[A Brazilian multicenter study to evaluate the clinical effectiveness and tolerance of isradipine SRO using ambulatory monitoring of arterial pressure in the treatment of mild and moderate arterial hypertension]. / Estudo multicêntrico brasileiro de avaliação de eficácia clínica e tolerabilidade da isradipina SRO através da monitorização ambulatorial da pressão arterial no tratamento da hipertensão arterial leve e moderada.

PURPOSE: To evaluate clinical efficacy and tolerability of isradipine SRO (I.SRO), 5 mg O.D. in essential hypertensives. METHODS: Eighty-three of 87 selected outpatients with a mean age of 51.3 years (ranging from 25 to 65), 33 male, 48 white, 29 black and others of different races, who had clinical supine and orthostatic diastolic blood pressure (DBP) > or = 95 mmHg and < or = 115 mmHg underwent the study. After a three-week wash-out period, patients received I.SRO 5 mg O.D. at 8:00 am for a six-week period (phase I). After this phase, patients received I.SRO 5 mg O.D. at 8:00 pm for a six-week period (phase II). The patients had a follow-up with an interval of three weeks and the ambulatorial blood pressure monitoring (ABPM) for 24 hours was performed with a SpaceLabs 90207 or Del Mar Avionics devices after the wash-out period and at the end of phases I and II. Measurements were performed at 15-min intervals during the day (6 am to 10 pm) and at 30-min intervals during the night (10 pm to 6 am). RESULTS: a) Heart rate did not show significant changes during the treatment period (phases I and II) when compared with the wash-out period; b) causal blood pressure: at the end of both treatment periods (phases I and II) there were statistically significant decreases (p < 0.001) in supine SBP and DBP compared with wash-out values. The mean SBP decreased from 161.6 +/- 14 to 144.3 +/- 13 mmHg (phase I) and to 141.8 +/- 13 mmHg (phase II). The mean DBP decreased from 103.4 +/- 6 to 91.2 +/- 7 (phase I) and to 89.1 +/- 8 (phase II); c) ABPM: the mean systolic 24-h ambulatory blood pressure was significantly reduced (p < 0.001) from 148.8 +/- 17 to 137.2 +/- 15 mmHg (phase I) and to 133.4 +/- 13 mmHg (phase II). The mean diastolic 24-h ambulatory blood pressure was significantly decreased (p < 0.001) from 94.3 +/- 9 to 87.0 +/- 9 (phase I) and to 85.8 +/- 8 mmHg (phase II). The mean daytime and nighttime, systolic and diastolic 24-h ambulatory blood pressure were: wash-out--152.3 +/- 17, 140.2 +/- 21, 97.4 +/- 9, 86.8 +/- 13; phase I--139.9 +/- 15, 130.0 +/- 17, 89.3 +/- 9, 81.3 +/- 10; phase II--136.7 +/- 13, 125.3 +/- 15, 88.5 +/- 8, 79.1 +/- 10, respectively. Blood pressure load (percentage of systolic blood pressure values > 140 mmHg or of diastolic blood pressure values > 90 mmHg) was significantly reduced from 62.2/62% (SBP/DBP), on the was-out, to 37.9/39.9% (SBP/DBP) on phase I and to 32.3/34.3% (SBP/DBP) on phase II; d) side effects: most frequently related were palpitations (2.3%), headache (1.1%), flush (1%) and ankle oedema (1%). They were in general, mild-to-moderate and disappeared after the first 3 weeks of treatment. Only two patients were withdrawn because of headache (one of them with previous diagnosis of migraine). CONCLUSION: I.SRO, given by oral route, in the dosage of 5 mg O.D. as monotherapy, was effective and well tolerated, promoted significant reduction on 24-h ambulatory blood pressure attenuating the early morning rise and did not interfere with the circadian rhythm of blood pressure. No significant differences were detected in the BP lowering effect when I.SRO was given during the morning or evening. These results may indicate that the drug is as suitable as one of the first choice for treating mild and moderate hypertensive patients.

[Fosinopril in a daily single dose in mild and moderate hypertension. Brazilian multicenter study]. / Fosinopril em dose única diária na hipertensão leve e moderada. Estudo multicêntrico brasileiro.

PURPOSE: To evaluate during 12 weeks the effectiveness and safety of once-a-day fosinopril (10 or 20 mg/day comparative to placebo) in mild to moderate hypertensives according to an open design comparative to placebo. METHODS: One hundred and nineteen patients were studied; 52 +/- 11 years (mean +/- sd) range 18 a 76 years, 86 women and 33 men, 57% whites, 26% blacks and 17% mulattos, 71 mild hypertensives (95 < or = diastolic pressure < or = 104mmHg) e 48 moderate hypertensives (101 < diastolic pressure < or = 115mmHg). RESULTS: There was a significant reduction in systolic/diastolic pressure on the 6th week of treatment (from 161 +/- 16/103 +/- 7 before to 148 +/- 16/94 +/- 9mmHg on the 6th week). On the 12th week of treatment there was an additional significant reduction in systolic/diastolic pressure (from 148 +/- 16/94 +/- 9 on the 6th week to 145 +/- 17/89 +/- 8mmHg on the 12th week). There was a "favorable" response in 71% of the patients on the 12th week; 62% showed diastolic pressure < or = 90mmHg and 9% presented diastolic reduction > or = 10mmHg. There was no difference in the normalization rates between whites and non-whites, mild and moderate hypertensive, obese and non-obese patients, under or above 50 years of age and those patients from no drug-treatment to those on 3 drug before the study. There was no clinically relevant changes in laboratory evaluations before and at the end of the study. The number of adverse reactions was reduced in comparison with previous treatment. CONCLUSION: Fosinopril, according to our and others data, is effective and safe for the treatment of mild to moderate hypertensives, in whites or non-whites, obese or non-obese, younger or older than 50 years and receiving 0 or 3 drugs before the study.

[Multicenter National Study for the evaluation of the efficacy and tolerance of nifedipine oral release osmotic system in mild to moderate hypertension]. / Estudo multicêntrico nacional para avaliação da eficácia e tolerabilidade da nifedipina oros em hipertensão arterial leve a moderada.

PURPOSE: Evaluation of the efficacy and tolerability of nifedipine oros in patients with mild to moderate essential hypertension without major target organ damage and the anti-hypertensive effect along the 24 hours. METHODS: Two hundred and three patients were studied. After two weeks placebo running period single dose of nifedipine oros (30 mg/day) was administered for 8 weeks. At the end of the 4th week, the non-responders (diastolic blood pressure > 90 mmHg or reduction in diastolic pressure < 10 mmHg), had the dosage increased to 60 mg/day. Laboratory tests and 24h blood pressure monitoring (60 patients) were performed at the beginning and at the end of the study. RESULTS: One hundred and ninety one patients completed the study. Fifty nine percent were considered responders at the end of the 4th week with nifedipine oros 30 mg/day and 41% needed dosage increment to 60 mg/day. At the end of the 8th week, all patients were considered responders to nifedipine oros. The blood pressure control extended throughout the 24h of the day. The most common adverse events were edema (14.6%) and headache (12.4%). Good and very good tolerability were informed by 85% of the patients. CONCLUSION: Nifedipine oros was able to control blood pressure efficaciously along the 24h period without important side effects. The possibility of once day dosage, increases the patient adherence to anti-hypertensive therapy.