Rimstar 4- FDC Clinical trial
In the 1990s, the WHO and other health organizations recommended the use of fixed dose combinations (FDCs) as a further step to help ensure simplified but standardized and adequate treatment regimen. This recommendation was based on the assumption as long as four drug FDCs (4- FDC) could provide the same satisfactory bioavailability of individual drugs, its efficacy would be equivalent to that of single drug formulations1. However, the WHO did not at that time have enough data from clinical trials to be able to make the recommendation to switch to single-drug formulations. The WHO still had to recommend that TB patients take four separate pills in order to beat their disease.
In the meantime, Sandoz had developed a four-drug combination: Rimstar 4- FDC, which contained Rifampicin, Isoniazid, Ethambutol Hydrochloride and Pyrazinamide in one tablet; as well as a two-drug combination- Rimactazid 150/75. Although the advantages of Fixed Dose Combinations for TB treatment were well known, practical experience with 4-FDCs was limited then1. Recognizing the need for more data, in 2002, Sandoz initiated a multinational, multi-centric clinical trial to assess the efficacy; safety and acceptability of short course regimen given as Rimstar 4- FDC compared with individual anti- TB drugs in patients with newly diagnosed smear positive pulmonary tuberculosis.
This prospective, open, randomized multicenter, multinational study was conducted in 26 centres in five countries - India, Pakistan, Thailand, Philippines and Egypt - and included 1159 patients with sputum smear- positive PTB. The study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice standards and the drug laws of the respective countries; the study protocol was approved by each local responsible ethics committee and signed informed consent was observed before inclusion.
The study demonstrated the overall efficacy of the Rimstar 4-FDC regimen as compared to the previous four-drug regimen, and significantly improved patient acceptability. The results of the study further helped improve the confidence of the physicians to prescribe fixed dose combinations is the treatment of tuberculosis.
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