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Worldwide clinical data on efficacy and safety of ciprofloxacin

Weltweit erfaßte klinische Daten zur Wirksamkeit und Sicherheit von Ciprofloxacin

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Summary

During the clinical trials 8,861 patients have been treated with ciprofloxacin worldwide. 3,822 of the therapeutic courses were valid for analysis of efficacy according to FDA standards. The following dosages were usually administered: UTI: 100 to 500 mg twice daily orally or 100 mg twice daily intravenously; RTI: 250 to 1000 mg twice daily orally or 200 mg twice daily intravenously; septicemia: 200 mg intravenously twice daily; gonorrhea: 250 to 500 mg single tablet orally; all other infections: 500 to 1000 mg twice daily orally or 200 mg twice daily intravenously. Ciprofloxacin was administered to 762 courses of lower RTI, 88 courses of upper RTI, 108 courses of bacteremia, 766 courses of skin structure infection, 142 courses of bone and joint infections, 149 courses of intra-abdominal infections, 33 courses of gastrointestinal infections, 1,633 courses of UTI, 49 courses of pelvic infections, 279 courses of STD, mainly gonorrhea, and three courses of meningitis. The clinical response was resolution in 76%, improvement in 18% and failure in only 6%. Bacteriologic response by all sites evaluable: pathogens were eradicated from 74%, markedly reduced in 2%, persisted in 10%. Relapse occurred in 4% and reinfection was observed in another 6%. The overall response was favourable for 90% of the patients. Drug safety was established on a data base of 8,861 courses worldwide. The following side-effects according to COSTART terminology were observed: digestive 5%, metabolic nutritional 4.6%, central nervous 1.6%, skin 1.4%, hemic and lymphatic 1%, cardiovascular 0.4%, body as a whole 0.4%, urogenital 0.3%, special senses 0.3%, musculo-skeletal 0.1%, respiratory 0.08%. Several courses had more than one reaction. Thus the total incidence of side-effects for the treated patient population was 10.2%. Ciprofloxacin is a highly effective drug and a breakthrough in several areas of medical interest. It is relatively safe and side-effects are usually mild or moderate in intensity and transient.

Zusammenfassung

Weltweit wurden 8861 Behandlungsverläufe während der klinischen Prüfung mit Ciprofloxacin dokumentiert. Nach FDA-Kriterien waren 3822 Behandlungsverläufe auswertbar für die Beurteilung der Wirksamkeit. Die nachfolgenden Dosierungen wurden üblicherweise angewandt: Harnwegsinfektionen: 100 bis 500 mg oral, zweimal pro Tag oder 2 × 100 mg intravenös; Atemwegsinfektionen: 250 bis 1000 mg oral zweimal pro Tag oder 2 × 200 mg intravenös; Sepsis: zweimal pro Tag intravenös 200 mg; Gonorrhoe: 1 Tablette zu 250 oder 500 mg; alle anderen Infektionen 500 bis 1000 mg zweimal pro Tag oral oder zweimal 200 mg intravenös. Bei folgenden Indikationen wurde Ciprofloxacin geprüft: Infektionen des Respirationstraktes — tiefe 762 Fälle, obere 88 Fälle, Sepsis — 108 Fälle, Haut- und Weichteilinfektionen — 766 Fälle, Knochen-und Gelenkinfektionen — 142 Fälle, intraabdominale Infektionen 149 Fälle, gastrointestinale Infektionen — 33 Fälle, Harnwegsinfektionen — 1633 Fälle, gynäkologische Infektionen — 49 Fälle, venerische Erkrankungen (hauptsächlich Gonorrhoe) — 279 Fälle und bei 3 Fällen mit Meningitis. Klinische Heilung wurde in 76% und deutliche Besserung in 18% aller Fälle erreicht, in nur 6% der Fälle versagte die Therapie. Bei 74% wurden die Bakterien eliminiert und bei weiteren 2% deutlich reduziert; sie persistierten bei 10% der Patienten. Ein Rückfall wurde bei 4% beobachtet und eine Reinfektion bei 6%. Das Gesamturteil (klinisches und bakteriologisches Ergebnis) war günstig für 90% der Patienten. Für die Beurteilung der Verträglichkeit konnten 8861 Behandlungsverläufe herangezogen werden. Die folgenden Nebenwirkungen (nach COSTART Organsystem) wurden beobachtet: Verdauungstrakt 5%, Metabolismus 4,6%, ZNS 1,6%, Haut 1%, Blut- und Lymphsystem 1%, Herz-Kreislauf 0,4%, Gesamtkörperreaktionen 0,4%, Urogenital 0,3%, Sinnesorgane 0,3%, Gelenk- und Muskeln 0,1% und Atemwege 0,08%. Bei mehreren Behandlungsverläufen wurde mehr als eine Nebenwirkung beobachtet, so daß die Gesamtinzidenz, bezogen auf die Patientenzahl, nur 10,2% beträgt. Ciprofloxacin ist hochwirksam und ein therapeutischer Durchbruch auf vielen Gebieten der Infektiologie. Es ist relativ gut verträglich; die beobachteten Nebenwirkungen waren in der Regel nur leicht oder mäßig schwer und vorübergehend.

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Authors and Affiliations

  1. Bayer AG, Pharma Forschungszentrum Aprather Weg, D-5600, Wuppertal 1

    P. Schacht,  V. Chyský,  G. Gruenwaldt,  R. Hullmann &  H. Weuta

  2. Miles Pharmaceuticals, Division of Miles Laboratories Inc., 400 Morgan Lane, 06516, West Haven, Conn., USA

    G. Arcieri M. D., E. Griffith M.D. & B. O'Brien V.D.M.

  3. Bayer Nederland B.V., divisie farma, Postbus 80, NL-3644 RR, Mijdrecht

    J. Branolte

  4. Bayer AG, Pharma-Deutschland, D-5090, Leverkusen

    H. Bruck & A. Westwood Ph.D.

  5. Bayer Pharma S.A., Département Médical, 49-51, Quai de Dion-Bouton, F-92815, Puteaux Cedex

    C. A. Konopka

  6. Bayer (Sverige) AB, Avd. för klin. prövn., Birger-Jarlsgatan 27, S-11145, Stockholm

    V. Rahm

  7. Bayer Yakuhin Ltd., P.O. Box Higashi 274, 540-91, Osaka, Japan

    T. Ryoki

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  1. P. Schacht
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  2. V. Chyský
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  3. G. Gruenwaldt
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  4. R. Hullmann
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  5. H. Weuta
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  6. G. Arcieri M. D.
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  7. E. Griffith M.D.
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  8. B. O'Brien V.D.M.
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  9. J. Branolte
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  10. H. Bruck
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  11. C. A. Konopka
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  12. V. Rahm
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  13. T. Ryoki
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  14. A. Westwood Ph.D.
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Schacht, P., Chyský, V., Gruenwaldt, G. et al. Worldwide clinical data on efficacy and safety of ciprofloxacin. Infection 16 (Suppl 1), S29–S43 (1988). https://doi.org/10.1007/BF01650504

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