Generic versus Non-Generic Formulation of Extended-Release Clarithromycin in Patients with Community-Acquired Respirator
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Clin Drug Invest 2009; 29 (4): 265-274 1173-2563/09/0004-0265/$49.95/0
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Generic versus Non-Generic Formulation of Extended-Release Clarithromycin in Patients with Community-Acquired Respiratory Tract Infections A Prospective, Randomized, Comparative, Investigator-Blind, Multicentre Study J.R. Snyman,1 H.S. Schoeman,2 M.P. Grobusch,3 M. Henning,4 W. Rabie,5 M. Hira,6 K. Parshotam,7 Y. Mithal,8 S. Singh9 and Z. Ramdas9 1 Department of Pharmacology, School of Medicine, University of Pretoria, Pretoria, South Africa 2 Private Consultant Biostatistician, Pretoria, South Africa 3 Infectious Disease Unit, Department of Clinical Microbiology and Infectious Diseases, NHLS and School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa 4 Vermaak and Partners Pathologists, Centurion, South Africa 5 Department of Family Medicine, University of the Free State, Bloemfontein, South Africa 6 Tshepong Health Centre, Johannesburg, South Africa 7 Private Practice, Roodepoort, South Africa 8 Private Practice, Johannesburg, South Africa 9 Ranbaxy (SA) (Pty) Ltd, Centurion, South Africa
Abstract
Background and objective: There is a general concern about the use of multisource (generic) antibacterials in the clinical setting with registration based solely on bioequivalence data. In order to address this concern, two modifiedrelease formulations of clarithromycin (i.e. the originator Klacid XL and the generic Klarithran MR) were compared in patients with acute communityacquired respiratory tract infections. Methods: Patients presenting with tonsillopharyngitis, sinusitis or pneumonia were randomized to receive either of the test drugs provided they clinically qualified for empirical clarithromycin treatment. The study endpoints were clinical and bacteriological cure rates, tolerability and safety. The study was designed to test for non-inferiority with regard to cure rates. Results: The main outcome of this study was that both agents had similar clinical (non-inferior) and bacteriological cure rates and demonstrated no difference in tolerability in patients. The study also demonstrated the clinical efficacy of clarithromycin when used as empirical treatment in patients with respiratory tract infections in community practice (i.e. 95% clinical cure rate).
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Conclusion: The clarithromycin extended-release multisource product (Klarithran MR) does not differ significantly from the originator (Klacid XL) and the clinical cure rate of the generic formulation is non-inferior to that of the originator. The two formulations are tolerated similarly.
Background Community-acquired respiratory tract infections (RTIs) are among the most prevalent infectious diseases in the developing world and constitute a substantial socioeconomic burden.[1] In 1990, lower RTIs were responsible for 4.3 million premature deaths worldwide.[1] RTIs are a major reason for patient visits to primary-care physicians but because of the usual benig
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