American Thoracic Society: Gamma Interferon 1b in Idiopathic Pulmonary Fibrosis
Speaker: Christopher J. Lettieri, MD, Respiratory Care Specialist, Pulmonary and Critical Care Service, Department of Medicine, Walter Reed Army Medical Center, Washington, DC.
Treatment with gamma-interferon 1b (IFN) (Actimmune®, InterMune) resulted in enhanced functional capacity and improved exercise tolerance in patients with idiopathic pulmonary fibrosis (IPF) when compared with control patients with IPF who were given the usual standard of care and who showed progressive declines in pulmonary function tests and in the six-minute walking test.
Investigators conducted a retrospective review of IFN-treated patients and untreated patients to assess serial pulmonary function, including measured forced vital capacity (FVC), forced expiratory volume in one second (FEV1), total lung capacity (TLC), carbon dioxide lung-diffusing capacity (DLco), and distance covered during the six-minute walking test. Variables were measured at the start of IFN therapy and after 12 months of therapy in the treated patients and at baseline and 12 months later in the control group. Changes consisting of either a decline or an improvement at 12 months were determined as a percentage from baseline measures. eriacta
Sixty-two patients were identified; 29 received IFN, and 33 did not. Those receiving IFN tended to be older and had higher spirometry scores and longer distances in the six-minute walking test. In the untreated patients, variables declined significantly from baseline values: FVC decreased by 18.3%; FEV1, by 19.3%; DLco, by 7.6%; and distance walked, by 38.1%. In contrast, after 12 months of therapy, patients in the IFN group showed stable spirometry values: FVC improved by 3.5%, FEV1 improved by 2%, and DLco improved significantly, by 19.2%. Walking distances also increased significantly—by 37.3%.
Palivizumab for Prophylaxis of Respiratory Syncytial Virus Disease
Speaker: Alan H. Cohen, MD, Senior Director of Medical Affairs, MedImmune, Inc., Gaithersburg, Maryland.
Palivizumab (Synagis®, MedImmune), a humanized monoclonal antibody marketed for the prevention of respiratory syncytial virus (RSV) disease in high-risk children, appeared to be safe and effective in children younger than two years of age with cystic fibrosis (CF).
Because little information is available on the effects of RSV prophylaxis in young children with CF, a study was designed to evaluate the safety of the drug and the short-term outcomes and severity of RSV in the U.S. A total of 186 children were enrolled in a randomized, double-blind, placebo-controlled study that was conducted over three RSV seasons, beginning in November 1998. The children were randomly assigned to receive either palivizumab 15 mg/kg intramuscularly or placebo, administered monthly over one RSV season for five months. They were observed for 150 days to determine safety endpoints and for 300 days to determine additional clinical outcomes.
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overall, 97% of patients in each study group completed the study; 96% of the children in each group received all five monthly doses. The monthly administration of palivizumab had an acceptable safety profile, and the drug was well tolerated. The overall incidence of adverse drug events (ADEs) and serious ADEs was similar in the children who received active prophylaxis and in those who received placebo. No serious ADEs related to palivizumab were reported, and no children died during the study.
Clinically, patients receiving palivizumab had fewer positive RSV antigen results, including during outpatient testing, with only 13% of those receiving the active drug versus 23% of those receiving placebo. No clinically meaningful differences were seen between the groups for multiple outcomes at follow up.
Rimonabant in Maintenance of Smoking Cessation
Speaker: Raymond Nicura, PhD, Professor and Director of Research, The Center for Behavioral and Preventive Medicine, Brown Medical School and Butler Hospital, Providence, Rhode Island.
Patients who successfully stopped smoking cigarettes while taking rimonabant (Acomplia®, Sanofi-Aventis) experienced a decreased incidence of weight gain, a recognized barrier to successful abstinence from smoking. In a large-scale clinical trial, continued long-term therapy with rimonabant proved to be an effective, well-tolerated aid for maintaining smoking cessation and reducing post-cessation weight gain.
Initially, 5,055 cigarette smokers (those who smoked 10 or more cigarettes daily) who were motivated to quit smoking were enrolled in a multiple-country, multicenter, double-blind, five-arm, placebo-controlled, two-year clinical trial. The patients were randomly assigned to take either rimonabant 5 or 10 mg each day.
At the 10th week, 1,661 successful quitters were randomly reassigned to receive either (1) rimonabant 5 mg/day (for those already receiving 5 mg in the initial clinical trial) or placebo, or (2) rimonabant 5 or 20 mg/day or placebo (for those already receiving 20 mg a day in the initial clinical trial).
Active treatment was continued for 42 weeks, followed by a 50-week off-drug period. The primary endpoint was the efficacy of rimonabant in enabling patients to abstain from cigarette smoking. Secondary endpoints included body weight, tobacco craving, quality of life, safety, and tolerability.
For the patients taking rimonabant 5 mg daily, no effect on maintenance was observed. The patients who were re-randomized to take placebo had relapse rates similar to those of patients receiving maintenance therapy with rimonabant 5 mg/day.
In contrast, at 52 weeks, a significant proportion of patients receiving rimonabant 5 mg or 20 mg daily during the maintenance period, who had initially received rimonabant 20 mg daily, continued to abstain from tobacco use; 41.8% of patients receiving 5 mg/day and 41.5% of those receiving 20 mg/day were able to maintain abstinence, compared with 32.1% of the placebo patients. erectalis 20
Rimonabant 20 mg/day significantly reduced post-cessation weight gain in those who achieved abstinence; however, weight gain after quitting cigarettes was similar for patients taking placebo and for those taking rimonabant 5 mg/day.
Fasting high-density lipoprotein-cholesterol concentrations were significantly increased with rimonabant 20 mg/day (by 9%) compared with placebo (by 0.8%).
Fasting triglyceride levels were significantly reduced with rimonabant 20 mg/day (by -0.18 mmol/L), compared with placebo (by 0.09 mmol/L).