Formulary Watch

The use of regular aspirin by individuals aged 40 and older who have been newly diagnosed with type 2 diabetes is a cost-effective treatment strategy, according to a study in the June issue of Diabetes Care, as reported by HealthDay News.

In patients with type 2 diabetes, a once-weekly formulation of exenatide (Byetta, Amylin Pharmaceuticals) is associated with sustained improvements in glycemic control and body weight over 52 weeks, and patients who switch from a twice-daily to a once-weekly regimen have further improvements in hemoglobin A1C and fasting plasma glucose, according to research published in the June issue of Diabetes Care, as reported in HealthDay News.

The use of certain nonsteroidal anti-inflammatory drugs (NSAIDs) by healthy people is associated with an increased risk of cardiovascular death, but naproxen (Aleve, Bayer Consumer) appears to have a safer cardiovascular risk profile, according to a study published online June 8 in Circulation: Cardiovascular Quality and Outcomes, as reported by HealthDay News.

The use of certain nonsteroidal anti-inflammatory drugs (NSAIDs) by healthy people is associated with an increased risk of cardiovascular death, but naproxen (Aleve, Bayer Consumer) appears to have a safer cardiovascular risk profile, according to a study published online June 8 in Circulation: Cardiovascular Quality and Outcomes, as reported by HealthDay News.

Hormone replacement therapy (HRT) skin patches containing low doses of estrogen carry less risk of stroke than oral therapy and may represent a safer alternative, according to a study conducted by researchers at the Lady Davis Research Institute of the Jewish General Hospital, published June 4 in the British Medical Journal.

Using massively parallel gene sequencing technology, researchers were able to identify specific genetic mutations that appear to be predictive of response to a drug commonly administered for metastatic colorectal cancer.

Five-year data from a seminal study in patients with type 2 diabetes who are at especially high risk of heart disease show that intensive glucose control does slow the progression of microvascular disease, but mortality is increased and there is no benefit on macrovascular complications.

A new post-hoc study of rosiglitazone and cardiac events in patients with type 2 diabetes is adding to the controversy surrounding the thiazolidinedione (TZD) agent. Lead author Richard Bach, MD, associate professor of medicine, Washington University, St. Louis, Mo., presented the new data during a late-breaking clinical study symposium Tuesday morning at the 70th Scientific Sessions of the American Diabetes Association, taking place in Orlando, Fla.

New data are changing the way gestational diabetes is diagnosed and treated.

Hemophilia: Etiology, complications, and current options in management; Rifaximin: A nonabsorbable, broad-spectrum antibiotic for reduction in the risk for recurrence of overt hepatic encephalopathy; Agents in late-stage development for the treatment of female and male cancers

Agents in late-stage development for the treatment of female and male cancers.

New Molecular Entity: Denosumab (Prolia) was approved in June as a treatment for postmenopausal osteoporosis in women at high risk for fracture.

Forty-two cases of progressive multifocal leukoencephalopathy (PML) in patients receiving the humanized monoclonal antibody natalizumab have been documented since 2006 from MedWatch reports.

New Formulation: Aztreonam for inhalation (Cayston) was approved to improve respiratory symptoms in cystic fibrosis patients with Pseudomonas Aeruginosa.

Recent FDA Approvals (through June 2010) related to Namenda XR, Dulera, Lucentis, Symbicort, Vimpat, Jevtana, Architecht HIV Ag/Ab Combo assay, Tasigna

Generic drugs approved by FDA (through June 2010): Venlafaxine hydrochloride extended-release capsules, Meropenem for injection, Adapalene 0.1% gel, Aztreonam for injection, Oxaliplatin for injection

On June 11, 2010, FDA announced in a drug safety communication that the agency was currently evaluating whether the use of the angiotensin II receptor blocker olmesartan (Benicar, Daiichi Sankyo) (also sold in combination with hydrocholorothiazide as Benicar HCT) was associated with increased cardiovascular mortality.

Transparency has become the lead philosophy governing biomedical research and regulation. FDA and the National Institutes of Health are requiring more disclosure of financial relationships between industry and scientists and physicians.

A systematic review assessing the comparative effectiveness of oral antidiabetic drugs for preventing patients at high risk from progressing to type 2 diabetes has found glitazones, biguanides, and alpha-glucosidase inhibitors reduced the relative risk of diabetes by as much as 63%, whereas insulin secretagogues had no effect.

New analyses from the phase 3 CLARITY (Cladribine Tablets Treating MS Orally) study reveal improvements in disease-free activity and the annualized relapse rate and a reduction in the use of healthcare resources in cladribine recipients compared with placebo in patients with relapsing-remitting multiple sclerosis (RRMS).

A recent landmark phase 3 trial in patients in remission from recurrent hepatic encephalopathy demonstrated that rifaximin at a dose of 550 mg twice daily is significantly more effective than placebo in maintaining remission and reducing the risk of hospitalization. Rifaximin's approval by FDA in March 2010, offers clinicians the first pharmacologic treatment for hepatic encephalopathy in more than 30 years.

In an on-line article published in the journal Ophthalmology, researchers reported a possible adverse association between certain selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs) and the development of cataracts in those aged >65.

A systematic review and meta-analysis evaluating the effects of rosiglitazone on cardiovascular morbidity and mortality confirmed the finding of increased odds of myocardial infarction with rosiglitazone.

Hemophilia is a rare congenital bleeding disorder, resulting from a deficiency of factor VIII (hemophilia A) or factor IX (hemophilia B). Deficiency of either of these factors interrupts normal hemostasis resulting in an inability to form a stable fibrin clot to halt bleeding. This article reviews the etiology of hemophilia, available pharmacologic approaches to bleeding episodes, and treatment options in the presence of complications.

A pilot study of resveratrol in 10 older adults suggests that the compound may be beneficial for patients with impaired glucose tolerance.

In patients with type 2 diabetes, treatment with exenatide once weekly for 1 year results in sustained improvements in glycemic control, body weight, cardiovascular risk markers, and markers of hepatic injury, according to a pooled analysis of 2 large clinical trials.

A post hoc analysis of 5 clinical trials of liraglutide suggests that it was significantly better than active comparators on a composite end point of glycated hemoglobin less than 7% without hypoglycemia or weight gain, reported French investigators.

Liraglutide is more successful in reducing glycated hemoglobin levels to 7% or less regardless of baseline glycated hemoglobin level compared with sitagliptin in adults with type 2 diabetes, said Melanie Davies, MD, MB ChB, professor of diabetes medicine, University of Leicester, United Kingdom.