ABSTRACT
The efficacy and safety of almitrine bismesylate, a new respiratory stimulant, in patients with the hypoxaemic form of chronic respiratory insufficiency caused by chronic bronchitis and emphysema has been assessed. The multicentre trial of 12 weeks duration was double-blind and placebo controlled, with individual and group comparisons. Twenty three patients received almitrine 50 mg b.d. p.o. and 17 took placebo. In the almitrine group a significant increase in PaO2 was achieved (control value 54.4 mm Hg, rising to 59.1 mm Hg after 6 weeks, and to 59.4 mm Hg after 12 weeks). There was also a significant decrease in PaCO2 in the almitrine group after 12 weeks. No correlation was found between the plasma almitrine concentration, PaO2 and PaCO2. Lung function (FVC, FEV1, FEV1/FVC, Raw, TLC, RV, FRC) did not change in either group, but the degree of dyspnoea and performance in the 6 min walking test were significantly improved in the almitrine group. Adverse reactions appeared in 6 out of 23 patients on almitrine bismesylate (headache, urticaria, breathlessness, diarrhoea, chest pain, nausea and vomiting), causing drop out of 4 patients. Thus, almitrine bismesylate can be considered useful in the treatment of patients with chronic respiratory insufficiency.
Subject(s)
Almitrine/therapeutic use , Lung Diseases, Obstructive/drug therapy , Adult , Aged , Almitrine/adverse effects , Bronchitis/complications , Chronic Disease , Double-Blind Method , Emphysema/complications , Female , Humans , Lung Diseases, Obstructive/etiology , Lung Diseases, Obstructive/physiopathology , Male , Middle Aged , Randomized Controlled Trials as Topic , Respiratory Function TestsSubject(s)
Airway Obstruction/drug therapy , Bronchodilator Agents/therapeutic use , Metaproterenol/analogs & derivatives , Theophylline/analogs & derivatives , Child , Child, Preschool , Drug Combinations , Drug Evaluation , Humans , Infant , Metaproterenol/therapeutic use , Theophylline/therapeutic useABSTRACT
The new beta-adrenergic phenylethy-aminoalkyl-xanthine derivative 7-(3-[2-(3,5-dihydroxyphenyl)-2-hydroxy-ethylamino]-propyl)-theophylline (reproterol, Bronchospasmin) was tested in two patient groups afflicted with bronchial asthma or chronic obstructive bronchitis. Neither single i.v. administration nor single and 4-week long-term application of blood pressure or ECG tracings. Dosages of i.v. 60 and 90 mug, single peroral administration of 20 mg or long-term therapy with 60 mg in either 3 or 6 daily doses, definitely and significantly improved disturbances in the pulmonary ventilation (Rt, EGV, FEV1). This new preparation represents a predominantly beta2-mimetic broncholysis as well as the absence of cardiovascular side effects.
Subject(s)
Bronchodilator Agents/adverse effects , Heart/drug effects , Lung Diseases, Obstructive/drug therapy , Phenethylamines/adverse effects , Xanthines/adverse effects , Administration, Oral , Blood Pressure/drug effects , Bronchodilator Agents/therapeutic use , Electrocardiography , Female , Heart Rate/drug effects , Humans , Injections, Intravenous , Male , Middle Aged , Phenethylamines/therapeutic use , Xanthines/therapeutic useABSTRACT
In a comparative study, two groups of patients suffering from bronchial asthma or chronic obstructive bronchitis were tested with the new broncholytic substance 7-(3-[2/24/k-dihydroxyphenyl-2-hydroxy-ethylamino]-propyl)-theophylline (reproterol, Bronchspasmin) versus the well proven drug orciprenaline. Both preparations were administered for four weeks in doses of 3 x 20 mg/day (some patients received 6 x 10 mg/day). Different variables of the lung function were examined twice weekly prior to and 1 hr following ingestion of the substance (FVC, FEV1, Rt, IGV, Palpha02). On the basis of findings in above variables, both reproterol and orciprenaline showed very good and significant broncholytic effects. The efficacy of reproterol, however, proved to be significantly superior to that of orciprenaline. This also has been confirmed in subjective reports of patients with regard to strength and duration of alleviation of their respiratory distress. Palpitation, slight tremor of the fingers, restlessness, pressure in the head and dizziness were mentioned as side effects. These symptoms occurred fairly often with orciprenaline, but relatively seldom with reproterol. This difference between the preparations was highly significant. Following four weeks of administration, no tachyphylaxis was observed. In view of the submitted results, reproterol represents, no doubt, a considerable addition to the presently available therapeutic collection of remedies for the treatment of obstructive airways diseases.