Inpharma 1594 - 30 Jun 2007 Cethromycin promising for community-acquired pneumonia Cethromycin * shows promise for the treatment of mild to moderate community-acquired pneumonia, according to the results of a phase III study. In the multicentre, randomised study, data were evaluated from 522 such patients who received cethromycin 300mg once daily or clarithromycin 250mg twice daily, for 7 days. For the primary endpoint, 91.5% of the per protocol cethromycin recipients (n = 224) achieved clinical cure, compared with 95.9% of the clarithromycin recipients (n = 221); cethromycin was considered noninferior to clarithromycin in this outcome measure (p = 0.0775). Furthermore, the incidence of adverse reaction was not significantly different between the cethromycin and clarithromycin groups. During the study, no serious adverse events associated with either drug were observed. There were also similar hepatic and cardiac side effect profiles reported for cethromycin and clarithromycin. The most frequent adverse events for the cethromycin recipients were mild-to-moderate diarrhoea, headache, nausea and vomiting. * Advanced Life Sciences Holdings, Abbott Laboratories; phase III in Europe, the US and a number of other countries for community- acquired pneumonia Advanced Life Sciences Holdings Inc. Cethromycin Achieves Primary Endpoint in Pivotal Phase 3 Pneumonia Clinical Trial. Media Release : 21 Jun 2007. Available from: URL: http://www.advancedlifesciences.com 809077157 1 Inpharma 30 Jun 2007 No. 1594 1173-8324/10/1594-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

Cethromycin promising for community-acquired pneumonia

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Page 1: Cethromycin promising for community-acquired pneumonia

Inpharma 1594 - 30 Jun 2007

Cethromycin promising forcommunity-acquired pneumoniaCethromycin* shows promise for the treatment of

mild to moderate community-acquired pneumonia,according to the results of a phase III study.

In the multicentre, randomised study, data wereevaluated from 522 such patients who receivedcethromycin 300mg once daily or clarithromycin 250mgtwice daily, for 7 days.

For the primary endpoint, 91.5% of the per protocolcethromycin recipients (n = 224) achieved clinical cure,compared with 95.9% of the clarithromycin recipients(n = 221); cethromycin was considered noninferior toclarithromycin in this outcome measure (p = 0.0775).

Furthermore, the incidence of adverse reaction wasnot significantly different between the cethromycin andclarithromycin groups. During the study, no seriousadverse events associated with either drug wereobserved. There were also similar hepatic and cardiacside effect profiles reported for cethromycin andclarithromycin. The most frequent adverse events forthe cethromycin recipients were mild-to-moderatediarrhoea, headache, nausea and vomiting.* Advanced Life Sciences Holdings, Abbott Laboratories; phase III inEurope, the US and a number of other countries for community-acquired pneumonia

Advanced Life Sciences Holdings Inc. Cethromycin Achieves Primary Endpoint inPivotal Phase 3 Pneumonia Clinical Trial. Media Release : 21 Jun 2007. Availablefrom: URL: http://www.advancedlifesciences.com 809077157