Preferential formulary listing of a proton-pump inhibitor (PPI): Compliance with policy in a Canadian military populationDecember 1st 2008
In 2003, the Canadian Forces (CF) drug benefit plan used preferential listing to control costs associated with proton pump inhibitors (PPIs); however, significant expenditures for nonbenefit PPIs continued. A database review was thus conducted to explain this anomalous usage pattern. This study provides further information regarding the effectiveness of preferred listing as a cost-saving measure, noting that adherence to such policies may be less than projected.
California court: Wyeth accountable for harms caused by generic metoclopramideNovember 13th 2008
On November 7, the First District Court of Appeal in San Francisco, California, overturned a previous ruling in the case of Conte v Wyeth and ruled that Wyeth, the manufacturer of Reglan (metoclopramide), should be held responsible for harm caused to Elizabeth Conte, who developed tardive dyskinesia after taking generic metoclopramide for nearly 4 years. The court upheld the previous ruling in favor of Purepac, Pliva, and Teva, manufacturers of generic metoclopramide.
Pneumonia mortality rates lower for statin usersNovember 13th 2008
In a large, population-based cohort study published in the Archives of Internal Medicine, current use of statins by patients hospitalized with pneumonia was associated with a decreased risk of death after hospital admission compared with nonusers of statins.
Metformin moderately protective against CV risk in type 2 diabeticsNovember 13th 2008
Compared with biguanides, thiazolidinediones, meglitinides, and second-generation sulfonylureas, metformin is the sole oral therapy associated with a decreased risk of cardiovascular (CV) mortality in patients with type 2 diabetes, according to a meta-analysis published in the Archives of Internal Medicine.
Diabetes treatment becoming more complex, more expensiveNovember 13th 2008
In a survey of trends in diabetes treatment from 1994 to 2007, investigators observed an increasing incidence of diabetes, a greater variety of drugs and combinations available for treatment, and a marked increase in the annual cost of diabetes medications.
Pre-emption case of Wyeth v Levine in hands of US Supreme CourtNovember 13th 2008
On November 3, the US Supreme Court heard arguments in the case of Wyeth v Levine; the ultimate decision of the Court on this case may set a precedent on the issue of pre-emption, a tenet that FDA actions regarding drug approvals and medication safety supersede state laws.
Conflicts of interest under investigation as policies begin to changeNovember 13th 2008
As conflicts of interest between academia and the pharmaceutical industry are again under investigation, several pharmaceutical companies and universities are beginning to change their policies on disclosures and funding.
Development of rimonabant and CP-945,598 for obesity is discontinuedNovember 13th 2008
One month after Merck announced that the company was discontinuing development of taranabant, an investigational selective blocker of the cannabinoid-1 (CB-1) receptor that was being studied for the treatment of obesity, Sanofi-Aventis and Pfizer announced that they were also halting the development of their investigational CB-1 receptor antagonists (rimonabant and CP-945,598, respectively).
Conte v Wyeth: Name-brand drug maker accountable for alleged harm caused by generic drugNovember 13th 2008
On November 7, 2008, a California Intermediate Appellate Court in San Francisco held that the "common-law duty [of Wyeth] to use due care in formulating its product warnings extends to patients whose doctors foreseeably rely on its product information when prescribing metoclopramide, whether the prescription is written for and/or filled with Reglan or its generic equivalent."
FDA modernizes drug development through public-private partnershipsNovember 1st 2008
After spending 4 years laying a foundation that will streamline clinical testing and drug development, FDA leaders are poised to move the agency's Critical Path Initiative (CPI) from concept to implementation. Despite public concerns about drug safety, dangerous imports, and rising pharmaceutical costs, CPI has not fallen by the wayside.
Finasteride not associated with increased risk of hip fracture in menNovember 1st 2008
A study published in the Journal of the American Medical Association reported that use of finasteride, a 5-alpha reductase inhibitor commonly used to treat benign prostatic hyperplasia (BPH), does not appear to be associated with an increased incidence of hip fractures in men; in fact, the agent appears to decrease the risk of hip fracture.
Beta-blockers are associated with reduced mortality in patients with COPD undergoing vascular surgeryNovember 1st 2008
An observational retrospective study published in the American Journal of Respiratory and Critical Care Medicine demonstrated that mortality is reduced when patients with chronic obstructive pulmonary disease (COPD) are treated with cardioselective beta-blockers before major vascular surgery.
Bivalirudin superior as adjunct antithrombotic therapy in patients with acute MI undergoing PCINovember 1st 2008
As a pharmacologic adjunct to stenting in patients with acute myocardial infarction (AMI), bivalirudin monotherapy outperformed the combination of a glycoprotein (GP) IIb/IIIa inhibitor and unfractionated heparin (UFH) over 1 year of follow-up, reported investigators at the 2008 Transcatheter Cardiovascular Therapeutics conference.
Alemtuzumab effective in treating early MS but associated with autoimmunityNovember 1st 2008
A phase 2 study published in the New England Journal of Medicine reported that alemtuzumab was more effective than interferon beta-1a in treating early, relapsing-remitting multiple sclerosis (MS), but the agent was also associated with higher rates of autoimmunity, including cases of immune thrombocytopenic purpura (ITP).
Spotlight on pharmaceutical pipeline database products: A useful resource for PBMs and MCOsNovember 1st 2008
To effectively gauge the potential clinical and economic impact of drug and biologic therapies that are pending FDA approval, the monitoring of pharmaceutical pipelines has become an essential function of pharmacy benefit management (PBM) companies and managed care organizations (MCOs); one source of pharmaceutical pipeline information is subscription-based pharmaceutical pipeline databases. Examples of some of these databases, along with the types of information provided and advantages and disadvantages of such products, are presented.
Prasugrel: A novel thienopyridine prodrug for the treatment of acute coronary syndromeNovember 1st 2008
Prasugrel is a thienopyridine prodrug under FDA review for the treatment of acute coronary syndrome (ACS) managed with percutaneous coronary intervention (PCI). Clinical trials have demonstrated statistically significant inhibition of platelet aggregation with prasugrel relative to placebo and clopidogrel; however, this improved efficacy outcome entails a significantly increased rate of bleeding.
Tibolone reduces fracture and breast CA risk, increases stroke riskOctober 14th 2008
The Long-Term Intervention on Fractures with Tibolone (LIFT) study demonstrated a reduced risk of vertebral fracture, breast cancer, and possibly colon cancer but a significantly increased risk of stroke in older postmenopausal women treated with tibolone versus those treated with placebo.
Case of PML reported in efalizumab-treated patientOctober 14th 2008
Genentech informed healthcare professionals that a 70-year-old patient who has been treated with efalizumab (Raptiva) for chronic psoriasis for >4 years has developed progressive multifocal leukoencephalopathy (PML), a rare, progressive disease of the central nervous system that is usually fatal.
Tiotropium improves long-term lung function in COPDOctober 14th 2008
In the Understanding Potential Long-Term Impacts on Function with Tiotropium (UPLIFT) trial, tiotropium therapy for patients with chronic obstructive pulmonary disease (COPD) was associated with long-term improvements in lung function, quality of life, and COPD exacerbations. The therapy did not, however, significantly reduce the rate of decline in forced expiratory volume in 1 second (FEV1) compared with placebo.
Congress to consider changes to Medicare Part D drug plansOctober 1st 2008
Even though the Medicare prescription drug benefit has provided access to medications at less-than-anticipated cost to the government-and lower out-of-pocket spending for seniors-many Democrats and consumer advocates want to overhaul the program. Critics contend that the federal government can negotiate prices with pharmaceutical companies that are lower than those obtained by private insurers operating prescription drug plans (PDPs), and some reformers charge that the program is too complex and confusing for elderly beneficiaries, pointing particularly to the infamous "donut hole" that is affecting more Medicare patients than anticipated.
ARBs demonstrate no beneficial effect on mortality in patients with heart failureOctober 1st 2008
A systematic search of the literature published in the International Journal of Clinical Practice demonstrated that angiotensin receptor blockers (ARBs) used as monotherapy or in combination with angiotensin-converting enzyme (ACE) inhibitors are not associated with a beneficial effect on mortality in patients with heart failure (HF).
Ipratropium associated with increased risk of death in patients with COPDOctober 1st 2008
A nested case-control analysis published in the Annals of Internal Medicine demonstrated an increased risk of all-cause and cardiovascular mortality among patients with recently diagnosed chronic obstructive pulmonary disease (COPD) treated with ipratropium.
Eltrombopag: A TPO receptor agonist for the treatment of chronic idiopathic thrombocytopenic purpuraOctober 1st 2008
Eltrombopag is a TPO receptor agonist that is currently pending FDA approval for the treatment of ITP. This agent has been granted orphan drug and priority review status. In May 2008, the Oncology Drugs Advisory Committee unanimously agreed that eltrombopag demonstrates a favorable risk:benefit profile for the short-term treatment of chronic ITP.