Varenicline for smoking cessation: a placebo-controlled, randomized study.

BACKGROUND AND OBJECTIVE: Varenicline tartrate, a novel, selective, nicotinic acetylcholine receptor partial agonist, has been developed specifically as a smoking cessation drug. This study evaluated the efficacy of a standard regimen of varenicline compared with placebo for smoking cessation in 333 subjects in China, Singapore and Thailand. METHODS: This 24-week, randomized, double-blind, placebo-controlled trial of varenicline, 1 mg bd, consisted of a 12-week treatment period followed by a 12-week non-treatment follow-up period. The primary study end-point was the 4-week continuous abstinence rate defined as the proportion of subjects who reported total abstinence from smoking and other nicotine products from weeks 9-12. A key secondary end-point was the continuous abstinence rate from weeks 9-24, defined as the proportion of subjects who achieved the primary end-point as well as total abstinence from all tobacco products from weeks 13-24. RESULTS: Both end-points were achieved by a significantly higher proportion of subjects in the varenicline group than in the placebo group. The 4-week continuous abstinence end-point was achieved by 50.3% and 31.6% in the varenicline and placebo groups, respectively (P = 0.0003), while continuous abstinence from weeks 9-24 was achieved by 38.2% and 25.0% of subjects, respectively (P = 0.0080). The treatment effect was generalizable by treatment centre and country. Varenicline was safe and appeared to be well tolerated by most subjects. CONCLUSION: Varenicline was significantly more efficacious for smoking cessation than placebo over a 12-week treatment period and a further 12-week non-treatment follow-up period in smokers from China, Singapore and Thailand. No significant side-effects were noted.

Rigid bronchoscopy and stenting for esophageal cancer causing airway obstruction.

BACKGROUND: Thirty percent of patients with esophageal cancer have malignant involvement of the major airways, leading to respiratory distress and life-threatening major airway obstruction. Tracheobronchial stenting has been reported to be effective in providing sustained relief from obstruction. METHODS: We conducted a chart review of all patients with advanced inoperable esophageal cancer who had malignant tracheobronchial obstruction requiring rigid bronchoscopy and airway stenting at our institution between June 1998 and July 2001. Outcome measures, which included survival, efficacy, and complications, were recorded. RESULTS: There were 11 patients (4 women) with a mean age of 61 years. Five patients had distant metastases at the time they underwent rigid bronchoscopy. Four patients who required mechanical ventilation for respiratory failure were successfully weaned off mechanical ventilation after the stenting procedure. All patients with dyspnea had immediate relief of respiratory symptoms, which was sustained for seven patients (64%). The mean duration of survival was 61 days. Two patients required repeat procedures, one for stent dislodgment on extubation and the other for stent migration. CONCLUSION: Stenting in patients with malignant tracheobronchial obstructions due to advanced esophageal cancer achieves immediate, dramatic, and sustainable relief in respiratory symptoms, conferring a survival benefit in patients whose conditions are otherwise deemed to be terminal.