Patients with multidrug-resistant tuberculosis may now
have another treatment option with delamanid, data from a multinational study
Researchers worldwide tested delamanid (Otsuka), a
nitro-dihydro-imidazooxazole derivative in patients with pulmonary MDR-TB. The
randomized, placebo-controlled trial included 481 patients who received 100 mg
delamanid twice daily, 200 mg twice daily or placebo for 2 months. The patients
also received the drug regimen recommended by WHO guidelines. Sputum cultures
were analyzed weekly.
Among patients who received 100 mg delamanid twice daily
with their background regimen, 45.4% demonstrated sputum conversion in liquid
broth by 2 months. In contrast, among patients who received placebo with their
background regimen, 29.6% had a sputum culture conversion in liquid broth.
Among those who received 200 mg delamanid with their background regimen, 41.9%
had a sputum culture conversion. All of these findings were similar in sputum
culture conversions in solid medium.
Figure 1. Lea Pehme, MD, and nurse Evi Kivi are examining a chest X-ray for signs of pulmonary tuberculosis at the Tartu University Clinics in Tartu, Estonia.
Figure 2. A patient in the TB ward at the Hospital Nacional Sergio E. Bernales in Lima, Peru.
Images: Venturi R; Otsuka
Adverse events were similar across all of the treatment
arms, and were mild to moderate in severity. There were fewer adverse events
among patients receiving 100 mg delamanid twice daily compared with those
receiving the 200 mg twice-daily dose. Although no episodes of prolonged QT
interval were associated any clinical events, the frequency of prolonged QT
interval was higher in the delamanid groups compared with the placebo group.
“A second large, randomized, controlled trial of 6
months of treatment with delamanid as part of a full background drug regimen
and including patients who have coinfection with HIV and are receiving ART has
been initiated and is designed to provide data on 30 months of follow-up
patients,” the researchers wrote. “It is important to learn more
about the use of delamanid in combination with other new and existing
antimycobacterial agents to develop better regimens for multi-drug resistant
Gler MT. N Engl J Med. 2012;366:2151-2160.
The researchers report no relevant financial