To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Cipro Proven Effective Against Common AECB Pathogens URL: http://www.pslgroup.com/dg/39DBE.htm Doctor's Guide September 23, 1997
WEST HAVEN, CT. -- September 23, 1997 -- Bayer Corporation, Pharmaceutical Division today announced the launch of a new marketing campaign for the 750 mg dose of its antibiotic, Cipro(R) (ciprofloxacin HC1) tablets, as a recommended therapy for patients suffering from acute exacerbations of chronic bronchitis (AECB). This initiative is based on new clinical evidence further validating the efficacy of Cipro in treating Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae -- the most common respiratory pathogens causing infections such as AECB. Bayer's will be focusing on educating physicians about the appropriate role of the 750 mg tablet, as well as a 35 percent wholesale product price reduction. This campaign comes at a time when emerging bacterial resistance makes selection of an appropriate antibiotic an increasing challenge to community-based physicians. Common AECB pathogens have demonstrated no clinically relevant resistance to Cipro, especially in comparison to traditional therapies -- such as amoxicillin and macrolides. Cipro has maintained an excellent susceptibility profile over 10 years of use. "As resistance continues to rise, physicians need an option like Cipro 750 mg to treat respiratory pathogens that may be resistant to standard treatment options," said Jerome Schentag, Pharm.D., Professor of Pharmaceutics and Pharmacy, SUNY Buffalo School of Pharmacy and Director, Clinical Pharmacokinetic Laboratory, Millard Fillmore Hospital. "The bacterial eradication and clinical success rates found in patients with AECB treated with Cipro provide sound evidence of the clinical effectiveness of this drug." Bayer undertook an extensive research program to demonstrate Cipro's utility in treating AECB and acute sinusitis. In AECB, Cipro 750 mg demonstrated an overall 94.8 percent clinical success. In acute sinusitis, a pivotal multicenter study found a 96 percent clinical response at four-week follow-up for Cipro 500 mg BID for 10 days. Respiratory tract infections are a major cause of illness worldwide, representing the most common reason for clinic visits (105 million in the United States in 1994). Sinusitis affects an estimated 35 million people and chronic bronchitis affects approximately 12.5 million people annually in the United States. International studies of resistance patterns in the past decade have shown resistance to standard antibiotics has increased in the three main causative pathogens in both AECB and acute sinusitis -- H. influenzae, M. catarrhalis and S. pneumoniae. For example, nearly 25 percent of S. pneumoniae isolates now exhibit resistance to penicillins. In addition, research shows that 36 percent of more than 2,000 strains of H. influenzae were resistant to beta-lactams and more than 10 percent of S. pneumoniae isolates now exhibit macrolide resistance. In contrast to standard first-line therapies such as the penicillins and macrolides, Cipro is unaffected by principal mechanisms of resistance encountered in common AECB and sinusitis pathogens. Cipro has maintained an excellent susceptibility profile over 10 years of use. A recent multicenter susceptibility surveillance study showed that Cipro was effective against 100 percent of H. influenzae and M. catarrhalis isolates and 94.1 percent of penicillin-resistant S. pneumoniae isolates. The most commonly reported side effects of therapy with Cipro tablets are nausea, diarrhea, vomiting, abdominal pain/discomfort, headache, rash and restlessness. The safety and effectiveness of ciprofloxacin in children, adolescents (less than 18 years of age), pregnant women, and lactating women have not been established. Serious and fatal reactions have been reported in patients receiving concurrent administration of ciprofloxacin and theophylline. Cipro 750 mg tablets are indicated for severe/complicated lower respiratory tract infections caused by E. coli, K. pneumoniae, E. cloacae, P. mirabilis, P. aeruginosa, H. influenzae, H. parainfluenzae, and S. pneumoniae, and also M. catarrhalis for the treatment of acute exacerbations of chronic bronchitis. Cipro 500 mg tablets are indicated for mild-to-moderate acute sinusitis caused by H. influenzae, S. pneumoniae and M. catarrhalis. More information on: Cipro, Bayer --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. 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