Laparoscopic adrenalectomy vs. radiofrequency ablation for the treatment of primary aldosteronism. A single center retrospective cohort analysis adjusted with propensity score.

BACKGROUND: Laparoscopic adrenalectomy (LA) is the gold standard treatment for unilateral primary aldosteronism. However, satisfactory results have also been published with radiofrequency ablation (RFA). The aim of this study was to compare LA and RFA for the treatment of primary aldosteronism. METHODS: A retrospective cohort study of the patients who underwent LA or RFA in a single center was performed. Morbidity and long-term effectiveness (cure rate and blood pressure control) were analyzed. A multivariate analysis with a propensity score was also performed. RESULTS: Thirty-four patients were included in the study, 24 in the LA group and 10 in the RFA group. Hypertension had been diagnosed a median of 12 years before the intervention. Hypertension was properly controlled before the intervention in 55.9% of the patients. Hypertensive crisis was more common during RFA (4.2% vs. 70.0%, p < 0.001), although no patient suffered any complication because of these crises. LA was longer (174.6 vs. 105.5 min, p = 0.001) and had a longer length of stay (median 2 vs 1 days, p < 0.001). No severe complications were observed in any of the patients. After a median follow-up of 46.2 months, more patients had hypertension cured and blood pressure controlled in the LA group (29.2% vs. 0%, p = 0.078 and 95.5% vs. 50.0%, p = 0.006, respectively). Also, patients in the LA group were taking less antihypertensive drugs (1.8 vs. 3.0, p = 0.054) or mineralocorticoid receptor antagonists (41.7% vs. 90.0%, p = 0.020). Multivariate analysis adjusted by propensity score showed that LA had an OR = 11.3 (p = 0.138) for hypertension cure and an OR = 55.1 (p = 0.040) for blood pressure control. CONCLUSIONS: Although RFA was a less invasive procedure than LA, hypertension was cured and blood pressure was properly controlled in more patients from the LA group. Patients who underwent LA were taking less antihypertensive drugs than patients who had undergone RFA.

[Primary care evaluation of the hypertensive patient management in specialized care after derivation (DERIVA-2 Study)]. / Valoración desde atención primaria del manejo del hipertenso en atención especializada (estudio DERIVA-DOS).

INTRODUCTION: To know the opinion/evaluation of the primary care physicians (PCPH) of the received information about patients that were attended in specialized care (SC). DESIGN: Cross-sectional study. LOCATION: Performed nationwide in primary care centers. PARTICIPANTS: Researchers from the primary care network. METHODS: We used the SEH-LELHA derivation criteria guidelines, plus an ad hoc survey that included demographic and anthropometric data, blood pressure levels, and the main reason for derivation to SC at the baseline and final (post-derivation) visit. In addition, time deployed for the study of every patient, changes in diagnosis and treatment, type of follow-up, issues throughout the derivation process and assessment of the medical referred to the PCPH were evaluated. RESULTS: With participation of 578 researchers from primary, the study included 1715 patients aged 60.7±13.3years, 62.7% male. Patients were taking 2.3±1.2 (range 0-10) antihypertensive drugs pre-referral and 2.5±1.2 (0-9) after derivation. Blood pressure levels changed from 166±21.6 /97.7±12.6mmHg to 143±14.4 /85.5±10.5mmHg. The number of controlled patients (BP<140 and <90mmHg) increased from 5.8% to 32.2%. Time between pre- and post-derivation visit was 72±64days (median 57days, IQ26-99). The PCPH received a medical report in 80.3% of cases, 76.9% with an explanation of the results of the complementary tests, 75.8% with additional information or a reasoning of treatment and in 71% of cases information about the patient future management. 63% of PCPH were fully agreed with the management of the specialist, 29% agree and 2% strongly disagree. The derivation was evaluated as effective or very effective in 86% of patients and no effective in 9%. CONCLUSIONS: Communication between AE and SC in HTA is valued satisfactorily by MAP. However there is still room for improvement in the process.

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.

Circulating endothelial-derived apoptotic microparticles and insulin resistance in non-diabetic patients with chronic heart failure.

BACKGROUND: The objective of this study was to assess the relationship between insulin resistance and apoptotic endothelial-derived microparticles (EMPs) in patients with chronic heart failure (CHF). METHODS: The study involved 300 CHF patients (186 males) aged 48-62 years with angiographically proven coronary artery disease and/or previously defined myocardial infarction. Insulin resistance was assessed by the homeostasis model assessment for insulin resistance (HOMA-IR). EMPs phenotype was determined by flow cytofluorometry. RESULTS: Depending on HOMA-IR cut-off point (over and <2.77 mmol/L×µU/mL) all patients were divided into two cohorts with (n=171) or without (n=129) IR, respectively. Circulating EMPs were higher in CHF patients with IR than in patients without IR. Interestingly, EMPs were directly related to NYHA functional class of CHF, HOMA-IR, NT-pro-BNP, hs-CRP and BMI. There was a significant association between the level of EMPs and HbA1c, gender (r=0.318, p<0.001 for male), age and smoking. On univariate and multivariate regression analysis we found that the NYHA class of CHF,NT-pro-BNP, hs-CRP, and left ventricular ejection fraction (LVEF) appeared to be independent predictors of increased circulatory apoptotic EMPs. The addition of HOMA-IR to the standard model (NYHA class CHF) improved the relative IDI by 19.9% for increased EMPs. For category-free NRI, 10% of events and 24% of non-events were correctly reclassified by the addition of HOMA-IR to the standard model for increased circulating EMPs. CONCLUSIONS: IR may be a contributing factor increasing circulating levels of apoptotic EMPs in non-diabetic CHF patients.

Impact of platelet phenotype on myocardial infarction.

In acute myocardial infarction patients the injured vascular wall triggers thrombus formation in the damage site. Fibrin fibers and blood cellular elements are the major components of thrombus formed in acute occlusion of coronary arteries. It has been established that the initial thrombus is primarily composed of activated platelets rapidly stabilized by fibrin fibers. This review highlights the role of platelet membrane phenotype in pathophysiology of myocardial infarction. Here, we regard platelet phenotype as quantitative and qualitative parameters of the plasma membrane outer surface, which are crucial for platelet participation in blood coagulation, development of local inflammation and tissue repair.

[Evaluation of referral process of the hypertensive patient in Spain: DERIVA study]. / Análisis del proceso de derivación del paciente hipertenso en España: Estudio DERIVA.

INTRODUCTION: An adequate communication between levels of medical attention is the key point for optimal treatment and outcomes of the hypertensive population. AIMS: The aim of this study was to evaluate the adequacy of the hypertensive patients' derivation from Primary Care to Specialized Care. As secondary objectives, the information registered on the derivation report was assessed and concordance between derivation reason and final diagnosis was analysed. DESIGN: This is an observational, descriptive, multicentre study. SITE: Study conducted at the national level. PARTICIPANTS: Specialty Care Physicians receiving hypertensive patients referred from primary care. PRINCIPAL MEASUREMENTS: On the baseline visit, the specialist physicians assessed the quality of the derivation records and attended the patient. After the study, final diagnosis and treatment is suggested on the final visit. RESULTS: 1769 subjects were included, mean aged 62,4 (13,6) years, 45% female. Time of diagnosis of hypertension was 8,0 (7,7) years. More than the half of the derivation records contained very good information (5,4%; CI4,3-6,5) or sufficient (50,7%; CI48,4-53,0). In 7,1% (IC5,9-8,3) derivation cause was not specified. 74,7% of the derivations were considered as appropriate, though 30% were late. Concordance between derivation reasons and final diagnosis was low (kappa index 0,208). CONCLUSIONS: A quarter of the hypertensive population is unnecessary derived to Secondary Care and 30% of the appropriately derived was late. We should improve the interrelation of attention in the hypertension and cardiovascular area between the both attention levels.

Are lead, cadmium and mercury risk factors for resistant hypertension?

BACKGROUND: Lead (Pb), cadmium (Cd) and mercury (Hg) are toxic trace elements that represent a public health problem as risk factors for cardiovascular disease and hypertension (HT) and could also contribute to the development of resistant hypertension (rHT) AIMS: To compare the blood concentrations of Pb, Cd and Hg in subjects with resistant and non-resistant HT and to define whether there is a relationship between its levels and rHT. METHODS: Cross-sectional study. Subjects aged ≥ 21 to ≤ 80 years with a body mass index < 40 kg/m2 were recruited on a discretionary basis from October 2001 to October 2004 in a hypertension unit of a tertiary hospital amongst those sent to the hypertension unit by their family physician. Resistant hypertension was defined according to the American Heart Association (AHA) criteria. Whole blood concentrations of Cd, Pb and Hg were measured by electrothermal atomic absorption spectrometry. RESULTS: 46 out of 73 included subjects (63%) suffered from rHT. Blood Pb median: HT 3.9 (IQR 2.7-5.2) vs. rHT 3.6 (IQR 2.8-6.0) µg/dL (p=0.941). Blood Cd median: HT 0.07 (IQR 0.07-0.80) vs. rHT 0.30 (IQR 0.07-0.65) µg/L (p=0.681). Blood Hg median: HT 7.9 (IQR 5.8-12.9) vs. rHT 7.3 (IQR 4.6-13.3) µg/L (p=0.611). Considering the 75th percentile of each element (Pb: 5.55 µg/dL, Cd: 0.75 µg/L, Hg: 13.15 µg/L), a multiple logistic regression analysis (adjusted for age, BMI, diabetes mellitus, clearance of creatinine and only for Cd the smoking habit) showed an OR = 3.44 (0.84-14.10, p=0.086) for Pb, OR = 1.80 (0.39-8.24, p=0.451), for Cd and OR = 2.31 (0.59-9.14, p=0.232) for Hg. Moreover, the stratified analyses showed that men with Pb ≥5.55 µg/dL have a 14 times higher risk of suffering from rHT (p=0.026). Interestingly, a 9-fold increased risk was found for non-obese subjects with elevated Pb levels, above 5.55 µg/dL (p=0.029). Also in men, the probability of suffering from rHT was more than 7 times higher if Cd levels were ≥ 0.75 µg/L (p=0.076). Most smokers had higher Cd levels, with a high risk of suffering from rHT (ORa 12.6 (0.8-200.2), p=0.072). CONCLUSION: A higher blood Pb levels, defined by the 75th percentile (Pb ≥ 5.55 µg/dL), is associated with a greater risk of suffering from rHT and to a lesser extent in the case of Cd and Hg.

[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.

[Evaluation and control of hypertensive diabetics seen in Primary Care centres in Spain. BRAND II study]. / Evaluación y control de los hipertensos diabéticos atendidos en centros de Atención Primaria de España. Estudio BRAND II.

OBJECTIVE: We aimed to verify the level of blood pressure and glucose control and treatment in hypertensive diabetics seen in Primary Care Centres in Spain. DESIGN: Descriptive study conducted on hypertensive diabetic patients who attended primary care centres for any reason. LOCATION: Primary Care centres throughout Spain. PARTICIPANTS: The study included 6,777 patients. MEASUREMENTS: Blood pressure, weight, height, waist circumference, blood analysis and treatment were recorded RESULTS: The mean age of the sample was 64.40 (11.50) years. Mean blood glucose was 141.8 (39) mg/dl, glycosylated haemoglobin was ≤7% in 45.9% of the sample, and blood pressure was under control (BP≤130/80 mmHg) in 9.8% of the patients studied. LDL Cholesterol was ≤100mg/dl in 25.3% of the sample. The drugs most used to control diabetes were; sulphonylureas 2259 patients (33.3%) and biguanides 3768 patients (55.6%). A total of 556 patients were on treatment with insulin, which represented 8.2% of the population studied. The drugs most used for hypertension were; diuretics in 3395 patients (50.1%) and angiotensin-converting enzyme inhibitors in 4053 patients (59.8%). CONCLUSIONS: A large proportion of hypertensive diabetics are insufficiently controlled.

[Hypertension due to persistent hypokalemia: a complex case]. / Hipertensión arterial secundaria con hipopotasemia persistente: un caso complejo.

High grade of suspect must be present to diagnose some of the multiple causes of secondary blood hypertension. In the literature, there are reports that describe the coincidence of 2 different aetiologies of secondary hypertension in one patient, but both of endocrine origin. This one is the first time that a case with simultaneity of fibromuscular dysplasia and hyperaldosteronism in the same patient is described. This is the case of a 40-year-sold hypertensive patient, with a normal previous study of secondary hypertension, which after presenting HELLP syndrome (hemolysis, elevated liver enzymes and low platelet count) during a pregnancy with foetal death was studied again to rule out a secondary aetiology for her hypertension. After various studies were performed the patient was diagnosed as having two secondary causes for her hypertension: primary hyperaldosteronism and fibromuscular dysplasia, and after a guided treatment, optimal control for blood pressure was attainted. With this clinical case we show the importance of the clinical suspicion and the need for perseverance in the diagnoses of secondary blood hypertension, and also the exclusivity of this case.

Specific hypertension smartphone application to improve medication adherence in hypertension: a cluster-randomized trial.

Introduction: Digital interventions, such as smartphone applications (apps), are becoming an increasingly common way to support medication adherence and self-management in chronic illness.Aim: To evaluate the effectiveness of the intervention in pharmacological therapeutic adherence in mild to moderate arterial hypertension (AHT), through an app installed on a mobile phone, as well as the degree of control reached by the patient with this tool.Methods: Prospective, randomized controlled trial, full study and multicenter study. Four primary care centers participated. One hundred and fifty-four hypertensive patients under antihypertensive treatment were included. Two groups were established: a control group (CG) with usual intervention (n = 77) and an intervention group (n = 77) (IG), targeting hypertensive people who owned and regularly used a mobile smartphone, specifically using the app called AlerHTA to promote health education and reminder of appointments. There were three visits: initial, 6 and 12 months. Drug adherence was measured by electronic monitors (MEMSs). The primary outcomes were average daily percentage adherence between 80 and 100%, and AHT control.Results: A total of 148 patients finished the study. Mean age was 57.5 ± 9.9. Global adherence was 77.02% (CI = 70.25-83.79) and daily adherence was 74.32% (CI = 67.29-81.35%). Daily adherence was 93.15% and 86.3% in IG, and 70.66% and 62.66% in CG after 6 and 12 months respectively (p < .05). The percentage of uncontrolled patients was 28.3% (CI = 21.05-35.55%). The control of high blood pressure at 12 months was 17.8% and 38.6% for IG and CG respectively (p < .05). The number of patients needed to treat to avoid non-adherence (NNT) was 4.23 patients.Conclusions: The intervention with an app installed on the mobile phones of hypertensive patients favors pharmacological therapeutic adherence and improves the percentage of hypertensive patient control.Trial registration: Spanish Agency of Medicine: EPA-SP UN-HTA-2015-01.

Implication of gestational diabetes treatment on maternal weight gain and low neonatal weight: a large retrospective cohort study.

INTRODUCTION: Objective: the treatment for gestational diabetes is based on diet, and this may modify maternal weight gain. The limited maternal weight gain is related to newborns with small weight for their gestational age (SGA), and many studies have found an increase of SGA in women with gestational diabetes (GD), but the reason for this is not clear. The objective of this study is to evaluate the effects of gestational diabetes treatment on maternal weight gain and neonatal weight. Methods: a retrospective cohort study of 1,765 patients with GD, according to the National Diabetes Data Group (NDDG) criteria. We assessed: pre-pregnancy BMI, total maternal weight gain (MWG), weight gain during the third trimester, gestational week of starting the treatment, and treatment modality (diet or diet plus insulin). Birth weight was adjusted by gestational age and gender: SGA (≤ 10th) and large for gestational age (LGA) (> 90th). Results: the percentage of newborns with weight ≤ 10 was 14.8 %. The diet and the time of initiation of the treatment were related to maternal weight gain (MWG) in the third trimester. For every 1 kcal/kg of variation in the diet (increase or decrease), a MWG variation of 0.03 (0.001-0.06) kg occurred (p < 0.01). For each week before the beginning of treatment, the mother did not gain 0.13 ± [(-0.15) - (-0.11)] kg in the third trimester (p < 0.01). The SGA was related to the lowest MWG in total gestation: 7.0 (IQR 3.0-10.4) kg vs 8.4 (IQR 5.0-11.6) kg (p < 0.01), and in the third trimester: 0.3 (IQR -0.9-1.5) kg vs. 0.9 (IQR -0.3-2.2) kg (p < 0.01). Conclusion: the dietary treatment for gestational diabetes leads to a lower maternal weight gain and induces an impact on neonatal weight.

INTRODUCCIÓN: Objetivo: el tratamiento para la diabetes gestacional se basa en la dieta y esto puede modificar el aumento de peso materno. Un aumento de peso materno limitado está relacionado con recién nacidos con bajo peso para su edad gestacional (SGA). Muchos estudios han encontrado un aumento de niños con bajo peso en mujeres con diabetes gestacional, pero la razón no está clara. El objetivo es evaluar los efectos del tratamiento de la diabetes gestacional sobre el aumento de peso materno y el peso neonatal. Métodos: estudio de cohortes retrospectivo en 1765 pacientes con diabetes gestacional. Evaluamos: IMC antes del embarazo, aumento de peso materno total, aumento de peso durante tercer trimestre, semana gestacional de inicio y modalidad de tratamiento (dieta o dieta más insulina). El peso al nacer se ajustó por edad gestacional y género: SGA (≤ 10) y grande para la edad gestacional (> 90). Resultados: el porcentaje de recién nacidos con peso ≤ 10 fue 14,8%. La dieta y el momento de inicio del tratamiento se relacionaron con aumento de peso materno en el tercer trimestre. Por cada 1 kcal/kg de variación en dieta (aumento o disminución) se produjo una variación de aumento del peso materno de 0,03 (0,001-0,06) kg (p < 0,01). Por cada semana antes de inicio del tratamiento la madre dejó de ganar 0,13 ± [(- 0,15)-(- 0,11)] kg en el tercer trimestre (p < 0,01). El SGA se relacionó con un aumento de peso materno más bajo en el total de la gestación: 7,0 (IQR 3,0-10,4) kg versus 8,4 (IQR 5,0-11,6) kg (p < 0,01), y en el tercer trimestre: 0,3 (IQR -0,9-1,5) kg vs. 0,9 (IQR -0,3-2,2) kg (p < 0,01). Conclusión: el tratamiento dietético para la diabetes gestacional puede conducir a un menor aumento de peso materno y a su influir en el peso neonatal.

Health perception in menopausal women.

AIM: The aim of this study is to find whether the worsening of health perception was related to the menopausal (MNP) state or to its negative consequences on cardiometabolic risk factors (CMRF) and the presence of depression/anxiety. METHODS: In this study, 2,562 women, 1,357 (53%) MNP and 1,205 (47%) non-MNP, were analyzed. Blood pressure, heart rate, body mass index, waist circumference, and depression/anxiety screening using the Hospital Depression/Anxiety Scale (HADS) were measured. We collected a blood sample in fasting state for glycemia, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol and triglycerides. Logistic regression models were fitted with a backward method from the potentially confusing variables of the menopause study groups. RESULTS: Age 49.4 (±15.9) years; 10.1% belonged to semi-rural population; 87.5% had children. Regarding the educational level, 22.1% had <5 years of education, 31.3% had between 6 and 7 years, 33.4% had between 8 and 12 years, and 13.2% had >12 years of education. The prevalence of CMRF was significantly higher in MNP women, except for smoking. We did not find any differences in the prevalence of depression or anxiety between MNP and non-MNP women. Health was perceived as worse among MNP women (P<0.05) and patients over 45 years of age than patients younger than 45 years. We found a relationship between the negative health perception with metabolic syndrome, depression, and anxiety, having children, smoking, residing in rural area, and low educational level; nevertheless, it is not correlative with MNP status. CONCLUSION: Perceived health should be viewed as a multifaceted condition related to social circumstances, and various symptoms in women, including menopause symptoms, but not with MNP state itself.

Effect of intensive multifactorial treatment on vascular progenitor cells in hypertensive patients.

BACKGROUND: Most hypertensive patients, despite a proper control of their cardiovascular risk factors, have cardiovascular complications, evidencing the importance of controlling and/or reversing target-organ damage. In this sense, endothelial dysfunction has been associated with the presence of cardiovascular risk factors and related cardiovascular outcomes. Since hypertension often clusters with other risk factors such as dyslipemia, diabetes and obesity, in this study we have investigated the effect of intensive multifactorial treatment on circulating vascular progenitor cell levels on high-risk hypertensive patients. DESIGN: We included108 hypertensive patients receiving intensive multifactorial pharmacologic treatment and dietary recommendations targeting blood pressure, dyslipemia, hyperglycemia and weight for 12 months. After the treatment period, blood samples were collected and circulating levels of endothelial (CD34+/KDR+, CD34+/VE-cadherin+) and smooth muscle (CD14+/endoglin+) progenitor cells were identified by flow cytometry. Additionally, plasma concentration of vascular endothelial growth factor (VEGF) was determined by ELISA. RESULTS: Most hypertensive patients (61±12 years, 47% men) showed cardiovascular parameters within normal ranges at baseline. Moreover, body mass index and the majority of the biochemical parameters (systolic and diastolic blood pressure, fasting glucose, total cholesterol, HDL-c, LDL-c, creatinine and hs-CRP) significantly decreased overtime. After 12 months of intensive treatment, CD34+/KDR+ and CD14+/endoglin+ levels did not change, but CD34+/VE-cadherin+ cells increased significantly at month 12 [0.9(0.05-0.14)% vs 0.05(0.02-0.09)% P<0.05]. However, VEGF plasma concentration decreased significantly overtime [89.1(53.9-218.7) vs [66.2(47.5-104.6) pg/mL, P<0.05]. CONCLUSIONS: Long-term intensive treatment in hypertensive patients further improves cardiovascular risk and increases circulating EPCs, suggesting that these cells could be a therapeutic target.

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

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.

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.

Professionals' perception of circuits of care for hypertensive or diabetic patients between primary and secondary care.

OBJECTIVE: To determine the flow of care for patients with type 2 diabetes mellitus (T2DM) and hypertension between primary care (PC) and specialized care (SC) in clinical practice, and the criteria used for referral and follow-up within the Spanish National Health System (NHS). DESIGN: A descriptive, cross-sectional, multicenter study. PLACEMENT: A probability convenience sampling stratified by number of physicians participating in each Spanish autonomous community was performed. Nine hundred and ninety-nine physicians were surveyed, of whom 78.1% (n=780) were primary care physicians (PCPs), while 11.9% (n=119) and 10.0% (n=100) respectively were specialists in hypertension and diabetes. KEY MEASUREMENTS: was conducted using two self administered online surveys. RESULTS: A majority of PCPs (63.7% and 55.5%) and specialists (79.8% and 45.0%) reported the lack of a protocol to coordinate the primary and specialized settings for both hypertension and T2DM respectively. The most widely used method for communication between specialists was the referral sheet (94.6% in PC and 92.4% in SC). The main reasons for referral to a specialist were refractory hypertension (80.9%) and suspected secondary hypertension (75.6%) in hypertensive patients, and suspicion of a specific diabetes (71.9%) and pregnancy (71.7%) in T2DM patients. CONCLUSIONS: Although results showed some common characteristics between PCPs and specialists in disease management procedures, the main finding was a poor coordination between PC and SC.

Manidipine versus enalapril monotherapy in patients with hypertension and type 2 diabetes mellitus: a multicenter, randomized, double-blind, 24-week study.

BACKGROUND: Blood pressure reduction is associated with a reduced risk for cardiovascular events and death, particularly in patients with both hypertension and type 2 diabetes mellitus. OBJECTIVE: The aim of this study was to compare the antihypertensive efficacy, tolerability, and effect on metabolic risk factors of manidipine, a new dihydropyridine calcium channel antagonist, and enalapril, a widely used angiotensin-converting enzyme inhibitor, in patients with mild to moderate essential hypertension and type 2 diabetes. METHODS: This multicenter, double-blind trial compared manidipine and enalapril in patients with type 2 diabetes and hypertension (diastolic blood pressure [DBP] 90-104 mm Hg, systolic blood pressure [SBP] < or =190 mm Hg). Following a 3-week, single-blind placebo run-in period, eligible patients were randomized to receive either manidipine 10 mg or enalapril 10 mg once daily for 24 weeks. The dose was doubled after 3 weeks in patients who had not responded to treatment (DBP > or =90 mm Hg). The primary efficacy end point was change in DBP from baseline to the end of the study. Secondary outcomes were the responder rate (DBP <90 mm Hg and/or a DBP reduction of > or =10 mm Hg) at the end of the study. Other secondary measures were changes from baseline to the end of the study in heart rate and in the following measures obtained by ambulatory blood pressure monitoring (ABPM): 24-hour, daytime, and nighttime mean DBP and SBP, and the trough:peak ratio. Blood glucose, glycosylated hemoglobin (HbA1c), total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, uric acid, and creatinine were measured at the end of the placebo run-in period and the end of treatment. The study had 80% power to detect a between-treatment difference in mean sitting DBP of >3 mm Hg. RESULTS: One hundred twenty-four patients were enrolled in the study. After the placebo run-in period, 13 patients were excluded from the study: 4 for DBP values outside the specified limits, 7 at their request, and 2 for adverse events. Thus, 111 patients met the eligibility criteria and were randomized to treatment (53 manidipine, 58 enalapril). The population consisted of 61 men and 50 women with a mean (SD) age of 62 (11) years and a body mass index of 28.2 (2.4) kg/m2. Among patients who completed the study, drug doses were doubled in 67.6% (25/37) of patients in the manidipine group and 60.0% (24/40) of patients in the enalapril group (P = NS). Similar reductions in blood pressure were observed in both groups, from a mean (SD) of 164 (12)/97.5 (5) mm Hg at baseline to 141 (12)/84.5 (6) mm Hg at the end of the study in the manidipine group (P < 0.01), and from 159 (12)/98 (4) mm Hg to 139 (12)/86 (8) mm Hg in the enalapril group (P < 0.01). The proportion of responders was 66.7% (32/48) in the manidipine group and 60.0% (30/50) in the enalapril group; the difference between groups was not significant. Twenty-four-hour ABPM revealed significant (P < 0.01) and similar reductions in blood pressure in both groups, with a trough:peak ratio of approximately -50%. Neither drug affected heart rate. Among the statistically significant changes in metabolic parameters, significant reductions in HbA(1c) (from 6.7% [1.4%] to 6.2% [1.1%]) and blood glucose concentrations (from 152 [44] to 143 [44] mg/dL) were observed only in the manidipine group (P < 0.05). The incidence of adverse events was similar between groups. CONCLUSIONS: In the present study, manidipine was as metabolically neutral and as effective as enalapril in reducing blood pressure in hypertensive patients with type 2 diabetes, providing a sustained 24-hour antihypertensive effect.

Primary aldosteronism and its various clinical scenarios.

BACKGROUND: Primary aldosteronism is the most frequent endocrine cause of secondary hypertension. Aldosterone excess damages the cardiovascular system. OBJECTIVES: We compared biochemical; morphological, and cardiovascular risk differences among hypokalemic and normokalemic primary aldosteronism. We evaluated either both presentations correspond to two different entities or a unique disease in different evolutive stage. MATERIAL AND METHODS: This is a retrospective study including 157 patients with primary aldosteronism divided into two groups: typical presentation (serum potassium < 3.5 mmol/l, n = 87) and atypical presentation (serum potassium > 3.5 mmol/l, n = 70). RESULTS: The typical presentation group showed higher family background of ischemic heart disease (P = 0.028), plasmatic aldosterone levels (P = 0.001), and cardiovascular added risk (P = 0.013). Although kalemia was corrected in the hypokalemic group after specific treatment, typical presentation maintained lower levels. Predictors of typical presentation were the highest tertile of aldosterone level, baseline DBP, and a longer evolution of hypertension. Aldosterone serum levels increased along time in primary aldosteronism and it can be considered as the most discriminative factor for the type of presentation. CONCLUSION: Primary aldosteronism presentation along with normokalemia or hypokalemia could be the same disease at different evolution stages. Adequate detection of normokalemic primary aldosteronism deserves an early and intentional diagnostic attitude.