Drugs
-
Randomized Controlled Trial Comparative Study Clinical Trial
Effects of roxatidine acetate on 24-hour gastric acidity. Early evening versus bedtime administration in healthy subjects.
The gastric antisecretory activity of roxatidine acetate was studied on 24-hour intragastric pH in 12 healthy male volunteers. The study was randomised, double-blind and double-dummy where either roxatidine acetate 150 mg as a slow release granulated formulation or placebo were administered at 7.30 pm or 10 pm. ⋯ There was no significant difference between the median intragastric pH values for early evening and bedtime administration of roxatidine acetate. The present data confirm that roxatidine acetate 150 mg inhibits gastric acid secretion but while a single evening dose is effective in controlling intragastric pH the results suggest there is no clear advantage in an early evening dose compared with a bedtime dose.
-
Randomized Controlled Trial Comparative Study Clinical Trial
The effects of roxatidine acetate on 24-hour intragastric acidity. Investigations in healthy volunteers and comparison with ranitidine and placebo.
In a series of double-blind randomised studies in normal volunteers with continuous intragastric pH monitoring, the effects of different dosage regimens of roxatidine acetate, a new H2-receptor antagonist, were compared with placebo and ranitidine. Roxatidine acetate 75 mg twice daily decreased median 24-hour gastric acidity from pH 1.6 to 3.2 and median nocturnal acidity from 1.5 to 3.0. ⋯ However, when drugs were taken after the evening meal (post cenam nocte; PCN) roxatidine acetate 150 mg was less potent than ranitidine 300 mg, with median night-time pH rising from 1.3 to 3.2 and 4.0, respectively, in 28 volunteers. Roxatidine acetate 300 mg PCN produced the greatest rise of pH, to 4.9, suggesting that the true potency ratio of the 2 drugs is between 1 and 2.
-
Randomized Controlled Trial Clinical Trial
The use of roxatidine acetate in fasting patients prior to induction of anaesthesia as prophylaxis against the acid aspiration syndrome.
Aspiration pneumonitis is one of the major causes of anaesthesia related deaths. H2-receptor antagonists are effective drugs for the prevention of the acid aspiration syndrome (Mendelson's syndrome). The new long-acting H2-receptor antagonist roxatidine acetate may be the first H2-receptor antagonist which could effectively reduce acid secretion following a single bedtime premedication on the evening before an operation. ⋯ The mean gastric volume in the placebo group was 23.3 +/- 27.1 ml, compared to 14.5 +/- 9.4 ml for roxatidine acetate. The 5 highest gastric volumes were observed in the placebo group (max 146 ml). A single bedtime oral premedication with roxatidine acetate 150 mg ensures a gastric pH above 2.5 until 11 am the following day.
-
This review will discuss the safety profiles of the angiotensin-converting enzyme (ACE) inhibitors captopril, enalapril and lisinopril in patients with hypertension. In general, the safety profiles of ACE inhibitors compare favourably with those of other agents used for the treatment of hypertension. Adverse effects are not common when ACE inhibitors are used at the currently recommended doses. ⋯ Other adverse effects such as cough and angioedema also occur with all ACE inhibitors. The mechanisms are poorly understood, making it difficult to predict in which patients they will occur. Adverse effects such as rash, dysgeusia, neutropenia and proteinuria, which were reported relatively frequently in the early experience with captopril, are reported less frequently with lower doses of captopril and do not appear to be a problem with other ACE inhibitors such as enalapril and lisinopril.
-
Randomized Controlled Trial Clinical Trial
The pharmacodynamics and pharmacokinetics of multiple doses of the new H2-receptor antagonist, roxatidine acetate, in healthy men.
Roxatidine acetate (HOE 760, TZU 0460) is a new H2-receptor antagonist which is more potent than cimetidine and ranitidine. A randomised, double-blind, placebo-controlled study was conducted in healthy men to determine the effects of multiple oral doses of roxatidine acetate on unstimulated gastric acid secretion, and to assess the preliminary multiple-dose pharmacokinetics of its active desacetyl metabolite. The subjects were randomised to receive either roxatidine acetate 150 mg or placebo daily at 9 pm for 14 days. ⋯ The gastric pH increased with the mean plasma concentrations of the desacetyl metabolite. Mean plasma levels at steady state were attained between the 4th and 7th days after which there was no evidence of appreciable accumulation of the desacetyl metabolite. Roxatidine acetate 150 mg administered orally at 9 pm for 14 days to healthy men was safe, well tolerated, and produced clinically relevant increases in gastric pH, and decreases in gastric acid concentration, without affecting gastric fluid volume.