Fixed-dose combinations of drugs versus single-drug formulations for treating pulmonary tuberculosis

Carmen R Gallardo1, David Rigau Comas2, Angélica Valderrama Rodríguez3, Marta Roqué i Figuls4, Lucy Anne Parker5, Joan Caylà6, Xavier Bonfill Cosp7

1. Hospital Universitario San Juan de Alicante, Preventive Medicine and Healthcare Quality Service, Alicante, Alicante, Spain
2. Iberoamerican Cochrane Centre - Biomedical Research Institute Sant Pau (IIB Sant Pau), Barcelona, Catalonia, Spain
3. Hospital Universitari Germans Trias i Pujol. Universitat Autònoma de Barcelona, Clinical of Pharmacology Department, Barcelona, Spain
4. CIBER Epidemiología y Salud Pública (CIBERESP), Iberoamerican Cochrane Centre - Biomedical Research Institute Sant Pau (IIB Sant Pau), Barcelona, Catalunya, Spain
5. Universidad Miguel Hernández de Elche, CIBER Epidemiología y Salud Pública (CIBERESP), Department of Public Health, History of Science and Gynaecology, Alicante, Spain
6. Agència de Salut Pública de Barcelona, Biomedical Research Institute Sant Pau (IIB Sant Pau), CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain
7. CIBER Epidemiología y Salud Pública (CIBERESP) - Universitat Autònoma de Barcelona, Iberoamerican Cochrane Centre - Biomedical Research Institute Sant Pau (IIB Sant Pau), Barcelona, Catalunya, Spain

Gallardo CR, Rigau Comas D, Valderrama Rodríguez A, Roqué i Figuls M, Parker LA, Caylà J, Bonfill Cosp X. Fixed-dose combinations of drugs versus single-drug formulations for treating pulmonary tuberculosis. Cochrane Database of Systematic Reviews 2016, Issue 5. Art. No.: CD009913. DOI: 10.1002/14651858.CD009913.pub2.

To read the full review please follow this link: http://onlinelibrary.wiley.com/wol1/doi/10.1002/14651858.CD009913.pub2/full

What are fixed-dose combinations and how might they improve care of people with tuberculosis

Tuberculosis (TB) is an important health problem, especially in developing countries. The treatment for pulmonary TB in new patients includes four oral medicines taken for six months, sometimes as fixed-dose combinations (FDCs) that are combined in one tablet, or taken separately as single-drug formulations. The World Health Organization recommends prescribers use fixed-dose combinations to reduce the number of tablets that people take. On the supply side, this might reduce prescribing errors and improve drug supply efficiency; on the patient's side, FDCS simplify treatment and improve adherence.

We conducted a review to assess the efficacy, safety, and acceptability of FDCs compared with single-drug formulations for treating people with newly diagnosed pulmonary TB.

What the research says

We searched for relevant trials up to 20 November 2015, and included 13 randomized controlled trials that enrolled 5824 people. Trials were published between 1987 and 2015 and included participants in treatment with newly diagnosed pulmonary TB in countries with high TB prevalence. Only two trials reported the HIV status of included participants.

There is probably little or no difference in FDCs compared to single-drug formulations for treatment failure (moderate quality evidence); relapse may be more frequent (low quality evidence); and the number of deaths were similar (moderate quality evidence).

There is little or no difference in sputum smear or culture conversion (high quality evidence), and no difference was shown for serious adverse events (moderate quality evidence) or adverse events that led to discontinuation of therapy (low quality evidence).

Authors’ conclusions

We concluded that fixed-dose combinations have similar efficacy to single-drug formulations for treating people with newly diagnosed pulmonary TB.