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Introduction: Adding LAMA to LABA/ICS is recommended to improve control in patients with persistent asthma. Methods: This observational, retrospective, before-and-after study considered patients diagnosed with asthma who started LABA/ICS + LAMA treatment (triple therapy, TT) between 1 January 2017 and 31 December 2018 and had been treated with LABA/ICS (dual therapy, DT) in the year before. Changes in lung function and exacerbation rates, healthcare resource utilization, and healthcare and non-healthcare costs (€2019) were estimated in patients with asthma in clinical practices in Spain. Data from computerized medical records from seven Spanish regions were collected ±1 year of LAMA addition. Results: 4740 patients (64.1 years old [SD: 16.3]) were included. TT reduced the incidence of exacerbations by 16.7% (p < 0.044) and the number of patients with exacerbations by 8.5% (p < 0.001) compared to previous DT. The rate of patients with severe exacerbations requiring systemic corticosteroids and their hospitalization rates significantly decreased by 22.5% and 29.5%. TT significantly improved FEV1, FVC, and FEV1/FVC, saving €571/patient for society. Younger patients with asthma (18–44 years old) and patients with severe asthma (FEV1 < 60%) performed better upon the initiation of TT. Conclusions: TT reduced asthma exacerbations, improved lung function and reduced healthcare costs vs. DT, particularly in patients requiring systemic corticosteroids to treat severe exacerbations. [ABSTRACT FROM AUTHOR]

Objective: This study aims to compare the hospitalization rate in individuals with schizophrenia who started their treatment with aripiprazole once monthly (AOM400) or atypical oral antipsychotics (OA) in Spain. Methods: This is an observational and retrospective study based on the electronic medical records from the BIG-PAC database. The study population consisted of individuals diagnosed with schizophrenia who initiated their treatment with AOM400 (AOM cohort) or atypical OA (OA cohort) from 01/01/2017 to 31/12/2019. A 1:1 propensity score matching (PSM) procedure was conducted to match individuals of both cohorts. The number and duration of hospitalizations, persistence to treatment, healthcare resources use, and costs were analyzed after 12 months. Results: After the PSM, 1,017 individuals were included in each cohort [age: 41.4 years (SD: 10.6); males: 54.6%]. During the follow-up period, the AOM cohort had a 40% lower risk of hospitalization than the OA group [HR: 0.60 (95% confidence interval, CI: 0.49–0.74)]. The median time to the first hospitalization was longer in individuals with AOM400 compared to those with OA (197 days compared to 174 days; p < 0.004), whereas hospital admissions were shorter (AOM400: 6 compared to OA: 11 days; p < 0.001). After 12 months, individuals receiving AOM400 were more persistent than those with OA (64.9% compared to 53.7%; p < 0.001). The OA cohort required more healthcare resources, mainly visits to primary care physicians, specialists, and emergency rooms than those receiving AOM400 (p ≤ 0.005 in all comparisons). AOM400 reduced the costs of hospitalizations, and emergency room, specialist and primary care visits by 50.4, 36.7, 16.1, and 10.9%, respectively, in comparison to the treatment with atypical OA. AOM400 led to annual cost savings of €1,717.9 per individual, from the societal perspective. Conclusion: Aripiprazole once monthly reduces the number and duration of hospitalizations, together with the treatment costs of schizophrenia, as it reduces the use of healthcare resources and productivity losses in these individuals. [ABSTRACT FROM AUTHOR]

To determine the disease burden and costs in patients with hip or knee OA and chronic moderate-to-severe refractory pain, receiving strong opioids in Spain. This was a 36-month longitudinal secondary analysis of the real-word OPIOIDS study. Patients aged ≥18 years with hip or knee OA and chronic moderate-to-severe refractory pain receiving strong opioids were considered. The disease burden included analgesia assessments (NRS scale), cognitive functioning (MMSE scale), basic activities of daily living (Barthel index), and comorbidities (severity and frequency). Costs due to the use of healthcare resources and productivity loss were estimated. 2832 patients were analyzed; age was 72.0 years (SD = 14.3), 76.8% were women. Patients had mainly been treated with fentanyl (n = 979; 37.6%), tapentadol (n = 625; 24.0%), oxycodone (n = 572; 22.0%), and buprenorphine (n = 425; 16.3%). Pain intensity decreased by 1 point (13.7%), with a 2.6-point decline in the cognitive scale (14.3%, with a 5.3%-increase in patients with cognitive deficit) over a mean treatment period of 384.6 days (SD: 378.8). Barthel scores decreased significantly yielding to a slightly increase in proportion of patients with severe-to-total dependency; 1.2%–2.9%. In the first year of treatment, average healthcare costs were €2013/patient, whereas the average productivity loss cost was €12,227/working-active patient. Strong opioids resulted in high healthcare costs with a limited reduction in pain, an increase in cognitive deficit, and a slight increase of patients with severe to total dependency over 36 months of treatment. [ABSTRACT FROM AUTHOR]

Background: COPD is a leading cause of death and disability. COPD therapy goals include reducing exacerbations and improving symptom control. Single-inhaler triple therapy (SITT) or multiple-inhaler triple therapy (MITT) is indicated for patients with frequent exacerbations despite bronchodilator therapy. No available evidence compares SITT vs MITT in Spain in terms of treatment persistence, exacerbations, and other outcomes.Research Question: Do COPD patients in Spain initiating SITT vs MITT have improved persistence, exacerbations, and health care resource utilization?Study Design and Methods: This real-world, observational, retrospective cohort study analyzed electronic health records in the Spanish National Healthcare System BIG-PAC database to identify COPD patients aged ≥ 40 years initiating SITT or MITT (using two or three inhalers) between June 1, 2018 and December 31, 2019. Comparative data on persistence (allowing up to 60 days without prescription refill), exacerbation rates, and health care resource utilization and costs during 12-month follow-up were analyzed. Multivariate adjusted analyses were performed.Results: Eligible patients (N = 4,625) initiating SITT (n = 1,011) or MITT (n = 3,614) had a mean age of 70.9 years; most were male (73.9%) with mainly moderate (62.0%) or severe (26.5%) airflow limitation. Between-cohort baseline characteristics were similar. At 12-month follow-up, SITT patients had higher persistence (hazard ratio [HR] = 1.37; 95% CI = 1.22-1.53; P < .001), reduced risk of exacerbations (HR = 0.68; 95% CI = 0.61-0.77; P = .001), and lower all-cause mortality risk (HR = 0.67; 95% CI = 0.63-0.71, P = .027), compared with MITT patients. SITT was associated with significantly reduced health care resource use (mean annual cost savings: €403 vs MITT). For both SITT and MITT, persistence was associated with improved exacerbation rates vs nonpersistence, and substantial adjusted mean annual cost savings (€2,115 and €2,700, respectively).Interpretation: Patients initiating SITT had a clinically relevant improvement in persistence leading to reductions in mortality, incidence of exacerbations, and health care resource use with consequent mean cost savings. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Purpose: To estimate the number of sick leave days and productivity costs in active workers with osteoarthritis (OA) who initiated opioid treatment for moderate/severe chronic pain in clinical practice in Spain. Patients and Methods: This is a secondary analysis of the longitudinal, retrospective OPIOIDS study, using electronic medical records (EMR) of patients aged ≥ 18 years, who started an opioid treatment for moderate/severe chronic OA pain between 2010 and 2015 after treatment failure with ≥ 1 first-line drugs (acetaminophen, metamizole and/or nonsteroidal anti-inflammatory drugs [NSAIDs]). The number of days of sick leave and productivity costs were analyzed during a follow-up period of 36 months. Results: A total of 5089 patients with moderate/severe chronic OA pain, aged 56.8 years (standard deviation [SD]: 4.6) (56.6% were female), were analyzed: 73.3% of them started a treatment with weak opioids and 26.7% of them were treated with strong opioids. At 36 months, adherence was 21.0% (strong opioids: 15.4%; weak opioids: 23.0%; p< 0.001), and 77% of patients had at least one sick leave related with chronic OA pain, with an average of 93 days off work in all working patients (120.5 days in patients with sick leaves). Besides, 16.9% of the study population had sick leave periods that lasted at least 6 months. Pain reduction was modest (− 1.2 points; − 4.0%, p< 0.001). The cost of sick leave was € 2594 patient/year, and factors such as older age (β=0.043), female sex (β=0.036), comorbidities (β=0.035) and strong opioid use (β=0.031) were associated with higher productivity costs (p< 0.05 in all associations). Conclusion: Active workers who started opioid treatment for moderate/severe chronic OA pain showed an increased frequency of sick leave and productivity cost, with a modest effect on pain relief. Older age, female sex, comorbidities, and strong opioids were associated with higher costs for society. [ABSTRACT FROM AUTHOR]

Introduction: This study aimed to describe utilization patterns, persistence, resource utilization and costs in patients with type 2 diabetes mellitus initiating treatment with glucagon-like peptide 1 receptor agonists in routine clinical practice in Spain. Methods: This retrospective study of medical records in the Big-Pac database identified adults starting treatment with once-weekly (QW) dulaglutide, exenatide-QW or once-daily liraglutide between 1 November 2015 and 30 June 2017. Patients were followed for up to 18 months from treatment initiation. Data on clinical characteristics of patients, treatment patterns, average daily dose and costs were obtained for the three cohorts. Persistence over the 18-month period was evaluated using Kaplan–Meier curves. All analyses were descriptive. Results: A total of 1402 patients were included in this study (dulaglutide [n = 492], exenatide-QW [n = 438] or liraglutide [n = 472]); 52.8% were men, and the mean (SD) age was 62 (11) years, glycated haemoglobin (HbA1c) was 8.1% (1.2) and body mass index was 35.5 (3.2) kg/m2 at treatment initiation. Persistence at 18 months was 59.1% (95% confidence interval [CI] 54.8–63.4) for dulaglutide, 45.7% (95% CI 41.0–50.4) for exenatide-QW and 46.6% (95% CI 42.1–51.1) for liraglutide. The average (SD) dose was 1.2 (0.4) mg/week for dulaglutide, 1.9 (0.3) mg/week for exenatide-QW and 1.1 (0.3) mg/day for liraglutide. The average reduction in HbA1c levels at 1 year was − 0.68% for patients who initiated dulaglutide, − 0.54% for patients who initiated exenatide-QW and − 0.50% for patients who initiated liraglutide. The mean (SD) total annual health care costs were €4072 (1946) for dulaglutide, €4418 (2382) for exenatide-QW and €4382 (2389) for liraglutide. Conclusion: Results suggest that patients who started treatment with dulaglutide had higher persistence over 18 months, presented lower HbA1c levels at 12 months and incurred lower annual total healthcare costs than patients who initiated exenatide-QW or liraglutide. Plain Language Summary: Type 2 diabetes has a major impact on patients psychologically and socially, as well as on healthcare costs. The glucagon-like peptide 1 receptor agonists (GLP-1 RAs) are drugs that help maintain blood sugar at healthy levels. They are often used as the first injectable drugs if oral treatments are no longer effective. This study aimed to analyse the use of GLP-1 RAs, and the costs involved, among patients with type 2 diabetes who started treatment with once-weekly dulaglutide, once-weekly exenatide or liraglutide in routine clinical practice in Spain. An electronic database of medical records was used to obtain data from 1402 patients who started treatment with these drugs and were followed for a 1.5-year period. Results of this study suggest that patients who were prescribed dulaglutide stayed on their treatment longer and could reduce their blood sugar levels more efficiently, and at a lower cost, than those who received once-weekly exenatide or liraglutide. These findings could be helpful to physicians prescribing these drugs when considering how to improve the management of type 2 diabetes. [ABSTRACT FROM AUTHOR]

Introduction: To determine the disease burden and costs in moderate-to-severe chronic osteoarthritis (OA) pain refractory to standard-of-care treatment in the Spanish National Health System (NHS). Methods: Ancillary analysis of the OPIOIDS real-world, non-interventional, retrospective, 4-year longitudinal study including patients aged at least 18 years with moderate-to-severe chronic OA pain refractory to standard-of-care with sequential NSAIDs plus opioids. Burden assessment included measurement of analgesia, cognitive functioning, basic activities of daily living, severity and frequency of comorbidities, and all-cause mortality. Costs accounted for healthcare resource utilization and related costs (year 2018). Results: Records of 13,317 patients were analyzed; 68.9 (14.7) years old, 71.3% (70.5–72.1%) women, 58.1% refractory to NSAID plus weak opioid and 41.9% to NSAID plus strong opioid, accounting for 10.7% (10.5–10.8%) of patients with chronic OA pain. Mean number of comorbidities was 2.9 (1.8) and its severity was 1.8 (1.7). Pain decreased by 0.9 points (12.2%) and cognitive declined by 2.3 points (9.1%, with 4.3% more patients with cognitive deficit) and dependency worsened by 0.4 points (0.5%, with 2.3% more patients with severe-to-total dependence) over a mean treatment period of 188.6 (185.4–191.8) days on NSAIDs followed by 400.6 (393.7–407.5) days on opioids. The adjusted mortality rate was higher in patients with OA taking NSAID plus strong opioids; hazard ratio 1.44 (1.26–1.65; p < 0.001). The 4-year healthcare cost was €7350/patient (€7193–7507 or €1838/year) and was higher in those taking strong versus weak opioids; €9886 (€9608–10,164, €2472/year) vs. €5519 (€5349–5689, €1380/year), p < 0.001. Analgesia cost (16.0% of total cost, 70.2% opioids) was higher with strong versus weak opioids, 19.6% vs. 11.3%, p < 0.001. Conclusions: In routine clinical practice in Spain, patients with moderate-to-severe chronic OA pain refractory to standard analgesic treatment with NSAIDs plus opioids reported modest reductions in pain, while presenting a considerable burden of comorbidities, cognitive impairment, and dependency. Healthcare costs significantly increased for the NHS particularly with NSAIDs plus strong opioids. [ABSTRACT FROM AUTHOR]

To compare healthcare resource use (HRU) and annual costs in type 2 diabetes mellitus (T2DM) patients with poor glycaemic control and obesity versus good glycaemic control without obesity. Observational retrospective study based on the analysis of electronic medical records from the BIG-PAC database, with one year of follow-up. T2DM patients aged ≥30 years who requested medical care during 2013 were included. Annual HRU and costs per patient were compared between a reference group (HbA1c ≥ 8%, BMI ≥30 kg/m2, receiving ≥2 oral antidiabetic drugs [OADs]) and a control group (HbA1c < 7% and BMI <30 kg/m2). Direct and indirect costs (lost productivity) were analysed. Cost comparisons across groups were made using the analysis of covariance (ANCOVA) for each cost component, with age, sex, time from diagnosis, Charlson comorbidity index, OAD number and sex by group interaction as covariates. During the follow-up, patients in the reference group (N = 2709) had a greater HRU than those in the control group (N = 5266), especially in the number of primary care (PC) visits (11.8 vs. 9.8; 95%CI: 11.5–12.1 vs. 9.6–10.0) and days of hospitalization (1.1 vs 0.6; 95%CI: 1.0–1.2 vs. 0.5–0.7). The main components of the total cost were hospital admissions (24.5%), productivity losses (16.3%), complementary tests (14.4%), PC visits (14.2%) and medication (13.6%) in the reference group and medication (19.6%), hospital admissions (18.7%) and PC visits (18.2%) in the control group. The corrected mean annual cost per patient was higher in the reference than in the control group: €1804 vs. €1309; p <.001. Poor glycaemic control and obesity in T2DM patients were associated with increased HRU and costs in routine clinical practice. [ABSTRACT FROM AUTHOR]

Objective: To determine the epidemiology and characterize the treatment prescribed for severe atopic dermatitis (AD) in children/adults in usual clinical practice.Methods: Observational, retrospective study made through review of medical records of Spanish patients aged ≥6 years. Patients diagnosed with severe AD who required care between 2013 and 2017 were included. The study groups were: 6-12 years; 13-18 years; and > 18 years. Patients were followed for 5 years. The main measurements were the prevalence of AD, comorbidity and treatment duration. Statistical significance was established as p <0.05.Results: We included 2323 patients with severe AD. The overall prevalence was 0.10% (95% CI: 0.09-0.11%) and was 0.39%, 0.23% and 0.07% in the 6-12 years, 13-18 years and >18 years age groups, respectively (p <0.001), the percentage of males was 58%, 48.6% and 39%, respectively, and general comorbidity was 0.1, 0.2 and 0.9 points, respectively (p <0.001).The most frequent comorbidities were asthma in 49.0%, 44.9% and 20.8%, respectively (p <0.001), and anxiety in 79.7%, 65.8% and 67.3%, respectively (p <0.001). Oral corticosteroids were administered in 97.3%, 90.9% and 81.7%, respectively (concomitant-medication). Cyclosporine (45.3%), azathioprine (15.9%) and methotrexate (9.0%) were the most frequently prescribed drugs; biologic agents were administered in 5.8% of patients (for AD).Conclusion: In AD the presence of comorbidities was significant, especially in the psychological, immunoallergic and cardiovascular areas. Cyclosporine was the most widely used immunosuppressant. There was a degree of variability in the use and duration of the treatments prescribed. [ABSTRACT FROM AUTHOR]

Despite size and relevance of uncontrolled diabetes, robust evidence on its effects on health care utilisation is very limited, especially among European countries. We employed longitudinal administrative data from Spain (2004-2010) to explore the relationship between uncontrolled type 2 diabetes and health care utilisation. We used a biomarker (glycated haemoglobin, HbA1c) to detect the presence of uncontrolled diabetes and explore its effects on both primary and secondary health care. We estimated a range of panel count data models, including negative binomials with random effects, dynamic and hurdle specifications to account for unobserved heterogeneity, previous utilisation and selection. We found uncontrolled diabetes in between 27 and 30% of patients of both genders. Our estimates suggested that although women appeared to systematically consume more health care compared to men, their consumption levels did not seem to be influenced by uncontrolled diabetes. Conversely, among men uncontrolled diabetes increased the average number of GP visits per year by between 3 and 3.4%, specialist visits by 5.3-6.1%, depending on specifications, and also extended annual hospital length of stay by 15%. We also found some evidence of heterogeneity in utilisation based on the level of uncontrolled diabetes among male individuals. Overall, our results suggested the need for different diabetes management plans depending on gender and levels of glycaemic control. [ABSTRACT FROM AUTHOR]

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 (β = 0.135, p = 0.001), time since diagnosis (β = 0.281, p = 0.023), and age (β = 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. [ABSTRACT FROM AUTHOR]

To analyze the effect of loss of exclusivity of data on the cost of treatment of peripheral neuropathic pain (PNP) with pregabalin or gabapentin in routine clinical practice. A retrospective observational study, with electronic medical records for patients enrolled at primary care centers managed by the health care provider Badalona Serveis Assistencials, who initiated treatment of PNP with pregabalin or gabapentin. The analysis used drugs and resources prices for year 2015. The 1163 electronic medical records (pregabalin; N = 764, gabapentin; N = 399) for patients (62.2% women) with a mean (standard deviation) age of 59.2 (14.7) years were analyzed. Treatment duration was slightly shorter with pregabalin than with gabapentin (5.2 vs 5.5 months; P = 0.124), with mean doses of 227.4 (178.6) mg and 900.0 (443.4) mg, respectively. The average study drug cost per patient was higher for pregabalin than for gabapentin; €214.6 (206.3) vs €157.4 (181.9), P < 0.001, although the cost of concomitant analgesic medication was lower; €176.5 (271.8) vs €306.7 (529.2), P < 0.001. The adjusted average total cost per patient was lower in those treated with pregabalin than in those treated with gabapentin; €2,413 (21192708) vs €3201 (2806-3.597); P = 0.002, owing to significantly lower health care costs; €1307 (1247-1367) vs €1538 (1458-1618), P < 0.001, and also non-health care costs; €1106 (8191393) vs €1663 (1279-2048), P = 0.023, that was caused by a significantly lower use of concomitant medication, fewer medical visits to primary care, and fewer days of sick leave. After loss of exclusivity of both drugs, pregabalin continued to show lower health care and non-health care costs than gabapentin in the treatment of PNP in routine clinical practice. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Overactive bladder (OAB) is a syndrome characterized by presenting symptoms of urgency, with or without urge incontinence, and normally accompanied by day and night frequency. Objective: The aim of this study was to evaluate the impact of lost work productivity [number of days of sick leave] in patients treated with fesoterodine versus tolterodine and solifenacin to treat OAB in Spain. Methods: A retrospective, observational study was carried out using the records (digital databases) of actively working patients (2008-2013). The study population comprised of patients from two autonomous communities; 31 primary care centres agreed to participate. Patients who began first treatment with antimuscarinics (fesoterodine, solifenacin or tolterodine) and who met certain inclusion/exclusion criteria were included in the study. Follow-up lasted for 1 year. The main outcome measures were comorbidity, medication possession ratio (MPR), treatment persistence, and number of days of sick leave and associated costs. Indirect costs were considered to be those related to lost work productivity (number of days of sick leave, exclusively), (1) due to OAB and (2) overall total. The cost was expressed as the average cost per patient (cost/unit). Multivariate analyses (Cox, ANCOVA) were used to correct the models. Results: A total of 3094 patients were recruited into the study; 43.0 % were treated with solifenacin, 29.2 % with tolterodine, and 27.8 % with fesoterodine. The average age of patients was 54 years (standard deviation 9.2), and 62.2 % were women. The comparison of fesoterodine versus solifenacin and tolterodine showed a higher MPR (90.0 vs. 87.0 and 86.1 %, respectively), higher treatment persistence (40.2 vs. 34.7 and 33.6 %), lower use of sick leave (22.8 vs. 52.9 and 36.7 %), total number of days of sick leave (5.1 vs. 9.7 and 9.3 days) and costs corrected for covariates (€371 vs. €703 and €683); p < 0.05. Conclusions: Despite the possible limitations of this study, active patients who began treatment with fesoterodine to treat OAB (compared with solifenacin or tolterodine) had fewer days of sick leave, resulting in lower costs due to lost productivity. [ABSTRACT FROM AUTHOR]

This paper estimates the increase of direct medical costs of both severe and moderate obesity and overweight with respect to a normal-weight individual using a two-part generalised linear model and a longitudinal dataset of medical and administrative records of patients in primary and secondary healthcare centres followed up over seven consecutive years (2004-2010) in Spain. Our findings indicate that severe and moderate obesity imposes a substantial burden on the Spanish healthcare system. Specifically, being severely obese is associated with increases in medical costs of 26 % (instrumental variables (IV) estimate, 34 %) compared to a normal-weight individual. The effects of moderate obesity and overweight are more modest, raising medical costs by 16 % (IV estimate, 29 %) and 8.5 % (IV estimate, 23 %), respectively. These changes in costs are slightly higher for those patients below the median age and for the women. Notwithstanding, the effects found in this study are comparatively much lower than that reported for the USA, based basically on a private healthcare system and characterised by a more obese population. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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 (€16.39 [1542; 1725]) compared with solifenacin {€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. [ABSTRACT FROM AUTHOR]

Objective The study aims to obtain the mean relative weights (MRWs) of the cost of care through the retrospective application of the adjusted clinical groups (ACGs) in several primary health care (PHC) centres in Catalonia (Spain) in routine clinical practice. Methods This is a retrospective study based on computerized medical records. All patients attended by 13 PHC teams in 2008 were included. The principle measurements were: demographic variables (age and sex), dependent variables (number of diagnoses and total costs), and case-mix or co-morbidity variables (International Classification of Primary Care). The costs model for each patient was established by differentiating the fix costs from the variable costs. In the bivariate analysis, the Student's t, analysis of variance, chi-squared, Pearson's linear correlation and Mann-Whitney-Wilcoxon tests were used. In order to compare the MRW of the present study with those of the United States (US), the concordance [intraclass correlation coefficient (ICC) and concordance correlation coefficient (CCC)] and the correlation (coefficient of determination: R2) were measured. Results The total number of patients studied was 227 235, and the frequentation was 5.9 visits/habitant/year) and with a mean diagnoses number of 4.5 (3.2). The distribution of costs was €148.7 million, of which 29.1% were fixed costs. The mean total cost per patient/year was €654.2 (851.7), which was considered to be the reference MRW. Relationship between study-MRW and US-MRW: ICC was 0.40 [confidential interval (CI) 95%: 0.21-0.60] and the CCC was 0.42 (CI 95%: 0.35-0.49). The correlation between the US MRW and the MRW of the present study can be seen; the adjusted R2 value is 0.691. The explanatory power of the ACG classification was 36.9% for the total costs. The R2 of the total cost without considering outliers was 56.9%. Conclusions The methodology has been shown appropriate for promoting the calculation of the MRW for each category of the classification. The results provide a possible practical application in PHC clinical management. [ABSTRACT FROM AUTHOR]

Objective To compare the cost of adding either pregabalin or gabapentin to the management of community-treated patients with peripheral neuropathic pain (PNP). Methods A retrospective observational study was conducted using medical records from a Spanish health care provider claims database. Patients receiving health care for PNP, above 18 years and for which either pregabalin or gabapentin was initiated between 2006 and 2008 were included. Economic evaluation included health care resource utilization costs and costs due to sick leave. Results A total of 1163 patients with PNP were eligible for analysis: 764 were prescribed pregabalin and 399 gabapentin in addition to current pain therapy. Mean age was 59.2 years and 62.2% were female. Concomitant use of analgesics was higher in the gabapentin cohort (3.2 vs. 2.7; P = 0.003), mainly due to non-steroidal anti-inflammatory drugs (74.9% vs. 69.5%; P = 0.018) and opioids (27.7% vs. 17.9%; P = 0.031). Adjusted total costs per patient was lower in pregabalin-treated patients (€2514 vs. €3241; P = 0.003), due to less sick leave (€1067 vs. €1633; P = 0.018) and lower health care costs (€1447 vs. €1609; P = 0.004). The higher acquisition cost of pregabalin (€351 vs. €191; P < 0.001) was largely compensated with lower costs in medical visits, physiotherapy, hospital stays and concomitant analgesics. Conclusions In community-treated patients with PNP, total costs were considerably less for those patients initiated with pregabalin therapy than for those patients starting gabapentin add-on therapy. The relatively higher treatment acquisition cost of pregabalin was largely compensated by the overall lower costs for the other components of health care resources and sick leave, thus reducing the economic impact on the health care provider's budget and society. [ABSTRACT FROM AUTHOR]

The objective of the study was to determine the use of resources and costs due to bone fractures in Spanish women above 50 years of age in the population scope. An observational and retrospective study was conducted in six primary care centers and two urban hospitals in Spain. Socio-demographic and co-morbidity data, use of resources (primary care consultations, complementary tests, medications, specialized care, hospitalizations, visits, urgencies), costs and productivity losses were registered. Records of 19 022 women were included, 7% showed some type of fracture between 2003 and 2007. Fractures were mostly associated with osteoporosis (OR: 3.2), ibromyalgia (OR: 2.4) and thyroid changes (OR: 2.2). In the corrected model, the total cost for patients who had a fracture was USD 3727 compared to USD 2705.5 (p<0.001) for those who did not have it. Patients with a fracture generate a greater use of resources, sanitation costs and work productivity losses. [ABSTRACT FROM AUTHOR]

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. Methods: 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. [ABSTRACT FROM AUTHOR]

Objectives. To evaluate the results of implementing a classification system based on adjusted clinical groups (ACG) at a primary health care (PHC) in a Spanish population. Methods. A retrospective, cross-sectional study based on the computerized medical records of outpatients seen in 2007 by the La Roca clinic, administered by a health services management company in La Roca del Vallès, Barcelona, Spain. The ACGs were formed according to the International Classification of Diseases, 9th Revision, Clinical Modification. The relative weight of each ACG's total average cost was calculated (in U.S. dollars) and based on these, the resources usage levels were established. The risk index (RI) and efficiency index (EI) for 2006 and the classification's explanatory power were determined. Results. A total of 8 294 patients were studied (82.7% coverage), with an average of 4.1 incidents per patient, 6.9 visits per patient, and 5.7 visits per person per year. Seven GCAs accounted for 51.0% of patients seen. The RI was 1.015, the EI was 0.975 visits, and the explanatory power of the ACG classification was 53.4% for visits and 74.8% for incidents. Conclusions. The ACG system allowed this patient population to be grouped by clinical status, which can help to, among other things, allocate resources and evaluate PHC team efficiency. [ABSTRACT FROM AUTHOR]

Background: To determine the referral rate (RR) per centre, its main causes and the adjusted efficiency indexes, through the retrospective implementation of the Adjusted Clinical Groups (ACG) in a Spanish primary care setting. Methods: Design descriptive-retrospective study. Attended patients by five primary care teams (PCT) during the year 2004 were included. General parameters, age, gender, dependent (visits and episodes), and comorbidity of each patient relative to each ACG are used as measures. The RR was defined as the quotient between the number of referrals and the visits made. Efficiency Index (El) was established dividing the observed by the expected referrals obtained by indirect standardization. Statistical significance P<0.05. Results: Studied patients 81 335 (use: 76.9%), 5.0:1:3.6 episodes and 7.9±7.8 visits/patient/year. Percentage of visits with a referral, adjusted for morbidity burden, was 7.5% (Ch 7.3-7.7); age: 48.3-1±22.7 years (women: 55.9%), P=0.000. The average of referrals was of 59.6 per 100 attended patients/year (P-= 0.000). Visits and episodes explain 34.1-68.1%, respectively (P=0.000), the explanatory power of the classification's variability was of 23.6% (P= 0.0001). El per centre were: 0.95 (CI: 0.82-1.08); 0.78 (CI: 0.63-0.93); 0.88 (Cl: 0.73-1.03); 1.15 (Ch 1.03-1.27) and 1.08 (Cl: 0.95-1.21), P=0.034 (family practice); and 0.83 (Cl: 0.70-0.96); 0.83 (Cl: 0.68-0.98); 0.84 (el: 0.70-0.98); 1.24 (CI: 1.12-1.36) and 1.16 (Ch 1.03-1.29), P= 0.041 (paediatrics), respectively. Conclusions: Adjusted morbidity by ACG explains an important part of the referrals variability. The study results must be interpreted cautiously even after adjustment by age, gender and morbidity. Should the results be confirmed, it would allow an improvement in the measurement of referrals for clinical management in the PCT. [ABSTRACT FROM AUTHOR]

Background: This study was conducted in order to determine the use of aspirin and to assess the achievement of therapeutic targets in diabetic patients according to primary (PP) or secondary prevention (SP). Methods: This is a retrospective, observational study including patients ≥18 years with diabetes mellitus followed in four primary care centers. Measurements included demographics, use of aspirin and/or anticoagulant drugs, co-morbidities, clinical parameters and proportion of patient at therapeutic target (TT). Descriptive statistics, chi-square test and logistic regression model were used for significance. Results: A total of 4,140 patients were analyzed, 79.1% (95% confidence intervals [CI]: 77.7-80.5%) in PP and 20.9% (95% CI: 18.2-23.7%) in SP. Mean age was 64.1 (13.8) years, and 49.3% of patient were men (PP: 46.3, SP: 60.7, p = 0.001). Aspirin was prescribed routinely in 20.8% (95% CI: 19.4-22.2%) in PP and 60.8% (95% CI: 57.6-64.0%) in SP. Proportion of patient at TT was 48.0% for blood pressure and 59.8% for cholesterol. Use of aspirin was associated to increased age [OR = 1.01 (95% CI: 1.00-1.02); p = 0.011], cardiovascular-risk factors [OR = 1.14 (95% CI: 1.03-1.27); p = 0.013], LDL-C [OR = 1.42 (95% CI: 1.06-1.88); p = 0.017] and higher glycated hemoglobin [OR = 1.51 (95% CI: 1.22-1.89); p = 0.000] were covariates associated to the use of aspirin in PP. Conclusion: Treatment with aspirin is underused for PP in patients with diabetes mellitus in Primary Care. Achievement of TT should be improved. [ABSTRACT FROM AUTHOR]

The article presents a response from the authors of "Economic Impact of Combining Metformin With Dipeptidyl Peptidase-4 Inhibitors in Diabetic Patients With Renal Impairment in Spanish Patients." Topics discussed include the conclusion that patients with RI receiving DPP-4 inhibitors and metformin had greater probability of achieving better metabolic control and how the authors evaluated total cost of patients receiving treatment and not the total cost of treatment.

Background: To determine the incidence of Treatment-Resistant Depression (TRD) in Spain and to estimate its economic burden, using real world data.Methods: A retrospective, observational-study was carried out using data from the BIG-PAC database®. Patients aged ≥18 years with a diagnosis of major depressive-disorder (MDD) who initiated a new antidepressant treatment in 2015-2017 were included. The patients were classified as TRD and non-TRD. Patients were classified as TRD if they had, during the first year of antidepressant treatment: a) failure with ≥2 antidepressants including the prescription of ≥3 antidepressants (N06A) or ≥2 antidepressant and ≥1 antipsychotic (N05A; including lithium) b) antidepressants administered for ≥ 4 weeks each, and c) the time between the end of one treatment and the initiation of the next was ≤ 90 days. Inherent limitations of data collection from databases should also be considered in this analysis (e.g., lack of information about adherence to treatment). Follow-up period: 18 months. The incidence rate was calculated as the number of TRD patients per 1,000 persons-year divided by the population attended.Outcomes: direct healthcare and indirect costs. Two sensitivity analyses were performed varying the index date and the period used to define TRD patients (6 vs.12 months).Results: 21,630 patients with MDD aged ≥ 18 years (mean age: 53.2 years; female: 67.2%) were analyzed, of whom 3,559 met TRD criteria, yielding a 3-year cumulative incidence of 16.5% (95%CI: 16%-17%) among MDD patients. The annual population incidence rate of TRD in 2015-2017, was 0.59, 1.02 and 1.18/1,000 person-years, respectively (mean: 0.93/1,000 person-year). Overall, mean total costs per MDD patient were €4,147.9, being higher for TRD than for non-TRD patients (€6,096 vs. €3,846; p<0.001): a) direct costs (€1,341 vs. €624; p<0.001), b) lost productivity (€1,274 vs. €821; p<0.001) and c) permanent disability (€3,481 vs. €2,401; p<0.001, adjusted). Sensitivity analyses showed no differences with the reported results.Conclusions: The population based TRD incidence in Spain was similar to recent data from other European countries. TRD is associated with greater resource use and higher costs compared with non-TRD patients. [ABSTRACT FROM AUTHOR]

• The prevalence of Depressive Disorders was 4.73% ant the incidence rates (2015–2017) were 7.12, 7.35 and 8.02 per 1000 person-years, respectively. • The estimated societal cost of Depressive Disorders in the Spanish adult population was € 6145 million. The mean cost per patient/year was € 3402. • Indirect costs related to long-term sick leaves/permanent disabilities have the greatest weight within the total cost of depressive disorder in Spain (60,5%). • Direct costs represent only 17,5% of the total costs of depression, representing 1,1% of the total Health Care Expenditure in 2017. Depressive Disorders are the most common psychiatric diagnoses in the general population. To estimate the frequency, costs associated with Depressive Disorders in usual clinical practice, and in the whole Spanish population, a longitudinal, retrospective, observational study was carried out using data from the BIG-PAC database®. Study population: all patients aged ≥ 18 years with a diagnosis of a Depressive Disorder in 2015–2017. Prevalence was computed as the proportion of Depressive Disorder cases in the adult general population, and the incidence rate, as the number of new Depressive Disorder cases diagnosed per 1,000 person-years in the population using health services, during 2015–2017. We collected demographic variables, comorbidity, direct health costs, and indirect costs (temporary and permanent disability). Health costs related to Depressive Disorders were estimated according to the annual resource use rate (resource/patient/year). Indirect costs were calculated according to the human capital method. Using the study data and information from the Spanish National Institute of Statistics, we estimated the cost of Depressive Disorders corresponding to the Spanish adult population, including premature mortality. 69,217 Depressive Disorder patients aged ≥ 18 years who met the inclusion/exclusion criteria were studied (mean age: 56.8 years; female: 71.4%). Prevalence of Depressive Disorders in the general population was 4.73% (95% CI: 4.70–4.76%). Annual incidence rates (2015–2017) were 7.12, 7.35 and 8.02 per 1,000 person-years, respectively. Total costs observed in our Depressive Disorder patients were € 223.9 million (corresponding to a mean of € 3,235.3; mean/patient/year), of which, 18.4% were direct health care costs and 81.6%, non-health indirect costs (18% temporary occupational disability, 63.6% permanent disability). Considering also the cost of premature death , the mean cost per patient/year was € 3,402 and the estimated societal costs of Depressive Disorders in Spain were € 6,145 million. The prevalence and incidence of Depressive Disorders are consistent with other series reviewed. Resource use and total costs (especially non-health costs) were high. [ABSTRACT FROM AUTHOR]

Purpose: Chronic obstructive pulmonary disease (COPD) is characterized by high morbidity and mortality, with a considerable consumption of healthcare resources (HRU). This study aims to obtain real world evidence regarding the consequences of COPD exacerbations and to provide updated data on the burden of this disease and its treatment., Patients and Methods: A retrospective study in seven Spanish regions was conducted among COPD patients diagnosed between 1/01/2010 and 31/12/2017. The index date was the diagnosis of COPD and patients were followed until lost to follow-up, death or end of the study, whichever occurred first. Patients were classified by patient pattern (incident or prevalent), type and severity of exacerbations, and treatments prescribed. Demographic and clinical characteristics were evaluated, together with the incidence of exacerbations, comorbidities, and the use of HRU, during the baseline (12 months before the index date) and the follow-up periods by incident/prevalent and treatment prescribed. Mortality rate was also measured., Results: The study included 34,557 patients with a mean age of 70 years (standard deviation: 12). The most frequent comorbidities were diabetes, osteoporosis, and anxiety. Most patients received inhaled corticosteroids (ICS) with long-acting beta agonists (LABA), or long-acting muscarinic agonists (LAMA), followed by LABA with LAMA. Incident patients (N=8229; 23.8%) had fewer exacerbations than prevalent patients (N=26328; 76.2%), 0.3 vs 1.2 exacerbations per 100 patient-years. All treatment patterns present a substantial disease burden, which seems to increase with the evolution of the disease (ie moving from initial treatments to combination therapies). The overall mortality rate was 40.2 deaths/1000 patient-years. General practitioner visits and tests were the HRU most frequently required. The frequency and severity of exacerbations positively correlated with the use of HRU., Conclusion: Despite receiving treatment, patients with COPD suffer a considerable burden mainly due to exacerbations and comorbidities, which require a substantial use of HRU., Competing Interests: JN and MJC are fulltime employees of AstraZeneca. ASM is a fulltime employee of Atrys Health. JJSC declares personal fees from AstraZeneca during the conduct of the study; personal fees and grants from GlaxoSmithKline and personal fees and non-financial support from AstraZeneca, Boehringer-Ingelheim, Bial, Chiesi, Menarini, and Novartis. JLI reports personal fees from AstraZeneca, Bayer, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Grifols, Menarini, Novartis, Orion, Pfizer, Sandoz, Teva, and Zambon during the conduct of the study. The authors report no other conflicts of interest in this work., (© 2023 Soler-Cataluña et al.)

Purpose: To determine the clinical and economic impact of inhaled corticosteroid (ICS) withdrawal in Spanish patients with COPD receiving triple therapy (TT) with ICS, long-acting β 2 -agonist (LABA), and long-acting muscarinic antagonist (LAMA)., Patients and Methods: This was an observational, retrospective study of BIG-PAC database medical records. Patients aged ≥40 years receiving TT from 2016 to 2018 were followed for 1 year. Two cohorts were identified: patients continuing TT (ICS+LABA+LAMA), and patients receiving TT with ICS withdrawn (LABA+LAMA). Variables included medication, exacerbations (moderate and severe), pneumonia, mortality, health resource use (HRU), and cost per patient/year. Cohorts were compared using propensity score matching (PSM). Multivariate statistical analysis using analysis of covariance and Cox proportional risks was conducted., Results: Of 6541 patients included, 5740 (87.8%) continued TT and 801 (12.2%) had ICS withdrawn. Patients with ICS withdrawal were younger, had lower disease burden, higher ICS doses, and more exacerbations compared with those continuing ICS. PSM matched 795 patients in each cohort. Mean age was 68.5 years (SD: 11.2), 69.9% were male, and mean Charlson index was 2.0. Patients with ICS withdrawal had more total exacerbations in the 12 months following withdrawal compared with patients continuing TT (36.6% vs 31.4%; p=0.030). No significant differences were found for pneumonia (3.3% vs 3.6%; p=0.583) and mortality (9.9% vs 7.5%; p=0.092). Median time to first exacerbation was shorter in patients with ICS withdrawal compared with those continuing ICS (HR: 0.69, 95% CI: 0.57-0.83; p<0.001). Mean health cost per patient/year among patients with ICS withdrawal was higher than those continuing TT (€2993 vs €2130; p<0.001)., Conclusion: ICS withdrawal in patients with COPD receiving TT was associated with increased exacerbations, HRU, and costs compared with continuing TT, with health and economic impacts on patients and the Spanish National Healthcare System, respectively. Pneumonia and mortality rates were similar between groups., Competing Interests: VNG, LAV-A, ASI, RC, SS, and MG-P are employees of GlaxoSmithKline; LAV-A and ASI also hold stocks in GlaxoSmithKline. AS-M and AS-N are employees of Real Life Data. Real Life Data received payments from GlaxoSmithKline to perform the study, but not for manuscript development. CG received fees from GlaxoSmithKline for her involvement in the study, but not for manuscript development. The authors report no other conflicts of interest in this work., (© 2022 Neches García et al.)

Introduction: There is little evidence on the relationship between achieved low-density lipoprotein cholesterol (LDL-C) levels and costs in patients on lipid-lowering therapy (LLT). We described healthcare resource use and costs (direct and indirect) by achieved LDL-C in patients receiving LLT after a recent myocardial infarction (MI) in Spain., Methods: This was a retrospective observational study of anonymized electronic medical records from seven regions in Spain (BIG-PAC ® database; n = 1.9 million). Eligible patients were adults (≥ 18 years) hospitalized for an MI between January 2015 and December 2017, treated with a statin and/or ezetimibe, and having recorded LDL-C values at baseline and during follow-up. Healthcare resource use and direct and indirect costs (in 2018, €) were described by achieved LDL-C levels during a follow-up of 18 months., Results: Of 6025 patients (mean age, 69.7 years; 77% male), only 11% achieved LDL-C goals as defined in the 2016 ESC/EAS guidelines (< 70 mg/dL), and just 1% reached the lower target (< 55 mg/dL) in the current 2019 guidelines. Achieving lower LDL-C levels translated to lower healthcare resource use and costs. Mean total (direct and indirect) costs ranged from €5044 for patients with LDL-C < 55 mg/dL to €7567 for patients with LDL-C ≥ 130 mg/dL., Conclusion: Very few patients achieved recommended LDL-C goals despite using LLT. Achieving lower LDL-C levels after an MI might be associated with lower healthcare resource use and costs. Use of more intensive LLT, leading to greater reductions in LDL-C, could therefore be beneficial both from a clinical and an economic perspective., (© 2022. The Author(s).)

Aims: To determine the first manifestation of cardiovascular or kidney disease (CVKD) and associated resource use in type 2 diabetes mellitus (T2DM) patients during seven years of follow-up., Methods: Observational-retrospective secondary data study using medical records of patients aged ≥18 years with T2DM and without prior CVKD between 2013 and 2019. The index date was 01/01/2013 (fixed date). The manifestation of CVKD was defined by the first diagnosis of heart-failure (HF), chronic-kidney disease (CKD), myocardial-infarction (MI), stroke or peripheral-artery disease (PAD). The main variables were baseline characteristics, manifestation of CVKD, mortality, resource use and costs. Descriptive analyses and Cox model were applied to the data., Results: 26,542 patients were selected (mean age: 66.6 years, women: 47.8%, mean duration of T2DM: 17.1 years). 18.7% (N=4974) developed a first CVKD manifestation during the seven years [distribution: HF (22.4%), CKD (36.6%), MI (14.5%), stroke (15.3%) and PAD (11.3%)]. Overall mortality was 8.3% (N=2214). The mortality risk of the group that developed HF or CKD as the first manifestation compared to the CVKD-free cohort was higher [HR: 2.5 (95% CI: 1.8-3.4) and 1.8 (95% CI: 1.4-2.3)], respectively. The cumulative costs per patient of HF (€50,942.80) and CKD (€48,979.20) were higher than MI (€47,343.20) and stroke (€47,070.30) and similar to PAD (€51,240.00) vs. €13,098.90 in patients who did not develop CVKD, p<0.001., Conclusions: In T2DM patients, HF and CKD were the first most common manifestations and had higher mortality and re-hospitalisation rates. HF and CKD were associated with the highest resource use and costs for the Spanish National-Health-System., (Copyright © 2021 SEEN and SED. All rights reserved.)

Background: Economic burden of community-acquired pneumonia (CAP) is recognized. Few studies have documented such burden in adults stratified by age, risk status, and by care setting. Spanish data available is scarce., Method: A retrospective, multicenter study in seven regions of Spain (2017-2019) was conducted. Patients ≥18 years with a primary all-cause CAP episode diagnosis were identified. Episode-level variables included risk-stratum based on presence of an immunocompromising/chronic condition, age, number and length of hospitalized and outpatient episodes, and CAP-related healthcare costs/sick leaves were included., Results: 7,108 episodes [mean age (SD): 59.2 (19.6), 50.42% male, 31.0% hospitalized] were analyzed. Low-risk group accounted for 47.7% of all CAP episodes, 31.5% moderate-risk and 20.8% high-risk. Pneumococcus was identified in 42.2% of cases. Mean CAP episode length was 22.9 days for hospitalized and 13.7 days for outpatient episode. Total healthcare cost for episode was higher in inpatient vs. outpatient: €3,955 vs. €511, p < 0.001, with higher sick leave cost (€3,281 vs. €2,632, p < 0.001), respectively., Conclusion: CAP required hospitalization cost is high regardless of age or comorbidities for the Spanish NHS. Given that almost half of the patients in this study did not have traditional risk factors for CAP, better preventative strategies should seriously be considered.

Introduction and Objectives: To describe the epidemiology and treatment of a large contemporary cohort of patients with heart failure (HF)., Methods: Observational, retrospective, population-based study using the BIG-PAC database, which includes people aged ≥ 18 years seeking care for HF between 2017 and 2019. The main variables were the prevalence/annual incidence rate, comorbidities, clinical variables, and medication administered., Results: We identified 19 762 patients with HF from a total of 1 189 003 persons seeking medical attention from 2017 to 2019 (2019: mean age, 78.3 years; 53.0% men). Distribution by type of left ventricular ejection fraction (LVEF) was as follows: 51.7% reduced, 40.2% preserved, and 8.1% mid-range. In 2019, the prevalence was 1.89% (95%CI, 1.70-2.08), with an incidence rate of 2.78 new cases per 1000 persons/y. No statistically significant differences were observed in prevalence and/or incidence from 2017 to 2019. Among patients with HF with reduced ejection fraction (HFrEF), 64% received beta-blockers, 80.5% angiotensin-converting enzyme inhibitor/angiotensin receptor blockers or sacubitril-valsartan, and 29.8% an aldosterone antagonist. In addition, from the diagnosis (baseline) to 24 months of follow-up, there was discreet treatment optimization, which was notable in the first 3 to 6 months., Conclusions: Epidemiological data on HF remained stable during the study period, with a lower prevalence than that reported in non-population-based studies. There is wide room for improvement in the optimization of medical treatment of HFrEF., (Copyright © 2020 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)

Introduction: In the EDITION clinical trial programme, patients with type 2 diabetes mellitus (T2DM) receiving insulin glargine (IGlar) U300 required 10-15% more insulin than those receiving IGlar U100. This study sought to determine whether this difference was apparent in real-world practice., Methods: In this observational, retrospective cohort study, electronic medical records in the Big-Pac® database (Real Life Data) relating to adult insulin-naïve patients with T2DM who initiated IGlar U100 or U300 treatment in Spain in 2016-2017 and remained on treatment for 18 months were selected. IGlar U100- and U300-treated patients were matched 1:1 (propensity score matching). The primary analysis compared changes from baseline in mean daily IGlar dose (U and U/kg) at 6 (± 2), 12 (± 2) and 18 (± 2) months between cohorts (paired t tests). Changes in glycated haemoglobin (HbA1c) and weight were analysed descriptively., Results: The IGlar U100 and U300 cohorts included 556 matched pairs (46.9% female) with the following mean (standard deviation) values at baseline, respectively: age 63.6 (12.8) versus 63.7 (11.9) years; years since diagnosis 9.5 (1.4) versus 9.5 (1.3); HbA1c 8.8 (1.3) versus 8.7 (1.5) %; weight 84.6 (16.9) versus 84.7 (17.1) kg. Mean IGlar dose at baseline was 0.19 U/kg/day (both cohorts). Patients receiving IGlar U300 showed a greater increase from baseline in IGlar dose at 6, 12 and 18 months [mean dose (U/kg/day) 5.1%, 10.3% and 12.8% greater, respectively, in IGlar U300-treated patients]. Mean HbA1c was 8.1% in both cohorts at 18 months. Mean (SD) weight at 18 months with IGlar U100 and IGlar300 was 86.8 (17.0) kg and 85.0 (17.1) kg, respectively., Conclusion: In real-world practice, insulin dose was significantly higher in IGlar U300-treated than U100-treated patients at 6, 12 and 18 months, with similar reductions in HbA1c. At equal IGlar price/unit in Spain, the increased dose requirements of IGlar U300 would result in higher costs., (© 2021. The Author(s).)

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.

Objective: We determined the percentage of patients with severe asthma and exacerbations and evaluated the costs of the disease based on blood eosinophil counts. Methods: A retrospective observational study based on the review of medical records in Spain was carried out. Patients ≥18 years of age requiring care during the years 2014-2015; diagnosed with asthma with at least 2 years of continuous records (at least one year prior to the index date defined as the first asthma medication prescription and at least one year after the index date) were included. Study groups: eosinophil counts <300 cells/μl and ≥300 cells/μl. Main variables: comorbidity, clinical parameters, exacerbations and annual asthma total costs. Results: A total of 268 severe asthmatic patients in Spain were included, representing 6.3% of the asthma population, with 58.6% having eosinophil count ≥300 cells/μl and 41.4% eosinophil count <300 cells/μl. The mean age was 56.1 years (63.4% women). Patients with eosinophilic inflammation (≥300 cells/μl) had lower FEV1 values (54.3% vs. 60.7%; p  < .001), poorer treatment adherence (65.6% vs. 77.3%; p  < .001), and a greater mean number of exacerbations (3.3 vs. 1.9; p  < .001). Exacerbations were correlated to FEV1 (β=‒.606), eosinophils (β = .255), immunoglobulin E (β = .152), and age (β = .128), p  < .001. The mean total asthma annual cost (ANCOVA) was 6222 vs. 4152 euros, respectively ( p  = .016). Health costs were associated with age (β = .323), FEV1 (β = .239), eosinophils (β = .177) and exacerbations (β = .158), p  < .01. Limitations: Those inherent to retrospective studies; the possible inaccuracy of diagnostic coding referring to severe asthma and other comorbidities and the external validity of the results. Conclusions: Health costs of patients with severe asthma were high. Total annual asthma costs and resource use were greater in patients with ≥300 cells/μl. Age, eosinophilia, exacerbations and FEV1 were associated with greater resource utilization and costs for the health system.

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., (Copyright © 2019 Elsevier España, S.L.U. All rights reserved.)

Purpose: Guidelines recommend the use of triple therapy with an inhaled corticosteroid (ICS), a long-acting β 2 agonist (LABA) and a long-acting muscarinic antagonist (LAMA) to reduce the risk of future exacerbations in symptomatic COPD patients with a history of exacerbations. This study aimed to estimate COPD-related healthcare resource use and costs, and subsequent exacerbation rates, for patients initiating multiple-inhaler triple therapy (MITT) early (≤30 days) versus late (31-180 days) following an exacerbation, in a real-world clinical setting., Patients and Methods: This was an observational, longitudinal, retrospective study using electronic medical records from the Spanish database of the Red de Investigación en Servicios Sanitarios Foundation. Patients ≥40 years old with a confirmed COPD diagnosis who were newly prescribed MITT up to 180 days after an exacerbation between January 2013 and December 2015 were included. Patients were followed from the date of MITT initiation for up to 12 months to assess COPD-related health care resource use (routine and emergency visits, hospitalizations, pharmacologic treatment), exacerbation rate, and costs (€2017); these endpoints were compared between early versus late groups., Results: The study included 1280 patients who met selection criteria: mean age 73 years, 78% male, and 41% had severe/very severe lung function impairment. The proportion of patients initiating MITT early versus late was 61.6% versus 38.4%, respectively. There were no statistically significant differences in baseline characteristics between groups. During follow-up, health care resource consumption was lower in the early versus late group, especially primary care and ED visits, leading to lower total costs (€1861 versus €1935; P <0.05). In the follow-up period, 28.0% of the patients in the early group experienced ≥1 exacerbation versus 36.4% in the late group ( P =0.002), with an exacerbation rate of 0.5 versus 0.6 per person per year ( P =0.022), respectively., Conclusion: Initiating MITT early (≤30 days after an exacerbation) may reduce health care costs and exacerbation rate compared with late MITT initiation., Competing Interests: ASI is employe of, and hold stocks in, GlaxoSmithKline plc. ASI is also unpaid part-time faculty at McMaster University, ON, Canada. SHL and AH were employees of GlaxoSmithKline plc. at the time of the study. ASM and EM received fees for their participation in the study. The authors report no other conflicts of interest in this work., (© 2019 Sicras Mainar et al.)

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., (Copyright © 2017 Elsevier España, S.L.U. All rights reserved.)

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.

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.

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 (β=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.

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., (Copyright © 2012 Elsevier España, S.L. All rights reserved.)

Objectives: The primary objective of this study was to identify the existence of chronic disease multimorbidity patterns in the primary care population, describing their clinical components and analysing how these patterns change and evolve over time both in women and men. The secondary objective of this study was to generate evidence regarding the pathophysiological processes underlying multimorbidity and to understand the interactions and synergies among the various diseases., Methods: This observational, retrospective, multicentre study utilised information from the electronic medical records of 19 primary care centres from 2008. To identify multimorbidity patterns, an exploratory factor analysis was carried out based on the tetra-choric correlations between the diagnostic information of 275,682 patients who were over 14 years of age. The analysis was stratified by age group and sex., Results: Multimorbidity was found in all age groups, and its prevalence ranged from 13% in the 15 to 44 year age group to 67% in those 65 years of age or older. Goodness-of-fit indicators revealed sample values between 0.50 and 0.71. We identified five patterns of multimorbidity: cardio-metabolic, psychiatric-substance abuse, mechanical-obesity-thyroidal, psychogeriatric and depressive. Some of these patterns were found to evolve with age, and there were differences between men and women., Conclusions: Non-random associations between chronic diseases result in clinically consistent multimorbidity patterns affecting a significant proportion of the population. Underlying pathophysiological phenomena were observed upon which action can be taken both from a clinical, individual-level perspective and from a public health or population-level perspective.

Objective: To carry out a budget impact analysis (BIA) of olmesartan/amlodipine (20/5, 40/5 and 40/10mg) marketed as a fixed combination (FC) in its approved indication for the National Health System (NHS)., Desig: We developed a decision tree model in order to estimate usual hypertension treatment algorithm in Spanish clinical practice., Settings: The BIA has been developed from the perspective of the NHS for a period of 3 years (years 2010-2012)., Participants: Spanish hypertensive population ≥ 35 years old., Interventions: Introduction into the market of a fixed combination (FC) olmesartan/amlodipine in Spain., Primary Measures: Expected costs to be assumed by the Spanish NHS (RRP-VAT) for hypertensive population able to be treated with the FC versus currently assumed costs by the NHS with free combination olmesartan and amlodipine., Results: Estimated pharmaceutical costs in hypertensive population treated with olmesartan and amlodipine (2 pills) would be €25.2M (1(st) year), €26.4M (2011), €27.6M (2012), with a total 3-year period of €79.2M. According to patient tree model, the population able to be treated with FC would be 71,283 patients (2010), with a growth rate of 4.8% in the successive years, which supposes an annual cost of €21.2M (2010), €21.8M (2011) and €22.4M (2012), with a total 3-year period of €65.4M. The BIA shows savings of €13.8M in a total 3-year period., Conclusion: The BIA of FC olmesartan/amlodipine could generate net savings of €13.8M for the NHS in the period ranging from years 2010 to 2012., (Copyright © 2010 Elsevier España, S.L. All rights reserved.)

Background and Objective: To determine the incidence of cardiovascular events (CVE) and health care costs in relation to compliance, persistence and level of blood pressure control when comparing patients treated with single-pill combinations (SPC) or free combinations (FC) for the treatment of hypertension., Patients and Methods: Observational, multicenter study that included patients>30 years old, from six primary care teams and two hospitals, who started pharmacological treatment for hypertension during 2006. Two study groups were established: SPC (ACEIs/diuretics; ARBs/diuretics) and FC (ACEIs+DIU; ARB+DIU, separately). Main variables studied were sociodemographic data, comorbidity, Charlson-index, compliance, persistence and achievement of therapeutic goals (ESH-ESC criteria). The cumulative incidence of CVE and a total-cost model were determined (differentiating: health/direct; non-health/indirect). Patients were followed for two years. Statistical analysis included logistic regression, Cox proportional hazards model and analysis of covariance. Statistical signification: p<0.05., Results: 1,605 patients were recruited, 1,112 (69.3%) receiving SPC and 493 (30.7%) receiving FC, p<0.001; mean age: 69.4 (12.2) years; women: 55.5%. FC treatments were associated with ischaemic heart disease (OR=1.4; 95% CI: 1.1-2.0) and organ failure (OR=1.5; 95% CI: 1.2-2.1), p<0.031. Patients on SPC showed better therapeutic compliance (77.6% vs 71.9%; p<0.001) and longer persistence of treatment (62.1% on-treatment at 24-months [95% CI: 56.3-67.9] vs 49.7% [95% CI: 38.5-60.9]; p<0.001). Optimal control of blood pressure was higher in SPC (48.9% [95% CI: 43.0-54.8] vs 46.7% [95% CI: 35.6-57.8]; p<0.001). Cumulative incidence of cerebrovascular accidents in FC was 4.6% vs 2.4% in SPC; p=0.041. The total health care costs were lower in SPC (1,650.7 € vs 1,674.8 €; p<0.001), including lower specialized care costs (316.1 € vs 382.9 €; p<0.001), fewer hospital admissions and less loss of labour productivity (44.5 € vs 88.4 €; p<0.001)., Conclusions: Better compliance and persistence with antihypertensive fixed-dose combinations improves therapeutic control, leading to a significant reduction of cerebrovascular accidents and total health care costs., (Copyright © 2009 Elsevier España, S.L. All rights reserved.)

Study Objective: Population based study to determine the clinical consequences and economic impact of using escitalopram (ESC) vs. citalopram (CIT) and venlafaxine (VEN) in patients who initiate treatment for a new episode of major depression (MD) in real life conditions of outpatient practice., Methods: Observational, multicenter, retrospective study conducted using computerized medical records (administrative databases) of patients treated in six primary care centers and two hospitals between January 2003 and March 2007., Study Population: patients >20 years of age diagnosed with a new episode of MD who initiate treatment with ESC, CIT or VEN who had not received any antidepressant treatment within the previous 6 months, and were followed for 18 months or more., Main Variables: socio-demographic variables, remission (defined as a patient completing 6 months of therapy), comorbidity, annual health care costs (medical visits, diagnostic and therapeutic tests, hospitalizations, emergency room and psychoactive drugs prescribed) and non-health care costs (productivity losses at work, mainly sick leave and disability)., Statistical Analyses: logistic regression and ANCOVA models., Results: A total of 965 patients (ESC = 131; CIT = 491; VEN = 343) were identified and met study criteria. ESC-treated patients were younger, with a higher proportion of males, and had a lower specific comorbidity (p < 0.01). ESC-treated patients achieved higher remission rates compared to CIT (58.0% vs. 38.3%) or VEN patients (32.4%), p < 0.001, and had lower productivity work losses compared to VEN patients (32.7 vs. 43.8 days), p = 0.042. No differences in productivity work losses were observed between ESC and CIT patients. Compared to the ESC group, higher costs in average/unit of psychoactive drugs were found in the VEN group (€643.00), p = 0.003, whereas no differences were observed between the ESC and CIT groups (€294.70 vs. €265.20). In the corrected model, total costs (health care and non-health care cost) were lower with ESC (€2276.20) compared to CIT (€3093.80), p = 0.047 and VEN (€3801.20), p = 0.045., Conclusions: ESC appears to be dominant in the treatment of new MD episodes when compared to CIT and VEN, resulting in higher remission rates and lower total costs.