• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

Cipro(R) XR (Ciprofloxacin Extended-Release) Demonstrates Rapid Symptom Improvement and Early Return to Activities in Women Suffering From Uncomplicated Urinary Tract Infections (uUTI)

Posted on: Tuesday, 19 October 2004, 12:00 CDT

ORLANDO, Fla., Oct. 18 /PRNewswire/ -- A new study shows that women receiving ciprofloxacin extended-release tablets for the treatment of uncomplicated urinary tract infections (uUTI) experienced a rapid improvement in symptoms, which allowed them to quickly resume daily activities. The study was presented last week at the 2004 American Academy of Family Physicians (AAFP) Annual Scientific Assembly and World Conference of Family Doctors (WONCA) in Orlando, Florida.

The Excellence in Therapeutic Response and Activity (eXtRa) study found that 38 percent of patients reported initial relief of UTI symptoms within three hours of taking Cipro XR, and half of the patients reported significant symptom improvement within six hours. Additionally, 87 percent of patients reported symptom improvement and 22 percent reported complete symptom relief within 24 hours.

At study entry, more than half of the patients reported a decreased amount of time spent at work or in other activities, which was reduced to 22 percent of patients at 24 hours upon taking Cipro XR, and 10 percent at 48 hours after having taken the drug.

"UTIs can be extremely painful and disruptive to a woman's life," said Dr. Richard Colgan, study investigator and Assistant Professor at the University of Maryland School of Medicine in Baltimore, and Medical Director, Department of Family Medicine. "In this study, Cipro XR was shown to provide fast symptom relief, enabling participants' to quickly return to their normal routines."

Typically, women with UTIs suffer an average of six days of symptoms, including pain, and endure two days of restricted activity and time lost from work.(1)

"When I am suffering from a UTI, it is extremely important that my symptoms go away as soon as possible," said Lauren Orrico, a recurrent UTI sufferer. "When discussing treatment options with my doctor, we work together to make sure I receive antibiotic therapy that makes me feel better quickly and allows me to promptly return to my day-to-day activities.

Uncomplicated UTI is a serious health problem that accounts for more than 8 million doctor visits a year.(2) However, prior to the eXtRa study, little research had been conducted on UTI symptom duration and its effects on patients' lifestyles. A previous study on how UTI symptoms interfered with women's lives found that most women had experienced some symptom relief 36 hours after the start of treatment, with most symptoms disappearing at 66 hours.(3)

About the Study

A total of 264 adult female outpatients with acute uncomplicated UTIs were enrolled in an open label, non-controlled, phase IV study conducted in 28 health centers in the United States. Female patients answered serial questionnaires to track time to symptom relief, and received once-daily extended-release ciprofloxacin 500 mg tablets for 3 days. Of the 276 patients, 99 percent were safety-valid, 96 percent completed at least 24 hours of questionnaires and were valid for symptom relief analysis, and 62 percent had pretherapy pathogens and were valid for efficacy analysis.

Safety-valid patients were primarily young women (mean age of 33 years) who had not experienced a UTI in the past year. Overall clinical cure rate was 96 percent and no serious adverse events or discontinuations due to adverse events were observed.

About Cipro XR

Cipro XR is indicated for the treatment of uncomplicated urinary tract infections, complicated urinary tract infections and acute uncomplicated pyelonephritis, or kidney infection due to susceptible strains of indicated organisms. Cipro XR was developed using a bilayer matrix of the active ingredient ciprofloxacin, and enables two different release mechanisms. The first is a rapid release of ciprofloxacin, which distributes to the serum and tissues within hours. This is followed by a second extended release of the active ingredient to allow sustained levels for more than 24 hours. Cipro XR is designed to target certain bacteria that cause UTIs and acute uncomplicated pyelonephritis by treating the infection at the source, providing relief of the uncomfortable symptoms often associated with these infections. In addition to targeted use, many antibiotics are prescribed twice daily, while Cipro XR offers patients the option of once-daily dosing. Cipro XR tablets are available at a 500 mg dosage strength over three days for uncomplicated UTI, and at a 1000 mg dosage strength over 7-14 days for complicated UTI and acute uncomplicated pyelonephritis.

Important Safety Considerations

Serious and fatal reactions have been reported in patients receiving concurrent administration of ciprofloxacin and theophylline. Monitor theophylline levels if concurrent administration cannot be avoided.

The safety and effectiveness of Cipro XR in children, adolescents less than 18 years of age, pregnant women and lactating women have not been established. Cipro XR is contraindicated in persons with a history of hypersensitivity to ciprofloxacin or any quinolone, and should be discontinued at the first sign of an allergic reaction.

Adverse reactions determined to be at least possibly drug-related occurring in greater than or equal to 1 percent of patients were nausea and headache. Antacids containing magnesium, aluminium, calcium, or other products containing metal cations, should be taken 2 hours after or 6 hours before oral administration of Cipro XR.

About Bayer Pharmaceuticals Corporation

Bayer Pharmaceuticals Corporation (http://www.bayerpharma.com/) is part of the worldwide operations of Bayer HealthCare AG, a subgroup of Bayer AG.

Bayer HealthCare, with sales of approximately 8.9 billion Euro in 2003, is one of the world's leading, innovative companies in the health care and medical products industry.

The company combines the global activities of the divisions Animal Health, Biological Products, Consumer Care, Diagnostics and Pharmaceuticals. 34,600 people are employed by Bayer HealthCare worldwide.

Our aim is to discover and manufacture innovative products that will improve human and animal health worldwide. Our products enhance well-being and quality of life by diagnosing, preventing and treating disease.

This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including its Form 20-F). Bayer assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

(1) Foxman and Frerichs. Epidemiology of urinary tract infection. I.

Diaphragm use and sexual intercourse. Am J Public Health. 1985;

75:1308

(2) Foxman B. Epidemiology of urinary tract infections: Incidence,

Morbidity, and Economic Costs. The American Journal of Medicine.

July 2002; 113(1A):5S-13S.

(3) Colgan R. Survey of symptom burden in women with uncomplicated

urinary tract infections. Clin Drug Invest. 2004; 24(1):55-60

Bayer Healthcare

CONTACT: Mark Bennett of Bayer Pharmaceuticals Corporation,+1-203-812-2160, Fax: +1-203-812-5824

Web site: http://www.bayerpharma.com/

Source: PRNewswire

More News in this Category