Emilio Márquez-Contreras

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.

¿Los pacientes con alto riesgo vascular toman correctamente la medicación antihipertensiva? Estudio Cumple-MEMS

INTRODUCTION AND OBJECTIVES To assess compliance with treatment inhibit the renin-angiotensin system (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers) in uncontrolled hypertension in patients at high cardiovascular risk. METHODS Prospective, longitudinal, multicenter study, carried out in 102 Spanish primary care centers. We included 808 uncontrolled hypertensive patients treated with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers who were at high vascular risk; 4 visits were conducted: baseline and 1, 3, and 6 months later. Compliance was measured by electronic monitors. We calculated the mean percentage compliance, the overall percentage of compliers, once-daily compliers, compliers with the prescribed time frame, and antihypertensive coverage. We considered a patient to be a complier when the percentage compliance was 80%-100%. RESULTS In all, 701 patients completed the study (mean age, 63.7 [11.1] years). The systolic and diastolic blood pressures decreased significantly (P<.0001) to 18.8 mmHg and 9.8 mmHg, respectively. The control rate was 70% (95% confidence interval, 65.6%-74.4%) (P=.0001). The rate of control was significantly higher among compliers than noncompliers (P<.05). The mean percentage of doses taken was 87.9% (95% confidence interval, 84.8%-91%) and the mean therapeutic coverage was 82.4% (95% confidence interval, 78.7%-86.1%). Overall, 73.3% of the patients were compliers (95% confidence interval, 69%-77.6%), 52.8% (95% confidence interval, 48%-57.6%) were once-daily compliers, and 46.5% (95% confidence interval, 41.9%-51.1%) complied with the prescribed time frame. Noncompliance was associated with a higher number of drugs prescribed (P<.001). CONCLUSIONS In hypertensive patients at high vascular risk, the rate of therapeutic noncompliance was very high, mainly when they took 5 or more pills daily.

Is there a predictive profile for clinical inertia in hypertensive patients? An observational, cross-sectional, multicentre study.

AbstractBackground: Some studies have described a large number of hypertensive patients who are followed by a primary care physician without achieving adequate blood pressure (BP) control but whose treatment nevertheless is not intensified. It is not known whether physicians are aware of this clinical inertia and what factors are associated with this problem. Objective: The aim of this study was to describe the factors associated with clinical inertia in hypertensive patients. Methods: This was an observational, cross-sectional, multicentre study conducted in a network of primary care centres and hospital hypertension units in Spain. Using a consecutive sampling approach, 512 physicians selected 5077 hypertensive patients in whom they suspected poor BP control after chart review. The main variables documented were BP control and cardiovascular risk according to European Society of Hypertension guidelines, changes in treatment after visit, type of treatment, and healthcare setting. A binomial logistic regression multivariate analysis, adjusted for physician, was performed. Results: Of the selected patients, 70.9% had poor BP control according to measurements taken in the physician’s office, and in 1499 (42.1%) of those poorly controlled patients, treatment was not intensified (clinical inertia). Factors associated with clinical inertia were as follows: being seen at a primary care centre (p<0.001), not having left ventricular hypertrophy (p<0.001) or microalbuminuria (p<0.001), taking fixed-dose (p=0.049) or free-dose (p=0.001) combination therapy, BP measured in other settings (nurse’s office, patient’s home) than the physician’s office (p=0.034) or the pharmacy (p=0.019), older age (p=0.032), and lower systolic (p<0.001) and diastolic (p<0.001) BP. Of the hypertensive patients with clinical inertia, 90.2% (95% CI 88.7, 91.7) had high cardiovascular risk. Conclusions: Clinical inertia was associated with a profile that included older age, lack of co-morbid conditions and being seen at a primary care centre.

Influencia de la medida correcta de la presión arterial en la toma de decisiones diagnósticas en la hipertensión arterial. Estudio MEDIDA

BACKGROUND AND OBJECTIVE We aimed to assess the influence of correct blood pressure (BP) measurement, following the recommendations of the Spanish Guideline of Hypertension 2005 (SGH), on the diagnostic decisions in hypertensive patients. PATIENTS AND METHOD Prospective, longitudinal, observational, multicenter study conducted in hypertensive patients with stable pharmacologic therapy in primary care units. 4040 patients were included, in whom BP was measured following current clinical practice at the first visit (visit 1). After 7 days no therapeutic changes could be made and BP was measured following the criteria of good BP measurement from the SGH (visit 2). Control rate was assessed both, following the investigators opinion and the SGH algorithm, at visits 1 and 2. Differences in therapeutic recommendations between visits were assessed. RESULTS 3436 patients were evaluable (48.9% women), with mean age (standard deviation) of 63.4 (11.4) years. Decreases in systolic/diastolic BP of 4.8 mmHg (95% confidence interval [CI], 4.5-5.1) and 2.8 mmHg (95% CI, 2.6-3.0) between visits were observed. The control rate following the investigators opinion was of 59.1% (95% CI, 57.4-60.8%) at visit 1 and 76.4% (95% CI, 75.0-77.9%) at visit 2, and the one following the criteria of the SGH was 32.2% (95% CI, 30.6-33.7%) at visit 1 and 46.6% (95% CI, 44.9-48.3%) at visit 2. The rate of patients in which therapeutic recommendations were changed was of 54.1% (95% CI, 52.4-55.7%). CONCLUSIONS Applying the recommendations of the SHG for correct BP measurement led to increased control rate in relation to a previous measurement, prompting changes in the therapeutic attitude.

Non-compliance and inertia in hypertensive Spaniards at high cardiovascular risk: CUMPLE study

Abstract Objective: To assess non-compliance (NC) and therapeutic inertia (TI) after 6 months of follow-up in hypertensive patients with poorly controlled blood pressure and high cardiovascular risk. Research design and methods: Longitudinal, multicentre study; 3900 uncontrolled hypertensive patients were recruited from 585 primary healthcare centres. Tablets were counted during visits at baseline, 1, 3 and 6 months. A tablet count between 80–100% was considered as compliant. Multivariate logistic regression was performed to determine variables associated with NC and TI. Results: A total of 3636 patients completed, mean age was 64.8 (SD 10.8) years, 53.7% being male. After one month, 61.8% (60.2–63.4) had uncontrolled blood pressure, 39.5% (37.9–41.1) were NC and 52.3% (50.2–54.4) had TI. At the end of follow-up, uncontrolled blood pressure was 34.6% (33.1–36.1) (p < 0.05), NC was 46.8% (45.2–48.4) (p < 0.05) and TI was 34.2% (31.6–36.8) (p < 0.05). The variable associated with NC was greatest number of antihypertensive treatments (OR 1.09, 95% CI 1.05–1.13, p < 0.001), and variables associated with TI were least number of antihypertensive drugs (OR 0.88, 95% CI 0.84–0.98, p < 0.001) and least number of diseases suffered (OR 0.95, 95% CI 0.92–0.98, p = 0.002). Limitations: Due to the complexity of measuring compliance, we have to assume measurement bias. Conclusions: Among uncontrolled hypertensive patients, after completing 6 months follow-up, approximately one out of two patients were NC and one out of three physicians committed TI.

Therapeutic compliance with rivaroxaban in preventing stroke in patients with non-valvular atrial fibrillation: CUMRIVAFA study

Abstract Objective: To assess compliance with treatment with rivaroxaban in patients with non-valvular atrial fibrillation. Methods: Prospective, longitudinal, multicenter study, developed in 160 Spanish primary or specialized care centers. We included 412 patients treated with rivaroxaban, prescribed for stroke prevention. Three visits were conducted: baseline, 6 and 12 months. Compliance was measured by using electronic monitors (MEMSs) that use a digital record in the form of a microchip in the lid of the drug container that automatically controls its opening and registers the time and date of the opening. We calculated the average compliance percentage (CP), global and daily compliance. We considered compliance to be when CP was 80–100%. Results: Three hundred and seventy patients ended the study (mean age 75.19, SD: 7.5 years). Global compliance was 84.1% (CI = 79.21–88.99%) and 80.3% (CI = 74.98–85.62%) after 6 and 12 months respectively. Daily compliance was 83.5% (CI = 78.53–88.57%) and 80% (CI = 74.65–85.35%) at 6 and 12 months. Significant differences in the CP between 6 and 12 months were observed. Global CP was 90.77% after 6 months and 89.65% at the end of the study. Daily CP was 90.14% and 87.66% at 6 and 12 months. There were significant CP differences between 6 and 12 months. Non-compliance was associated with a higher number of concomitant diseases, number of drugs taken and weight. Conclusions: The percentage of compliance with rivaroxaban was high. A profile of variables that need to be modified in current medical practice, associated with non-compliance, was detected.

Evaluación de la situación actual del cumplimiento terapéutico en la hipertensión arterial en España, en opinión de los pacientes. Proyecto Cumplex II

Objetivos Evaluar la opinion de los hipertensos espanoles sobre diferentes aspectos relacionados con el cumplimiento terapeutico. Metodologia Estudio descriptivo transversal mediante una encuesta a pacientes hipertensos en tratamiento antihipertensivo estable, realizada en centros de Atencion Primaria de Espana. Se recogieron datos demograficos, se midio el cumplimiento mediante los cuestionarios de Batalla, Morisky-Green y Haynes-Sackett, y se interrogo sobre las causas por las que dejaban de tomar los comprimidos en alguna ocasion, la causa que consideraban mas frecuente de incumplimiento y las estrategias que desearian que su medico o enfermera realizasen para mejorar el cumplimiento. Resultados Se incluyeron 4.952 pacientes (91,9%) (edad media: 62,6 anos; desviacion estandar [DE] 10,7 y 47,2% mujeres). Fueron cumplidores el 90,3% (intervalo de confianza [IC] 99% = 89,2-91,4) mediante el cuestionario de Haynes-Sackett, el 11,3% (IC 99%=10,1-12,5) segun Morisky- Green y el 69,5% (IC 99% = 67,8-71,2) segun el de Batalla. Las causas mas frecuentes por las cuales dejaron de tomar alguna vez la medicacion fueron los olvidos involuntarios (77,4% [IC 99% = 67,8-71,2]) quedarse sin medicacion (45,4% [IC 99% = 43,6-47,2]) y no encontrarse bien (34,5% [IC 99% = 32,8-36,2]). La causa de incumplimiento considerada como principal fueron los olvidos (80,3% [IC 99% = 78,8-81,8]). Entre las estrategias que los pacientes deseaban para mejorar el cumplimiento, las preferencias oscilaron entre el 88,6% (IC 99% = 87,4-89,8) para la prescripcion del menor numero posible de comprimidos y el 10,8% (IC 99% = 9,7-11,9) para el contacto con el medico por correo electronico. Conclusiones La principal causa de incumplimiento son los olvidos casuales, la estrategia preferida es la simplificacion del tratamiento y los pacientes encuestados muestran escasas preferencias por el uso de nuevas tecnologias.

[A study on the subjective compliance and acceptance of oral lanzoprazole in traumatology. The ECOFT-TR Study].

Abstract Objective To assess compliance with oral lansoprazolee disintegrating tablets (LODT) in patients treated by traumatology specialists. Material and method A multicenter, observational, cross-sectional study involving 370 traumatology specialists and patients aged 18 or more. Study logistics were sponsored by Almirall Laboratories, S.A.; neither investigators nor patients received any economic compensation for their participation. Patient subjective compliance with LODT was assessed with the Haynes Sackett test. Acceptability was based on patients global assessments of the drug organoleptic characteristics and properties of use, and preferences regarding previous treatments, recorded by means of a self-administered 15-item ad hoc questionnaire with a 2–5-point Likert-type scale, that patients fulfilled once. Results One thousand and eighty five patients were analyzed for the main endpoint. Mean age was 56.09 (13.8) years; 56.77% were women. Mean treatment duration was 51.24 (38.8) days. 94.74% of the patients complied with the treatment. Mean percentage of compliance was 94.5 (12.12); 91.09% of patients rated the treatment as “acceptable or highly acceptable.” No significant differences were observed between compliant and non-compliant patients in terms of demographic or clinical variables. Mean percentage of compliance was significantly higher among patients without concomitant illness or treatment and without difficulties in taking tablets. One non-serious adverse reaction was reported in one (0.09%) patient. Conclusions Compliance with lansoprazolee orally disintegrating tablets was high. Patients reported that this formulation improved their compliance and that they preferred LODT to previous medication. Tolerability was excellent.

Validation of the electronic prescription as a method for measuring treatment adherence in hypertension

OBJECTIVE To validate electronic prescriptions (e-prescriptions) as a method for measuring treatment adherence in patients with hypertension. METHODS This prospective study initially included 120 patients treated for hypertension in primary care centers. Adherence was measured using the gold standard, the medication event monitoring system (MEMS), versus the index test, the e-prescription program, at baseline and at 6, 12, 18 and 24 months. We calculated the adherence rate using the MEMS and the medication possession ratio (MPR) for the e-prescriptions. We considered patients adherent if they had an adherence rate of 80% to 100%. To validate the e-prescription, we obtained measures of diagnostic accuracy, the Kappa concordance index, and the area under the ROC curve (AUC). RESULTS We included 102 patients. Overall adherence was 77.4% by MEMS (95%CI: 66.8-88) and 80.4% (95%CI: 70.3-90.5) by MPR. At 24 months, sensitivity was 87% and specificity, 93.7%. The AUC was 0.903 (95%CI: 0.817-0.989). CONCLUSION Measures of treatment adherence were not significantly different between e-prescription and gold standard at most visits, and the e-prescription showed good discriminatory diagnostic capacity. PRACTICE IMPLICATIONS If patients are included in an e-prescription program for at least 2 years, e-prescription is an inexpensive method to measure adherence in hypertension.

Strategies for improving dabigatran adherence for stroke prevention in patients with non-valvular atrial fibrillation: education and drug intake reminders (FACILITA study)

Abstract Objective To assess the efficacy of a mixed intervention, educational, and reminder calendar of the intake, as a strategy to improve therapeutic adherence with dabigatran in patients with non-valvular atrial fibrillation (NVAF). Methods This was a prospective, longitudinal, multi-center study, carried out in 110 specialized healthcare centers in Spain. Seven hundred and twenty-six patients treated with dabigatran prescribed for stroke prevention were included. A cluster randomization was performed based on two groups: (1) Control Group (CG) as usual clinical practice, and (2) Intervention Group (IG) with a mixed strategy: (a) Healthcare education, and (b) Use of a reminder calendar for taking the anticoagulant medication. Three visits took place: baseline and follow-up at 6 and 12 months. Compliance was measured by using electronic monitors (MEMS). Average adherence percentage (%; Average AP) and daily compliance (%; Daily AP) was calculated. A patient was considered adherent when AP was 80–100%. Results Six hundred and twenty-five patients completed the study (315 in the IG and 310 in the CG). Daily AP was 91.97% at 6 months and 91.05% after 12 months in the IG and 82.26% and 82.63% in the CG. Average adherence was 90.79% and 89.20% in the IG and 64.51% and 63.22% in the CG at 6 and 12 months, respectively. Significant differences were observed in the Daily AP and Average AP, with higher percentages in the IG. In the non-adherents group, the number of concomitant drugs, baseline, and 6 months SBP values, 6 and 12 months DBP values, and weight, total cholesterol, and LDL cholesterol were significantly higher. The number needed to treat (NNT) was 3.84 patients to prevent one non-adherence. Conclusions A mixed intervention, consisting of patient education and a simple calendar reminder of drug intake, is an effective strategy to improve dabigatran therapeutic adherence in patients with NVAF. The percentage of adherence with dabigatran was high.