Clinical efficacy and safety of beclomethasone dipropionate inhalation capsules inhaled by Cyclohaler compared with Becotide Rotacaps inhaled by Rotahaler.

The study was undertaken to compare the efficacy and safety of beclomethasone dipropionate inhalation powder inhaled by Rotahaler (Becotide Rotacaps, Glaxo Wellcome) and by Cyclohaler (Beclomethasone Cyclocaps, Pharmachemie). Both the Cyclohaler and the Rotahaler are single-dose dry powder inhalation devices for inhalation capsules. 182 asthma patients stabilized on inhaled beclomethasone dipropionate 800 micrograms daily, were randomly assigned to treatment with 800 micrograms beclomethasone dipropionate inhaled by Rotahaler (91 patients) or Cyclohaler (91 patients) in a double-blind manner, using the double-dummy method. It was shown that the asthma remained stable during the 16-week study period with both preparations. There were no statistically significant differences in the pulmonary parameters (morning PEF, evening PEF, FEV1). The test/reference ratio of the morning PEF (99.5%, CI 93.0% - 106.5%) was well within the equivalence interval, which had been set a priori from 85% to 117.6%. There were no marked differences between the Cyclocaps and Rotacaps group in symptom scores and adverse events. A total of 12 patients had an asthma exacerbation: 8 exacerbations occurred in the Rotahaler group and 4 in the Cyclohaler group. The difference was not statistically significant. The use of rescue medication was somewhat higher in the Rotahaler group, but the difference did not reach statistical significance. Significantly more patients (17 patients) withdrew from the study in the Rotahaler group than in the Cyclohaler group (5 patients). In conclusion, there was no difference in asthma control of patients treated with Beclomethasone Cyclocaps inhaled by Cyclohaler and Becotide Rotacaps inhaled by Rotahaler. Both preparations are therapeutically equivalent.

A postmarketing study of flunarizine in migraine and vertigo.

This prospective, open multi-centre study on flunarizine focused on the risk/benefit ratio of the use of flunarizine in the prophylaxis of migraine and in the treatment of vertigo, due to disorder of the vestibular system. The assessment of risks focused on the incidence of new events of depression and/or extrapyramidal syndrome during flunarizine treatment. For migraine, flunarizine was compared to propranolol in 686 patients; for vertigo, flunarizine was compared to betahistine in 198 patients. The incidence of depression during follow-up in this study was significantly higher in the flunarizine group than in the propranolol group in the condition of migraine. There were no observations of an extrapyramidal syndrome. There was a suggestion that flunarizine has more benefits than propranolol in the condition of migraine, and that betahistine has more benefit than flunarizine in the condition of vertigo. Differences in dosages could possible explain these differences.

Localisation of the aminoglycoside-(3)-N-acetyltransferase isoenzyme II in Escherichia coli.

For the location of the aminoglycoside-(3)-N-acetyltransferase isoenzyme II (AAC(3)-II) in the bacterial cell, two strains were studied: Escherichia coli HB101(pJV03), producing the 31-kDa AAC (3)-II enzyme, and E. coli HB101, which served as a control. From each strain five protein fractions were prepared: culture supernatant, and proteins occurring in the periplasm, cytoplasm, inner membrane and outer membrane. All fractions were tested for enzymatic activity of AAC(3)-II. Most of the acetylating activity was found in the cytoplasmic fraction. The distribution of marker enzymes showed a good separation between the periplasmic and the cytoplasmic fraction.