Treatment persistence and adherence and their consequences on patient outcomes of generic versus brand-name statins routinely used to treat high cholesterol levels in Spain: a retrospective cost-consequences analysis.

BACKGROUND: High blood lipoprotein concentrations are one of the major risk factors for cardiovascular diseases. Drug therapy is the base of treatment; statins in particular. Both brand-name and generic presentations are available for statin therapy of high cholesterol levels. Factors that may influence their use in routine medical practice include, among others, patient persistence and adherence to treatment as prescribed by physicians. The aim of this retrospective analysis was to provide real-world evidence of treatment persistence and adherence and their consequences on economic and patient outcomes of generic versus brand-name statins routinely used to treat high cholesterol levels in Spain. METHODS: Existing real-world electronic medical records abstracted from a database of two regions in Spain were analyzed. The analysis compared generic versus brand-name statins data from subjects' who started treatment between July 1, 2010 and June 30, 2012. Treatment persistence, adherence expressed as medication possession ratio (MPR), healthcare resource utilization and their costs were analyzed together with patient's at-goal rates of low-density-lipoprotein-cholesterol (LDL-c), incidence of any major cardiovascular event (CVE) and all-cause mortality during a 5-year follow-up period. Multivariate analyses were applied. RESULTS: A total of 13,244 records were included. Persistence was lower with generics; adjusted hazard ratio -HR- [95% confidence interval]: 0.86 [0.82-0.91], p < 0.001) and MPR was also lower: 61.5% vs. 65.1% (p < 0.001). Less patients with generics reached their LDL-c goal: 39.2% [38.3-40.2%] vs. 42.0% [40.2-43.7%]; adjusted odds ratio; 0.87 [0.80-0.95], p = 0.003. Compared to brand-name statins, the observed probability of occurrence of a CVE; HR: 1.31 [1.15-1.50], p < 0.001, and also all-cause deaths; HR: 1.36 [1.15-1.62], was significantly higher with generics; p < 0.001 in both cases. Adjusted mean total healthcare cost per patient was also higher with generic than with brand-name statins: €9118 (9059-9176) vs. €7980 (7853-8808) [adjusted difference: €1137 (997-1277), p < 0.001]. CONCLUSION: This retrospective cost-consequences analysis found poorer treatment persistence and adherence in patients who first started therapy with generic instead of brand-name statins in routine medical practice in Spain. Also, patients receiving generics were more unlikely to reach LDL-c goals, showed increased probability of having CVE and all-cause mortality at a higher cost to payers.

Statins after recent stroke reduces recurrence and improves survival in an aging Mediterranean population without known coronary heart disease.

WHAT IS KNOWN AND OBJECTIVE: The effect of a statin-based medical intervention on prevention of fatal and non-fatal stroke recurrence and the incidence of all-causes mortality have been explored previously in aging populations within the scope of clinical trials research. However, such evidence needs to be explored under conditions of routine clinical practice. The objective of this study was to determine whether statin therapy in patients with a first stroke episode reduces the incidence of 6-year recurrent fatal or non-fatal stroke and all-cause mortality in an aging Mediterranean population without known coronary heart disease followed in routine medical practice. METHODS: A retrospective study was carried out using records on death, hospitalizations owing to stroke and history of statin therapy included in the Badalona Serveis Assistencials (BSA) database. The cohort studied consisted of consecutive patients covered by the BSA health provider plan with a first-ever acute stroke episode during January 2003 until December 2008, for whom there was available information covering the 6-year follow-up period. Recurrence rate (RR) and incidence rate (IR) of fatal/non-fatal stroke and all-causes mortality were computed. Association with statin therapy was assessed by means of calculation of relative risk (RR) and hazard ratio (HR) using multivariate logistic regression and Cox proportional hazards models controlling for confounding covariates. RESULTS AND DISCUSSION: The cohort comprised a series of 601 consecutive patients [57% men, 75·9 (12·4) years old (88% >60 years)]. Of these, 32% received statins, which were associated with lower fatal/non-fatal recurrent stroke RR; 7% vs. 18% [adjusted RR=0·32 (CI: 0·16-0·61), P=0·001] and lower IR; 16·78 vs. 45·22 events/year-1000 subjects [adjusted HR=0·35 (0·19-0·64), P=0·001]. Similarly, observed all-causes mortality was lower in the cohort receiving statins; 11% vs. 16% [adjusted RR=0·29 (CI: 0·08-1·12), P=0·072], and also mortality rate; 26·09 vs. 36·25 deaths/year-1000 subjects [adjusted HR=0·23 (0·08-0·67), P=0·007]. WHAT IS NEW AND CONCLUSIONS: Statin therapy in patients with first-ever acute stroke lowers the risk of 6-year stroke recurrence and improves survival in an aging Mediterranean cohort. These results add additional evidence in routine clinical practice to the observed effects of statins in clinical trials.

[Morbi-mortality and use of recourses after acute coronary syndrome in a Spanish population]. / Morbimortalidad y consumo de recursos asociados tras síndrome coronario agudo en una población española.

OBJECTIVES: To describe the management of patients suffering acute coronary syndrome (ACS) and to determine its clinical and economic consequences in a Spanish population. METHODS: A multicenter, retrospective claim database study including patient medical records from 6 primary care centers, two hospitals and two years of follow-up was carried out. Patients ≥30 years, suffering a first acute coronary syndrome (ACS), between 2003 and 2007, were included. Groups: acute coronary syndrome with and without ST segment elevation. VARIABLES: socio-demographic, co-morbidities, metabolic syndrome (MS), biochemical parameters, drugs, cumulative incidence (total mortality and cardiovascular events (CVE: including myocardial infarction, stroke and peripheral artery disease) and total costs. STATISTICAL ANALYSIS: logistic regression, Kaplan-Meier curves and ANCOVA; (P<.05). RESULTS: A total of 1020 patients were included. Mean age: 69 years; males: 65%. Groups: ST segment elevation ACS (N=632; 62%). Co-morbidities: hypertension (56%), dyslipidemia (46%) and diabetes (38%). Prevalence of MS: 59% (CI 95%: 56-62%). All biochemical parameters had improved after two years of follow-up. The average total cost per patient was €14,069 (87% direct costs; 13% productivity loss costs). Direct costs: primary care (20%), specialty care (67%); hospitalization costs represented 63% of total costs. The average total cost for patients presenting more than one CVE was 22,750€ vs 12,380€ for those patients who suffered only one (P<.001). Cumulative incidence: total mortality 14%; CVE: 16%. CONCLUSIONS: In the current clinical practice, and despite the clinical efforts carried out, patients with an ACS are still at a high risk of suffering further CVE, representing a high cost burden to the health care system.

[Comorbidity and health resources use in smokers. An analysis from a primary care setting]. / Comorbilidades y consumo de recursos sanitarios en población fumadora. Un análisis desde Atención Primaria.

BACKGROUND: To ascertain the morbidity profile, achievement of the clinical control objectives, resources use and the incidence of cardiovascular events (CVE) in smoking subjects in Primary Care settings (PC). METHODS: Retrospective multicentric study. All smoker subjects older than thirty years attended in any of five PC settings were included. A comparative cohort was established with non-smokers. Primary measures were: presence of CVE, age, gender, Charlson index, history/co-morbidity and clinics parameters and direct costs (fixed and variable; visits, drugs, diagnostic test and referrals). Multiple logistic regression analysis and ANCOVA models were applied for models correction, P<0.05. RESULTS: 55,653 patients were included. 20.8% (95% confidence intervals [CI]:20.5-21.1%) were smokers. Non-smokers were younger (48.2 versus 55.9 years), with more men (60.8%), P<0.01; and a similar Charlson index (0.3 versus 0.3; P=NS). The proportion of smokers in hypertensive population was 18.8% and in diabetics 9.6%. CVE presence in smokers were 4.9% versus 4.2% and the accumulated incidence/annual of 14.2 per thousand versus 12.5 per thousand, P<0.028. Smokers showed higher levels of serum triglycerides (136.3 mg/dl) and LDL-cholesterol (128.0 mg/dl, P<0.001). Smoking habit was independent related to the alcoholism (Odds ratio, OR=5.3) and the EPOC (OR=2.5), in presence of CVE (OR=1.2, P<0.001). Adjusted direct costs non differences showed: euro660.10 versus euro654.11, P=NS (in all components). CONCLUSIONS: CVE annual incidence in smoking subjects was greater, with a minor average of age. Smokers presented a similar number of co-morbidities and total/patient costs. Clinical control objectives should be better in Primary prevention of the cardiovascular risk factors. To give up smoking should be the best strategy to diminish CVE incidence.

[Efficiency profile in the neurological referrals effectuate reference specialists: use case-mix system adjusted clinical groups]. / Perfil de eficiencia en las derivaciones neurológicas efectuadas a los especialistas de referencia: utilización del sistema de casuística Ajusted Clinical Groups.

OBJECTIVES: To determine the general referral and neurological rate per center and the adjusted efficiency indexes, through the retrospective implementation of the Adjusted Clinical Groups (ACG) in a primary care setting. PATIENTS AND METHODS: To design multicenter retrospective study. Attended patients by five primary care teams (PCT) during the year 2006 were included. The main measurements were general parameters, age, gender, dependent (visits and episodes) and morbidity of each patient relative to each ACG. The referral rate was defined as the quotient between the number of referrals and the visits made. Efficiency Index (EI) was established dividing the observed by the expected referrals obtained by indirect standardization. Statistical significance, p < 0.05. RESULTS: Studied patients 80775 (use: 72.4%), 4.8 +/- 3.5 episodes and 7.9 +/- 8.2 visits/patient/year. Percentage of visits with a referral was 9.0% (confiance interval [CI]: 8.8-9.2); age: 44.8 +/- 22.8 years (women: 54.6%), p = 0.000. The average of referrals was of 70.5 per 100 attended-patients/year (p = 0.000) 2.5% referrals of the total were made to the neurological, being patient of greater age, with predominance of women and displaying the head pain/migraine as main consultation reason. Visits and episodes explain 43.2%-73.9% respectively (p = 0.000), the explanatory power of the classification's variability was of 46.3% (p = 0.0001) and the referral 20.1%. EI per center were: 0.97 (CI: 0.77-1.18), 0.79 (CI: 0.57-1.01), 0.88 (CI: 0.62-1.14), 1.29 (CI: 0.94-1.65) and 0.91 (CI: 0.58-1.25), p = 0.023 (family practice) and 0.90 (CI: 0.47-1.33), 0.78 (CI: 0.35-1.21), 0.93 (CI: 0.43-1.44), 1.21 (CI: 0.60-1.82) and 0.97 (CI: 0.39-1.56), p = 0.031 (pediatrics); respectively. CONCLUSIONS: Adjusted morbidity by ACG explains an important part of the referrals variability. A low percentage was derived to neurology. 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.

[Morbidity and costs associated with depressive syndrome in stroke sufferers in a population]. / Morbilidad y costes asociados al síndrome depresivo en sujetos con ictus en un ámbito poblacional.

OBJECTIVE: To measure morbidity and the associated costs of depressive disorders (DD) in subjects who have had a stroke in a population treated by primary care settings under usual clinical practice conditions. METHOD: Cross-sectional, retrospective studies. Adult stroke patients with DD were included in the study, and treated by five primary care settings (PCS) during 2006. A comparative group was formed with the rest of non-DD patients. The main measurements taken were: age, sex, history/co-morbidity, Charlson index, clinical parameters and corresponding outpatient costs; drugs, diagnostic tests, referrals and visits. Multiple logistic regression analysis and ANCOVA were used to correct the models. RESULTS: A total of 2,566 stroke patients were assessed. 17.7% (95% CI, 16.2-19.2%) were identified as having DD; average age: 69.5 years (12.6); 57.2% of those were female. In the correction of the model, females (OR: 2.1), obesity (OR: 1.1) and neuropathy (OR: 2.2), were significantly associated with DD in stroke patients. The adjusted total costs of DD were higher in most components, euro 2,037.55 versus euro 1,498.24, p < 0.001. 73.4% of the total cost was drugs-derived. CONCLUSIONS: Prevalence of DD was higher in stroke patients, and was more associated with females, obesity and neuropathy. The patient cost is high and patients use more health resources.

[Persistence to treatment and resources use with inhaled fixed-dose combinations of corticosteroids and long-acting ß-adrenergic agonists for the treatment of asthma: A population-based retrospective study]. / Persistencia al tratamiento y uso de recursos con corticosteroides y agonistas ß-adrenérgicos de larga duración inhalados a dosis fijas para el tratamiento del asma: estudio retrospectivo de base poblacional.

OBJECTIVE: To determine the persistence, exacerbations, and use of resources in patients who use inhaler treatment with fluticasone propionate/formoterol (PF/Form) in relation with other combinations of inhaled corticosteroid/long-acting ß-adrenergic (ICS/LABA) at fixed doses, for the treatment of asthma in real-life practice. MATERIAL AND METHODS: Observational study conducted by reviewing medical records. The study included subjects ≥18 years of age who started treatment with ICS/LABA and who met certain inclusion/exclusion criteria. The follow-up was carried out for one year. Study groups: a) PF/Form and b) Other-combinations (Other-ICS/LABA). MAIN MEASUREMENTS: Persistence, medication possession ratio (MPR), exacerbations, and costs (direct/indirect). The statistical analysis was performed using regression models, with a P<.05. RESULTS: A total of 3,203 patients were included in the study. By groups: a) FP/Form: 7.0% and b) Other-ICS/LABA: 93.0%. The mean age was 52.2 years, and 60.8% were women. A total of 44.9% of patients had persistent-moderate asthma. Patients under treatment with FP/Form were associated with greater persistence (67.6 vs. 61.2%, P=.043), a higher RPM (80.6 vs. 74.3%, P=.002), and less exacerbations (16.0 vs. 21.9%, P=.021), particularly severe-exacerbations (4.0 vs. 7.7%, P=.043). The mean/unit of the total cost (ANCOVA) was lower in patients under treatment with PF/Form (2,033 vs. € 2,486, P=.012), respectively. The total cost was associated with: Exacerbations (ß=0.618), asthma-severity (ß=0.214), age (ß=0.073), and lack-adherence (RPM: ß=-0.031), P<.01. CONCLUSIONS: Patients undergoing treatment with PF/Form were associated with greater adherence to treatment (persistence, RPM), a circumstance that leads to less severe exacerbations and total costs for the national health system. These differences could be due to the pharmacological properties of the drug or other factors not measured.

[Use of resources and costs associated with non-adherence to inhaled corticosteroid treatment in asthma]. / Uso de recursos y costes asociados a la no adherencia al tratamiento con corticoides inhalados en el asma.

OBJECTIVE: To estimate adherence to asthma treatment with inhaled corticosteroid in clinical daily practice, and its relationship with exacerbations, as well as its use of resources and costs. MATERIAL AND METHODS: An observational, retrospective study using the electronic medical records of the Badalona Health Service provider. The study included patients≥15 years old with a confirmed diagnosed of asthma, and who initiated treatment with an inhaled corticosteroid between January 2010 and December 2011. The follow-up period was 24 months. Adherence to treatment was measured using the medication possession ratio. Two groups were established: adherent (ADH; medication possession ratio≥80%) and non-adherent (non-ADH; medication possession ratio<80%) patients. The main demographic and clinical variables, including exacerbations, were collected, along with the healthcare and non-healthcare (days of absence from work) resource use, and costs. RESULTS: The study included a total of 2,303 patients, with a mean age of 48.6 years, and 64.3% females. Just over half (52.6%) of the patients had moderate persistent asthma, and 51.0% of patients adhered to treatment. In the non-ADH patients, 63.4% suffered at least one exacerbation in the follow-up period, compared with 37.4% of the adherent patients (P<.001). The non-ADH patients also consumed a higher percentage of healthcare resources in Primary Care (22.5 vs. 17.4%), secondary care (3.3 vs. 2.5%), and emergency visits (1.4 vs. 0.2%) during the follow-up period (P<.001 in all cases). No statistical significance differences were observed in the days of absence from work. Mean annual cost of non-ADH patients was 1,431€/patient, compared with 722€/patient (P<.001) of ADH patients. CONCLUSION: Lack of adherence was associated with an increase in exacerbation rates, as well as healthcare resource consumption and costs.

Economic Impact of Atopic Dermatitis in Adults: A Population-Based Study (IDEA Study). / Impacto económico de la dermatitis atópica en adultos: estudio de base poblacional (estudio IDEA).

OBJECTIVE: To determine resource usage and costs associated with atopic dermatitis in adults according to severity and comorbid conditions in daily clinical practice. PATIENTS AND METHODS: We performed an observational, retrospective study based on a review of registries of patients aged ≥18 years who sought health care in 2013 and 2014 in an area of Catalonia, Spain, with a population of 215,634 persons. We established 3 classes of severity depending on the treatment prescribed. The variables evaluated were total comorbid conditions, concomitant/specific medication, and direct/indirect health care costs. The statistical analysis was based on multiple regression models. Statistical significance was set at P<.05. RESULTS: We included 6,186 patients with a diagnosis of atopic dermatitis (mean age, 47.1 years; women, 61.6%). We established 3 groups based on severity, as follows: mild (n=3,445 [55.7%]); moderate (n=2,361 [38.2%]); and severe (n=380 [6.1%]). Severe atopic dermatitis was associated with risk of presenting comorbid conditions (ß=0.192), namely, asthma (ß=0.138), depression (ß=0.099), cardiovascular events (ß=0.087), obesity (ß=0.085), and smoking (ß=0.025); P<.001. Costs reached €9.3 million (health care costs, 75.5%; loss of productivity, 24.5%), with an average unit cost of €1,504 per year. The corrected average unit cost (ANCOVA) was greater in severe atopic dermatitis compared with moderate and mild disease (€3,397 vs. €2,111 vs. €885; P<.001), respectively. CONCLUSIONS: Severe atopic dermatitis generates considerable usage of health care resources and high costs for the National Health System. These are in proportion with the severity of the disease. General comorbid conditions and asthma were the factors with the greatest impact on health care costs.

Clinical and economic consequences of treating patients with peripheral neuropathic pain with brand name or generic drugs in routine clinical practice: The effects of age and sex. / Efecto de la edad y el género sobre las consecuencias clínicas y económicas del tratamiento con especialidad farmacéutica de marca o genérica en pacientes con dolor neuropático periférico en práctica clínica habitual.

OBJECTIVE: We aimed to analyse the effects of age and sex on pain and cost for patients with chronic peripheral neuropathic pain (PNP) who have started treatment with brand name gabapentin versus generic gabapentin (EFG). METHODS: We conducted a retrospective multicentre study using electronic medical records (EMR) for patients of both sexes, older than 18, who began treatment with brand name or generic gabapentin. Adherence (medication possession ratio [MPR]), persistence, use of healthcare resources, cost, and pain reduction were measured for one year. RESULTS: We analysed 1369 EMRs [61.1% women; mean age 64.6 (15.9), 52.4%≥65 years]; 400 used brand name drugs while 969 used generic gabapentin. Persistence and adherence were higher in patients using brand name gabapentin (7.3 vs 6.3 months, P<.001; 86.5% vs 81.3% MPR, P<.001). Lower healthcare costs were observed in patients using brand-name gabapentin in both age groups (<65 and ≥65). Mean difference in cost per patient amounted to €221 (95%CI: 59-382) and €217 (95%CI: 51-382) in the <65 and ≥65 age groups, respectively (P<.01). Mean difference in cost among men amounted to €197 (63-328), while mean difference in cost among women amounted to €239 (96-397) (P=.005 and P=.004, respectively). Compared with EFG, brand treatment showed greater pain relief: 13.5% (10.9-16.2) and 10.8% (8.2-13.5) in <65 and ≥65year patients, respectively (P<.001), and 10.7% (8.2-13.2) and 13.8% (11.0-16.5) in women and men respectively (P<.001). CONCLUSIONS: Regardless of sex and age, patients who started PNP treatment with brand name medication showed greater persistence and adherence to treatment than those taking generic drugs. Brand name treatment also involved lower healthcare costs, and greater pain relief.

[Comorbidity and related costs as a burden in the treatment of outpatients with depressive disorders in a primary care setting]. / Comorbilidad y coste ambulatorio asociado a los pacientes con trastornos depresivos en un ámbito poblacional.

OBJECTIVE: To study the impact of depressive disorders (DD) on health care expenditure and to measure associated comorbidity in patients in primary care settings (PCS) under normal clinical practice conditions. METHOD: A retrospective cohort study was carried out. The study cohort consisted of outpatients aged over 14 years of age with an established diagnosis of DD (ICPC; P76) treated in a PC health centre during 2004. A comparative cohort was formed with the remaining outpatients without DD, treated in that health centre. Main factors for calculation were: age, gender, history/comorbidity and health resource use and the corresponding outpatient costs; drugs, diagnostic tests, visits to specialists and PC physicians. Multiple logistic regression analysis and ANCOVA models were used in order to adjust costs and comorbidities between the cohorts of patients. RESULTS: A total of 64,072 subjects were assessed; 6,592 patients with DD [10.3% (CI: 8.2-12.4%), 74.5% (CI: 73.4%-75.6%) females]. DD outpatients displayed a higher number of episodes of comorbidities/year (mean +/- SD; 7.4 +/- 4.3 vs. 4.7 +/- 3.3, p < 0.0001) and global medical visits/patient/year (12.0 +/- 9.3 vs. 7.4 +/- 7.6, p < 0.0001). The main comorbidities associated to DD were neurological disorders [Odds ratio (95% CI); 2.1 (CI: 1.5-2.6), p < 0.0001], alcoholism [1.6 (CI: 1.3-1.9), p < 0.0001] and malignancies [1.3 (CI: 1.1-1.5), p < 0.0001]. DD were associated with significantly higher adjusted total costs; 1,083.8 euro (SEM; 8.4 euro) vs. 684.1 euro (3.4 euro), p < 0.0001. Higher costs were displayed for elderly patients. Sixty-two percent of the total cost was related to drugs. CONCLUSIONS: Prevalence of DD was higher, particularly in women. Following adjustment in accordance with comorbidity, age and sex, DD outpatients used more health care resources and implied higher costs. Higher costs were associated with age.