Economists and health experts on all sides are clamoring for more evidence on how medical products and procedures compare in safety, efficacy and cost. Legislative proposals before Congress include a range of initiatives to spur more comparative effectiveness (CE) research.
Trumpeting the now-popular battle cry of transparency, many states are attempting to control the contractual arrangements between pharmacy benefit services providers and their clients. Because of the historical issues around hidden revenue streams and misaligned objectives, it is no wonder the public sector is taking note.
State regulation of pharmacy benefit managers (PBMs) would benefit states and consumers by providing a regulatory framework for the only entity involved in delivery of a healthcare benefit to the consumer that is largely unregulated.
Briefs of FDA actions/approvals of drugs, doses, and indications
A summary of several automated IV and syringe preparation systems and a discussion of the technology's impact on pharmacy efficiency.
A phase 3 study evaluating the use of gabapentin alone and in combination with an antidepressant in women with hot flashes who had an inadequate response with antidepressant monotherapy demonstrated that gabapentin reduced hot flashes by approximately 50%, whereas the combination of an anti-depressant with gabapentin appeared to offer no additional benefit.
A review of agents in late-stage development for the treatment of HIV/AIDS (May 2007).
Briefs of FDA actions/approvals of drugs, doses, and indications
Pediatric exclusivity program and generic biotech therapies as related to PDUFA IV.
Results of a study conducted to determine whether users of nonformulary blood glucose meters would increase their formulary compliance if they were provided with targeted information and an offer for a free formulary meter.
A summary of several automated IV and syringe preparation systems and a discussion of the technology's impact on pharmacy efficiency.
Patients with silent ischemia but no coronary artery disease (CAD) may benefit from treatment with antianginal drug therapy, according to results of The Swiss Interventional Study on Silent Ischemia Type I (SWISS II)
Nicotine patches used for smoking cessation are safe in patients with coronary artery disease (CAD) and active stress-induced myocardial ischemia, according to the results of a randomized trial.
An 80-mg dose of atorvastatin administered 12 hours before angioplasty, followed by a 40-mg dose administered 2 hours before the procedure significantly reduces the risk of major cardiovascular events during the month after the intervention, according to the results of The Atorvastatin for Reduction of Myocardial Damage during Angioplasty-Acute Coronary Syndromes (ARMYDA-ACS) trial.
Results of FUSION II, a randomized, double-blind, placebo-controlled study involving 920 patients with stage D chronic decompensated HF, presented at the 56th Annual Scientific Session of the ACC.
New research presented at the AAD's 65th Annual Meeting regarding treatment of biologic psoriasis with adalimumab and efalizumab.
A meta-analysis of randomized controlled trials demonstrated that anticoagulant prophylaxis of hospitalized patients statistically significantly reduced their risk of developing both a pulmonary embolism (PE) and deep vein thrombosis (DVT).
Intensive statin therapy in elderly patients may be more effective than moderate statin therapy in improving lipid levels and reducing all-cause death, according to a prospective, international, multicenter, randomized, double-blind, double-dummy, parallel-arm trial in elderly patients with documented coronary artery disease (CAD).
Patients with osteoarthritis or rheumatoid arthritis who are taking etoricoxib may experience significantly fewer upper gastrointestinal (GI) events compared with those taking diclofenac, according to the pooled results of 3 randomized trials.
Sorafenib significantly improves progression-free survival in patients with advanced clear-cell renal-cell carcinoma, according to results from a phase 3, randomized, double-blind, placebo-controlled trial.
In a systematic review and meta-analysis, the use of beta-carotene, vitamin A, and vitamin E, either alone or combined, was associated with an increased risk of all-cause mortality.
Prospective treatment with rosuvastatin can slow the hemodynamic progression of asymptomatic aortic stenosis. This was the conclusion of the prospective, open-label Rosuvastatin Affecting Aortic Valve Endothelium (RAAVE) trial.
In a randomized, double-blind, parallel-group trial, triple therapy with tiotropium plus salmeterol (SAL) and fluticasone failed to reduce the proportion of patients with chronic obstructive pulmonary disease (COPD) experiencing exacerbations requiring treatment with systemic corticosteroids and/or antibiotics (the primary end point) compared with tiotropium plus salmeterol or tiotropium alone.
The combination of aspirin (ASA) and oral anticoagulation (OAC) significantly reduces the odds of thromboembolism, but has no effect on all-cause mortality versus OAC alone, according to a systematic review and meta-analysis.
A post-hoc analysis invloving 4 prospective, randomized trials demonstrated that treatment of CAD with statins increases HDL-C, and the increases correlate with a positive impact on disease progression.
A phase 3 study evaluating the use of gabapentin alone and in combination with an antidepressant in women with hot flashes who had an inadequate response with antidepressant monotherapy demonstrated that gabapentin reduced hot flashes by approximately 50%, whereas the combination of an anti-depressant with gabapentin appeared to offer no additional benefit.
Patients who fail to adhere to warfarin therapy as prescribed are more likely to experience problems with anticoagulation control, according to the authors of the International Normalized Ratio Adherence and Genetics (IN-RANGE) study.
Alteplase demonstrated to be safe and effacious for use in treatment of stroke within 3 hours of onset, according to a large multicenter, observational study.
Treament of hypertension with a polypill is more effacious than single-drug treatment, according to a randomized, controlled, open-label trial.
