Introduction of bedaquiline for the treatment of drug-resistant TB in the Philippines.

Treatment outcomes in patients with drug-resistant tuberculosis (DR-TB) remains unsatisfactory in the Philippines. To address this, we implemented the use of new anti-TB drugs and novel regimens. The Philippine National Tuberculosis Control Program (NTP) participated in the Bedaquiline (BDQ) Donation Program created by the US Agency for International Development and Janssen. Despite availability of donated medicine, there was a delay in the implementation of BDQ, both under operational research and programme conditions. The main challenges encountered were delayed approval by national and institutional ethics boards; limited experience of the NTP in the conduct of operational research into new drugs; and the lack of confidence of healthcare staff in the use of new and re-purposed anti-TB drugs. Technical assistance from partners and capacity building on clinical management of DR-TB and on pharmacovigilance among health workers were vital in overcoming these challenges. Over a 3-year period (from 2016-2018), 448 patients were initiated on BDQ-based regimens.

Efficacy and safety of budesonide/formoterol compared with salbutamol in the treatment of acute asthma.

This study compared the efficacy and safety of budesonide/formoterol (Symbicort) Turbuhaler)) with salbutamol pressurized metered-dose inhaler (pMDI) with spacer for relief of acute bronchoconstriction in patients with asthma. In this randomized, double-blind, parallel-group study, patients (n = 104 allocated to treatment; n = 103 received treatment; mean age 45 years) seeking medical attention for acute asthma (mean FEV(1) 43% of predicted) received two doses repeated at t = -5 and 0 min of either budesonide/formoterol (320/9 microg, two inhalations) or salbutamol (100 microg x eight inhalations); total doses 1280/36 microg and 1600 microg, respectively. All patients received prednisolone 60 mg at 90 min and FEV(1) was assessed over 3h. FEV(1) 90 min after dosing (primary variable) increased compared with pre-dose FEV(1) by an average of 30% and 32% for budesonide/formoterol and salbutamol, respectively (P = 0.66), with similar increases at all timepoints from 3 to 180 min for both groups. Mean pulse rate over 3h was significantly higher in the salbutamol group versus the budesonide/formoterol group (92 vs. 88 bpm; P < 0.01). No treatment differences were seen for other vital signs, including ECG. High-dose budesonide/formoterol was effective and well tolerated for the treatment of acute asthma, with rapid onset of efficacy and a safety profile over 3h similar to high-dose salbutamol.