Diabetes mellitus comorbidity in patients enrolled in tuberculosis drug efficacy trials around the world: A systematic review

Autor: Michelle J Pena, Muhammad Zubair, Job F M van Boven, Nurul Cholifah Lutfiana, Jan-Willem C. Alffenaar
Rok vydání: 2019
Předmět:
Drug
medicine.medical_specialty
Drug trial
Tuberculosis
CONVERGING EPIDEMICS
PULMONARY TUBERCULOSIS
media_common.quotation_subject
Antitubercular Agents
review
Comorbidity
030226 pharmacology & pharmacy
law.invention
Efficacy
DOUBLE-BLIND
03 medical and health sciences
0302 clinical medicine
Randomized controlled trial
Risk Factors
law
Internal medicine
Diabetes mellitus
Tuberculosis
Multidrug-Resistant
Diabetes Mellitus
Prevalence
Humans
Medicine
Pharmacology (medical)
030212 general & internal medicine
MULTIDRUG-RESISTANT TUBERCULOSIS
Risk factor
EARLY BACTERICIDAL ACTIVITY
media_common
Pharmacology
Clinical Trials as Topic
diabetes
Systematic Review and Meta‐analysis
business.industry
drug trials
RESEARCH AGENDA
OPEN-LABEL
medicine.disease
RANDOMIZED-TRIAL
tuberculosis
TREATMENT OUTCOMES
business
HIGH-DOSE VITAMIN-D-3
Zdroj: British Journal of Clinical Pharmacology
ISSN: 1365-2125
0306-5251
DOI: 10.1111/bcp.13935
Popis: AIMS: With a prevalence of 16%, diabetes mellitus (DM) is one of the most frequent non-communicable comorbidities of tuberculosis (TB). DM is a major risk factor for adverse TB outcomes and may require personalized TB drug dosing regimens. However, information on the inclusion of DM in TB drug trials is lacking. We aimed to assess the percentage of recent TB drug efficacy trials that included DM patients. METHODS: A systematic review was performed and reported according to PRISMA guidelines. PubMed, Science Direct, and ClinicalTrials.gov databases were systematically searched for TB drug trials published between January 1 2012 to September 12 2017. Primary outcome was the percentage of TB drug trials performed around the world that included DM patients. RESULTS: Out of the included 41 TB drug trials, 12 (29.3%) reported DM comorbidity among the study participants. Nine trials (21.9%) excluded all patients with DM comorbidity, ten (24.4%) excluded only insulin-dependent or uncontrolled DM, and 10 (24.4%) did not mention whether DM was included or excluded. Of the 12 trials that included DM comorbidity, the majority did not report the diagnostic criteria for DM and none reported outcomes in the DM sub-population. Inclusion of DM was higher in drug-resistant-TB trials (67%, p=0.003, versus drug-susceptible) and trials performed in Asia (60%, p=0.006, versus Africa). CONCLUSIONS: Less than one in three recent TB drug trials reported the inclusion of DM. To better reflect real-world DM prevalence and differential TB drug effectiveness, inclusion of DM patients requires increased attention for future TB drug trials.
Databáze: OpenAIRE
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