[Double blind study of the efficacy and safety of the fixed dose combination of enalapril 10 mg/nitrendipine 20 mg versus the increase of amlopidine dose in essential hypertensive patients not controlled with amlodipine 5 mg]. / Estudio doble ciego de la eficacia y la seguridad de la combinación a dosis fija de 10 mg de enalapril/20 mg de nitrendipino en comparación con el incremento de dosis de amlodipino en pacientes con hipertensión esencial no controlada con 5 mg de amlodipino.

INTRODUCTION: Combined therapy or dose-tiration are acceptable second-line therapeutic options after a first treatment failure. MATERIAL AND METHODS: This double blind clinical trial compared the fixed dose combination of enalapril 10 mg/nitrendipine 20 mg (E/N) with amlopidine 10 mg (A) in 323 hypertensive patients not previously controlled with amlodipine 5 mg. RESULTS: After 6 weeks of treatment, the E/N and A groups had similar percentages of blood pressure normalization (55% versus 60.2%; p = 0.4588). The adverse events related with the treatment were significantly less frequent with E/N than with a (19.8% versus 37%; p = 0.0029), especially due to a lower incidence of malleolar edema in E/N (11.1% versus 33.6%; p < 0.0001). CONCLUSION: Combining the efficacy and tolerability data, treatment with E/N permitted control of blood pressure of 2.8 patients per every patient with adverse events, while this rate for A was 1.6 to 1.

Estudio doble ciego de la eficacia y la seguridad de la combinación a dosis fija de 10 mg de enalapril/20 mg de nitrendipino en comparación con el incremento de dosis de amlodipino en pacientes con hipertensión esencial no controlada con 5 mg de amlodipino / Double blind study of the efficacy and safety of the fixed dose combination of enalapril 10 mg/nitrendipine 20 mg versus the increase of amlopidine dose in essential hypertensive patients not controlled with amlodipine 5 mg

Introducción. En hipertensión arterial el tratamiento combinado y el incremento de la dosis se consideran opciones terapéuticas útiles tras el fracaso del tratamiento inicial. Material y método. Ensayo clínico doble ciego que comparó la combinación a dosis fijas de 10 mg de enalapril/20 mg de nitrendipino (E/N) con 10 mg de amlodipino (A) en 323 pacientes hipertensos no controlados previamente con 5 mg de amlodipino. Resultados. Tras 6 semanas de tratamiento los grupos E/N y A tuvieron porcentajes similares de normalización de la presión arterial (55% frente al 60,2%; p = 0,4588). Los acontecimientos adversos relacionados con el tratamiento fueron significativamente menos frecuentes con E/N que con A (19,8% frente al 37%; p = 0,0029), especialmente por una menor incidencia del edema maleolar en E/N (11,1% frente al 33,6%; p < 0,0001). Conclusión. Combinando los datos de eficacia y tolerancia, el tratamiento con E/N permitió el control de la presión arterial de 2,8 pacientes por cada paciente con acontecimientos adversos, mientras que para A esta tasa fue de 1,6 a 1 (AU)

Introduction. Combined therapy or dosetiration are acceptable second-line therapeutic options after a first treatment failure. Material and methods. This double blind clinical trial compared the fixed dose combination of enalapril 10 mg/nitrendipine 20 mg (E/N) with amlopidine 10 mg (A) in 323 hypertensive patients not previously controlled with amlodipine 5 mg. Results. After 6 weeks of treatment, the E/N and A groups had similar percentages of blood pressure normalization (55% versus 60,2%; p = 0.4588). The adverse events related with the treatment were significantly less frequent with E/N than with a (19.8% versus 37%; p = 0.0029), especially due to a lower incidence of malleolar edema in E/N (11.1% versus 33.6%; p < 0.0001). Conclusion. Combining the efficacy and tolerability data, treatment with E/N permitted control of blood pressure of 2.8 patients per every patient with adverse events, while this rate for A was 1.6 to 1 (AU)

[Regression of cardiac hypertrophy in hypertensive patients treated with captopril]. / Regresión de la hipertrofia cardiaca en pacientes hipertensos tratados con Captopril.

We studied the echographic LVH indexes early detected in recent AHT. We analyzed the LVH regression after 12 months of treatment with Captopril. We describe the modifications observed in the lipidic metabolism. We studied 25 patients with an average age of 40 years and maximum essential arterial hypertension with 15 months of evolution. Septal thickness showed a reduction in systole and diastole at 6 months (p < 0.01). The posterior wall thickness decreased 3 mm in systole and diastole at 12 months (p < 0.001). Afterload diastolic diameter improved at 6 months. LV mass decreased from 321 gr to 279 gr at 6 months and to 268 at 12 months (p < 0.001); the same reduction was observed in mass index. At six months, total cholesterol and LDL had decreased (p < 0.05) and HDL-cholesterol had increased, although without statistical significance. Triglycerides showed a significant decrease at 12 months (p < 0.001). Seventy per cent of the patients were controlled with Captropil 100 mg/day and the remainder, with 50 mg.

[Double blind comparative randomized study of the efficacy of celiprolol versus amiloride-hydrochlorothiazide in mild to moderate AHT]. / Estudio comparativo randomizado a doble ciego de la eficacia del celiprolol "versus" amiloride-hidroclorotiazida en la HTA ligera-moderada.

We tried to assess the antihypertensive effectivity of a betablocker, celiprolol, in the control of mild to moderate essential arterial hypertension. A double-blind randomized comparative study was conducted between celiprolol and amiloride-hydrochlorothiazide in 40 patients with mild to moderate essential hypertension. Both drugs were effective in the therapeutical control of hypertension, although reductions in systolic blood pressure were more significant among the celiprolol group, being the percentage of patients with reduction of diastolic blood pressure below 90 mmHg., 89.5% in the celiprolol group and 82.4% in the amiloride group. The average dose of celiprolol used was 200 mg/day, with few mide effects.

[Changes in the glycolytic pathway in patients with essential arterial hypertension]. / Alteraciones de la vía glucolítica en pacientes con hipertensión arterial esencial.

The defect of the sodium pump of the blood cell membrane in patients with essential blood hypertension, can induce changes in the metabolic use of ATP, especially at glucolytic pathway level. We studied the blood levels of ATP (32.51 +/- 10.80 mg/100 ml), 2,3-DPG (0.82 +/- 0.47 mumol/ml), piruvate (0.36 +/- 0.16 mg/100 ml) and lactate (18.88 +/- 4.53 mg/dl), of a group of 50 patients with essential blood hypertension and of 50 healthy persons in the control group (17.09 +/- 6.37 mg/100 ml, 0.45 +/- 0.23 mumol/ml, 0.33 +/- 0.15 mg/100 ml and 17.32 +/- 3.85 mg/dl respectively). There were statistically significant differences between ATP (p less than 0.0005) levels and 2,3-DPG and lactate (p less than 0.05). These results force us to study the presence of those changes on peripheral tissues to see whether they play an important role in hypertension complications, especially in respect of the vascular wall.

[The role of prostacyclin and thromboxane in the antihypertensive action of enalapril]. / Papel de la prostaciclina y tromboxano en la acción antihipertensiva del enalapril.

Enalapril produces an inhibition of the angiotensin-renin system, correlating the pre-therapy plasmatic renin activity with blood pressure decrease, during its administration. This does not always happen, data to the contrary existing in literature, suggesting that there are some other acting mechanisms. We studied 34 hypertensive patients, whose blood pressure levels were controlled by Enalapril at a mean dosage of 12.32 +/- 0.9. Determining plasmatic concentration of 6-keto PGF1a (a prostacyclin metabolite), T x B2 (a thromboxane A2 metabolite), their distribution, plasmatic renin activity and a radiological and biochemical study. We found a significant increase in their distribution and plasmatic renin at the end of the essay. The results suggest a possible double active mechanism: angiotension-renin and prostaglandins systems, owing to the imbalance occurring between prostacyclin and thromboxane, the first named being the most favoured. This, together with easy application and the lack of side effects, made this drug useful for treatment of blood hypertension.

[Intraerythrocyte levels of glucose-6-phosphate dehydrogenase in patients with essential arterial hypertension and persons with normal blood pressure. Modifications after nifedipine therapy]. / Niveles intraeritrocitarios de glucosa 6 fosfato deshidrogenasa en pacientes con hipertensión arterial esencial y sujetos normotensos. Modificaciones después del tratamiento con nifedipina.

We evaluate the levels of intra-erythrocytes glucose-6-phosphate-dehydrogenase (G6PD) in a group of 50 patients with essential blood hypertension (EBH) (214.76 +/- 38.31 mU/ml) and in a group of 50 healthy persons (130.11 +/- 49.50 mU/ml) (p minor of 0.0005). At the same time, we have analysed the intraerythrocyte levels of G6PD of 34 healthy sons and daughters of hypertensive parents, detecting high levels in 13 of them. We observed a significant decrease of G6PD after the therapy with nifedipine in 20 hypertensive patients (p less than 0.0005). We conclude that measurement of G6PD enzyme activity can prove to be a good marker of essential hypertension. This change occurs at an early stage and is noticeable in high risk persons with family predisposition. It is possible to modify levels by working on cation changes through membrane cells by calcium-antagonist.

Bisoprolol and nifedipine SR in the treatment of hypertension in the elderly.

Forty outpatients (11 men and 29 women) aged between 65 and 85 years (mean age of 68 years) with mild to moderate hypertension [mean systolic/diastolic blood pressure (SBP/DBP) after 2 weeks on placebo of 175/102 mm Hg] were included in a randomized, double-blind, parallel-group study to compare the efficacy and tolerance of 10 mg of bisoprolol once daily (o.d., n = 20) and 20 mg of nifedipine sustained release (SR) b.i.d. (n = 20) during 4 weeks of treatment. SBP and DBP were significantly reduced compared to baseline with both treatments. There was no significant difference in efficacy between the two treatments after 2 and 4 weeks. After 2 weeks, the number of patients with normalized DBP (< or =90 mm Hg) was higher with bisoprolol than with nifedipine, this difference no longer being present after 4 weeks. Resting heart rate was significantly reduced with bisoprolol from 78+/-8 to 68+/-9 beats/min after 4 weeks, but there was no change in heart rate with nifedipine. Adverse events were reported by 6 patients on bisoprolol (20 events) and 12 patients on nifedipine (51 events) and the overall tolerance of bisoprolol was considered to be significantly better than that of nifedipine. Because bisoprolol is equally effective when administered once daily in comparison with nifedipine SR, which has to be given twice daily, and since bisoprolol exhibits a better tolerance, this beta-blocker appears to be a useful drug of first choice for the treatment of elderly hypertensive patients.

[Effect of an oral calcium supplement in the treatment of slight-to- moderate essential arterial hypertension]. / Influencia de un suplemento oral de calcio en el tratamiento de la hipertensión arterial esencial ligera-moderada.

51 patients with mild essential hypertension (EH) were randomly divided into two groups; the first group (31 patients) was treated with 1 g. of oral calcium during a period of 8 weeks; the second group received a placebo. The treated with calcium showed a significant decrease in blood pressure (BP), the maximal reduction being of 6 mm Hg in the systolic pressure (SBP) and 3 mm in the diastolic (DBP) at the end of the 8th week. We found a substantial positive relationship between the decrease in SBP and seric renin activity (p less than 0.05), as well as a significant negative relationship (p less than 0.05) between DBP and the seric level of parathyroid hormone (PTH). During the administration of the oral calcium supplement, the BP decreased in an inverse proportion to the plasmatic renin and seric level of PTH.