[Evaluation of cardiovascular risk in the cross-sectional phase of the Mediterranean Study]. / Valoración del riesgo cardiovascular en la fase transversal del estudio Mediterránea.

INTRODUCTION AND OBJECTIVES: The Mediterranean study quantifies high cardiovascular risk (HCR), consistency between REGICOR (R) and low risk SCORE (LS) scales, altered blood pressure (ABP) values in hypercholesterolemia (HC) without any history of hypertension (HT), high total cholesterol (HTC) values with HT with no background of HC and cardiac and renal damage in hypertensive patients. PATIENTS AND METHODS: A national, cross-sectional and multicenter study was performed with the participation of 751 physicians. The physicians individually evaluated 7,973 patients with HT and 5,319 with HC. HCR was defined as over 10% with R and 5% with LS. Intra-class correlation coefficient (ICC) and Pearson coefficient (r) were calculated. The percentages of ABP and HTC were quantified. Creatinine (cr) value, glomerular filtration rate using Cockroft-Gault (CG), and prevalence of left ventricular hypertrophy (LVH) were analyzed. RESULTS: Regarding hypertensive patients: 17.3% HCR with R and 26.1% with LS. ICC = 0.222 (p < 0.0001), r = 0.61 (p < 0.0001), 64.7% HTC. There was no evaluation of LVH in 31.2% and a prevalence of 5.1%, prevalence of lesion and kidney failure (KF) of 4.7% and 1.6% respectively based on CR and 15.9% KF by CG. In HC patients, there was 21.1% of HCR with R and 21.5% with LS; ICC = 0.190 (p < 0.0001), r = 0.64 (p < 0.0001) and 33.7% ABP. CONCLUSIONS: The SCORE scale identifies more patients with HCR than the REGICOR one in HT patients and a similar amount in HC patients. Consistency between both scales is poor. A significant ABP/HTC was found. In HT patients, the patients who were not evaluated for LVH and the percentage of KF are important.

Estudio de farmacovigilancia con lercanidipino. Datos del estudio ZANyCONTROL / Study of drug surveillance with lercanidipine. Data on ZANyCONTROL study

Introducción: Valorar la eficacia del lercanidipino en el control de la hipertensión arterial, así como su tolerabilidad clínica y bioquímica.Material y método: Estudio observacional, multicéntrico, abierto, de seguimiento a medio plazo realizado en centros de atención primaria. Participaron 206 médicos de atención primaria que incluyeron a 1.455 hipertensos de 20 a 75 años. A todos se les indica tratamiento con lercanidipino 10 mg/día en monoterapia. Si no se alcanza el control, se añade enalapril 20 mg/día. Se hicieron controles clínicos con medición de la presión arterial en la consulta al inicio y tras 1, 3 y 6 meses de iniciado el tratamiento con lercanidipino. Se valoran los posibles efectos adversos o abandono del tratamiento. Al inicio y al final del estudio se realizó analítica y se midieron las variables antropométricas.Resultados: Inicialmente, se excluye a 189 (12,9%) pacientes por violaciones al protocolo. Inician tratamiento 1.266 pacientes. De ellos, 876 (69,2%) acaban con lercanidipino 10 mg/día en monoterapia, de los que el 72,3% alcanza normotensión. De los 364 a los que se añadió enalapril, el 61,3% alcanzó normotensión. El control general de los pacientes tratados en el estudio alcanzó el 68,4% de los casos. La evolución del perfil bioquímico mostró una disminución significativa de la glucemia basal, que pasó de 104,3 a 101,94 mg/dl (p < 0,001); el colesterol total, que evolucionó de 221,5 a 213,6 mg/dl (p < 0,001), y el colesterol de las lipoproteínas de baja densidad, que pasó de 143,5 a 136,2 mg/dl (p < 0,001). Apareció un total de 63 reacciones adversas (el 4,3% de los pacientes). Sólo se registraron 5 abandonos por efectos secundarios.Conclusiones: El lercanidipino es un tratamiento antihipertensivo efectivo en monoterapia que se ve potenciado por la combinación con enalapril. Este efecto se acompaña de una excelente tolerabilidad(AU)

Introduction: The study has aimed to evaluate the effectiveness of lercanidipine in the control of the hypertension as well as its clinical tolerability and biochemistry. Material and method: This is an observational, multicenter, open label study with a mean follow-up period in primary care sites. A total of 206 primary care physicians participated, and 1455 hypertensive patients from 20 to 75 years were included. All were treated with lercanidipine 10 mg/day in monotherapy. If their blood pressure was not controlled, enalapril 20 mg/day was added. Clinical controls were made with measurement of the blood pressure in the consultation at the onset, and then at 1, 3, and 6 months of initiating treatment with lercanidipine. The possible adverse effects or dropouts from treatment were evaluated. Laboratory analyses were performed at the beginning and end of the study and the anthropometric were measured.Results: A total of 189 patients were initially excluded due to protocol violations (12.9%), so that 1266 patients began treatment. Of these, 876 were finally treated with lercanidipine 10 mg/day as single drug therapy (69.2%), 72.3% of them achieving normal blood pressure. In 364 patients, enalapril was added, 61.3% achieving normal blood pressure. The global control of the patients treated in the study was 68.4%. The evolution of the biochemical profile showed a significant decrease of the baseline glycemia that went from 104.3 mg/dl to 101.94 mg/dl (p < 0.001), of the total cholesterol that evolved from 221.5 mg/dl to 213.6 mg/dl (p < 0.001) and of the LDL cholesterol that evolved from 143.5 mg/dl to 136.2 mg/dl (p < 0.001). There were 63 adverse reactions (4.3% of the patients). There were only 5 dropouts due to side effects.Conclusions: Lercanidipine is a effective antihypertensive treatment in monotherapy which is enhanced by association with enalapril. This effect is accompanied by an excellent tolerability(AU)

[Evaluation of cardiovascular risk in the longitudinal phase of the Mediterranean study]. / Valoración del riesgo cardiovascular en la fase longitudinal del estudio Mediterránea.

INTRODUCTION AND OBJECTIVES: There is little information on cardiovascular longitudinal studies. In Spanish patients with hypertension (AHT)) and/or hypercholesterolemia (HC), with poor initial control of blood pressure (BP) and/or total cholesterol (TC), incidence rate (IR), cumulative incidence (CI), relative risks (RR), survival curves (SC), therapeutic compliance (TC) were quantified and the Framingham-Anderson scale (FAS) was adjusted to our patients. PATIENTS AND METHODS: A total of 6,893 primary prevention patients with AHT and/or with HC were included in primary prevention, with an average of 1.22 years of follow-up. A total of 480 physicians participated. Incidence rate (IR), cumulative incidence (CIN), relative risks (RR), survival curves (SC) by Kaplan-Meier method, and therapeutic compliance (TCOM) by Haynes-Sackett self-reported questionnaire were calculated. The Framingham-Anderson scale (FAS) was validated with Pearson's correlation coefficient (r) and intraclass correlation index (ICI). RESULTS: CIN was 1.59% (1.31-1.90); the IR 1,321.6 cardiovascular events/ 100,000 patients/year (1,026.6-1,598.8). RRs with statistical significance were: age (p = 0.03). Blood pressure at the end of the study (p = 0.02), coronary background (p = 0.00), left ventricular hypertrophy (LVH) (p = 0.00), microalbuminuria (p = 0.02), CT >/= 250 mg/dl (p = 0.01), fasting glycemia (Gb) >/= 126 mg/dl (p = 0.00), creatinine >/= 1.2 mg/dl at the beginning (p = 0.00) and at the end of the study (p = 0.00), and poor compliance in HC patients (p = 0.00). SC have statistical significance (p < 0.05) for AHT background, fasting glucose >/= 126 mg/dl, target organ damage, and high cardiovascular risk with FAS scale. The adjusted FAS formula for global cardiovascular risk was (0.415 x FAS Risk%) + 0.517%, r = 0.9962 (p = 0.00) and ICI = 0.9969 (p < 0.0001). CONCLUSIONS: The equation for the FAS scale was adjusted for Spanish AHT/HC patients. Prognostic factors and SC were calculated. Benefit between TC and decrease of CVR in HC patients was quantified.

Valoración del riesgo cardiovascular en la fase longitudinal del estudio Mediterránea / Evaluation of cardiovascular risk in the longitudinal phase of the Mediterranean study

Introducción y objetivos. Es escasa la información de estudios cardiovasculares longitudinales. En hipertensos (HTA) y/o hipercolesterolémicos (HCL) españoles, con mal control inicial de la presión arterial (PA) y/o del colesterol total (CT) se cuantifica la tasa de incidencia (TI), la incidencia acumulada (IA), los riesgos relativos (RR), las curvas de supervivencia(CS), el cumplimiento terapéutico (CU) y se ajusta la escala de Framingham-Anderson (FA) a nuestro entorno. Pacientes y métodos. Se analizaron 6.893 HTA y/o HCL en prevención primaria que aportaronun promedio de 1,22 años de seguimiento. Participaron 480 médicos. Se calcularon: la TI, IA y los RR; el método de Kaplan-Meier para la CS; Haynes-Sackett adaptado para el CU; el ajuste de FA por la recta de los mínimos cuadrados, coeficiente de correlación de Pearson (r) e intraclase (cci).Resultados. La IA fue 1,59% (1,31-1,90); la TI de 1.321, 6 eventos cardiovasculares por100.000 pacientes/año (1.026,6-1.598,8). Los RR significativos fueron: edad (p = 0,03),PA final (p = 0,02), antecedentes coronarios (p = 0,00), hipertrofia ventricular izquierda(HVI) (p = 0,00), microalbuminuria (p = 0,02), CT ≥ 250 mg/dl al inicio (p = 0,01), glucemia basal (Gb) ≥ 126 mg/dl al inicio (p = 0,00), creatinina ≥ 1,2 mg/dl al inicio (p = 0,00) y fi nal (p =0,00), y no CU en HCL (p = 0,00). Las CS realizadas por antecedentes de HTAy/o HCL, existencia o no de Gb ≥ 126 mg/dl, existencia o no de lesión de órganos diana, y tener o no riesgo cardiovascular (RCV) alto con FA, fueron significativas (p < 0,05). El ajuste del FA para RCV global fue: (0,415 x Riesgo FA%) + 0,517%, obtuvo una r = 0,9962(p = 0,00) y un cci = 0,9969 (p < 0,0001).Conclusiones. Se ajustó la ecuación FA en nuestros pacientes, con datos propios. Se cuantificaron los factores pronósticos y CS. Se cuantificó un beneficio entre CU y disminución de RCV en HCL (AU)

Introduction and objectives: There is little information on cardiovascular longitudinal studies. In Spanish patients with hypertension (AHT)) and/or hypercholesterolemia (HC), with poor initial control of blood pressure (BP) and/or total cholesterol (TC), incidence rate (IR), cumulative incidence (CI), relative risks (RR), survival curves (SC), therapeutic compliance (TC) were quantified and the Framingham-Anderson scale (FAS) was adjusted to our patients. Patients and Methods: A total of 6,893 primary prevention patients with AHT and/or with HC were included in primary prevention, with an average of 1.22 years of follow-up. A total of 480 physicians participated. Incidence rate (IR), cumulative incidence (CIN), relative risks (RR), survival curves (SC) by Kaplan-Meier method, and therapeutic compliance (TCOM) by Haynes-Sackett self-reported questionnaire were calculated. The Framingham-Anderson scale (FAS) was validated with Pearson's correlation coefficient (r) and intraclass correlation index (ICI). Results: CIN was 1.59% (1.31-1.90); the IR 1,321.6 cardiovascular events/ 100,000 patients/year (1,026.6-1,598.8). RRs with statistical significance were: age (p=0.03). Blood pressure at the end of the study (p=0.02), coronary background (p=0.00), left ventricular hypertrophy (LVH) (p=0.00), microalbuminuria (p=0.02), CT≥250mg/dl (p=0.01), fasting glycemia (Gb)≥126mg/dl (p=0.00), creatinine≥1.2mg/dl at the beginning (p=0.00) and at the end of the study (p=0.00), and poor compliance in HC patients (p=0.00). SC have statistical significance (p<0.05) for AHT background, fasting glucose≥126mg/dl, target organ damage, and high cardiovascular risk with FAS scale. The adjusted FAS formula for global cardiovascular risk was (0.415 x FAS Risk%) + 0.517%, r=0.9962 (p=0.00) and ICI=0.9969 (p<0.0001). Conclusions: The equation for the FAS scale was adjusted for Spanish AHT/HC patients. Prognostic factors and SC were calculated. Benefitbetween TC and decrease of CVR in HC patients was quantified (AU)

[The ZANyCONTROL study. The role of the pharmacy]. / Estudio ZANyCONTROL. Papel de la oficina de farmacia.

OBJECTIVE: To compare blood pressure levels measured in the pharmacy with those obtained in the patient's home or Primary Care centres (doctor's surgery or treatment room). METHOD: Multicentre, open-label, observational, and medium-term follow-up study. LOCATION: Primary Care in the Spanish healthcare system. PARTICIPANTS: 206 general or family practitioners who consecutively selected a maximum of 10 patients each; 1,588 patients were recruited. INTERVENTIONS AND MAIN MEASUREMENTS: Home blood pressure (BP)monitoring, measurements taken in clinics (doctor's surgery and treatment room) and pharmacies (usual apparatus and validated Omrom M4); ambulatory monitorization was performed on 190 patients (model Spacelab 90207). RESULTS: 1,399 patients were included (50.4% women), with a mean age of 60.1 (standard deviation [SD]: 9.7) years. BP values obtained in doctor's surgeries were significantly higher than those obtained in treatment rooms, pharmacies and at home (P < 0.01 in all cases). The smallest differences were observed between the pharmacy and home measurements, with 0.69 (SD: 8.1) for the systolic BP (p = 0.007) and 0.15 (SD: 5.48) for diastolic BP (p = 0.370). DISCUSSION: The ZANyCONTROL study supports the idea that BP measurements taken on hypertensive patients in the pharmacy properly reflect their real BP; it is an accessible and effective method for measuring blood pressure. It is important that the sphygmomanometer in the pharmacy is validated and works correctly.

Estudio ZANyCONTROL. Papel de la oficina de farmacia / The ZANyCONTROL study. The role of the pharmacy

Introducción. Se pretende comparar las medicionestensionales efectuadas en las oficinas de farmaciacon las obtenidas en el domicilio del paciente o enlos centros de Atención Primaria (consulta médica yde enfermería).Material y métodos. Estudio observacional,multicéntrico y abierto, de seguimiento a medio plazo.Emplazamiento: ámbito de la Atención Primaria delsistema sanitario español. Participantes: 206 médicosgenerales o de familia que seleccionaron por muestreoconsecutivo un máximo de 10 pacientes cada uno. Sereclutaron 1.588 pacientes. Intervenciones ymediciones principales: medidas de presión arterial(PA) en el domicilio (automedida de PA), consulta(médico y enfermería) y oficina de farmacia (aparatohabitual y Omrom M4 validado). A 190 pacientes seles realizó una monitorización ambulatoria de PA conun aparato Spacelab, modelo 90207.Resultados. Se incluyeron 1.399 pacientes (50,4%mujeres), con una edad media de 60,1 (desviaciónestándar [DE]: 9,7) años. Los valores de PAobtenidos en las consultas de los médicos fueronsignificativamente superiores a los obtenidos en lasconsultas de enfermería, las farmacias y losdomicilios (p < 0,01 en los tres casos). Las menoresdiferencias se observaron entre las medidas defarmacia y de domicilio, que fueron de 0,69 (DE:8,1) para la PA sistólica (p = 0,007) y de 0,15 (DE:5,48) para la PA diastólica (p = 0,370).Conclusiones. El estudio ZANyCONTROL apoya laidea de que las mediciones de PA efectuadas ennuestros hipertensos en las oficinas de farmaciareflejan convenientemente la PA real, por lo que esun método accesible y eficaz para valorar su estadotensional. Es importante que el esfigmomanómetropresente en la farmacia esté validado y funcionecorrectamente

Objective. To compare blood pressure levelsmeasured in the pharmacy with those obtained inthe patient’s home or Primary Care centres (doctor’ssurgery or treatment room).Method. Multicentre, open-label, observational, andmedium-term follow-up study. Location: PrimaryCare in the Spanish healthcare system. Participants:206 general or family practitioners whoconsecutively selected a maximum of 10 patientseach; 1,588 patients were recruited. Interventionsand main measurements: home blood pressure(BP)monitoring, measurements taken in clinics(doctor’s surgery and treatment room) andpharmacies (usual apparatus and validated OmromM4); ambulatory monitorization was performed on190 patients (model Spacelab 90207).Results. 1,399 patients were included (50.4%women), with a mean age of 60.1 (standarddeviation [SD]: 9.7) years. BP values obtained indoctor’s surgeries were significantly higher thanthose obtained in treatment rooms, pharmacies andat home (P < 0.01 in all cases). The smallestdifferences were observed between the pharmacyand home measurements, with 0.69 (SD: 8.1) forthe systolic BP (p = 0.007) and 0.15 (SD: 5.48) fordiastolic BP (p = 0.370).Discussion. The ZANyCONTROL study supports theidea that BP measurements taken on hypertensivepatients in the pharmacy properly reflect their realBP; it is an accessible and effective method formeasuring blood pressure. It is important that thesphygmomanometer in the pharmacy is validatedand works correctly

Influencia de distintos ambientes sobre los valores de la presión arterial medida con dispositivo automático / Influence of different settings on the blood pressure values measured with automatic device

Introducción. Es necesario tener la mejor información posible sobre la validez de la medida de la presión arterial (PA) en las consultas de enfermería, en el domicilio de los pacientes y en las oficinas de farmacia, lo que incluye realizar lecturas de la PA con instrumentos electrónicos validados. Los objetivos de este estudio fueron conocer la influencia del ambiente sanitario (consulta médica, consulta enfermería y farmacia) y no sanitario (domicilio) en las cifras de PA y la relación de éstas con la PA determinada por monitorización ambulatoria. Material y métodos. Estudio transversal y multicéntrico que incluyó pacientes hipertensos mayores de 30 años tratados con fármacos antihipertensivos y reclutados mediante muestreo consecutivo. La medida de PA se realizó siguiendo normas estandarizadas, un solo día, atendiendo a la siguiente secuencia: primero, en el domicilio de los pacientes (automedida); después de manera alternativa, en la consulta médica y de enfermería, y finalmente, en la farmacia. En todos los casos se utilizó un monitor electrónico automático validado. En una muestra de pacientes no seleccionados se realizó monitorización ambulatoria de la PA con instrumento validado. Resultados. Se incluyeron 1.399 pacientes (50,4 % mujeres), con edad media (DE) de 60,1 (9,7) años. Los valores de PA obtenidos en las consultas de los médicos fueron significativamente superiores a los obtenidos en las consultas de enfermería, en las farmacias y en los domicilios (p < 0,01 en los tres casos). Las diferencias medias fueron más acusadas para las determinaciones realizadas en consulta del médico y el domicilio, siendo de 2,79 (9,5) mmHg (p < 0,001) para la PA sistólica (PAS) y de 0,88 (6,3) mmHg (p < 0,001) para la PA diastólica (PAD). Las menores diferencias se observaron entre las medidas de farmacia y de domicilio, siendo de 0,69 (8,1) mmHg para la PAS (p = 0,007) y de 0,15 (5,48) para la PAD (p = 0,370). La PAS obtenida en domicilio y la PAD obtenida en consulta de enfermería se relacionaron más estrechamente con la PAS y la PAD ambulatoria diurna. Discusión. Las lecturas de PA medidas en domicilio, consultas de enfermería y oficinas de farmacia son inferiores a las registradas por los médicos y se relacionan bien con la monitorización ambulatoria. Nuestros resultados indican que la medida de PA en domicilio, consulta de enfermería y oficinas de farmacia minimiza el efecto de blanca inducido por el médico

Introduction. The best possible information on the validity of the blood pressure (BP) measurement must be available in the nursing consultations, in the patients' home and in the pharmacies. This includes making readings of the BP with validated electronic instruments. The objectives of this study were to know the influence of the health care setting (medical consultation, nursing consultation and pharmacy) and non-sanitary one (home) in the BP values and their relationship with BP measured by out-patient monitoring. Material and methods. Cross-sectional and multicenter study that included hypertensive patients over 30 years treated with antihypertensive drugs and enrolled by consecutive sampling. BP measurement was done following standardized guidelines, on a single day, according to the following sequence: first in the patients' home (self-measurement), after, alternatively, in the medical and nursing consultation and finally in the pharmacy. In every case, a validated automatic electronic monitor was used. In a sample of non-selected patients, out-patient monitoring of the BP was done with validated instrument. Results. A total of 1,399 patients (50.4 % women), with mean age (SD) of 60.1 (9.7) years were included. The BP values obtained in the physician's consultation were significantly greater than those obtained in the nursing consultation, in the pharmacy and in the homes (p < 0.01 in the three cases). The mean differences were more outstanding for the measurements done in the physician's consultation and at home, it being 2.79 (9.5) mmHg (p < 0.001) for the systolic BP (SBP) and 0.88 (6,3) mmHg (p < 0.001) for the diastolic BP (DBP). The smallest differences were observed between the pharmacy and home measurements, these being 0.69 (8.1) mmHg for the SBP (p = 0.007) and 0.15 (5.48) for the DBP (p = 0.370). The SBP obtained at home and the DBP obtained in the nursing consultation were related more closely with the daytime out-patient SBP and BBP. Discussion. The BP readings measured at home, nursing consultation and pharmacy are inferior to those recorded by the physicians and are well related with the out-patient monitoring. Our results indicate that the measurement of BP at home, nursing consultation and pharmacy minimize the white coat effect induced by the physician

[Chronobiology, chronotherapy and vascular risk]. / Cronobiología, cronoterapia y riesgo vascular.

The importance of rhythmic activities in humans, and their influence on the diseases are underscored. Clinical chronology is fundamental in order to interpret the physiopathological basis of temporary variations. Knowing the variability of the biological processes also makes it possible improving the effect of drugs utilized and minimize their adverse effects. This is the objective of Chronotherapy. We apply chronology and Chronotherapy in cardiovascular diseases, since many of them adjust their prevalence for specific rhythms. One thinks about the mechanisms or factors that favor cardiovascular diseases, especially those related to the circadian variations of blood pressure. We also review the variations in the pharmacokinetics of the drugs used in the treatment of cardiovascular diseases, delving further into the analysis of its effects according to their administration schedule. We can conclude that the use of those drugs according to the chronological knowledge makes possible to achieve better results in the control of cardiovascular diseases, and a greater safety in its use.

Cronobiología, cronoterapia y riesgo vascular / Chronobiology, chronotherapy and vascular risk

Se señala la importancia de las actividades rítmicas en los humanos y su influencia en la enfermedad. La cronología clínica es fundamental para interpretar las bases fisiopatológicas de esas variaciones temporales. Conocer la variabilidad de los procesos biológicos permite también mejorar el efecto de los medicamentos utilizados y minimizar sus efectos secundarios. A ese fin se dedica la cronoterapia. Aplicamos la cronobiología y la cronoterapia a las enfermedades cardiovasculares, ya que muchas de ellas ajustan su prevalencia a determinados ritmos. Se reflexiona sobre los mecanismos o factores que las favorecen, especialmente los relacionados con las variaciones circadianas de la PA. También revisamos las variaciones en la farmacocinética de los medicamentos que se usan en su tratamiento, profundizando en el análisis de sus efectos según el horario de administración. Podemos concluir que el uso de los mismos, según los conocimientos cronológicos, permite conseguir mejores resultados en el control de estos procesos y una mayor seguridad en su uso

The importance of rhythmic activities in humans, and their influence on the diseases are underscored. Clinical chronology is fundamental in order to interpret the physiopathological basis of temporary variations. Knowing the variability of the biological processes also makes it possible improving the effect of drugs utilized and minimize their adverse effects. This is the objective of Chronotherapy. We apply chronology and Chronotherapy in cardiovascular diseases, since many of them adjust their prevalence for specific rhythms. One thinks about the mechanisms or factors that favor cardiovascular diseases, especially those related to the circadian variations of blood pressure. We also review the variations in the pharmacokinetics of the drugs used in the treatment of cardiovascular diseases, delving further into the analysis of its effects according to their administration schedule. We can conclude that the use of those drugs according to the chronological knowledge makes possible to achieve better results in the control of cardiovascular diseases, and a greater safety in its use

[Clinical usefulness of blood pressure autoevaluation]. / Utilidad clínica de la automedida de la presión arterial.

Without a doubt blood pressure autoevaluation facilitates hypertension diagnosis, control and treatment. This also helps research, makes possible costs reduction and is an easy, safe, and useful method. Its use should be favored in the new model of patient-based clinical practice.

Utilidad clínica de la automedida de la presión arterial / Clinical usefulness of blood pressure autoevaluation

Están fuera de toda duda los beneficios que la automedida de presión arterial aporta en el mejor diagnóstico, control y tratamiento del hipertenso. También ayuda a la investigación, permite reducir costes y es un método fácil, seguro y útil. En el nuevo modelo de práctica clínica centrada en el enfermo se debe favorecer su uso

Without a doubt blood pressure autoevaluation facilitates hypertension diagnosis, control and treatment. This also helps researchs, makes possible costs reduction and is an easy, safe, and useful method. Its use should be favored in the new model of patient-based clinical practice

[Evaluation of psychosomatic symptomatology in hypertensive patients treated with lercanidipine (LERCAPSICO study)]. / Valoración de la semiología psicosomática en hipertensos tratados con lercanidipino (estudio LERCAPSICO).

OBJECTIVE: To value the grade of anxiety and psychosomatic semiology in hypertensive patients treated with lercanidipine and to analyse their evolution. A secondary objective is to carry out a pharmacovigilance study with lercanidipine. MATERIAL AND METHODS: Prospective multicentre observational 6 month study in primary hypertensive patients with SBP between 140-180 mm Hg and/or 90-110 mm Hg DBP. After a washout period of 10 days, treatment with 10 mg (1-0-0) lercanidipine is initiated. If BP is not controlled treatment with ramipril 2.5 mg/day is instaured. Clinical check-ups are carried periodically with measurements of BP, Heart Rate, objective valuation of tolerance to the drug and observance. At the initiation and end of the study biochemical check-ups are carried out, the level of anxiety is measured using the STAI questionnaire (Trait subscale) (Evaluation in decatipes 0-4 without ansiety 4-7 moderate ansiety, 7-10 high ansiety) and the psychosomatic profile with a questionnaire designed by this group. (Scale 0-18; 0 large semiology, 18 without semiology). Clinical tolerance to the drug is valued both subjectively and objectively. RESULTS: On included 538 patients. On registred 54 drop out, with side effects (3.75/). Completed the study 484 (237 M, 247 F), 429 of them with Lercanidipine in monotherapy (88.6/). Mean age 60.9 +/- 10.7. Mean BMI 29.1 +/- 5. The grade of anxiety did not alter during the study passing from 4.6 +/- 1.7 at the beginning of the study to 4.5 +/- 1.7 at the end of the study (valuation in decatypes) (ns). The psychosomatic semiology changed favourably from 10.7 +/-4.2 to 12.5 +/- 3.7 (p<0.00005). The evolution according to sex is similar. The mean SBP decreased from 165.6 +/- 12.2 mm Hg to 137.9 +/- 10.4 mm Hg (p<0.00005) and the mean DBP decreased from 96.5 +/- 8.1 mm Hg to 81.0 +/- 6.1 mm Hg (p<0.00005). Clinical tolerance was very good. Biochemical parameters were modified substantially: initial cholesterolemia 227.7 mg/dl and final cholesterolemia 213.6 mg/dl (p<0.00005); initial glucose 108.4 mg/dl and final glucose 105.7 mg/dl (p<0.00005). CONCLUSIONS: The mean level of anxiety in the group studied is confirmed not to vary during the length of the study. Psychosomatic semiology is reduced being statistically significant. Lercanidipine is shown to be very effective as antihypertensive and well tolerated. 164

Valoración de la semiología psicosomática en hipertensos tratados con lercanidipino (estudio LERCAPSICO) / Evaluation of psicosomatic semiology in hypertensive patients treated with lecarnidipine (LERCAPSICO study)

Objetivo: Valorar el grado de ansiedad y semiología psicosomática en hipertensos tratados con lercanidipino y analizar su evolución. Secundariamente se plantea un estudio de farmacovigilancia con lercanidipino. Material y métodos: Se diseña un estudio prospectivo observacional multicéntrico, de 6 meses de seguimiento para hipertensos esenciales con PAS entre 140-180 mm Hg y/o 90-110 mm Hg de PAD. Tras un periodo de lavado de 10 días, se inicia tratamiento con lercanidipino 10 mg (1-00). Si no se logra control de la PA se asocia ramipril 2,5 mg/día. Se realizan controles clínicos periódicos con medición de la PA, FC, valoración objetiva de tolerancia y observancia. Al inicio y al final del estudio se practican controles bioquímicos y se valora el nivel de ansiedad (cuestionario STAI; subescala Rasgo) (Valoración en decatipos 0-4 ausencia de ansiedad 4-7 ansiedad moderada 7-10 ansiedad marcada) y el perfil psicosomático (cuestionario de diseño propio) (Escala 0-18; 0 mucha presencia de semiología, 18 total ausencia). La tolerancia clínica al fármaco se valora subjetiva y objetivamente. Resultados: Se incluyen 538 pacientes. Se registran 54 abandonos. Por efectos secundarios el 3,75 por ciento. Finalizan 484 (237 V, 247 M) de ellos 429 con lercanidipino en monoterapia (88,6 por ciento). Edad media 60,9 + 10,7 años. Su IMC fue de 29,1 + 5. El grado de ansiedad no se alteró durante el estudio, pasó de 4,6 + 1,7 al inicio a 4,5 + 1,7 al final (valoración en decatipos) (ns) y la semiología psicosomática evolucionó favorablemente de 10,7 + 4,2 a 12,5 + 3,7 (p<0,00005). Por sexos la evolución es similar. La PAS media bajó de 165,6 + 12,2 mm Hg a 137,9 + 10,4 mm Hg (p<0,00005) y la PAD media disminuyó de 96,5 + 8,1 mm Hg a 81,0 + 6,1 mm Hg (p<0,00005). La tolerancia clínica fue muy buena. Los parámetros bioquímicos mejoraron significativamente: colesterolemia inicial 227,7 mg/dl y final 213,6 mg/dl (p<0,00005); glucosa inicial 108,4 mg/dl y final 105,7 mg/dl (p<0,00005).Conclusiones: Se comprueba un nivel medio de ansiedad en el colectivo analizado que no varía a lo largo del estudio. La semiología psicosomática se reduce significativamente. El lercanidipino se muestra muy eficaz en el control tensional y con una buena tolerancia (AU)

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