Higher rate of improvement, lower rate of adverse effects with clarithromycin for acute exacerbations of chronic bronchitis

San Francisco, Calif., May 23, 2001 – Data from a study presented today at the 97th annual meeting of the American Thoracic Society show that patients who were treated with clarithromycin (Biaxin®, Abbott Laboratories) for an acute exacerbation of chronic bronchitis (AECB), experienced a higher rate of improvement and fewer adverse events than patients who were treated with other leading antibiotics, including levofloxacin (Levaquin®, Johnson & Johnson) and cefuroxime axetil (Ceftin®, GlaxoSmithKline).

“According to the study results, more patients with chronic bronchitis who were treated with clarithromycin improved compared to patients treated with the other antibiotics,” said Lee R. Weiss, M.D., F.A.C.E.P., chairman, department of emergency medicine, Knox Community Hospital, Mount Vernon, Ohio, and lead investigator of the study. “Specifically, clarithromycin offers an important alternative in the treatment arsenal for patients with an acute exacerbation of chronic bronchitis, as it offers a higher cure rate and fewer side effects.”

Study Results

A randomized, prospective, multi-center study of 283 patients, compared clarithromycin 500 mg BID, levofloxacin 500 mg QD, and cefuroxime axetil 250 mg BID in patients with AECB. Each drug was administered for 10 days. For six weeks prior to randomization, patients with suspected AECB completed a questionnaire designed to assess disease severity and antimicrobial treatment. Eligible patients were required to have chest radiographs negative for pneumonia or structural lung disease (other than chronic obstructive pulmonary disease).

Among the eligible patients, 97 were randomized to clarithromycin, 94 to levofloxacin, and 92 to cefuroxime axetil. No significant difference was observed in disease between any groups at the start of the study. Among evaluable patients, clinical cure/improvement was observed in 87.9 percent (80 of 91) of those treated with clarithromycin, 87.3 percent (76 of 87) of those treated with levofloxacin, and 79.7 percent (67of 84) of those treated with cefuroxime axetil. Additionally, none of the patients (0 out of 91) treated with clarithromycin was hospitalized for antimicrobial treatment, compared to 3.4 percent (3 of 87) who were treated with levofloxacin, and 3.6 percent (3 of 84) who were treated with cefuroxime axetil.

Overall, patients with AECB treated with clarithromycin 500 mg BID experienced a higher rate of clinical cure/improvement and lower rates of adverse events leading to treatment, withdrawal, and need for hospitalization as compared to those who received levofloxacin 500 mg QD and cefuroxime axetil 250 mg BID.

In adult respiratory clinical trials, the most common adverse events experienced were nausea, abnormal taste, or diarrhea (three percent); dyspepsia, abdominal pain, or headache (two percent).

Acute exacerbation of chronic bronchitis (AECB) is the seventh most prevalent of all chronic conditions, affecting 14 million Americans each year. The majority of cases of AECB occur in Americans under aged 45, and more women contract the disease than men. AECB is one of the most common illnesses diagnosed by primary care physicians. It is characterized by the presence of mucus-producing cough and obstruction for at least three consecutive months a year for two successive years.

Biaxin tablets are indicated for mild-to-moderate infections in adults for the treatment of pharyngitis/tonsillitis due to Streptococcus pyogenes; for the treatment of acute maxillary sinusitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae; for the treatment of acute bacterial exacerbation of chronic bronchitis caused by Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis; or Streptococcus pneumoniae; and for the treatment of pneumonia due to Haemophilus influenzae, Mycoplasma pneumoniae, Streptococcus pneumoniae, or Chlamydia pneumoniae.

Knox Community Hospital is a 117-bed hospital located in central Ohio, approximately 50 miles northeast of Columbus. It offers comprehensive treatment by over 90 physicians in 25 specialties. Services include a fully-equipped Emergency Services team supported around-the-clock by ancillary services; a Heart Center that offers heart catheterizations, arteriograms, and a nationally certified cardiac rehabilitation program; a wide range of physical therapy and rehabilitation programs; a corporate healthcare program; and a dozen specialty clinics ranging from Sleep Lab to Ostomy/Wound care.

The hospital has received national recognition for its efficient and timely care of heart attack patients and was selected as one of the country’s top-performing hospitals by the 1996 100 Top Hospitals: Benchmarks for Success study. A new Emergency Services area was just opened to better care for increasing numbers of emergency patients – 99 percent of emergency patients receive complete care at Knox Community Hospital. The new area is part of the largest expansion the hospital has made since its opening. It includes a new Rehabilitation and Wellness facility with an orthopedic pool, as well as an expansion of the Laboratory, Specialty Clinics and Day Surgery.