A randomized, double-blind, 12 weeks comparison of Lovastatin and Gemfibrozil in the treatment of patients with primary hypercholesterolemia was performed in 31 patients. After a placebo and diet period (4 weeks), they were assigned to either Lovastatin 20 mg nightly or Gemfibrozil 600 mg twice daily, if their total serum cholesterol was < 300 mg/dl, and to either Lovastatin 40 mg nightly or Gemfibrozil 600 mg/12 if it was > 300 mg/dl. In both cases, the Lovastatin dose was doubled after 6 weeks, if serum cholesterol remained > 200 mg/dl. The dose of Gemfibrozil kept constant. Lovastatin reduced serum cholesterol from 354 +/- 91 mg/dl to 253 +/- 62 mg/dl (p < 0.001), LDL-cholesterol from 277 +/- 104 to 192 +/- 71 mg/dl (p < 0.001) and serum triglyceride level from 125 +/- 66 a 84 +/- 41 mg/dl. The corresponding reductions achieved by Gemfibrozil were: 343 +/- 86 to 290 +/- 72 mg/dl (p < 0.01), 264 +/- 89 to 217 +/- 67 mg/dl (p < 0.05) and 152 +/- 84 to 89 +/- 41 mg/dl (p < 0.001), respectively. Lovastatin therapy caused a 30.6% reduction in total cholesterol level, while Gemfibrozil achieved a 19.47%. There were no significant changes in HDL-cholesterol. Patients had no serious or clinically significant adverse effects. The current data suggest that Lovastatin (an inhibitor of HMG-Coa reductase) may provide one important means for lipid-lowering therapy in patients with primary hypercholesterolemia.

Adolescent↗

PubMedDate not supplied

[Comparative bioavailability and pharmacokinetics of Dolotren retard and Dolotren].

A randomized crossover study was designed in order to evaluate the bioequivalence of a sustained-release preparation (DR) of diclofenac sodium (Dolotrén RETARD) with respect to an enteric coated (D) tablet (Dolotren). For this purpose the bioavailability of both formulations, orally administered in single and multiple doses, was determined. Nine healthy volunteers were included in this study, receiving 100 mg of D and 100 mg of DR, firstly in single dose and then for 15 days b.i.d. for D group and once a day for DR group. For the analytical determination of diclofenac, blood samples at established time intervals, the day of the single dose and the 3rd, 7th and 15th day of multiple dose administration, were taken. The following kinetic parameters were determined: Cmac, tmax, alpha and beta, clearance, ka, area under the curve and absolute and relative bioavailability. When administered both endovenous and orally, the great interindividual variability in the kinetic characteristics of diclofenac sodium is evidenced. The lag time (tlag) for DR is 0.4 h, shorter than for D (2.2 h), which indicates a faster absorption in the upper sections of the gastrointestinal tract. Also tmax was shorter for Dr (1.9 h) than for D (4.3 h). Cmax obtained with D was higher tan with DR. The diclofenac sodium elimination process from plasma is significantly slower with DR than with D (t1/2 beta = 18.1 h and 2.5 h, respectively). In consequence, quantifiable plasmatic levels are maintained for at least 24 hours after administration of DR, but not of D. Absolute bioavailability of both preparations is about 80%, with great interindividual variations. Significant differences between the two preparations could not be demonstrated. Relative bioavailability between DR and D was 91.5%. None of the preparations when administered in repeated doses, D every 12 hours and DR every 24 hours, produced accumulation, neither their pharmacokinetic characteristics changed. Clinical and biological tolerance of both preparations were excellent, at doses used and for the period of time studied. Dolotren Retard is absorbed orally faster than Dolotren and maintains plasmatic levels longer, which allows it to be administered once a day, with a lesser incidence of undesirable effects related to Cmax.

Administration, Oral↗

PubMedDate not supplied

[A pharmacovigilance study with bentazepam in a sample of 1046 psychiatric outpatients].

A pharmacovigilance study was performed upon 1,046 ambulatory patients that have been treated in external psychiatric consultation with bentazepam. The sample size made possible to detect with 99% of security the incidence higher to 5% secondary effects, as mouth dryness, somnolence, asthenia, gastralgias/dyspepsias, constipation and sickness. It has as well been possible to detect the most usual ways of coprescription, and the most frequent was with antidepressants drugs that undertook approximately 1/3 of the sample and that it was responsible for some of the secondary effects observed. The bentazepam treatment cut down significatively the score mean in Hamilton scale for the anxiety after 10-15 days of treatment. According to an intention analysis a therapeutic profit was got in the 76.7% of the sample depending on medical criteria and the 74.0% on patient criteria after 20-30 days of the treatment. The results obtained are discussed in terms of the sample characteristics.

Adult↗

PubMedDate not supplied

[The antihypertensive efficacy and tolerance of bopindolol (LT 31-200) in hypertensive patients].

A open study with increasing doses of bopindolol, a nonselective beta-blocker of long half-life has been carried out in patients with mild and moderate hypertension in order to assess the efficacy and security of the treatment in short and long term. Twenty patients (22 women and 8 men) were included with the ranging ages from 36 to 62 years old (x +/- SD 51.6 +/- 7.6) whose blood pressures were higher than 160 mm Hg for the systolic value and between 90 and 125 mm Hg for the diastolic (x +/- SD 165 +/- 7.2 and 102.6 +/- 6.7 respectively). Nineteen from the twenty patients (95%) responded satisfactorily after 20 weeks of oral bopindolol treatment once a day showing significative statistical differences on forth week of the treatment versus blood pressure rates of placebo's period. Similar results were obtained with regard to the cardiac frequency. HDL cholesterol rates increased significantly as well as the ratio HDL cholesterol/total cholesterol.

Adrenergic beta-Antagonists↗

PubMedDate not supplied

[Platelet antiaggregants in the treatment of vasculopathies].

A complete and vast study about platelet antiaggregants, alone or associated to other drugs, is presented. Studying firstly these drugs, and afterwards its clinical use: cerebral ischemia, myocardium acute infarct, angor pectoris, revascularization coronary surgery, coronary percutaneous transluminal angioplasty, valvular prosthesis, valvulopathies, vascular prosthetic grafts, and others.

Angioplasty, Balloon, Coronary↗

PubMedDate not supplied

Possible interaction between cyclosporine and josamycin.

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Cyclosporins↗

PubMedDate not supplied

[Celiprolol].

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Adrenergic beta-Antagonists↗

PubMedDate not supplied

[Functions of a hospital clinical pharmacology service].

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Clinical Trials as Topic↗

PubMedDate not supplied

[Effectiveness and tolerance of norfloxacin compared with trimethoprim-sulfamethoxazole in the treatment of uncomplicated urinary tract infections].

Forty patients with uncomplicated urinary tract infections were randomized to receive norfloxacin (400 mg) twice daily or trimethoprim-sulfamethoxazole (160-800 mg) twice daily for 10 days. The percentage of patients with bacteriological outcomes of eradication was significantly greater (p = 0.0310) with norfloxacin (90%) than the obtained percentage with trimethoprim-sulfamethoxazole (55%). The clinical response was, also, significantly better (p = 0.0012) in the norfloxacin group (100%) than in the trimethoprim-sulfamethoxazole group (55%). Two patients receiving trimethoprim-sulfamethoxazole experienced clinical side effects-gastrointestinal in nature but the treatment was not discontinued. In the norfloxacin group clinical side effects were not observed. No adverse hematological or biochemical changes were noted. From these results, we conclude that norfloxacin is more effective than trimethoprim-sulfamethoxazole in the therapy of uncomplicated urinary tract infections.

Clinical Trials as Topic↗

PubMedDate not supplied

[Functions of a clinical pharmacology hospital service].

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Hospital Departments↗

PubMedDate not supplied

[Phase I study of a tolmetin-paracetamol (AU-8001) ester].

A cross-over study of a tolmetin-paracetamol ester was performed on 6 healthy females. The low biodisponibility obtained might preclude its therapeutic use.

Acetaminophen↗