The cognitive and behavioral effects and the safety of oxiracetam therapy during a placebo-controlled trial and the relevant follow-up up to 1 year in patients with senile dementia of Alzheimer type (SDAT) and multi-infarct dementia (MID) of mild to moderate degree were studied. Sixty male and female outpatients participated in the double-blind, placebo-controlled, parallel-group, randomized trial, comparing the effects of oxiracetam 800 mg b.i.d. and placebo during 90 days of treatment. At the end of therapy, statistical analysis evidenced significant improvements in the group receiving oxiracetam in respect to the placebo group on Mini Mental State Examination, Auditory Continuous Performance Test, Rey’s 15 Words Test, Block Tapping Test, Mattis Word Fluency, Luria Alternating Series and Instrumental Activities of Daily Living. Afterwards, 29 of the 30 patients who received oxiracetam, participated in the open follow-up study, receiving 800 mg b.i.d. oxiracetam for a total standard period of 1 year. Statistical improvements in comparison to baseline were again found on the same tests of the first 90 days (except for Rey’s 15 Words Test) and on the Memory item of the Inventory of Psychic and Somatic Complaints Elderly. During the late phase of the follow-up, statistically significant worsenings in comparison to baseline were observed on Digit Span Backward, Gibson’s Spiral and some non-memory items of IPSC-E. Neither severe adverse events were observed during the whole study, nor changes in routine laboratory examinations. In conclusion, in the present population of patients with mild to moderate degree dementia, the safety of 1,600 mg/day of oxiracetam also up to 1 year of treatment was confirmed. Clinical efficacy was also confirmed, although some improvements seen after the first months were not completely maintained after 12 months.
In 65 subjects with chronic obstructive pulmonary disease, mainly chronic bronchitics, all exhibiting arterial hypoxemia and moderate to severe airways obstruction (FEV1 ranging from 625 to 1,980 ml), the following data were regularly followed-up over 3 years: clinical status, chest X-rays, ECG, arterial blood gases, pulmonary volumes, pulmonary hemodynamics (at least two catheterizations were performed). Strasbourg 67000 (France The follow-up period defined by the time elapsed between the first and the last hemodynamic investigation was 57.1 ± 17.4 months, range 36–120 months. 25 patients died after a mean follow-up period of 64.3 ± 21.3 months. 38 patients experienced one or several right heart failure (RHF) episodes. These episodes were significantly more frequent in the decreased patients (3.6 ± 3.3) than in the survivors (1.2 ± 1.6). The pulmonary artery mean pressure (PAP) for the whole group varied little, from 21.0 ± 7.7 to 23.9 ± 9.9 Torr (p < 0.005). PAP increased by more than 5 Torr in 19 cases only. In these cases with hemodynamic ‘worsening’ final PaO2 was lower (p < 0.001) and final PaCO2 was higher (p < 0.01) than in patients with hemodynamic ‘stability’. A significant negative correlation was found between chronological changes of PaO2 and PAP: r = -0.38, p < 0.01. After RHF episodes, PAP usually returned to its baseline level (6 exceptions for 38 subjects). There was a satisfactory correlation between the hemodynamic (PAP) evolution and clinical, X-rays (transverse heart diameter) and ECG evolution. In cases with ECG worsening (n = 15) the PAP varied significantly from 24.4 ± 4.6 to 34.6 ± 10.6 Torr (p < 0.005). These results emphasize the prognostic value of (irreversible) ECG changes in the course of chronic obstructive pulmonary disease (COPD).
The scopolamine model of amnesia has been used to test the pharmacodynamic efficacy of oxiracetam in 12 healthy volunteers. The subjects were divided into four experimental groups, according to a double-blind cross over incomplete randomized block design. After a baseline neuropsychological examination, each subject received in two separate sessions one of the following treatments, as acute oral doses: oxiracetam 800, 1600, 2400 mg or placebo. One hour after treatment scopolamine hydrobromide (0.5 mg) was given subcutaneously. The cognitive performance was tested before and 1, 2, 3 and 25 h after scopolamine administration. Scopolamine caused a deterioration of performance of verbal episodic memory, semantic memory and attention tests. In comparison to placebo, oxiracetam improved the overall test performance, with a statistically significant difference at the dose of 1600 mg on delayed recall of word lists, and showed dose-related antagonism of scopolamine-induced effects also on semantic memory and attention. The efficacy of an acute dose of oxiracetam in reducing scopolamine-induced cognitive impairment supports the potential usefulness of this pharmacological model of amnesia for studying the effects of cognition enhancers in humans.
Cadralazine (ISF 2469) was administered to 24 hypertensive patients in single oral doses of 7.5, 10, 15, 20 and 30 mg, according to a single-blind, placebo-controlled, within-patient change-over design. The study was done in 2 stages: in the first a range including the upper and lower doses was studied (7.5, 15, 30 mg and placebo), and in the second the range of doses was restricted (10, 15, 20 mg and placebo). The drug produced a significant decrease in blood pressure in the supine and standing positions. The decrease became clinically important starting from the 15 mg dose. Its action was still significant 12 h after administration. A significant increase in heart rate was also observed. All the effects were correlated with the dose. Side effects occurred mainly after the 30 mg dose. Thus, cadralazine, in a single oral dose in man, showed good antihypertensive activity starting from the 15 mg dose, and its effect was dose-related, slow in onset and long-lasting.
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