Formulary Watch |

Inhaled corticosteroids associated with decreased risk of lung cancer in patients with COPD

In a large, nested cohort study, use of inhaled corticosteroids at doses greater than 1,200 mcg/d was associated with a 61% reduction in the risk of developing lung cancer in patients with chronic obstructive pulmonary disease.

Prevention and treatment of chemotherapy-induced nausea and vomiting: A review

Nausea and vomiting (emesis) are among the most distressing side effects of chemotherapy and are associated with significant clinical consequences. Four distinct types of chemotherapy-induced nausea and vomiting (CINV) have been described: acute, delayed, anticipatory, and breakthrough. Clinical practice guidelines provide specific recommendations for controlling the different types of CINV depending on the emetogenic potential of the chemotherapy regimen being used. Three classes of antiemetics are considered potent and well-tolerated options: 5-HT3 serotonin-receptor antagonists, corticosteroids, and neurokinin-1-receptor antagonists. Phenothiazines, butyrophenones, cannabinoids, metoclopramide, and benzodiazepines are also sometimes used to prevent CINV caused by minimally emetogenic chemotherapy or to treat breakthrough CINV. This article reviews the currently available antiemetic agents and clinical practice guidelines for the management of CINV.

Bifeprunox: A partial dopamine-receptor agonist for the treatment of schizophrenia

Schizophrenia is a chronic psychiatric disorder that affects an estimated 1% of the population. This disorder may be treated with typical (first-generation) or atypical (second-generation) agents; a recognized concern regarding these agents is that long-term use has been associated with increased risks of serious side effects, either neurologic or metabolic in nature. Bifeprunox is a partial dopamine-receptor agonist under investigation for the treatment of patients with schizophrenia.If approved, bifeprunox may serve as an additional option for the acute and maintenance treatment of schizophrenia.

Inhaled corticosteroids may provoke oropharyngeal adverse events

In a meta-analysis, inhaled corticosteroids were associated with a risk of oropharyngeal adverse events.

FDA action related to medication safety and reliability, June 2007

Briefs of FDA actions related to medication safety and reliability (ie, boxed warnings, dear healthcare provider letters)

Oral, but not transdermal, estrogen use associated with increased risk of venous thromboembolism

Oral estrogen use in postmenopausal women may elevate the risk of venous thromboembolism (VTE); however, the use of transdermal estrogen does not appear to increase the risk of VTE.

AzaSite: New formulation recently approved by FDA for azithromycin ophthalmic solution 1%

A new formulation for azithromycin, an antibacterial agent, is now approved by FDA for the treatment of bacterial conjunctivitis.

FDA actions in brief, June 2007

Briefs of FDA actions/approvals of drugs, doses, and indications

First-time generic approvals, June 2007

First-time generic drug approvals: Zolpidem immediate-release; nimodipine

FDA pipeline preview, June 2007

The latest FDA action (through June 2007) related to sipuleucel-T (Provenge), tramadol (CIP-Tramadol ER), isotretinoin (CIP-Isotretinoin), bazedoxifene (Viviant), irbesartan plus hydrochlorothiazide (Avalide), prednisolone 1.0% plus tobramycin 0.3% ophthalmic suspension (T-Pred), pixantrone, SPRC-AB01

Altabax: Retapamulin ointment, 1% recently approved by FDA as new molecular entity

Retapamulin ointment, 1% is now approved by FDA as an antibacterial agent for the topical treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes.

Singulair: FDA approves new indication for montelukast

Montelukast, a leukotriene receptor antagonist, is now approved by FDA for the prevention of exercise-induced bronchoconstriction.

Drug Watch: Agents in late-stage development for the treatment of epiepsy/seizures (June 2007) (PDF)

A review of agents in late-stage development for the treatment of epilepsy/seizures (June 2007).

FDA actions in brief

Briefs of FDA actions/approvals of drugs, doses, and indications

Automated IV and syringe preparation increases safety, reduces errors

A summary of several automated IV and syringe preparation systems and a discussion of the technology's impact on pharmacy efficiency.

Gabapentin monotherapy as effective as gabapentin plus antidepressant in treatment of hot flashes

A phase 3 study evaluating the use of gabapentin alone and in combination with an antidepressant in women with hot flashes who had an inadequate response with antidepressant monotherapy demonstrated that gabapentin reduced hot flashes by approximately 50%, whereas the combination of an anti-depressant with gabapentin appeared to offer no additional benefit.

Drug Watch: Agents in late-stage development for the treatment of HIV/AIDS (May 2007) (PDF)

A review of agents in late-stage development for the treatment of HIV/AIDS (May 2007).

Sitaxsentan: A new endothelin-receptor antagonist for the treatment of pulmonary arterial hypertension

FDA actions in brief

Briefs of FDA actions/approvals of drugs, doses, and indications

Policymakers weigh incentives for pediatric studies and policies to allow generic versions of biotech therapies

Pediatric exclusivity program and generic biotech therapies as related to PDUFA IV.

Targeted patient education increases formulary compliance in a 3-tier pharmacy benefit

Results of a study conducted to determine whether users of nonformulary blood glucose meters would increase their formulary compliance if they were provided with targeted information and an offer for a free formulary meter.

Automated IV and syringe preparation increases safety, reduces errors

A summary of several automated IV and syringe preparation systems and a discussion of the technology's impact on pharmacy efficiency.

SWISS II: Antiangina agents result in improved outcomes in patients with silent ischemia but without CAD

Patients with silent ischemia but no coronary artery disease (CAD) may benefit from treatment with antianginal drug therapy, according to results of The Swiss Interventional Study on Silent Ischemia Type I (SWISS II)

Nicotine patch demonstrated to be safe in smokers with CAD

Nicotine patches used for smoking cessation are safe in patients with coronary artery disease (CAD) and active stress-induced myocardial ischemia, according to the results of a randomized trial.

ARMYDA-ACS: Short-term atorvastatin treatment improves intervention outcomes

An 80-mg dose of atorvastatin administered 12 hours before angioplasty, followed by a 40-mg dose administered 2 hours before the procedure significantly reduces the risk of major cardiovascular events during the month after the intervention, according to the results of The Atorvastatin for Reduction of Myocardial Damage during Angioplasty-Acute Coronary Syndromes (ARMYDA-ACS) trial.

FUSION II: Nesiritide infusions in stage D HF not linked to increased risk of hospitalization, renal toxicity

Results of FUSION II, a randomized, double-blind, placebo-controlled study involving 920 patients with stage D chronic decompensated HF, presented at the 56th Annual Scientific Session of the ACC.

Biologic psoriasis treatment options expanding

New research presented at the AAD's 65th Annual Meeting regarding treatment of biologic psoriasis with adalimumab and efalizumab.

Researchers say anticoagulant prophylaxis in at-risk hospital patients can prevent VTE

A meta-analysis of randomized controlled trials demonstrated that anticoagulant prophylaxis of hospitalized patients statistically significantly reduced their risk of developing both a pulmonary embolism (PE) and deep vein thrombosis (DVT).

Intensive statin therapy demonstrated to be safe and effective in the elderly

Intensive statin therapy in elderly patients may be more effective than moderate statin therapy in improving lipid levels and reducing all-cause death, according to a prospective, international, multicenter, randomized, double-blind, double-dummy, parallel-arm trial in elderly patients with documented coronary artery disease (CAD).

Etoricoxib results in fewer upper GI events compared with diclofenac users according to MEDAL program

Patients with osteoarthritis or rheumatoid arthritis who are taking etoricoxib may experience significantly fewer upper gastrointestinal (GI) events compared with those taking diclofenac, according to the pooled results of 3 randomized trials.