Clinical news updates from the 2008 American Heart Association Scientific Sessions; Preferential formulary listing of a proton-pump inhibitor; Drug Watch: Agents in late-stage development for the treatment of multiple sclerosis
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New molecular entity: Fesoterodine (Toviaz), a muscarinic receptor antagonist, was approved on October 31, 2008, for the treatment of overactive bladder
Second-generation antidepressants generally have equivalent efficacy, according to a review published in the Annals of Internal Medicine. Although these agents demonstrate similar response rates, differences in onset of action or side effects may affect prescribing decisions.
Labeling updates and warnings through December 2008 for efalizumab and bisphosphonates
Treatment with bevacizumab is associated with a significantly increased risk of venous thromboembolism, according to a meta-analysis published in the Journal of the American Medical Association.
During his campaign for the presidency, President-elect Barack Obama stated that all Americans have a right to healthcare and that he will expand coverage for the uninsured. Many voters cited healthcare as a key election issue; however, the need to address a rising unemployment rate and low economic growth may force Obama to seek more limited changes in the near future.
Among the new data presented at the 2008 AHA Scientific Sessions were the results of JUPITER, as well as a phase 2 study of rivaroxaban and an observational study of DES versus BMS in diabetics.
Recent FDA action (through December 2008) related to denileukin, ferumoxytol, cetuximab, HQK-1001, ALD-101, NTX-010, and RTA 402
Generic drugs approved by FDA (through December 2008) including levetiracetam tablets, dorzolamide/timolol ophthalmic solution, and dorzolamide ophthalmic solution
Recent FDA approvals (through December 2008) related to Kogenate FS, Treanda, Prezista, Seroquel XR, Apriso, Precedex, Reyataz, Vaprisol, LoSeasonique, Astepro, Apidra, Risperdal Consta, Stalevo, Akten, Taxus, and Ontak.
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New biologic: C1 inhibitor (human) (Cinryze) was approved on October 10, 2008, for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema
New molecular entity: Lacosamide (Vimpat), an antiepileptic drug, was approved on October 28, 2008, as adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years or older
New molecular entity: Silodosin (Rapaflo), an alpha-blocker, was approved on October 8, 2008, for the treatment of the signs and symptoms of BPH
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.
Agents in late-stage development for the treatment of multiple sclerosis
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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.
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.
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.
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.
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.
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.
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).
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