Sinus and Allergy Health Partnership Releases New Guidelines for Treatment of Bacterial Rhinosinusitis

Pharmacology Watch

New guidelines for the treatment of bacterial rhinosinusitis were published in the January supplement of Otolaryngology-Head and Neck Surgery by the Sinus and Allergy Health Partnership. The goal of the guidelines is to reduce the use of antibiotics for viral infections and to use the most appropriate antibiotic for bacterial infections. The guidelines recommend antibiotics if patients are getting worse after 5-7 days or if they are not better after 10-14 days. Patients with mild disease should be treated with cefpodoxime (Vantin), cefuroxime (Ceftin), amoxicillin, amoxicillin/clavulanate (Augmentin), or cefdinir (Omnicef). Patients with moderate disease or those with recent antibiotic exposure should receive amoxicillin/clavulanate, ceftriaxone, or one of the respiratory fluoroquinolones including gatifloxacin (Tequin), moxifloxacin (Avelox), or levofloxacin (Levaquin). The respiratory quinolones do not include ciprofloxacin. This is a follow-up to the group’s first guidelines, which were published in 2000 (Otolaryngol Head Neck Surg. Supplement. 2004;130:1).

Steroids Not Linked to Risk of Fractures

Long-term use of inhaled steroids for the treatment of respiratory diseases or nasal steroids for the treatment of allergic rhinitis are not associated with an increased risk of fractures if they are used in normal doses, according to a study from Canada. Researchers conducted a case-control study of all elderly Québec residents who were dispensed respiratory medications and could be followed for at least 4 years from 1988 to 2001. The rate of hip or upper extremity fractures was not increased in those patients who used daily inhaled corticosteroids (RR, 0.97). The rate of upper extremity fractures increased by 12% with every 1000 mg increase in the daily inhaled corticosteroid, but the rate of hip fractures did not increase. The rate of hip fractures was only elevated with very high doses (more than 2000 mg per day) of inhaled corticosteroid. Nasal steroids did not increase the risk at any dose. The authors conclude that long-term use of inhaled and nasal corticosteroids at usual recommended doses is not associated with the risk of fracture (Am J Resp Crit Care Med. 2004;169:83-88).

ADT Puts Men at Risk for Osteoporosis

Men treated for prostate cancer with androgen deprivation therapy (ADT) are at risk for osteoporosis and fractures, according to a new study. One year of ADT resulted in 2-8% bone loss in the lumbar spine and 1.8-6.5% bone loss in the femoral neck. The study was a meta-analysis of 9 studies that included a total of 208 patients. The authors suggest that men starting ADT should be considered for bone mineral density measurement, and men at high risk should be offered a bisphosphonate (published online January 19, 2004. Cancer).

Study Shows Valsartan May Improve Sexual Function in Postmenopausal Women

A new study suggests that valsartan may improve sexual function in hypertensive postmenopausal women. Researchers randomized 120 postmenopausal women aged 51-55 with mild-to-moderate hypertension to valsartan 80 mg daily or atenolol 50 mg daily for 16 weeks. Doses were doubled if diastolic blood pressures remained above 90 mm Hg. The end point was a questionnaire that self-evaluated various aspects of sexual desire, orgasmic response, and coital activity. The drugs lowered blood pressure equally effectively. Women in the valsartan group noted significantly improved sexual desire (38% increase, P < .01), changes in behavior (45% increase, P < .001), and sexual fantasies (51% increase, P < .001). In the atenolol group, scores for sexual desire and sexual fantasies significantly worsened (18% decrease, P < .01, and 23% decrease, P < .001, respectively). The authors conclude that in the study group, hypertensive postmenopausal women in their 50s, valsartan improved some aspects of sexual function, whereas atenolol worsened it. They further speculate the drugs may have differential effects on serum hormone levels, specifically testosterone (Am J Hyperten. 2004;14:77-81).

New Direct-to-Consumer Pharma Advertising Rules Considered

Anyone who watched the Super Bowl can verify that direct-to-consumer advertising of prescription pharmaceuticals is big business. Now the FDA is considering tighter restrictions on the content of these ads, requiring pharmaceutical companies to highlight key risks associated with the drugs rather than listing the large number of potential side effects in small print. The guidelines encourage companies to use less cluttered formats for print ads, perhaps even using bullet points to set the import risks apart. Print ads currently contain an extensive list of side effects similar to the package insert, often in a similarly small font, frequently on a separate page from the main advertisement. The FDA is also considering changing the criteria for "reminder" ads that simply name the drug without giving the indication for its use. Currently, these ads do not require information on adverse effects and often run close to disease awareness campaigns also paid for by the drug company. These new FDA restrictions have not been finalized and are sure to be opposed by Pharma.

FDA Actions

Boehringer Ingelheim Pharmaceuticals has received FDA approval to market tiotropium bromide inhalation powder (Spiriva) for the treatment of COPD. Tiotropium, a once-daily anticholinergic agent, is indicated for the long-term maintenance treatment of bronchospasm associated with COPD.

Modafinil (Provigil) has been approved for improving wakefulness in patients with excessive sleepiness due to obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder. The drug is currently approved for improving wakefulness in patients with narcolepsy.

The FDA has approved a 3-day course of azithromycin (Zithromax) for the treatment of acute bacterial sinusitis. The drug, which is dosed at 500 mg once a day, is the only 3-day regimen approved for this indication. Azithromycin is currently approved for the treatment of community-acquired respiratory infections and skin infections, as well as otitis media.

Olanzapine (Zyprexa) has been approved for maintenance treatment of bipolar disorder. The drug appears to be effective in delaying relapse into either mania or depression in bipolar patients. Olanzapine was approved in 2000 for the short-term treatment of acute mixed or manic episodes associated with bipolar disorder.

The FDA has also approved a combination of olanzapine and fluoxetine (Prozac) for the treatment of bipolar depression. The combination drug will be marketed under the trade name Symbyax. Quetiapine fumarate (Seroquel) was also recently approved for monotherapy and adjunct therapy with lithium and divalproex, for the short-term treatment of acute manic episodes associate with bipolar I disorder.

This supplement was written by William T. Elliott, MD, FACP, Chair, Formulary Committee, Kaiser Permanente, California Division; Assistant Clinical Professor of Medicine, University of California-San Francisco. Telephone: (404) 262-5413. E-mail: In order to reveal any potential bias in this publication, we disclose that Dr. Elliott reports no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study.