Pharmacy

In an analysis of fracture risk associated with loop diuretic use among postmenopausal women in the Women's Health Initiative (WHI) study, investigators demonstrated no significant association between loop diuretic use and fractures or changes in bone mineral density (BMD). With prolonged use of loop diuretics, however, the risk of fracture was modestly increased.

Initial results of the Women's Health Initiative (WHI) study demonstrated an increased risk of breast cancer among postmenopausal women treated with estrogen plus progestin. A new long-term analysis of this study published in the New England Journal of Medicine demonstrated that breast cancer incidence decreased markedly after WHI study participants discontinued hormone therapy.

Pfizer is discontinuing a phase 3 study of axitinib for the treatment of advanced pancreatic cancer. An analysis by an independent data safety monitoring board demonstrated that there was no improvement in survival among patients treated with axitininb plus gemcitabine versus those treated with gemcitabine alone.

Confusing drug names, or "look-alike/sound-alike names" (LASAs), are among the most common reasons for medication errors worldwide; these errors can lead to both morbidity and mortality. Both technological innovations and better communication can help healthcare professionals track and prevent these medication mix-ups.

Among members of the new administration, congressional leaders, payors, and providers, many are eager to transform the nation's healthcare system to curb unnecessary spending and make coverage more fair and efficient. A chief problem is that the US healthcare bill keeps increasing faster than the rest of the economy, with little to show in the way of quality improvement.

Dronedarone, an investigational antiarrhythmic agent being studied for the management of AF and atrial flutter, has a pharmacologic mechanism of action that is similar to that of amiodarone, but dronedarone lacks an iodine moiety, which may result in less thyroid and pulmonary toxicity. Dronedarone is currently pending FDA approval; the agent was granted priority review in August 2008.

The challenge of controlling HIV in patients with resistance to antiretrovirals has contributed to accelerated research into treatments with novel antiretroviral activity.

New molecular entity: Plerixafor (Mozobil), a hematopoietic stem cell mobilizer, was approved on December 15, 2008, for mobilization of hematopoietic stem cells for autologous transplantation in patients with NHL and MM

New molecular entity: Degarelix, a GnRH receptor antagonist, was approved on December 24, 2008, for the treatment of advanced prostate cancer

New molecular entity: Milnacipran (Savella), a selective norepinephrine and serotonin reuptake inhibitor, was approved on January 14, 2009, for the management of fibromyalgia

For the last few years, FDA has struggled with a depleted workforce, obsolete information technology (IT), and, according to its advisory Science Board, a weak science base. A new administration and new FDA leadership may provide an opportunity for change.

In newly released guidance for industry regarding good reprint practices for the distribution of journal articles and reference publications on off-label uses of approved drugs, FDA states that distribution of such materials is acceptable if the publications meet certain criteria for objectivity.

After completing a review of the final clinical study report from the Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia (ENHANCE) trial, FDA stated that treatment with ezetimibe/simvastatin (Vytorin, Merck/Schering-Plough) did not result in significant changes in carotid artery thickness compared with simvastatin (Zocor, Merck), but the combination of ezetimibe and simvastatin did lead to significantly greater decreases in low-density lipoprotein (LDL) cholesterol compared with simvastatin alone.

Not so long ago, medically underserved rural communities had only limited options, if any, when need arose for healthcare services and pharmaceutical support. That situation is finally changing, as necessity and technology converge in emerging applications of telepharmacy, the delivery of pharmaceutical care by means of telecommunications and information technologies to patients at a distance from large, usually urban tertiary healthcare centers.

New molecular entity: Eltrombopag (Promacta), a TPO receptor agonist, was approved on November 20, 2008, for the treatment of thrombocytopenia in patients with chronic ITP.

Generic drugs approved by FDA (through January 2009) including rocuronium injection and budesonide inhalation suspension

Acute coronary syndrome (ACS) encompasses a series of heart conditions associated with myocardial ischemia.

Sugammadex is a novel, first-in-class, selective relaxant binding agent that encapsulates the nondepolarizing aminosteroid muscle relaxants rocuronium and vecuronium, reversing and preventing their neuromuscular block (NMB) action. Clinical trials have demonstrated that sugammadex is effective in reversing both rocuronium- and vecuronium-induced NMB, and the agent has been well tolerated in studies.

FDA announced that the agency is evaluating data from a clinical study in which all-cause mortality was increased among patients treated with tinzaparin (Innohep, Celgene) versus patients treated with unfractionated heparin (UFH).

Rosiglitazone was associated with an increased risk of all-cause mortality and congestive heart failure (CHF) compared with pioglitazone in an inception cohort study of patients aged >65 years. Patients treated with rosiglitazone or pioglitazone demonstrated similar rates of myocardial infarction (MI) and stroke. These results were published in the Archives of Internal Medicine.

Patients with chronic hepatitis C virus (HCV) infection who have not responded to previous treatment with pegylated interferon alfa-2a (peginterferon) and ribavirin do not demonstrate a reduced rate of disease progression when they undergo long-term treatment with pegylated interferon alfa-2a compared with untreated patients. These results were published in the New England Journal of Medicine.

Evidence supports the clinical equivalence of generic and brand-name cardiovascular drugs, according to a meta-analysis published in the Journal of the American Medical Association. Despite this evidence, more than half of the editorials discussing the issue of generic interchangeability that were assessed in this analysis do not support generic substitution for brand-name cardiovascular drugs.

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.

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.

Generic drugs approved by FDA (through December 2008) including levetiracetam tablets, dorzolamide/timolol ophthalmic solution, and dorzolamide ophthalmic solution

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