[Prevention of therapeutic inertia in the treatment of arterial hypertension by using a program of home blood pressure monitoring]. / Eficacia de un programa de automedida domiciliaria de la presión arterial como estrategia para disminuir la inercia terapéutica.

OBJECTIVE: To evaluate the efficacy of a program of home blood pressure monitoring (HBPM) on therapeutic Inertia (TI) in mild-to-moderate hypertension (AHT). DESIGN: Controlled, randomised clinical trial. SETTING: Forty six clinics in 35 primary care centres. Spain. PARTICIPANTS: A total of 232 patients with uncontrolled hypertension were included. INTERVENTION: Two groups with 116 patients were formed: 1) Control group (CG): standard health intervention; 2) Intervention group (IG): patients who were included in the HBPM program. MAIN MEASUREMENTS: TI was calculated by the ratio: Number of patients whose pharmacological treatment was not changed in each visit/Number of patients with an average BP 140mmHg and/or 90mmHg in the general population or 130 and/or 90 mmHg in diabetics. The mean BPs and the percentage of controlled patients were calculated. The mean number of people that required an intervention in order to avoid TI was calculated (NI). RESULTS: A total of 209 patients completed the study, with TI in 35.64% (95% CI=29.85%-41.43%) of the sample, and in 71.63% (95% CI=63.9-79.36%) of the uncontrolled hypertensive patients. The TI was 22.42% (95% CI=24.2-37%) in the IG and 50% (95% CI=37.75-62.25) in the CG (p<.05) in visit 2, and 25.23% (95% CI=14.84-35.62) and 46.07% (95% CI=33.85-58.29) in the final visit for IG and CG, respectively (P<.05). The NI was 4.3. CONCLUSIONS: TI was very significant among the uncontrolled hypertensive patients. The studied interventions are effective for improving TI.

[Therapeutic non-compliance with insulin in the treatment of diabetes mellitus 2]. / El cumplimiento terapéutico con insulina en el tratamiento de la diabetes mellitus tipo 2: estudio CUMINDIAB.

OBJECTIVE: To determine the percentage of therapeutic noncompliance among type 2 diabetes patients on treatment with insulin. DESIGN: Prospective multicentre study. SETTING: Nine Primary Care Health Centre in Huelva (Spain). PARTICIPANTS: A total of 121 type 2 diabetics, who, in the opinion of their doctor, need to start treatment with insulin or have their insulin treatment modified. MAIN MEASUREMENTS: Five visits were made (enrolment, 6, 12, 18 and 24 months). The variables analysed were, fasting blood glucose, glycosylated haemoglobin, compliance with insulin treatment, measured by counting insulin units. The percentage compliance (PC) was calculated by (PC = Total No. of insulin units expected to be consumed / Total No. of insulin units that should have been taken x 100). A complier was considered as one who achieved a PC between 80 and 100%. RESULTS: There were 103 evaluable subjects (85.8%) with a mean age of 66.4 (SD 11.6) years, and 45 were male (42.8%). The mean percentage compliance with insulin was 90.9% (95% CI, 84.2-97.6%). At the 6, 12, 18 and 24 months visits it was 92.1% (95% CI, 85.6-98.6%), 92.3, 90.1 and 89.2% (95% CI, 81.7-96.7%), respectively. Overall patient compliance was 74.75% (95% CI, 64.3-85.2%). For the visits, compliance was 82.5% (95% CI, 73.3-91.7%), 77.7%, 73.8% and 71.8% (95% CI, 60.9-82.7%), respectively (P<.05 initial-final). CONCLUSIONS: A quarter of the diabetic patients did not comply with their insulin treatment.

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.

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.

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.

[Non-pharmacological intervention as a strategy to improve antihypertensive treatment compliance]. / Intervención no farmacológica como estrategia para favorecer el control de la hipertensión arterial y mejorar el cumplimiento antihipertensivo.

OBJECTIVE: To evaluate the efficacy of an intervention by means of an educational magazine on treatment compliance in uncontrolled arterial hypertension (AHT). DESIGN: Controlled, randomised clinical trial. SETTING: 87 primary care centres. Spain. PARTICIPANTS: A total of 450 patients with uncontrolled hypertension were included. INTERVENTION: Two groups of 225 patients were formed: 1) Control group (CG): standard health intervention; 2) Intervention Group (IG): received a twice monthly educational magazine at home. MAIN MEASUREMENTS: Compliance was measured using the Medication Event Monitoring System (MEMS-Aardex). Compliance rate (CR) was recorded. Compliers were defined as individuals with a treatment compliance of 80-110%. The percentage of compliers, the mean percentage of doses taken and the percentage of patients taking the medication at the correct times were estimated. The mean blood pressures (BPs) and the percentage of controlled patientswere calculated. The number needed to treat (NNT) was calculated. RESULTS: A total of 393 individuals were evaluable (Age: 62.4 years), 196 in the IG and 197 in the CG. There were 83.2% (95% CI 78-88.4) and 49.2% (95% CI 42.2-56.2) (P=0.0001) of overall compliers in the IG and CG, respectively and 74% (95% CI: 67.9-80.1) and 42.6% (95% CI=35.7-49.5) (P=0.0001) of correct times compliers. A total of 81.6% (95% CI=76.2-86.5%)) were controlled in the IG and 56.3% (95% CI=49.4-63.2) in the CG. The NNT was 3.3 patients. CONCLUSIONS: Therapeutic non-compliance was very high. The educational magazine is an effective strategy to improve the compliance and degree of control of the AHT.

[Control of therapeutic inertia in the treatment of arterial hypertension by using different strategies]. / El control de la inercia terapéutica en el tratamiento de la hipertensión arterial mediante diferentes estrategias.

OBJECTIVE: To evaluate the efficacy of different interventions on therapeutic Inertia (TI) in mild-to-moderate hypertension (AHT). DESIGN: Controlled, randomised clinical trial. SETTING: Two hundred clinics in 5 primary care centres. Spain. PARTICIPANTS: A total of 1104 patients with uncontrolled hypertension were included. INTERVENTION: Four groups with 276 patients were formed: 1) Control group (CG): standard health intervention; 2) Education intervention and a program of home blood pressure monitoring (HBPM) (EG); 3) Card control intervention and HBPM programme (CHG); 4) Education intervention, card control and HBPM programme (ECHG). MAIN MEASUREMENTS: TI was calculated by the rate: (Number of patients whose pharmacological treatment was not changed in each visit/Number of patients with an average BP 140mmHg and/or 90mmHg in the general population or 130 and/or 90 mmHg in diabetics). The mean BPs and the percentage of controlled patients were calculated. The mean number of people that required an intervention in order to avoid TI was calculated (NI). RESULTS: A total of 921 patients completed the study, and 1842 visits were made, with TI in 36.8% (IC=5.8%) of the sample and in 82.58% (IC=8.2%) of the uncontrolled hypertensive patients. The TI was 60% (CI=4.2%), 38.4% (CI=4.4%) 30.2 (CI=4.3%) and 14.7 (CI=3.3%) (p=0.001) for CG, EG, CHG and ECHG, respectively. The percentage controlled at the end of study was 35.3% (CI=1.1%), 54.7% (CI=1.8%), 60.2% (CI=2.1%) and 65.1% (CI=2.2%) (p<0.01) for CG, EG, CHG and ECHG, respectively. The NI were 4.6, 3.3 and 2.2 for CG, EG, CHG and ECHG, respectively. CONCLUSIONS: TI was very significant among the uncontrolled hypertensive patients. The studied interventions are effective for improving TI.

[Therapy compliance in cases of hyperlipaemia, as measured through electronic monitors. Is a reminder calendar to avoid forgetfulness effective?]. / El cumplimiento terapéutico en las dislipemias medido mediante monitores electrónicos. Es eficaz un calendario recordatorio para evitar los olvidos?

OBJECTIVE: To analyse the efficacy of the intervention with a calendar reminder of the medication taking in the treatment of the hyperlipidemias. DESIGN: Controlled, randomised clinical trial. SETTING: Twelve clinics at 5 primary care centres, Spain. PARTICIPANTS: Two hundred and twenty people diagnosed with hypercholesterolaemia according to Spanish Consensus criteria were chosen. INTERVENTION: Two groups were formed. The control group (CG) of 110 patients, who received the doctor's normal treatment; and the Intervention group (IG) of 110 patients, who received in addition a calendar remider of medication taking. MAIN MEASUREMENTS: Meausured of compliance was performed by moniotrs electronic (MEMS) and cholesterol, triglycerides, HDL-C, and LDL-C determined at the start, and at the third and sixth months. Percentages of patients complying (80%-110%), the mean compliance percentage and the degree of control were compared. The reduction of absolute and relative risk (RAR and RRR) and the mean number of people that required an intervention in order to avoid non-compliance (NI) were calculated. RESULTS: One hundred and eighty eight people (85.45%) completed the survey, 96 in the IG and 92 in the CG; 26.55% were non compliers with the therapy (CI, +/-6.3%) (IG, 10.5%, CI, +/-4.6%; CG, 42.6%, CI, +/-10.1% [P<.0001]). Mean compliance ran at 88,1% (IC, +/-4.6%) overall, at 92% (CI, +/-5.4%) in the IG and at 84% (CI, +/-7.4%) in the IG (P<.05). The RAR was 32.1%, the RRR 75.35%, and the NI was 3.1 patients. The patients with cholesterol controlled ran at 66.7% (CI, +/-9.4%) in the IG and 41.2% in the CG (P<.001). CONCLUSIONS: The calendar reminder intervention is an efficacious way of improving the percentage of patients complying with lipaemia treatment.

[Prevalence of white-coat hypertension and masked hypertension in the general population, through home blood pressure measurement]. / Prevalencia de la hipertensión de bata blanca e hipertensión enmascarada en la población general, mediante automedición domiciliaria de la presión arterial.

OBJECTIVE: To determine the prevalence of white-coat hypertension (WCH) and masked hypertension (MH) in the general population, by means of home blood pressure measurement (HBPM). DESIGN: Cross-sectional, descriptive study. SETTING: Four primary care centres. PARTICIPANTS: A sample of 1400 individuals over 18 years old, selected from the Municipal Register of Inhabitants (Huelva, Spain) and randomised and stratified by age and gender. MAIN MEASUREMENTS: Two blood pressure (BP) measurements in clinic (CBP) and 12 measurements in a week of BP by HBPM were performed (OMRON 705-CP). Pressure was seen as normal when CBP means were <140/90 mm Hg and HBPM was <135/85 mm Hg. WCH was defined as when CBP was >140/90 mm Hg and HBPM <135/85 mm Hg, and hypertension when CBP was >140 mm Hg and HBPM >135/85 mm Hg or patients were in treatment for hypertension. MH was when CBP was <140/90 mm Hg and at home was >135 mm Hg and/or 85 mm Hg. RESULTS: A total of 1153 individuals (82.35% of the sample) with mean age of 45.4 (SD, 16.1) were included: 560 men and 593 women. The prevalence of MH was 8.9% (CI+/-1.6) in the general population and 9.8% (CI+/-3.2) in individuals with hypertension. WCH prevalence was 3.6% (CI+/-1.05) overall and 12.8% (CI+/-3.6) in hypertense patients, with its prevalence increasing steadily as age groups rose (P = .001). CONCLUSIONS: The prevalence of WCH in the general population is low, whereas the prevalence of MH is high.

[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.