Drug Pipeline

Tight glucose control for a mean period of 6.5 years produces long-lasting cardiovascular benefits in patients with type 1 diabetes, according to a study published in the New England Journal of Medicine (NEJM).

FDA officials are reviewing an unexpected recommendation from the agency's Drug Safety and Risk Management Advisory Committee to add black box warnings to attention deficit/hyperactivity disorder (ADHD) stimulant medications. In addition to advising the agency about clinical trial designs that could better assess cardiovascular risks associated with ADHD therapies, members of the advisory committee called for immediate action to caution prescribers and patients about potential adverse events associated with these drugs. Concerns about increased risk of myocardial infarction, stroke, and sudden death have emerged with increased prescribing of stimulant ADHD drugs for adults and children?an estimated 4 million patients use these mediations, including more than 1 million adults.

Isradipine capsules 2.5 and 5 mg (equiv to Dynacirc capsules)

The serine protease inhibitor aprotinin (Trasylol, Bayer) may increase the risk of renal failure, myocardial infarction, heart failure, stroke, and encephalopathy among patients undergoing coronary artery bypass graft (CABG) surgery, according to an observational study in the New England Journal of Medicine (NEJM).

By increasing intestinal fluid secretion, lubiprostone increases motility in the intestine, thereby increasing the passage of stool and alleviating symptoms associated with constipation. Lubiprostone was approved on January 31, 2006, for the treatment of chronic idiopathic constipation (CIC) in adults.

The anti-anginal and anti-ischemic properties of ranolazine are not dependent on reductions in heart rate or blood pressure. Ranolazine was approved on January 27, 2006, for the treatment of chronic angina. Because ranolazine prolongs the QT interval, it should be reserved for patients who have not achieved an adequate response with other anti-anginal drugs.

The Medicare Prescription Drug Plan, which began January 1, 2006, makes the federal government the largest purchaser of pharmaceuticals in the United States, and probably in the world. It is projected that the Centers for Medicare and Medicaid Services (CMS) will spend more than $1 trillion on medications over the next decade, a volume that will influence the pharmaceutical market more broadly and generate new initiatives to encourage utilization of more cost-effective treatments.

Although experience tells us that formulary conversion programs are commonplace, they are discussed fairly infrequently in the literature. A recent MEDLINE search did not identify any conversion programs similar to a human growth hormone (HGH) program implemented at HIP Health Plan of New York (HIP-NY).

In an attempt to improve patient outcomes and control costs, a guide to empiric antimicrobial therapy, including a urinary tract infection (UTI) algorithm, was distributed to hospital physicians at an academic medical center. A retrospective study was conducted to assess the impact of the guide on physician prescribing of empiric antimicrobial therapy for UTIs. Prior to the implementation of the guide, 45% (n=55) of patients with UTIs were treated consistently with the algorithm. Although not statistically significant, consistency increased to 51% (n=45) after implementation of the guide. The initial publication of a guide to empiric antimicrobial therapy did not significantly influence physician prescribing patterns regarding UTIs. Educational sessions at the time of implementation along with reinforcement of the guidelines may further impact prescribing habits and influence algorithm compliance.

New inhalable insulin formulation approved

Kinase inhibitor approved for GIST and advanced renal cell carcinoma

Hydromorphone tablets 2, 4, and 8 mg (equiv to Dilaudid tablets)

Patients who have switched statins should receive special care as they are substantially less likely to be compliant and remain on the treatment long enough to obtain its full benefits, researchers reported in the American Journal of Managed Care.

Objective: Pharmacy-managed medication assistance programs (MAP) have the potential to recoup losses incurred by the pharmacy department, but whether this offsets the personnel cost of the program has not been well-established. The purpose of this study was to conduct a cost-benefit analysis of the pharmacy-managed MAP at an urban teaching clinic at Hartford Hospital in Hartford, Conn.

Hydromorphone tablets 2, 4, and 8 mg (equiv to Dilaudid tablets)

Moxifloxacin

Sorafenib tablets

The number-one health policy issue for the new year is to find ways to keep healthcare costs under control. An aging population and more costly medical technology could increase current spending trends. These developments could have an impact on efforts to reduce the number of uninsured people in the United States and could prompt initiatives to make consumers more aware of treatment costs and options.

Sitaxsentan, a highly selective endothelin-A (ET-A) receptor antagonist undergoing FDA review as an alternative to bosentan for pulmonary arterial hypertension (PAH) treatment, demonstrated improved efficacy over bosentan in a recent study.

The presence of antibodies to heparin is an independent risk factor for potentially serious complications following cardiac surgery, even in patients who do not develop heparin-induced thrombocytopenia (HIT), said David Kress, MD, at the 71st international scientific assembly of the American College of Chest Physicians in Montreal, Quebec, Canada.

A pivotal phase 3 trial of a fully human monoclonal antibody, denosumab, that prevents bone destruction is under way and includes 7,800 postmenopausal, osteoporotic women aged 60 to 90 years. The primary endpoint is new vertebral fractures versus placebo and secondary end points are safety and tolerability of the new agent. Phase 2 clinical trials have demonstrated that denosumab is superior to aldendronate in preserving bone mineral density (BMD), reported researchers during the American College of Rheumatology Annual Scientific Meeting in San Diego, Calif.

Beta blockers, touted for 3 decades as first-line drugs in the treatment of hypertension, are less than optimum in comparison to other antihypertensive drugs and raise the risk of stroke, according to a meta-analysis published online by The Lancet.

Patients who have switched statins should receive special care as they are substantially less likely to be compliant and remain on the treatment long enough to obtain its full benefits, researchers reported in the American Journal of Managed Care.

Utilizing statin therapy, researchers have provided further evidence that absolute reductions in LDL-C reduce the incidence of coronary heart disease (CHD) and other major vascular events.