A double-blind, controlled, multicenter, randomized study comparing the antihypertensive effectiveness and tolerance of a daily dose of two nifedipine formulations: nifedipine microgranules versus nifedipine osmotic pump.

INTRODUCTION: Controlled clinical studies have clearly established the advantages of blood pressure (BP) reduction. However, optimal control of BP in the population is still not adequate. Monotherapy is ineffective in the majority of hypertensive patients, and multidrug therapy increases costs. OBJECTIVE: The objective of the study was to assess to what extent and how uniformly BP can be controlled with two different 24-hour drug-releasing formulations of nifedipine, used as monotherapy. METHODS: One hundred ninety-two patients of both genders, aged 18 to 65 years, with mild to moderate (Stage 1 and 2) essential hypertension with systolic BP <200 mm Hg and diastolic BP between 90 and 115 mm Hg were randomized in a double-blind, double-dummy fashion to receive sustained-release formulations of 30 mg nifedipine/day either as microgranules (NMG) or via osmotic pump (NOP) for 8 weeks. Office BP was measured at baseline (after 2 weeks of placebo) and after the third to fourth week of treatment. If at the third to fourth week the systolic BP/diastolic BP did not reach values of <140/<90 mm Hg, the dose was doubled to 60 mg/day. Monotherapy that did not yield these BP values at 8 weeks was considered a failure. Ambulatory monitoring of blood pressure (AMBP) was also performed after the placebo period and at the end of treatment. Smoothness index (SI) and trough/peak ratio (T/P) were calculated and their correlation was checked. RESULTS: The initial systolic/diastolic BP values were similar at baseline and decreased significantly after the third to fourth week of treatment, with no difference between the groups. The proportions of patients reaching the goal BP (<140/<90 mm Hg) were similar in the two groups: NMG, 71%, and NOP, 78% (P = 0.12). There were no changes in the heart rate in either group. There was no difference between groups in the reduction in mean arterial pressure measured by AMBP. The frequency of SI values >1.4 and T/P ratios of >0.5 was similar in both groups. An important correlation was found between the SI and T/P values. The incidence of adverse effects was low and similar in both groups. CONCLUSIONS: Target BP was reached in more than 70% of patients receiving monotherapy with either formulation. Both formulations were tolerated well.

[Use of glucomannan dietary fiber in changes in intestinal habit]. / Uso de la fibra dietética de glucomannan en la modificación del hábito intestinal.

It has been proven that fiber is effective in the treatment of multiple nosological entities, specially of the colonic pathology. In the present study, two dose of Glucomannan (3 gr/day and 4 gr/day) were evaluated within the modification of the intestinal habit and stool characteristics. 60 patients were included in a random, parallel, double blind, cross over trial study versus placebo. The modification of the intestinal habit was evaluated through variations of daily and weekly evacuations, appraising the stool's consistency and size, satiety after meals tiresomeness between meals, constipation, diarrhea and flatulence. An increase in the number of daily and weekly evacuations during the Glucomannan vs placebo treatment was appreciated and, between the two dose of Glucomannan, a difference was observed as to the large the dose, the large the number of daily and weekly evacuations. Evacuations during the phase of Glucomannan 3 gr/day increased 0.5 times per day, 3 more per week above baseline values. On the 4 gr/day treatment of Glucomannan evacuations increased 0.9 times per day, 6 more per week above baseline values. Patient during the placebo period presented no statistically significant different. No difference was appreciated as to post-meal satiety, nor tiresomeness between meals, possibly due to treatment periods being 5 weeks long. No larger number of cases with diarrhea or flatulence were appreciated with the use of Glucomannan. Glucomannan proved to be superior to placebo, and the 3 gr/day and 4 gr/day doses turned out to beneficial in the improvement of the assessed parameters--better results were obtained using 4 gr/day of Glucomannan than 3 gr/day.

The affinity of low density lipoproteins for an arterial macromolecular complex. A study in ischemic heart disease and controls.

Levels of serum cholesterol, triglycerides, lipoprotein pattern and the insolubilization of serum low density lipoproteins (LDL, betalipoprotein) by a factor present in arterial intima--media extracts was investigated in 55 patients with acute coronary heart disease and 50 healthy controls. In blood samples obtained 24 h after the episode, the serum betalipoproteins from male normotensive patients showed a high tendency to precipitate when incubated with the intima-media extracts, nearly twice the value measured in the control group. This affinity returned almost to control level after 21 days in the hospital. Hypertensive patients showed a serum cholesterol higher than the controls but almost no difference in LDL-arterial factor interaction. The composition of isolated LDL was studied in 7 patients and 8 controls and it was found that the total cholesterol/protein plus phospholipid ratio has a positive exponential correlation with the lipoprotein-arterial factor affinity. The results of LDL analyses suggest that a change in their composition, frequent in normotensive patients, can lead to an increased affinity of this lipoprotein for arterial intimamedia components. It is proposed that this process could be an additional risk factor contributing to the deposition of LDL in the arterial wall.