o for two months, (p<0.001; RR 1.35 [1.17-1.56]). Only two pt deaths (1.0%) occurred in the long-term treatment group, while 19 (8.3%) occurred in the short-term treatment group; this difference was statistically significant (p<0.001; RR = 0.13 [0.03-0.53]) [6].
09/10/2012 17:24:38
Otsuka is conducting a randomised, double-blind, placebo-controlled PIII trial to assess the safety & efficacy of delamanid 200mg daily for 6 months in pts with pulmonary sputum culture-positive, multidrug-resistant TB (NCT01424670). The primary outcome measure is the proportion of pts who achieve sputum culture conversion at 2 months. The trial is expected to enrol 390 pts in Estonia, Latvia & Lithuania. As of Sep 11, the trial was actively recruiting in Latvia & Lithuania. Data collection for the primary outcome is expected to complete in Aug 13 [4,5].
10/08/2012 10:41:43
Jun 12: Results from PIIb trial (n=481) showed a 53% increase in sputum culture conversion (SCC) after two months between study subjects receiving delamanid 100 mg BD plus a background regimen consistent with WHO treatment guidelines compared with subjects receiving placebo plus background regimen alone. 45.4% of subjects in the delamanid 100 mg BD group and 41.9% of subjects in the delamanid 200 mg BD group, vs. 29.6% in the placebo group, achieved SCC in the Mycobacterial Growth Indicator Tube (MGIT) system after two months of treatment (p=0.008 and 0.039 respectively). [1]
08/06/2012 08:35:37
Evidence Based eva luations
EPAR http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002552/WC500166234.pdf
EMA doc http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500146651
References
Available only to registered users
Category
BNF Category: Antituberculous drugs (05.01.09)
Pharmacology: a nitro-dihyroimidaz-oxazole derivative that inhibits mycolic acid synthesis, inhibiting formation of the mycobacterial cell envelope
Epidemiology: In 2010 there were 8,587 cases of TB in the UK (13.9 per 100,000), a 6% reduction on the previous year. Higher incidence rates occur in some areas of the UK, and those with incidences >40/100,000 have immunisation policies to prevent spread. Pulmonary TB accounts for 60% of TB in the UK. [2]
Indication: Tuberculosis
Additional Details: multi-drug resistant
Method(s) of Administration
Oral
Company Information
Name: Otsuka
US Name: Otsuka
NICE Information
In timetable: No
When: /
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