Clinical therapeutics
-
Clinical therapeutics · Oct 2005
Randomized Controlled Trial Multicenter Study Comparative StudyRosiglitazone/metformin fixed-dose combination compared with uptitrated metformin alone in type 2 diabetes mellitus: a 24-week, multicenter, randomized, double-blind, parallel-group study.
Management of type 2 diabetes mellitus (DM) that involves uptitration of monotherapy to the maximum dose has been associated with delays in achieving glycemic control and an increased number of adverse events (AEs). Studies have reported the benefits of adding a thiazolidinedione to metformin (MET), but none has compared the effect of adding a thiazolidinedione to MET versus increasing the daily dose of MET to 3 g. ⋯ In this study, the RSG/MET fixed-dose combination (8 mg/2 g per day) was an effective and well-tolerated treatment for type 2 DM and enabled more patients to reach glycemic targets than high-dose MET (3 g/d).
-
Clinical therapeutics · Oct 2005
Randomized Controlled Trial Multicenter StudyTriple therapy with glimepiride in patients with type 2 diabetes mellitus inadequately controlled by metformin and a thiazolidinedione: results of a 30-week, randomized, double-blind, placebo-controlled, parallel-group study.
This study evaluated the efficacy and tolerability of glimepiride in patients with type 2 diabetes mellitus that was inadequately controlled with a combination of immediate- or extended-release metformin and a thiazolidinedione. ⋯ In these patients with type 2 diabetes that was not adequately controlled by dual combination therapy with metformin and a thiazolidinedione, the addition of glimepiride improved glycemic control compared with placebo with an acceptable tolerability profile. Although there were significantly more episodes of hypoglycemia with triple therapy than with dual therapy and placebo, the risk for severe hypoglycemia was low.
-
Clinical therapeutics · Oct 2005
Randomized Controlled Trial Multicenter StudySafety profile of a nicotine lozenge compared with that of nicotine gum in adult smokers with underlying medical conditions: a 12-week, randomized, open-label study.
Nicotine polacrilex lozenges deliver 25% to 27% more nicotine compared with equivalent doses of nicotine polacrilex gum. The increased nicotine exposure from the lozenge has raised questions about the relative safety of the lozenge and gum. ⋯ The 4-mg nicotine lozenge and 4-mg nicotine gum had comparable safety profiles in these patients with label-restricted medical conditions.
-
Clinical therapeutics · Oct 2005
ReviewErlotinib: small-molecule targeted therapy in the treatment of non-small-cell lung cancer.
Erlotinib is an oral tyrosine kinase inhibitor, targeting the human epidermal receptor type 1/ epidermal growth factor receptor, recently approved by the US Food and Drug Administration (FDA) for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) after the failure of more than 1 or 2 previous chemotherapeutic regimens. ⋯ For patients with NSCLC in whom more than 1 or 2 previous chemotherapeutic regimens have failed, erlotinib is an effective therapy with significant overall survival benefits. The use of erlotinib as first-line therapy in combination with platinum-based chemotherapeutic regimens, however, has failed to demonstrate efficacy in the treatment of NSCLC.