Quality of life with rivaroxaban in patients with non-valvular atrial fibrilation by therapeutic compliance.

OBJECTIVE: To assess the quality of life (QOL) with rivaroxaban in patients with non-valvular atrial fibrilation (NVAF) related to therapeutic compliance. METHODS: Prospective, longitudinal, multicenter study was 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 electronic monitoring systems. QOL was measured by a specific questionnaire. We calculated the percentage of compliance means, the percentage of daily compliers and the score of QOL. RESULTS: Three hundred and seventy patients finished the study (mean age 75.19 SD: 7.5 years). Daily compliance was 83.5% (CI 78.53-88.57%) (n = 309) and 80% (CI 74.65-85.35%) at 6 and 12 months, respectively. Average QOL rating was 112.85 (SD 29.31) in non-compliant and 111.80 (SD 29.31) in the compliant group (p = Not significant), and after 12 months of 124.67 (SD 30.78) and 83.47 (SD 26.44), respectively (p < 0.0001), with a decrease in the score compliers (p < 0.01) and an increase in non-compliant group (p < 0.05). A higher number of drugs consumed, as well as the number of diseases/conditions suffered, the older age of the patients and having been previously treated with VKA were associated with a higher overall score (worse QOL). CONCLUSIONS: QOL in NVAF patients treated with rivaroxaban improved significantly over the study group at the expense of compliers. A worse QOL was associated with pluripathology, polymedication, older patients and previous treatment with VKA.

Evaluation of the relationship between effervescent paracetamol and blood pressure: clinical trial.

BACKGROUND: Paracetamol's solubility is achieved by adding to the excipient sodium salts, either as bicarbonate, carbonate or citrate. As the relationship between salt and hypertension is well known, due to the sodium content it has raised a hypothesis that may interfere with the control of that risk factor. Therefore, the objective of this study is to evaluate the effect on blood pressure of effervescent paracetamol compared to non-effervescent, in hypertensive patients. METHODS/DESIGN: This is the protocol of a phase IV multicenter clinical trial, randomized, controlled, crossover, open, which will compare the effect of two different formulations of paracetamol (effervescent or non-effervescent) in the blood pressure of hypertensive patients, with a seven weeks follow up. 49 controlled hypertensive patients will be included (clinical BP lower than 150 and 95 mmHg, and lower than 135 mmHg and 85 mmHg in patients with diabetes or a history of cardiovascular event, and daytime ambulatory measurements lower than 140 and 90 mmHg) and mild to moderate pain (Visual Analog Scale between 1 and 4). The study was approved by the ethics committee of the Fundació Jordi Gol i Gurina and following standards of good clinical practice. The primary endpoint will be the variations in systolic BP in 24 h Ambulatory Blood Pressure Monitoring, considering significant differences 2 or more mmHg among those treated with non-effervescent and effervescent formulations. Intention-to-treat and per-protocol analysis will be held. DISCUSSION: Despite the broad recommendation not to use effervescent drugs in patients with hypertension, there are relatively little studies that show exactly this pressor effect due to sodium in salt that gives the effervescence of the product. This is the first clinical trial designed to study the effect of effervescence compared to the non-effervescent, in well-controlled hypertensive patients with mild to moderate pain, performed in routine clinical practice. TRIAL REGISTRATION: NCT 02514538.

[The influence of correct blood pressure measurement on the diagnostic decisions in hypertensive patients. MEDIDA study]. / 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.

[Prevention of atrial fibrillation in hypertensive patients]. / Prevención de la fibrilación auricular en el paciente hipertenso.

A large percentage of patients with hypertension suffer from atrial fibrillation (AF). The presence of hypertension increases the risk of AF, which in turn aggravates hypertension. The ability of drugs to interfere with specific signal transduction pathways easing the presence of AF in hypertensive patients is promising. To date, the most effective mechanism appears to be the inhibition of the renin-angiotensin-aldosterone system with angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin-II receptor blockers (ARBs). This approach is under active investigation. Several trials have assessed the effectiveness of these drugs in the prevention of AF. Data show that both, ACEIs and ARBs, appear effective to prevent AF. However, a lack of prospective randomized double-blind trials data limits their application in absence of any other indication.

[Cardiovascular risk profile of uncontrolled hypertensive patients. The Control-Project study]. / Perfil de riesgo cardiovascular de los pacientes con hipertensión arterial no controlada. Estudio Control-Project.

BACKGROUND AND OBJECTIVE: To assess absolute cardiovascular risk and co-morbidities in uncontrolled hypertensive patients (blood pressure [BP]>or=140/90 mmHg or>or=130/80 mmHg in diabetics) attending Primary Care Physicians in Spain, and to determine the attitudes of these physicians towards this problem. PATIENTS AND METHOD: Cross-sectional, multicenter study involving 356 general practitioners around Spain. Absolute cardiovascular risk was assessed according to ESH-ESC 2003 Guidelines in a sample of 1,710 patients. RESULTS: Two hundred ninety seven patients were excluded by several reasons and a total of 1,413 hypertensive patients were valuable (mean age: 65.3+/-11.4 years; 56.7% women). Normal BP values (<140/90 mmHg) were exhibited by 0.2%, high-normal BP (120-139/80-89 mmHg) were exhibited by 2.8%, grade 1 hypertension (140-159/90-99 mmHg) by 49.9%, grade 2 hypertension (160-179/100-109 mmHg) by 39.3%, and grade 3 hypertension (>or=180/110 mmHg) by 7.9%. Associated cardiovascular risk factors were observed in 96.0% of patients (95% CI=94.7-97.2%), target organ damage in 34.5% (95% CI=31.6-36.5%), and cardiovascular clinical disease in 36.0% (95% CI=33.5-38.5%). According to ESH-ESC 2003 Guidelines 34.0% (CI=31.5-38.2%) were at very-high risk; 29.4% (95% CI=26.4-32.8%) at high risk; 30.4% (95% CI=27.2-33.7%) at moderate risk and 5.4% (95% CI=3.9-7.2%) at low risk of cardiovascular disease. Despite the high absolute risk, physicians did not do any therapeutic change in 30.4% (95% CI=28.2-33.5%) of uncontrolled hypertensive patients. Most of them (64.26%) considered that bad compliance to life style changes was the reason for inadequate BP control. The most frequent measure introduced was the association of additional drugs. CONCLUSIONS: Absolute cardiovascular risk in uncontrolled hypertensive patients attending Primary Care Physicians in Spain is very relevant. Sixty-five percent of these patients are at high or very high risk with a high prevalence of target organ damage or associated cardiovascular clinical disease. Therapeutic attitudes towards these patients are still very conservative although they are improving compared with previous studies.

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.

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

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.

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

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.

Do Patients With High Vascular Risk Take Antihypertensive Medication Correctly? Cumple-MEMS Study.

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.

[Compliance with hypertension therapy in Spain, according to the views of family doctors. Complex project]. / El cumplimiento terapéutico en la hipertensión arterial en España, según la opinión de los médicos de familia. Proyecto Cumplex.

OBJECTIVES: To evaluate physicians' knowledge of therapy compliance, their attitudes towards it and their training needs in this field. DESIGN: Transversal, descriptive study using a questionnaire. SETTING: Primary care centres in Spain. PARTICIPANTS: Three thousand and thirty-four general practitioners. MAIN MEASUREMENTS: Definition of non-compliance, non-compliance in their own consultations and in the rest of Spain, methods of measurement, causes, association with therapy failure, efficacy and use of compliance-enhancing strategies, and need for training. RESULTS: Most participants (92%; 95% CI, 91.1-92.9) defined non-compliance as patients' failure to take 5%-20% of their pills. A total of 32.4% (95% CI, 30.9%-33.9%) of the physicians estimated that less than 10% of their patients were non-compliers, whereas 6.8% (95% CI, 6.0-7.6) thought this was also the rate in the rest of Spain. The preferred methods of measurement were patient response (77.0%; 75.7-78.4) and their own clinical experience (76.0%; 74.6-77.4). About half (50.7%) believed that lack of compliance was associated with therapy failure in more than 50% of cases. The presence of adverse side-effects was considered a very important cause of poor compliance by 81.9%. The most common and effective strategies were: use of single-dose drugs (84.3%; 83.1-85.5) and nursing support (84.9%; 83.8-86.0). Moreover, 65.2% (63.7-66.7) of the surveyed physicians had not received any education about compliance as medical students and 42% (40.4-43.6) said further training in compliance was needed. CONCLUSIONS: A high percentage of physicians define compliance incorrectly and believe that other doctors have more non-complying patients than they do. They tend to favour non-validated measuring methods and they lack training.

[Analysis of studies published on hypertension treatment non-compliance in Spain between 1984 and 2005]. / Análisis de los estudios publicados sobre el incumplimiento terapéutico en el tratamiento de la hipertensión arterial en España entre los años 1984 y 2005.

OBJECTIVE: To analyse therapy non-compliance in hypertension treatment in Spain, after a review of studies published between 1984 and 2005. DESIGN: Systematic review. DATA SOURCES: Data searches used Internet (Medline and Spanish index on doctoral these), a manual search of several Spanish journals, and bibliographic references to compliance from detected articles and through personal contact with experts. Descriptors used were: hypertension and patient compliance, compliance, adherence, patient drop-outs, treatment refusal, and their combinations. SELECTION OF STUDIES: Studies conducted in Spain and published between 1984 and 2005 were included, along with original articles, congress abstracts or doctoral theses, which used as a method of measurement pill count or counting of spaces in electronic monitoring systems, and which defined as non-compliers patients with a compliance percentage <80% and >110%. DATA EXTRACTION: The percentage of non-compliers was calculated, with 95% confidence intervals and weighted average of the percentage of non-compliers in each study. RESULTS: Twenty-six research studies published in Spain, excluding 2 analytical studies, were found. A total of 3553 patients with hypertension were included, of which 32.53% were non-compliers (n= 1156; 95 CI, 29.83-35.23) and 67.47% were compliers (n=2397; 95% CI, 65.67-69.27). The weighted average of non-compliance was at 32.78%. CONCLUSIONS: The percentage of therapy non-compliance in the treatment of hypertension in Spain has fallen in recent years, although it continues to be high.

Efficacy of telephone and mail intervention in patient compliance with antihypertensive drugs in hypertension. ETECUM-HTA study.

OBJECTIVE: To study the efficacy of telephone and mail intervention in therapeutic compliance among patients with mild to moderate hypertension. DESIGN: A prospective controlled multicenter clinical trial. SETTING: Eighty-five primary care centers in Spain, with a duration of 6 months. PATIENTS: A total of 636 patients with newly diagnosed or uncontrolled hypertension were included. Interventions. The patients were randomized and distributed between the following groups: (i) control (CG) - under routine clinical management; (ii) mail intervention (MIG) - received a mailed message reinforcing compliance and reminding of the visits (15 days, 2 and 4 months); (iii) telephone intervention (TIG) - received a telephone call at 15 days, then at 7 and 15 weeks. MAIN OUTCOME MEASURE: Five visits were scheduled, with the measurement of blood pressure and counting of tablets. Compliers were defined as subjects showing 80-110% drug consumption. Calculations were made of mean percentage compliance (MPC) and compliers, mean blood pressure and percentage controlled subjects. RESULTS: Five hundred and thirty-eight patients completed the study (261 males); 85.5% were compliers (CI = 82.5-88.5; n = 460). The MPC was 95.1+/-19.6% (CI = 93.28-96.92). The CG consisted of 182 individuals, MIG = 172 and TIG = 184. Compliers represented 69.2% of the CG (CI 62.5-75.9%), 91.3% (CI = 87.1-95.5) of the MIG (p = 0.0001) and 96.2% of the TIG (CI 93.5-98.9%); the final MPC was 89.6%+/-15 in CG, 96.6%+/-12 in MIG and 99.1+/-26.8 in TIG (p = 0.0001). The percentage of controlled subjects was 47.2% in CG (CI = 40-54.4), 61.3% in MIG (CI = 54.1-68.5%) and 63.3% in TIG (CI = 56.4-70.2%) (p<0.05). CONCLUSIONS: TIG and MIG are effective measures for improving patient compliance in hypertension.