SNC) asociada a los pacientes portadores del virus de la hepatitis C crónica (VHC). Se realizó un diseño transversal. Se incluyeron pacientes ≥18 años en tratamiento con AADp durante el año 2017. Las variables recogidas fueron: comorbilidad, medicación-concomitante (SNC) y potenciales IF. Los AADp analizados fueron: a) Sofosbuvir/Velpatasvir (SOF/VEL), b) Glecaprevir/Pibrentasvir (GLE/PIB) y c) Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX). Análisis-estadístico descriptivo. Se reclutaron 1.170 pacientes; edad-media de 60,1 años y el 56,4% varones. El promedio de medicamentos-concomitantes fue de 3,2 por paciente/año. El porcentaje de potenciales/posibles IF entre los AADp y los medicamentos-concomitantes sobre el SNC fueron: 2,7% contraindicaciones, 11,3% significativas y 4,2% débiles. En función de los AADp, estos porcentajes fueron los siguientes: SOF/VEL (2,7%; 0,0%; 4,4%), GLE/PIB (2,7%; 26,5%; 1,6%) y SOF/VEL/VOX (2,7%; 6,8%; 4,4%), respectivamente. Un tercio de los pacientes con VHC muestran un uso de medicación-concomitante de acción sobre el SNC. Será importante seleccionar un AADp que tenga una baja tasa de potenciales IF para simplificar el tratamiento. SOF/VEL se presenta como una buena alternativa en comparación con los AADp seleccionados, principalmente en el uso concomitante de antipsicóticos y analgésicos.

Overall clinical and economic impact of non-alcoholic fatty liver disease.

OBJECTIVES: to establish the clinical and economic consequences (resource utilization and healthcare costs) of non-alcoholic fatty liver in the setting of the usual clinical practice in Spain. PATIENTS AND METHODS: an observational, retrospective study was performed based on a review of the medical records of adult patients ≥ 18 years of age who sought medical care from 2017 to 2018. Patients were categorized into two groups according to fibrosis stage (estimation method: FIB-4): a) F0-F2; and b) F3-F4 (advanced fibrosis). Follow-up lasted one year. Primary endpoints included comorbidity, concomitant medication, resource utilization and costs. Results were analyzed using a multivariate approach with p < 0.05. RESULTS: a total of 8,151 patients were recruited with a mean age of 61.1 years and 51.5 % were male. By group: a) mild fibrosis n = 7,127, 87.4 %; and b) advanced fibrosis n = 1,024, 12.6 % (6.8 % with liver cirrhosis). The most common comorbidities included 63 % dyslipidemia, 52 % obesity, 52 % hypertension and 35 % diabetes. The average number of drugs used was 2.1 per patient. Patients with advanced fibrosis (F3-F4) had a higher average number of concomitant medications (2.5 vs 2.1; p < 0.001) and a higher AST/ALT ratio (1.1 vs 0.8; p < 0.001). The average cost (patient-year) for subjects with advanced fibrosis, corrected for covariates, was higher (€1,812 vs €1,128, p < 0.001). Age, morbidity, concomitant medication, fibrosis stage and total costs were higher in patients with diabetes. CONCLUSIONS: patients with advanced fibrosis were associated with more comorbidity and concomitant medications, which resulted in higher healthcare costs for the National Health System.

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.

Budgetary Impact Analysis of Reimbursement Varenicline for the Smoking-Cessation Treatment in Patients with Cardiovascular Diseases, Chronic Obstructive Pulmonary Disease or Type-2 Diabetes Mellitus: A National Health System Perspective.

AIMS: The study aimed to assess the budgetary impact (BI) of reimbursing varenicline in patients with chronic obstructive pulmonary disease (COPD), type-2 diabetes mellitus (t2-DM) or cardiovascular diseases (CVD). METHODS: The BI was estimated comparing the current non-reimbursed scenario versus a projected reimbursed scenario using the Spanish National Health System (SNHS) perspective. A hybrid model was developed using epidemiological data and Markov chains to estimate smoking cessation rates with varenicline during a 5-year horizon. Costs of cessation were considered in the reimbursement scenario only. Efficacy, expressed as a 1-year continuous abstinence rate, was derived from clinical trials. Cost savings due to smoking cessation were extracted from local cost-of-illness studies. Results are shown as incremental cost savings. Univariate sensitivity analysis was also applied. RESULTS: A total of 68,684 patients stopped smoking in the reimbursed scenario compared with 15,208 without reimbursement. In the reimbursed scenario, total savings accounted for €36.3 million, showing 14.6 million accumulated additional savings compared with the scenario without reimbursement. Sensitivity analyses showed results to be robust with monetary savings starting in the third year of modeling. CONCLUSION: Reimbursement of varenicline in smoking cessation is a cost-effective health policy in the SNHS in COPD, t2-DM or CVD, and could produce cost savings starting in the third year of implementation.

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.

Costs of ulcerative colitis from a societal perspective in a regional health care area in Spain: A database study.

OBJECTIVES: To estimate the management of UC associated costs from the societal perspective in Spain. METHODS: Observational, longitudinal study with retrospective data collection based on reviews of outpatient health records. Socio-demographic, clinical and sick leave information was gathered. Patients diagnosed of UC between 2002 and 2012, older than 18 years, followed-up by a minimum of 12 months post diagnosis, with at least two clinical and use of resources data recorded, were included. RESULTS: 285 UC patients [51.2% men; 44.5 (SD: 15.6) years old; 88.4% without family history of UC; 39.3% proctitis; 5.6 (2.5) years disease follow-up] participated. More than half (65.6%) were active workers, 75.9% were on sick leave for reasons different from UC [mean 0.66 (0.70) times per year] during (mean) 28.43 (34.45) days. Only 64 patients were on UC-related sick-leaves, lasting (mean) 26.17 (37.43) days. Absenteeism due to medical visits caused loss of 29.55 (21.38) working hours per year. Mean direct and indirect annual cost per UC patient were €1754.10 (95%CI: 1473.37-2034.83) and €399.32 (282.31-422.69), respectively. Absenteeism was estimated at €88.21(32.72-50.06) per patient per year, in which sick-leaves were the main component of indirect costs (88.2%). Age, UC family history, diarrhea at diagnosis, blood and blood-forming organs diseases and psychological disorders were the main predictors of indirect costs. CONCLUSIONS: UC is a costly disease for the society and the Spanish National Healthcare System. Indirect costs imply a major burden by affecting the most productive years of patients. Further research is needed considering all components of productivity loss, including presenteeism-associated costs.

[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.

Comorbidity of dementia: a cross-sectional study of primary care older patients.

BACKGROUND: The epidemiologic study of comorbidities of an index health problem represents a methodological challenge. This study cross-sectionally describes and analyzes the comorbidities associated with dementia in older patients and reviews the existing similarities and differences between identified comorbid diseases using the statistical methods most frequently applied in current research. METHODS: Cross-sectional study of 72,815 patients over 64 seen in 19 Spanish primary care centers during 2008. Chronic diseases were extracted from electronic health records and grouped into Expanded Diagnostic Clusters®. Three different statistical methods were applied (i.e., analysis of prevalence data, multiple regression and factor analysis), stratifying by sex. RESULTS: The two most frequent comorbidities both for men and women with dementia were hypertension and diabetes. Yet, logistic regression and factor analysis demonstrated that the comorbidities significantly associated with dementia were Parkinson's disease, congestive heart failure, cerebrovascular disease, anemia, cardiac arrhythmia, chronic skin ulcers, osteoporosis, thyroid disease, retinal disorders, prostatic hypertrophy, insomnia and anxiety and neurosis. CONCLUSIONS: The analysis of the comorbidities associated with an index disease (e.g., dementia) must not be exclusively based on prevalence rates, but rather on methodologies that allow the discovery of non-random associations between diseases. A deep and reliable knowledge about how different diseases are grouped and associated around an index disease such as dementia may orient future longitudinal studies aimed at unraveling causal associations.

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.

Age and gender differences in the prevalence and patterns of multimorbidity in the older population.

BACKGROUND: The coexistence of several chronic diseases in one same individual, known as multimorbidity, is an important challenge facing health care systems in developed countries. Recent studies have revealed the existence of multimorbidity patterns clustering systematically associated distinct clinical entities. We sought to describe age and gender differences in the prevalence and patterns of multimorbidity in men and women over 65 years. METHODS: Observational retrospective multicentre study based on diagnostic information gathered from electronic medical records of 19 primary care centres in Aragon and Catalonia. Multimorbidity patterns were identified through exploratory factor analysis. We performed a descriptive analysis of previously obtained patterns (i.e. cardiometabolic (CM), mechanical (MEC) and psychogeriatric (PG)) and the diseases included in the patterns stratifying by sex and age group. RESULTS: 67.5% of the aged population suffered two or more chronic diseases. 32.2% of men and 45.3% of women were assigned to at least one specific pattern of multimorbidity, and 4.6% of men and 8% of women presented more than one pattern simultaneously. Among women over 65 years the most frequent pattern was the MEC pattern (33.3%), whereas among men it was the CM pattern (21.2%). While the prevalence of the CM and MEC patterns decreased with age, the PG pattern showed a higher prevalence in the older age groups. CONCLUSIONS: Significant gender differences were observed in the prevalence of multimorbidity patterns, women showing a higher prevalence of the MEC and PG patterns, as well as a higher degree of pattern overlapping, probably due to a higher life expectancy and/or worse health. Future studies on multimorbidity patterns should take into account these differences and, therefore, the study of multimorbidity and its impact should be stratified by age and sex.

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.

The CNIC-polypill (acetylsalicylic acid, atorvastatin, and ramipril), an effective and cost-saving secondary prevention strategy compared with other therapeutic options in patients with ischaemic heart disease.

Aims: The retrospective NEPTUNO study evaluated the effectiveness of the Centro Nacional de Investigaciones Cardiovasculares (CNIC)-polypill (including acetylsalicylic acid, ramipril, and atorvastatin) vs. other therapeutic approaches in secondary prevention for cardiovascular (CV) disease. In this substudy, the focus was on the subgroup of patients with ischaemic heart disease (IHD). Methods and results: Patients on four strategies: CNIC-polypill, its monocomponents as loose medications, equipotent medications, and other therapies. The primary endpoint was the incidence of recurrent major adverse CV events (MACEs) after 2 years. After matching, 1080 patients were included in each cohort. The CNIC-polypill cohort had a significantly lower incidence of recurrent MACE compared with monocomponents, equipotent drugs, and other therapies cohorts (16.1 vs. 24, 24.4, and 24.3%, respectively; P < 0.001). The hazard ratios (HRs) for recurrent MACE were higher in monocomponents (HR = 1.12; P = 0.042), equipotent drugs (HR = 1.14; P = 0.031), and other therapies cohorts (HR = 1.17; P = 0.016) compared with the CNIC-polypill, with a number needed to treat of 12 patients to prevent a MACE. The CNIC-polypill demonstrated a greater reduction in LDL cholesterol (LDL-c; -56.1 vs. -43.6, -33.3, and -33.2% in the monocomponents, equipotent drugs, and other therapies, respectively; P < 0.001) and systolic blood pressure (-13.7 vs. -11.5, -10.6, and -9.1% in the CNIC-polypill, monocomponents, equipotent drugs, and other therapies, respectively; P < 0.001) compared with other cohorts. The CNIC-polypill intervention was less costly and more effective than any other therapeutic option, with €2317-€2407 cost savings per event prevented. Conclusion: In IHD, the CNIC-polypill exemplifies a guideline-recommended secondary prevention treatment linked to better outcomes and cost saving compared with other therapeutic options.

Influence of the COVID-19 pandemic on patients receiving oral anticoagulants for the treatment of non-valvular atrial fibrillation.

Background: Frequent monitoring of patients declined during the COVID-19 pandemic, harming patients with chronic diseases who critically needed correct monitoring. We evaluated the impact of the COVID-19 pandemic in patients with non-valvular atrial fibrillation (NVAF) receiving treatment with vitamin K antagonists (VKA) or non-vitamin K antagonist oral anticoagulants (NOAC) in clinical practice in Spain. Methods: This observational, retrospective study analyzed prevalent patients treated with NOAC/VKA on 14/03/2019 (pre-COVID-19 period) and 14/03/2020 (COVID-19 period), who were followed up to 12 months. The study also considered incident patients who started treatment with NOAC/VKA between 15/03/2019 and 13/03/2020 (pre-COVID-19 period) and from 15/03/2020 to 13/03/2021 (COVID-19 period). Demographic characteristics, comorbidities, effectiveness, treatment patterns, and healthcare resource utilization were considered. Results: Prevalent patients amounted to 12,336 and 13,342 patients, whereas 1,612 and 1,602 incident patients were included in the pre-COVID-19 and COVID-19 periods, respectively. Prevalent patients treated with VKA had more strokes, thromboembolism, and major bleeding compared to those receiving NOAC, particularly during the COVID-19 period. NOAC patients had a 12 % lower risk of death than those on treatment with VKA (Hazard ratio = 0.88 [95 % CI: 0.81 - 0.95], p = 0.033). In addition, VKA patients were less persistent after 12 months than NOAC patients (pre-COVID-19 period: 52.1 % vs. 78.9 %, p < 0.001; COVID-19 period: 49.2 % vs. 80.3 %, p < 0.001), and required more healthcare visits and hospitalizations than those on treatment with NOAC. Conclusion: Compared to VKA, NOAC seems to have reduced the incidence of severe events and the use of healthcare resources for NVAF, particularly during the pandemic.

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.