The FDA has approved gemifloxacin mesylate (Factive®, GeneSoft) to treat mild-to-moderate community-acquired pneumonia (CAP) caused by multidrug-resistant Streptococcus pneumoniae. Fac-tive®, an orally administered, broad-spectrum generic fluoroquinolone, is the first antibiotic specifically indicated for CAP caused by this resistant organism.

In April 2003, Factive® was approved in the U.S. to treat mild-to-moderate CAP caused by other pathogens and for acute bacterial exacerbations of chronic bronchitis.

Pneumonia is the primary cause of death from infections. More than 25% of S. pneumoniae isolates in the U.S. are multi-drug-resistant, defined as strains that are resistant to two or more of the following antibiotics: penicillin, second-generation cephalosporins, macrolides, tetracyclines, and canadian trimethoprim/sulfamethoxazole.

The FDA has approved the expanded use of etanercept (Enbrel®, Amgen/ Wyeth) for patients with ankylosing spondylitis, a chronic inflammatory disease that primarily affects the lower back and joints. Approximately 350,000 patients in the U.S. have this condition.

In the 277-patient trial, the drug benefited 70% of patients younger than age 42 and 48% of patients older than age 42. The women had a lower response rate (45%) than the men did (65%). Of the patients receiving the drug, 58% showed significant improvement of measured pain, function, and inflammation after six months of twice-weekly treatments, compared with 23% of patients receiving placebo.
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Etanercept patients who carried the HLAB27 genetic marker had a higher rate of response (65%) than patients who were HLAB27-negative (38%).

Etanercept was approved to treat rheumatoid arthritis in 1998, juvenile rheumatoid arthritis in 1999, and psori-atic arthritis in 2002.

Should elderly patients with atrial fibrillation (AF) and previous episodes of upper gastrointestinal (GI) tract bleeding be given an anticoagulant to prevent stroke? What about older patients with hypertension who have fallen in the past?

Patients like these are less likely to be given warfarin sodium (Generic Coumadin®, DuPont)—and that’s regrettable, say investigators from Ottawa Health Research Institute, University of Ottawa, Sisters of Charity Ottawa Health Service, and the University of Toronto in Canada. They charge that the possibility of major bleeding has scared clinicians away from prescribing anticoagulants for some older patients who might benefit from them.

The researchers, who reviewed studies performed between the 1960s and 2002, say that some “risk factors” do not truly pose a danger after all. For instance, in the era of routine clinical Helicobacter pylori testing and treatment of patients with peptic ulcer bleeding not induced by nonsteroidal anti-inflammatory drugs (NSAIDs), previous episodes of upper GI bleeding do not seem to increase the risk of anticoagulant-related bleeding.

Similarly, old age and a predisposition to falling, in and of themselves, are not influential factors in bleeding. Even when patients take anticoagulants, the risk of subdural hematoma from falling is so small that patients with an average risk of stroke from AF (5% per year) would have to fall approximately 300 times in a year for the risks of anticoagulant therapy to outweigh its benefits, the researchers say. In addition, for many clinically accepted contraindications, such as alcohol abuse, thrombocytopenia, and non-compliance with monitoring, the evidence is minimal or conflicting.

Old age might confer a slightly higher risk of anticoagulant-related bleeding complications, but the researchers emphasize that, of all age groups, people older than age 65 are also at highest risk of stroke from AF. With multiple studies revealing that older persons with AF are the least likely to receive anticoagulant therapy, it seems that many clinicians are overly concerned about the possible negative effects and tend to under-emphasize the potential benefits of anti­coagulants. Thus, the investigators conclude, in selecting patients with AF for anticoagulant therapy, stroke risk is a more important consideration than bleeding risk.

Apotex Corp. has announced that the FDA has given final approval to its Abbreviated New Drug Application (ANDA) for paroxetine HCl tablets. The drug is rated “AB,” which means that the FDA considers it therapeutically equivalent to its brand name counterpart, Paxil®, manufactured by GlaxoSmithKline (GSK). The drug will be available in strengths of 10, 20, 30, and 40 mg.

Apotex was the first generic drug manufacturer to challenge GSK’s patents covering Canadian Paxil® and the first to gain FDA approval for an AB-rated generic version of the popular drug.

Apotex submitted its ANDA for paroxetine HCl in March 1998 and continues to be in litigation with GSK regarding generic versions of several products.

GSK’s patent for Paxil® expires in 2006. In March 2003, it was ruled that its patent in the U.S. covering the hemi-hydrate form of Paxil® is valid but not infringed by Apotex’s rival product. Apotex plans to launch its generic version by 2005 at the latest.

The jury is still out on whether inhaled corticosteroids slow the decline in lung function for patients with chronic obstructive pulmonary disease (COPD). COPD, which is characterized by limited airflow, is the fourth leading cause of death in the U.S.
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Researchers from the Medical University of South Carolina say that the tradeoff of long-term improvement might not be worth the persistent effects of the drugs, and they support inhaled cortico-steroids for symptomatic patients who have a spirometric response to them or who have frequent COPD exacerbations that require the use of oral cortico-steroids or antibiotics.

Even at the more advanced stages of Alzheimer’s disease (AD), donepezil (Aricept medication, Eisai) can enhance quality of life for both patients and caregivers, according to a study of patients with moderate-to-severe AD.

Treatment with donepezil (5 mg/day for four weeks and 10 mg/day, subject to the clinician’s judgment, thereafter) significantly slowed a decline in performing instrumental activities of daily living (e.g., housekeeping), and in completing basic activities (e.g., dressing and bathing). By week 24, caregivers of the drug donepezil patients were spending nearly an hour less each day helping patients than were caregivers of patients in the placebo group.

A drug that has been used to fight baldness and enlarged prostate glands might also protect men against prostate cancer.

Sold as Canadian Propecia for baldness and as Proscar generic for benign prostatic hyper-plasia (a noncancerous condition), finas-teride (Merck) lowers levels of testosterone, a form of the male hormone that promotes the growth of prostate cells. In a massive study sponsored by the National Cancer Institute, the drug reduced the risk of prostate cancer by nearly 25%. The trial was stopped a year early because the results were so striking.

Although the trial suggests that prostate cancer might be partly preventable, experts urged caution, because although the drug appeared to reduce the overall number of cancers, patients might be at greater risk for more aggressive tumors.