Outlook: Clinical Trials

Pharmacy TimesAugust 2009
Volume 75
Issue 8

www.PharmacyTimes.com Pharmacy Times | 08.09 n 93 Novel Diabetes Drug Enhances Glucose Control, Reduces Weight Albiglutide (Syncria) significantly reduced blood glucose levels and provided weight loss across weekly, biweekly, and monthly dosing, according to phase 2 data presented at the American Diabetes Association 69th Scientific Sessions in New Orleans. The randomized, multicenter, double-blind, parallel-group study enrolled 356 type 2 diabetes patients previously treated with diet and exercise or metformin (mean baseline A1C 8%). Patients received either subcutaneous placebo, alb iglutide weekly (4, 15, or 30 mg), biweekly (15, 30, or 50 mg), or monthly (50 or 100 mg), or exenatide (open-label reference arm, in metformin-treated patients) over 16 weeks. Dose-dependent reductions in A1C with albiglutide 30 mg weekly, 50 mg biweekly, and 100 mg monthly were 0.9%, 0.8%, and 0.9%, respectively (P<.05). The A1C reduction by placebo was 0.2%. Open-label exenatide A1C reduction was 0.5%. Weight loss (approximately 2-4 lb) was observed across all doses. NEWS & VIEWS OUTLOOK Increased Valganciclovir Duration Better Protects Transplant Patients Doubling the duration of prophylaxis with oral valganciclovir (Valcyte) reduced the incidence of cytomegalovirus (CMV) disease by 56% in high-risk kidney transplant patients within the first year posttransplant, according to the results of a phase 3 study. The global, multicenter, double-blind IMPACT (Improved Protection Against Cytomegalovirus in Transplant) study randomized 326 high-risk kidney allograph recipients to either 100 days of treatment with valganciclovir (900 mg once daily) post-transplant followed by 100 days of placebo, or 200 days of valganciclovir (900 mg once daily) posttransplant. The results showed that the 200-day valganciclovir treatment prevented CMV disease in 84% of patients and reduced the incidence of CMV disease by 56%, compared with the 100-day valganciclovir treatment. The data were presented at the 9th annual American Transplant Congress 2009. Tobramycin inhalation powder (TIP) showed improved lung function in cystic fibrosis (CF) patients with respiratory Pseudomonas aeruginosa infection, compared with placebo, according to the results of a phase 3 placebo-controlled study. The investigational formulation of tobramycin also decreased sputum P aeruginosa density, hospitalization, and other antibiotic use, compared with placebo. For the study, patients with CF were given treatment with TIP 112 mg twice daily or matching placebo in a 1:1 ratio during cycle 1 (28 days on and 28 days off treatment). This was followed by 2 cycles during which all patients received TIP. The primary efficacy variable was relative change in forced expiratory volume in 1 second (FEV1) percent predicted from day 1 to day 28 of cycle 1. Patients on TIP showed a significant improvement in FEV1% predicted with an average improvement of 13%, compared with placebo (P = .0016) at 28 days. At the end of the first full cycle (day 56), improvement over placebo in predicted lung function was maintained. The results of the study were presented at the American Thoracic Society 2009 International Conference in San Diego. n Better Lung Function with Respiratory Infection Drug for Cystic Fibrosis Patients Clinical Trials Everolimus Shows Antitumor Effect in Patients with Multiple Lymphomas Data from a phase 2 study showed that everolimus (Afinitor) tablets significantly reduced tumor size by 50% or more in 1 of 3 patients with refractory or relapsed lymphoma. The results of the open-label trial of 145 lymphoma patients, presented at the 14th annual European Hematology Association congress in Berlin, Germany, showed the 33% overall response rate, which is defined as complete or partial tumor shrinkage (95% confidence interval [CI], 26%-41%). The median time to disease progression for all 145 patients was 4.3 months (95% CI, 3.6-5.9 months), and the median duration of response for the 48 responders was 6.8 months (95% CI, 5.4-11 months). The disease did not progress at all at 6 months for 19 of the responders. A phase 3 trial is under way to investigate adjuvant treatment with everolimus in preventing relapse in patients with diffuse large B-cell lymphoma.

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