News

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.

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.

Results of a double-blind, randomized, contolled trial of vildagliptin versus rosiglitazone demonstrate similar efficacy and tolerability in patients with type 2 diabetes.

Pulmonary arterial hypertension (PAH) is a disease state characterized by vascular narrowing and increased pulmonary vascular resistance. Physical symptoms, which may include fatigue or weakness, exertional dyspnea, and peripheral edema, are often nonspecific and can mimic more common disorders encountered in clinical practice. Healthcare professionals have been limited in which medications could be used to treat this condition because clinical data have been scarce. Recently, multiple new classes of medications, many of which are very costly, have become available; these agents offer physicians more therapeutic options for the treatment of PAH. Managed-care organizations have been challenged with suggesting the appropriate place in therapy for these new agents, as well as ensuring their safe and cost-effective utilization. This review summarizes the data available for the drugs used to treat PAH, with the goal of helping organizations to make appropriate decisions regarding the proper use of these agents.

Briefs of FDA actions related to medication safety and reliability (ie, boxed warnings, dear healthcare provider letters)

A large retrospective cohort study demonstrated an increased risk of suicide with use of the antidepressant venlafaxine.

First-time generic drug approvals: Nadolol/bendroflumethiazide and ciprofloxacin

The latest FDA action (through May 2007) related to armodafinil (Nuvigil), tacrolimus (Prograf), sipuleucel-T (Provenge), Etoricoxib (Arcoxia), AZD-103/ELND005 (Transition), rNAPc2, Satraplatin, and Ganciclovir

Levetiracetam (Keppra) is now approved by FDA as an antiepileptic agent for adjunctive therapy in treatment of primary generalized tonic-clonic seizures in patients with idiopathic generalized epilepsy.

HepaGam B, a solution of hepatitis B immune globulin (human), is now approved by FDA for the prevention of hepatitis B recurrence after liver transplantation in HBsAg-positive patients.

The combination of sitagliptin/metformin is now approved by FDA to improve glycemic control in adult patients with type 2 diabetes mellitus.

While new breeds of consumer medical devices-as well as healthcare-oriented variations of existing devices, such as cell phones, computers and televisions-might hold enormous promise, stakeholders across the industry agree that formidable technical, regulatory, security and reimbursement obstacles continue to stand in the way. The current healthcare delivery model is under pressure, which has many anticipating an alternative model of care that places greater emphasis on technologically advanced in-home care and monitoring.

LOW-PREVALENCE rheumatoid arthritis (RA) has not gained attention equal to that of more common chronic diseases, but it has earned a spot on the list of complex diseases ripe for disease management.

LOW-PREVALENCE rheumatoid arthritis (RA) has not gained attention equal to that of more common chronic diseases, but it has earned a spot on the list of complex diseases ripe for disease management.

Providing quality health care while watching the bottom line is the eternal balancing act for managed care organizations. Outpatient rehabilitation - an often-neglected area - stands to significantly impact quality and the bottom line.

Healthcare organizations are intimately familiar with intense prosecutorial scrutiny resulting from the government's battle against fraud and corruption. There are prominent examples of focused federal fraud investigations, resulting in hefty settlements. Congress has now enlisted the healthcare industry in their campaign against fraud.

As more health plans turn to automated, speech-enabled calls to reach out to members with welcome programs, preventive health reminders, or with more sensitive information about a specific condition, they must use an appropriate approach. Done correctly, such phone programs can provide a cost-effective way to speak with members.

THE BEST STEP therapy programs first consider medical evidence regarding patient outcomes when identifying drug classes for inclusion, according to industry experts.

IN THE PAST TWO DECADES, the progress of pharmacy benefit management has brought about sophisticated strategies including formularies, utilization management and generic substitution. David B. Snow Jr., CEO of Medco Health Solutions, is bargaining that the next decade of pharmacy benefit management will bring enhanced patient therapy, personalized medicine and dramatic opportunities in the generic market-points all pharmacy benefit teams will have to ponder.