Vicente Francisco Gil-Guillén

Adherence to Therapies in Patients with Type 2 Diabetes

Adherence to therapy is defined as the extent to which a person’s behavior in taking medication, following a diet, and/or executing lifestyle changes, corresponds with agreed recommendations from a healthcare provider. Patients presenting with type 2 diabetes mellitus are initially encouraged to maintain a healthy diet and exercise regimen, followed by early medication that generally includes one or more oral hypoglycemic agents and later may include an injectable treatment. To prevent the complications associated with type 2 diabetes, therapy frequently also includes medications for control of blood pressure, dyslipidemia and other disorders, since patients often have more than three or four chronic conditions. Despite the benefits of therapy, studies have indicated that recommended glycemic goals are achieved by less than 50% of patients, which may be associated with decreased adherence to therapies. As a result, hyperglycemia and long-term complications increase morbidity and premature mortality, and lead to increased costs to health services. Reasons for nonadherence are multifactorial and difficult to identify. They include age, information, perception and duration of disease, complexity of dosing regimen, polytherapy, psychological factors, safety, tolerability and cost. Various measures to increase patient satisfaction and increase adherence in type 2 diabetes have been investigated. These include reducing the complexity of therapy by fixed-dose combination pills and less frequent dosing regimens, using medications that are associated with fewer adverse events (hypoglycemia or weight gain), educational initiatives with improved patient–healthcare provider communication, reminder systems and social support to help reduce costs. In the current narrative review, factors that influence adherence to different therapies for type 2 diabetes are discussed, along with outcomes of poor adherence, the economic impact of nonadherence, and strategies aimed at improving adherence.

Efficacy of a home blood pressure monitoring programme on therapeutic compliance in hypertension: the EAPACUM- HTA study

Objective To evaluate the efficacy of a programme of home blood pressure measurement (HBPM) on therapeutic compliance in mild-to-moderate hypertension. Design A prospective controlled multicentre clinical trial. Setting Forty primary care centres in Spain, with a duration of 6 months. Patients A total of 250 patients with newly diagnosed or uncontrolled hypertension were included. Interventions The patients were randomly selected and distributed in two groups: (1) the control group (CG) who received standard health intervention; (2) the intervention group (IG): the patients in this group received an OMRON in their homes for a programme of HBPM. Main outcome measure Four visits were scheduled, for the measurement of blood pressure (BP). They were provided with an electronic monitor for measuring compliance (monitoring events medication system; MEMS). Therapeutic compliance was defined as a drug consumption of 80–110%. A number of variables were calculated using the MEMS. The mean BP were calculated and the percentage of controlled patients. Results A total of 200 patients completed the study (100 in each group). Compliance was observed in 74 and 92%, respectively, in the CG and IG [95% confidence interval (CI) 63.9–84.1 and 86.7–97.3; P = 0.0001], the mean percentage compliances were 87.6 and 93.5% (95% CI 81.2–94 and 80.7–98.3; P = 0.0001), the percentages of correct days were 83.6 and 89.4%, the percentages of subjects who took the medication at the prescribed time were 79.89 and 88.06%, and the levels of therapeutic cover were 86.7 and 93.1%. The number needed to treat to avoid one case of non-compliance was 5.6 patients. The differences in the mean decreases in BP were significant for diastolic BP, with a greater decrease observed in the IG. Conclusions An HBPM programme using electronic monitors is effective in improving compliance in arterial hypertension, measured using the MEMS.

Independent impact of obesity and fat distribution in hypertension prevalence and control in the elderly

Background Studies on the impact of weight excess and fat distribution on blood pressure are usually limited to young and middle-aged population, and data on the elderly are scarce. Methods and results We performed an analysis of the Prevencion de Riesgo de Ictus, a population-based study on individuals aged 60 years or more in Spain, to assess the impact of weight excess, stratified by body mass index (normal <25; overweight 25–29.9; obesity ≥30 kg/m2), and waist circumference [increased if ≥88 cm (women) or ≥102 (men)] on the prevalence on hypertension and lack of blood pressure control. In 6263 individuals (mean age 71.9 years old, 53.3% women; 73.0% with diagnosed hypertension), prevalence of obesity was 35.0%, and 65.6% showed an increased waist circumference. Body mass index and waist circumference showed an independent impact on the prevalence and absence of hypertension control. In a multivariate model including age, sex, body mass index, and waist circumference, prevalence of hypertension was higher in the overweight and obesity groups (odds ratio 1.41 and 1.96, respectively, compared to normal weight), and in those with increased waist circumference (odds ratio 1.25) compared with normal waist circumference. After further adjustment for antihypertensive therapy, overweight, and obesity (odds ratio 1.40 and 1.59, respectively) as well as increased waist circumference (odds ratio 1.39) were independently related to absence of blood pressure control. The impact of waist circumference on hypertension and blood pressure control was shown in each category of body mass index. Conclusion In this cross-sectional study in an elderly population, body mass index and waist circumference showed an independent and direct impact on the prevalence of hypertension and on the absence of blood pressure control.

Effectiveness of the 2010-2011 seasonal influenza vaccine in preventing confirmed influenza hospitalizations in adults: A case-case comparison, case-control study

Abstract Introduction We estimated influenza vaccine effectiveness (IVE) to prevent laboratory-confirmed influenza-related hospitalizations in patients 18 years old or older during the 2010–2011 influenza season. Methods We conducted a prospective case-control study in five hospitals, in Valencia, Spain. Study subjects were consecutive emergency hospitalizations for predefined conditions associated with an influenza-like illness episode <8 days before admission. Patients were considered immunized if vaccinated ≥14 days before influenza-like illness onset. Cases were those with a real time reverse transcriptase polymerase chain reaction (RT-PCR) positive for influenza and controls were RT-PCR positive for other respiratory viruses. Adjusted IVE was estimated as 100×(1−adjusted odds ratio). To account for indication bias we computed adjusted IVE for respiratory syncytial virus related hospitalizations. Results Of 826 eligible hospitalized patients, 102 (12%) were influenza positive and considered cases, and 116 (14%) were positive for other respiratory viruses and considered controls. Adjusted IVE was 54% (95% confidence interval, 11–76%). By subgroup, adjusted IVE was 53% (4–77%) for those with high-risk conditions, 59% (16–79%) for those ≥60 years of age, and, 54% (4–79%) for those ≥60 years of age with high-risk conditions. No influenza vaccine effect was observed against respiratory syncytial virus related hospitalization. Conclusion Influenza vaccination was associated with a significant reduction on the risk of confirmed influenza hospitalization, irrespective of age and high-risk conditions.

Clinical inertia in diagnosis and treatment of hypertension in primary care: Quantification and associated factors

Abstract Objectives. The objective of the present study was to quantify both diagnostic and therapeutic inertia in hypertension and to identify patient-associated variables. Patients and methods. Cross-sectional, multicenter study of 35 424 subjects carried out in 428 health centers and/or primary care clinics in the Valencian Community, Spain, in a preventive activity conducted during 2003 and 2004. Diagnostic inertia was identified when a patient without known hypertension had high blood pressure (BP) but was labeled “normal” by the medical staff, and therapeutic inertia when treatment was not modified for a hypertensive patient on the presence of high BP values. Bivariate and multivariate statistical analyses were performed to identify patients characteristics associated with inertia. Results. Diagnostic inertia was present in 32.5% (95% CI 31.4–33.6) and therapeutic inertia in 37.0% (95% CI 35.6–38.5) of the cases. Both were more frequent in cases of isolated systolic or diastolic high BP. In the multivariate models, the factors associated with diagnostic inertia were type-2 diabetes (p=0.041), non-smoking (p=0.004), previous coronary heart disease (p=0.001), BP values (p<0.001) and body mass index (p=0.031), whereas for therapeutic inertia they were type-2 diabetes (p=0.003), previous coronary heart disease (p=0.016) or stroke (p<0.001) and BP values (p<0.001). Conclusions.Clinical inertia, either diagnostic or therapeutic, was present in one of every three cases of high BP. The most frequent factors associated with clinical inertia were the presence of associated conditions, which requires lower BP goals and the BP values.

Concordancia de las escalas REGICOR y SCORE para la identificación del riesgo cardiovascular alto en la población española

Introduction. The aims of this study were to evaluate the consistency between the SCORE (Systematic Coronary Risk Evaluation) and REGICOR (Registre Gironi del Cor) scales in identifying high cardiovascular risk and to describe the characteristics of those individuals for whom scale results were discrepant. Methods. This cross-sectional study involved 8942 subjects aged 40-65 years who had an indication for a complete lipid profile. The agreement between SCORE (for low-risk countries) and Framingham-REGICOR (with a high risk threshold of 10%) scales in classifying patients as high risk was evaluated using the kappa statistic. Subjects for whom there was a discrepancy between classifications were identified and variables associated with this discrepancy were determined by multivariate analysis involving binary logistic regression. Results. The REGICOR scale classified 6.7% of subjects (95% confidence interval [CI], 6.2-7.3) as highrisk, while SCORE classified 12.5% (95% CI 11.8-13.2) as high-risk. Discrepant findings were observed in 10.2% of the total population (8% had a high risk on SCORE but not REGICOR, and 2.2% had a high risk on REGICOR but not SCORE; κ=0.420; P<.001). The best agreement was observed between SCORE and REGICOR with a high-risk threshold of 8% (κ=0.463). Multivariate analysis showed that a high risk on SCORE but not REGICOR was associated with lower age, female sex, a high fasting glucose level, and raised diastolic blood pressure, and a high risk on REGICOR but not SCORE, with male sex,

Screening for sight threatening diabetic retinopathy using non-mydriatic retinal camera in a primary care setting: to dilate or not to dilate?

Objectives:  To evaluate three different strategies (without or with mydriasis) for community based screening for sight threatening diabetic retinopathy (STDR).

Determinant Factors of Osteoporosis Patients' Reported Therapeutic Adherence to Calcium and/or Vitamin D Supplements A Cross-Sectional, Observational Study of Postmenopausal Women

Background: Among the various treatments for osteoporosis, calcium and/or vitamin D supplements are frequently included.Objective: The objective of the study was to analyse adherence to calcium and/or vitamin D treatment and to identify related predictors of non-adherence in a sample of postmenopausal women treated for osteoporosis in primary care.Methods: A cross-sectional, observational study was conducted in a sample of postmenopausal women receiving pharmaceutical treatment for osteoporosis with vitamin D and/or calcium. Sociodemographic, general and osteoporosis-related data were collected. Patient’s perceptions of the adverse effects of treatment, their knowledge of osteoporosis (Batalla test), their attitude towards treatment (Morisky-Green test) and their self-reported therapeutic adherence (Haynes-Sackett test) were assessed.Results: Of 630 women (mean age ± SD 64.1 ± 8.7 years) evaluated, 36.2% (95% CI 32.4, 39.9) had problems with treatment tolerability, 63.5% (95% CI 59.7, 67.3) had good knowledge of osteoporosis, 20.5% (95% CI 17.3, 23.6) had a good attitude to treatment and 50.0% (95% CI 46.1, 53.9) had good self-reported adherence to treatment. Patients in the poor adherence group had higher mean body mass index (p = 0.014), more concurrent pathologies (p = 0.003), more tolerability problems (p < 0.001) and worse attitude to treatment (p <0.001). The multivariate model showed a positive relationship between therapeutic adherence and good attitude to treatment (odds ratio [OR] = 11.7; p <0.001), not having tolerability problems (OR = 3.3; p <0.001) and no polymedication (OR = 0.80; p = 0.017).Conclusions: Only one in two postmenopausal women with osteoporosis who take calcium and/or vitamin D have good self-reported therapeutic adherence to this treatment. Determinant factors of adherence to calcium and/or vitamin D treatment were patient’s attitude to the treatment, tolerability problems with the treatment and number of concurrent treatments.

Framingham risk score for prediction of cardiovascular diseases: a population-based study from southern Europe.

Background The question about what risk function should be used in primary prevention remains unanswered. The Framingham Study proposed a new algorithm based on three key ideas: use of the four risk factors with the most weight (cholesterol, blood pressure, diabetes and smoking), prediction of overall cardiovascular diseases and incorporating the concept of vascular age. The objective of this study was to apply this new function in a cohort of the general non Anglo-Saxon population, with a 10-year follow-up to determine its validity. Methods The cohort was studied in 1992-94 and again in 2004-06. The sample comprised 959 randomly-selected persons, aged 30-74 years, who were representative of the population of Albacete, Spain. At the first examination cycle, needed data for the new function were collected and at the second examination, data on all events were recorded during the follow-up period. Discrimination was studied with ROC curves. Comparisons of prediction models and reality in tertiles (Hosmer-Lemeshow) were performed, and the individual survival functions were calculated. Results The mean risks for women and men, respectively, were 11.3% and 19.7% and the areas under the ROC curve were 0.789 (95%CI, 0.716-0.863) and 0.780 (95%CI, 0.713-0.847) (P<0.001, both). Cardiovascular disease events occurred in the top risk tertiles. Of note were the negative predictive values in both sexes, and a good specificity in women (85.6%) and sensitivity in men (79.1%) when their risk for cardiovascular disease was high. This model overestimates the risk in older women and in middle-aged men. The cumulative probability of individual survival by tertiles was significant in both sexes (P<0.001). Conclusions The results support the proposal for “reclassification” of Framingham. This study, with a few exceptions, passed the test of discrimination and calibration in a random sample of the general population from southern Europe.

Tendencias en mortalidad por infarto de miocardio. Estudio comparativo entre España y Estados Unidos: 1990-2006

INTRODUCTION AND OBJECTIVES Mortality from myocardial infarction is declining in high income countries, but the magnitude of this decline could differ between countries. We sought to compare the mortality trends from myocardial infarction between Spain and the United States. METHODS This was an observational retrospective study. Crude data were obtained from public databases. Standardized mortality rates were calculated for the last 17 years available for both countries (1990 to 2006), and stratified by age and sex. Joinpoint regression analysis was used for the trends analysis and projections. RESULTS There has been a steady decline in mortality from myocardial infarction in both countries from 1990 to 2006. However, the magnitude of this decline was greater in the United States (relative reductions in men: 42.7% [Spain] and 59.7% [United States], and in women: 40% [Spain] and 57.4% [United States]). The estimated annual percentages of decline in mortality were greater in the United States (men: -10.7%, women: -5.1%) than in Spain (men: -1.9%, women: -5.1%). Projections for 2012 suggest that the mortality from myocardial infarction will be lower in men in the United States (53.33/100,000) than in Spain (81.52/100,000), while for women it will be equal (32.56/100,000 in the United States and 33.56/100,000 in Spain). CONCLUSIONS The decline in mortality from myocardial infarction has been more pronounced in the United States than in Spain, and projections for upcoming years suggest in the United States it will evolve to rates below those expected in Spain for men and equal rates for women.