Registro Latinoamericano de monitorización ambulatoria de la presión arterial (MAPA-LATAM): una necesidad urgente / Latin-American Ambulatory Blood Pressure Registry (MAPA-LATAM): An urgent need

La hipertensión arterial (HTA) es el principal factor de riesgo de enfermedad cardiovascular. Aunque es un problema global, independiente de la situación económica, región, raza o cultura, los datos disponibles con respecto a Latinoamérica no son muy abundantes. Por otra parte, las guías clínicas enfatizan la importancia de obtener lecturas fiables de la presión arterial. Por ello, se recomienda el uso de la monitorización ambulatoria de la presión arterial (MAPA), que mejora su precisión y reproducibilidad, ayudando a un mejor diagnóstico, en la toma de decisiones terapéuticas, y representa una mejor estimación pronóstica que las medidas en consulta. Lamentablemente, no existe ningún registro prospectivo global de MAPA para toda Latinoamérica que analice la prevalencia de HTA, el grado de su conocimiento, su porcentaje de tratamiento y el grado de control. En consecuencia, los autores de este artículo consideran prioritaria su puesta en marcha (AU)

Hypertension (HT) is one of the main risk factors for cardiovascular disease. Although it is a global problem, independently of economic situation, region, race or culture, the data available on Latin America are limited. Clinical guidelines emphasise the importance of obtaining reliable blood pressure readings. For this reason, the use of ambulatory blood pressure monitoring (ABPM) is recommended. This improves precision and reproducibility, resulting in better diagnosing and therapeutic decision-making, and constitutes a better estimation of prognosis than office measurements. Unfortunately, there is no global prospective ABPM registry for all of Latin America that analyses HT prevalence, the level of knowledge about it, treatment percentage and the degree of control. Consequently, the authors of this article consider its implementation a priority (AU)

Latin-American Ambulatory Blood Pressure Registry (MAPA-LATAM): An urgent need.

Hypertension (HT) is one of the main risk factors for cardiovascular disease (CVD). Although it is a global problem, independently of economic situation, region, race or culture, the data available on Latin America are limited. Clinical guidelines emphasise the importance of obtaining reliable blood pressure readings. For this reason, the use of ambulatory blood pressure monitoring (ABPM) is recommended. This improves precision and reproducibility, resulting in better diagnosing and therapeutic decision-making, and constitutes a better estimation of prognosis than office measurements. Unfortunately, there is no global prospective ABPM registry for all of Latin America that analyses HT prevalence, the level of knowledge about it, treatment percentage and the degree of control. Consequently, the authors of this article consider its implementation a priority.

[Dose and efficacy of botulinum toxin in pediatric patients with spasticity]. / Dosis y eficacia de la toxina botulinica en pacientes pediatricos con espasticidad.

AIM: To evaluate the effectiveness of botulinum toxin in the treatment of upper and lower limb spasticity in pediatric patients in a real clinical setting. PATIENTS AND METHODS: A retrospective study was conducted based on information from clinical records of 79 pediatric patients with spasticity in different clinical forms and severity treated with botulinum toxin type A. The improvement of rigidity and mobility was estimated by the attending physician through physical examination, evaluating the gait, rating on the Ashworth scale and measurement of joint mobility angles using a goniometer. The number of injections, the interval between them, the site of application and the dose were recorded, considering the reduction of at least one point on the Ashworth scale or an increase in the degrees of joint mobility as treatment response. RESULTS: Patients received injections in a mean of 10 ± 7 muscles at intervals of 4 to 50 weeks (average: 13 ± 9 weeks). A 90% also received rehabilitation. The knee, ankle and wrist showed presented a higher percentage of improvement. An improvement in the degrees of movement was found in 24% of patients. CONCLUSION: The application of botulinum toxin type A was effective for the treatment of spasticity in the pediatric population.

TITLE: Dosis y eficacia de la toxina botulinica en pacientes pediatricos con espasticidad.Objetivo. Evaluar la efectividad de la toxina botulinica en el tratamiento de la espasticidad de los miembros superiores e inferiores en pacientes pediatricos en un entorno clinico real. Pacientes y metodos. Se realizo un estudio retrospectivo basado en el historial clinico de 79 pacientes pediatricos con espasticidad en diferentes formas clinicas y grados de afectacion tratados con toxina botulinica tipo A. La mejoria de la rigidez y movilidad fue estimada por el medico tratante mediante exploracion fisica, evaluando la marcha, la calificacion en la escala de Ashworth y la medicion de los angulos de movilidad articular mediante un goniometro. Se registro el numero de inyecciones, el intervalo entre ellas, el sitio de aplicacion y la dosis, y se considero una respuesta positiva al tratamiento la disminucion del al menos un punto en la escala de Ashworth o un incremento en los grados de movilidad articular. Resultados. Los pacientes recibieron inyecciones en 10 ± 7 musculos diferentes en intervalos de 4 a 50 semanas (media: 13 ± 9 semanas). Un 90% de los pacientes recibio rehabilitacion. Las articulaciones de la rodilla, el tobillo y la muñeca presentaron un mayor porcentaje de mejoria. En el 24% de los pacientes se encontro mejoria en los grados de movimiento articular. Conclusion. La aplicacion de toxina botulinica tipo A fue efectiva para el tratamiento de la espasticidad en la poblacion pediatrica.

Aportes del Primer Consenso Internacional sobre Hipertensión grado 1 con riesgo cardiovascular bajo a moderado / Contributions of the First International Consensus on grade 1 Hypertension with low to moderate cardiovascular risk

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Factores sociodemográficos y hospitalarios relacionados con el nivel de ansiedad en familiares con pacientes pediátricos / Social, demographic, and hospital factors related to anxiety levels among relatives of pediatric patients / Fatores sociodemográficos e hospitalares relacionados com o nível de ansiedade em familiares com pacientes pediátricos

Introducción: La asistencia al niño hospitalizado y su familia es uno de los ámbitos que hoy requiere un esfuerzo por investigar. Conocer los factores relacionados con la ansiedad que viven los familiares en la UCIP, abre caminos para desarrollar modelos de intervención y Planes de Cuidados de Enfermería dirigidos a favorecer el afrontamiento y mejorar el bienestar familiar intrahospitalario. Objetivo: Determinar la relación de los factores sociodemográficos y hospitalarios con el nivel de ansiedad que presentan los familiares con pacientes hospitalizados en la unidad de cuidados intensivos pediátricos (UCIP). Metodología: Estudio cuantitativo, descriptivo y transversal. Se utilizó un instrumento de elaboración propia para la identificación de factores sociodemográficos y hospitalarios; y la escala de Inventario de Ansiedad Estado-Rasgo de Spielberger (IDARE) para la medición del nivel de ansiedad. Resultados: 34 familiares que participaron -11.8% (4) hombres; y 88.2% (30) mujeres- la edad promedio fue de 29 años, las puntuaciones de ansiedad estado y ansiedad rasgo indican que al no conocer algún albergue se presenta una diferencia significativa en el nivel de ansiedad estado de los familiares (X

Introduction: Aid to hospitalized children and their relatives is an issue which requires further research. Knowing the factors related to the anxiety that these children's relatives experience in the PIUC can broaden the scope to develop intervention models and Nursing Care Plans to address these issues and improve the intra-hospital family wellbeing. Objective: To determine the relationship between the social, demographic, and hospital factors with the levels of anxiety experienced by the relatives of hospitalized patients in the Pediatric Intensive Care Unit (PICU). Methodology: Quantitative, descriptive, and transversal study. An own-designed instrument to identify social, demographic, and hospital factors, and the Spielberger's State-Trait Anxiety Inventory (STAI) to estimate the levels of anxiety were used. Results: Thirty four relatives participated, 11.8% (4) were male and 88.2% (30) female. The average age was 29 years old. The anxiety state and trait scores suggest that, when information on shelters in not available, there are significant differences in the state of anxiety (X

Introduçãoa: assistência da criança hospitalizada e da sua família, é um dos âmbitos que na atualidade requer um esforço para pesquisar. Conhecer os fatores relacionados com a ansiedade que experimentam os familiares na UCIP, abre caminhos para desenvolver modelos de intervenção e Planos de Cuidados de Enfermagem dirigidos a favorecer o enfrentamento e melhorar o bem-estar familiar intra-hospitalar. Objetivo: Determinar a relação dos fatores sociodemográficos e hospitalares com o nível de ansiedade que apresentam os familiares com pacientes hospitalizados na Unidade de Cuidados Intensivos Pediátricos (UCIP). Metodologia: Estudo Quantitativo, descritivo e transversal. Utilizou-se um instrumento de elaboração própria para a identificação de fatores sociodemográficos e hospitalares; e a escala de Inventário de Ansiedade Estado-Traço de Spielberger (IDARE) para a medição do nível de ansiedade. Resultados: 34 familiares participaram, 11.8% (4) homens e 88.2% (30) mulheres, a média da idade foi de 29 anos, as pontuações de ansiedade estado e ansiedade traço, indicam que quando conhecer algum abrigo se apresenta uma diferença significativa no nível de ansiedade estado dos familiares (X

Clinical efficacy and safety of telmisartan 80 mg once daily compared with enalapril 20 mg once daily in patients with mild-to-moderate hypertension: results of a multicentre study.

The efficacy and safety of once-daily telmisartan 80 mg vs. once-daily enalapril 20 mg in the treatment of essential hypertension were evaluated in a multicentre, single-blind, placebo-controlled, randomised trial. In total, 68 patients (49 females, 19 males) with mild-to-moderate hypertension, defined as morning supine systolic blood pressure (SBP) 141-149 mmHg, diastolic blood pressure (DBP) 95-114 mmHg, were enrolled. After a 4-week placebo run-in phase, patients were randomly assigned to treatment with telmisartan or enalapril administered once daily in the morning for 8 weeks. No statistically significant differences were found in the baseline characteristics of patients in either group. Both SBP and DBP were decreased in both treatment groups, but the reductions were statistically different in favour of telmisartan (SBP, p = 0.013; DBP, p = 0.002). The incidence of adverse effects was lower in the telmisartan group, with the absence of cough. In conclusion, telmisartan is more effective and better tolerated than enalapril for the treatment of hypertension and has the advantage that it does not cause cough.

Clinical efficacy and safety of telmisartan 80 mg once daily vs. atenolol 50 mg once daily in patients with mild-to-moderate hypertension.

The objective of this open-label, parallel-group comparative study was to assess the clinical efficacy and safety of once-daily treatment for 8 weeks with telmisartan 80 mg in comparison with atenolol 50 mg on systolic blood pressure (SBP) and diastolic blood pressure (DBP) in patients with mild-to-moderate hypertension (morning supine SBP 141-199 mmHg, DBP 95-114 mmHg). A total of 58 patients were enrolled. The comparability of the two treatment groups was statistically documented at the beginning of the study. Telmisartan was more effective than atenolol, with a decrease in SBP of 21.7 mmHg vs. 11.8 mmHg (p = 0.03) and a non-significant decrease in DBP of 14.7 mmHg vs. 10.1 mmHg. The safety profiles of both drugs were very similar; both drugs were well tolerated. In conclusion, once-daily telmisartan 80 mg is more effective than once-daily atenolol 50 mg in lowering SBP with no negative chronotropism. Furthermore, telmisartan was as well tolerated as atenolol in the treatment of mild-to-moderate essential hypertension in adults.

Semipersonalized psychological evaluation of quality of life in hypertensive patients during a trial with two calcium antagonists: a multicenter Latin-American Study (LASTLHY).

OBJECTIVE: The main objective of this study was to evaluate well-being and physical activity of 248 hypertensive patients, including 177 females, who had previously been included in the Latin-American Study on Lacidipine in Hypertension (LASTLHY). SUBJECTS, MATERIALS AND METHODS: This open study was carried out in 12 clinical centers in Argentina, Brazil, Colombia, Mexico and Venezuela, to compare, over a period of 16 weeks, the antihypertensive action of a fixed-dose, once daily of 4 mg lacidipine administered orally to 120 patients and 30 mg nifedipine GITS (Gastro-Intestinal Therapeutic System) administered to 128 patients, aged between 40 and 65 years. All patients had mild to moderate hypertension and treatment was begun at the end of a one-week placebo run-in period (end of week -1). Well-being and physical activity were assessed by means of single questionnaire, which reflected the physical and cultural diversities amongst the clinical centers and patients. The questionnaire included 13 multiple-choice and 8 contingent open questions. The score of each question was multiplied by a coefficient related to the importance of each question to the patient (semipersonalization); the coefficient was obtained from cultural and socioeconomic data collected at the time of enrollment. The semipersonalization was carried out by a blind psychological study with respect to the medication and had a high repeatability in the assignment of personalized coefficients to the score of each question. The scores of each question were added to obtain an overall well-being and activity scoring. The possible theoretical range for the overall scoring in this study was 10 - 124. RESULTS: See Table 1. CONCLUSION: The study revealed that the administration of calcium channel blockers such as lacidipine and nifedipine GITS, and lacidipine in particular, produced low incidence of side effects, and lacidipine in particular induced significant improvement in the quality of life.

Semipersonalized psychological evaluation of quality of life of hypertensive patients in a trial with two calcium antagonists: a multicenter Latinamerican study (Lastlhy)

The main objective of this study was to evaluate well being and physical activity of two hundred and forty eight hypertensive patients, of which, one hundred and seventy seven were female, who had previously finished the Latin American Study on Lacidipine in Hypertension (LASTLHY). This was an open study carried out in twelve clinical centers situated in Argentina, Brazil, Colombia, Mexico and Venezuela, to compare, over a period of sixteen weeks, the antihypertensive actions of fixed-dose once daily oral monopharmacotherapy of 4 rng of lacidipine (n=120) patients VS. 30 mg of nifedipine (n=128) patients aged between 40-65 years old, with mild to moderate hypertension beginning at the end of a four weeks placebo run-in (end of week-1). Well being and physical activity were assessed through an experimental single questionnaire, which was administered taking into consideration the physical and cultural diversities amongst the clinical centers and patients. The questionnaire included thirteen multiple-choice and eight contingent open questions. The score to each question was multiplied by a coefficient according to the importance of each question for each patient (semipersonal ization); the coefficient was evaluated from cultural and socioeconomic information collected at the time of enrollment. The semipersonalization was carried out by a blind psychological study with respect to the medication and had a high repeatability in the assignment of personalized coefficients to the score of each question. The scores of each question were added to obtain an overall weil being and activity scoring. The possible theoretical range for the overall scoring in this study was 10-124

A comparative study of policosanol Versus acipimox in patients with type II hypercholesterolemia.

An 8-week, randomized, double-blind study comparing the efficacy and tolerability of policosanol and acipimox was conducted in patients with type II hypercholesterolemia. Prior to entry into active treatment, all patients followed a standard cholesterol-lowering diet for 12 weeks. Sixty-three patients were randomized to receive either policosanol (10 mg/day) or acipimox (750 mg/day) tablets for 8 weeks under double-blind conditions. Both groups were similar at randomization. Policosanol significantly reduced total cholesterol (p < 0.0001) (15.8%), low-density lipoprotein (LDL)-cholesterol (21%) and the ratios of LDL-cholesterol to high-density lipoprotein (HDL)-cholesterol (15.8%) and cholesterol to HDL-cholesterol (11.5%). Acipimox significantly lowered both cholesterol and LDL cholesterol by 7.5%. The percent changes of total cholesterol, LDL-cholesterol and both ratios were larger in the policosanol group than in the acipimox group. Both drugs were well tolerated. Acipimox significantly increased (p > 0.001) aspartate amino transferase levels but only four patients showed increases above the normal limit. Policosanol significantly reduced creatinine values (p > 0.05) but no patients had values out of the normal range. Four patients withdrew from the study (two from each group) but none withdrew because of adverse effects. No adverse effects were reported in the policosanol group, while five patients on acipimox reported adverse effects (hot flushes, nausea, vomiting, headache, hypochondrial pain and leg edema). These results indicate that policosanol (10 mg/day) was more effective and well tolerated than was acipimox (750 mg/day) in this study population.

Cerebral cortex blood flow and vascular smooth muscle contractility in a rat model of ischemia: a correlative laser Doppler flowmetric and scanning electron microscopic study.

The present study was undertaken to ascertain the role of smooth muscles and pericytes in the microcirculation during hyperperfusion and hypoperfusion following ischemia in rats. Paired external carotids, the pterygopalatine branch of the internal carotids and the basilar artery were exposed and divided. Reversible inflatable occluders were placed around the common carotids. After 24 h, the unanesthetized rat underwent 10-min ischemia by inflating the occluders. Continuous cortical cerebral blood flow (c-CBF) was monitored by laser Doppler flowmetry. The measured c-CBF was below 20% of control (P < 0.001) during ischemia. A c-CBF of 227.5 +/- 54.1% (P < 0.001) was obtained during reperfusion hyperemia. A c-CBF of 59.7 +/- 8.8% (P < 0.001) occurred at the nadir of postischemic hypoperfusion, and this was followed by a second hyperemia. The cytoarchitecture of the vascular smooth muscles and pericytes was assessed by scanning electron microscopy. Samples were prepared using a KOH-collagenase digestion method. In control rats, arteriolar muscle cells showed smooth surfaces. Capillary pericytes were closely apposed to the endothelium. Immediately after reperfusion, transverse membrane creases were observed on the smooth muscle surfaces. During maximal hyperemia the creases disappeared. When c-CBF started to decrease the creases became visible again. Throughout the postischemic hypoperfusion the creases remained. Capillary endothelial walls became tortuous in the late phase of hypoperfusion. During the second hyperemia most arteriolar muscle cells showed smooth surfaces. Some pericytes appeared to have migrated from the vascular wall. The morphological changes of smooth muscle membranes suggest that they are related to specific perfusional disturbances during ischemia and reperfusion.

Digit preferences observed in the measurement of blood pressure: repercussions on the success criteria in current treatment of hypertension.

In a multicenter, open, noncomparative trial to assess the efficacy of an angiotensin-converting enzyme inhibitor, quinapril (Accupril; Parke-Davis), after 12 weeks of treatment in 667 adult patients 19-83 years of age with stage 1-3 hypertension, conducted by 85 physicians in primary health care, with systolic blood pressure (SBP) < 140 mm Hg and diastolic blood pressure (DBP) < 90 mm Hg as criteria for normalization, the efficacy of the drug was 75.1%. When an analysis was made of the frequency tables of BP recorded by the physicians in the case-report forms, a clear numerical preference was found in which the DBP was expressed in multiples of 5 in 81.3% of the cases and the SBP was expressed in multiples of 10 in 19% of the records, so that when a cutoff point <140/90 mm Hg is chosen in daily practice, 130/85 mm Hg is actually being selected. It suffices to change the criteria to accept as normal values less than or equal to instead of less than 140/90 mm Hg to increase the efficacy of the drug from 75.1% to 90.7% in our trial. Therefore, it is proposed to use multiples of 5 for DBP and multiples of 10 for SBP as cutoff points and the diffusion of clear recommendations on BP measurement.

Usefulness of low-dose, once-daily quinapril as monotherapy for patients with hypertension.

A drug surveillance study was performed to determine the tolerance and safety of quinapril in the treatment of patients with stage 1 or 2 hypertension. The trial was noncomparative, open-label, uncontrolled, and nonrandomized. Patients with secondary hypertension, heart failure, other heart diseases, and other serious conditions were excluded. After a washout period of 2 weeks, 752 patients (316 men and 436 women) with diastolic blood pressure (DBP) between 90 and 115 mm Hg and systolic blood pressure (SBP) between 140 and 200 mm Hg were entered into the treatment phase. The mean age of patients (+/- SD) was 53.1 +/- 11.4 years. Patients initially received 10 mg/d quinapril for 4 weeks. For nonresponders, the dosage was titrated up to a maximum of 40 mg. Active treatment continued for 12 weeks. Initial blood pressures (mean +/- SD) were DBP, 102 +/- 6.1 mm Hg, and SBP, 163 +/- 14.4 mm Hg. Final blood pressures were DBP, 83 +/- 6.5 mm Hg, and SBP, 135 +/- 11.6 mm Hg. The response rate for the therapeutic goal (DBP < 90 mm Hg and SBP < 140 mm Hg, or a reduction in SBP > or = 20 mm Hg) was 67.1%; 41 patients did not complete the study. The most common adverse events were cough, headache, and dizziness; only 10 patients (1.3%) failed to complete the study because of adverse events. Quinapril, as used in current private clinical practice, is well tolerated and effective for the treatment of patients with stage 1 or 2 hypertension.

Clinical acceptability of ACE inhibitor therapy in mild to moderate hypertension, a comparison between perindopril and enalapril.

The aim of this 3-month double-blind study was to assess the antihypertensive effect and acceptability of perindopril in comparison with enalapril in patients with mild to moderate essential hypertension. After a 4-week placebo run-in period, 161 patients with supine diastolic blood pressure (DBP) between 95 and 115 mmHg were randomized to receive perindopril 4 mg or enalapril 10 mg once daily. If supine DBP was higher than 90 mmHg, treatment was adjusted monthly, first by doubling the dose and then by addition of hydrochlorothiazide 12.5 mg. After 3 months of active treatment the decrease in supine and standing blood pressures was statistically significant within both groups but was not statistically different between groups. The percentage of patients (65%) who achieved supine DBP of < or = 90 mmHg in the perindopril group was not significantly different from the enalapril group (73%). Monotherapy resulted in control of supine DBP in 56% of the perindopril group and 58% of the enalapril group; the addition of hydrochlorothiazide resulted in control of supine DBP in 6% and 15% respectively. The number of withdrawals for adverse events was statistically significant between groups (0 in the perindopril group and 7 in the enalapril group, p = 0.01). During active treatment the most frequently reported complaints were headaches and cough; there was not statistically difference between groups. Changes in laboratory parameters were minor and not significantly different between the two groups except for serum glucose, potassium, and triglyceride levels. In conclusion, there was no significance between perindopril and enalapril in terms of efficacy. Clinical acceptability seems to be better in the perindopril group.(ABSTRACT TRUNCATED AT 250 WORDS)

Meta-analysis of three trials with quinapril in the treatment of mild-to-moderate hypertension in the Mexican population.

A meta-analysis was performed to examine the therapeutic effect of quinapril in the treatment of patients with mild-to-moderate hypertension. Data from three clinical trials conducted in Mexico and including a total of 426 patients were examined using a retrospective approach and statistical methods. The meta-analysis proved that quinapril induces positive diastolic and systolic responses at all the doses studied, particularly at the 10-mg dose. At this dose, 94.1% of patients reduced their diastolic blood pressure (DBP) by 10 mm Hg or attained a DBP of < or = 90 mm Hg. Overall, quinapril reduced DBP by between 14.8 and 24.8 mm Hg proportionally to the baseline DBP. Systolic blood pressure decreased 16 to 35.7 mm Hg from baseline levels. We conclude that the meta-analysis allowed a clearer and more dependable handling of the results regarding effectiveness and optimum dose of quinapril.

Quinapril in the treatment of hypertension in primary care centers.

A multicenter, open, prospective study was carried out to establish the efficacy and safety of quinapril 10.0, 20.0, or 40.0 mg, or 20 mg plus 12.5 mg hydrochlorothiazide (HCTZ) given once daily in 256 patients with mild-to-moderate essential hypertension treated in primary care units in Mexico. The study consisted of a 4-week placebo washout period, followed by 12 weeks of active treatment. Quinapril doses were titrated upward at 4-week intervals to three dosage levels. Patients who did not respond to 20-mg doses were randomly assigned to receive 40 mg quinapril daily or 20 mg quinapril plus 12.5 mg HCTZ daily until the end of the study. Quinapril was useful as monotherapy in 78% of the 256 patients (92.9% of patients who completed the study were evaluable): 73.3% of patients required only 10 mg, and their average blood pressure was similar to that of patients who required doses of greater than 10 mg. Only 12.2% of responsive patients required either 40 mg of quinapril or 20 mg of quinapril plus HCTZ 12.5 mg. Quinapril was equally effective and safe in elderly patients (> 60 years old) and in obese and nonobese patients. A low incidence of adverse effects in our patients confirms quinapril's safety, and no adverse changes were observed in laboratory tests.

[The treatment of chronic stable angina with isradipine. A cooperative Latin American study]. / Tratamiento de la angina crónica estable con isradipina. Estudio cooperativo latinoamericano.

In order to study the efficacy and tolerance of isradipine, a new Ca++ antagonist for the treatment of stable chronic angina, a multicentric cooperative study was carried out in eight Latin American countries (Argentine, Chile, Colombia, Ecuador, Mexico, Peru, Uruguay and Venezuela), which included 169 patients (60% men and 40% women), average age 62.6 +/- 9.7. Patients with more than 4 biweekly anginal crisis were accepted, with one or more of the following inclusion criteria: coronariographic evidence of obstruction greater than 60% in one or more vessels, IAM history, positive scintigraphy and positive effort test. The trial was single-blind, with placebo during the admission phase (2 weeks) and active treatment for 12 weeks. isradipine was administered in increasing doses of 2.5, 5, and 7 mg thrice a day, according to the presence or absence of anginal crisis. It was observed that the average frequency of weekly pains decreased from 8.2 +/- 7 under placebo to 6.3 +/- 7.5 under isradipine at low doses, and to 2.0 +/- 2.0 (p less than 0.001) under maximum doses. TNT intake decreased parallel also in a significant way. At the end of the trial, 37% of patients had become asymptomatic, and angina had reduced to less than two crisis a week in 33%. A clear relation doses-effect was observed. There was no alteration in laboratory exams neither in ECG. Seven patients had complications derived from the evolutional course of disease (2 IAM, 5 unstable angina and one sudden death). Adverse events were relatively frequent and the majority derived from vasodilator effect (tibial oedema 37%, flushing 17%, headache 23%).(ABSTRACT TRUNCATED AT 250 WORDS)

Effects of ketanserin on left ventricular hypertrophy in hypertensive patients.

Ketanserin, a serotonergic S2-receptor antagonist, was used in a prospective study in nine hypertensive patients with ECG criteria of left ventricular hypertrophy (LVH). Echocardiographic measurement with M mode was made after 1 month of placebo, and after 3, 6, and 12 months of ketanserin treatment as monotherapy at a mean dose of 31 mg bid. Ketanserin treatment decreased mean left ventricular mass by 9.3% at 3 months (not significant), by 15.3% at 6 months (p less than 0.008), and by 26.2% at 12 months (p less than 0.02), with a tendency towards improvement in left ventricular ejection fraction, which was not statistically significant. The study showed a sustained effect upon regression of LVH in hypertensives, with preservation of left ventricular function.

Evaluation of a new antihypertensive agent ketanserin versus methyldopa in the treatment of essential hypertension in older patients: an international multicenter trial.

The serotonergic antagonist ketanserin (K) was compared to methyldopa (M) in a four-center international study in 119 hypertensive patients over 50 years of age. After a 4-week placebo run-in period, patients randomly received K (20-40 mg b.i.d.) or M (250-500 mg b.i.d.) for 3 months. The drugs were given in monotherapy for at least 1 month, then a diuretic could be added if blood pressure remained abnormally high. For the patients on monotherapy, active drug was replaced by placebo at the end of the 3-month period until the patients were hypertensive again. K and M had a similar effect on systolic blood pressure, but diastolic blood pressure was reduced significantly more by K than by M. Significantly more patients had their blood pressure normalized in the K group (75%) than in the M group (49%). The twice daily dosage schedule caused trough blood pressure control with both drugs. No rebound hypertension occurred at discontinuation of treatment. Monotherapy with K caused a decrease in heart rate (-5 beats/min) while M produced no change. Body weight decreased with K (-0.5 kg) and increased with M (+ 0.4 kg). No important hematological or biochemical changes were seen with either drug. Slightly fewer patients reported adverse reactions during K monotherapy (40%) than with M (45%). In the latter group mainly central side effects were observed. The data confirm K to be an effective first-line antihypertensive agent with a favorable side-effect profile.