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Clinical Trials

Prilosec (omeprazole)/Biaxin (clarithromycin) Combination Therapy

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved April 1996

Specific Treatments:

duodenal ulcers

General Information

Prilosec in combination with Biaxin has been approved for the treatment of subjects with H. pylori infection and duodenal ulcer to eradicate H. pylori, the bacteria now believed to cause approximately 90% of peptic ulcers. H. pylori eradication has been shown to reduce the risk of duodenal ulcer recurrence. Prilosec is marketed by Astra Merck and Biaxin is marketed by Abbott Laboratories.

The recommended dosage for eradicating H. pylori is Prilosec 40 mg once daily and Biaxin 500 mg three times daily for the first 14 days, followed by Prilosec 20 mg once daily for days 15 to 28.

Clinical Results

In clinical trials, the combination of Prilosec and Biaxin had H. pylori eradication rates of up to 83%. Among subjects in whom H. pylori has been eradicated, ulcer recurrence rates have been as low as five percent six months after therapy.

Side Effects

The Prilosec-Biaxin regimen has been generally well tolerated: side effects, which are usually mild and transient included taste perversion, nausea, and headache.

Additional Information

Peptic ulcers affect approximately five million Americans each year. It is estimated that 10% of the population will develop an ulcer during their lifetime. In the past, ulcers were believed to be caused by lifestyle factors such as stress and diet. Later, researchers discovered that an imbalance between digestive fluids and the stomach's ability to defend itself against these powerful substances resulted in ulcers.

However, researchers now know that the H. pylori bacteria (along with acid secretion) damages stomach and duodenal tissue, causing inflammation and ulcers in 90% of ulcer subjects. Treatment with Prilosec and Biaxin is considered a dramatic medical advance because elimination of H. pylori means that the ulcer will not only heal but also will not likely return.

H. pylori is a spiral-shaped bacterium found in the stomach. Like most germs, H. pylori bacteria is thought to be transmitted from person-to-person contact. Experts believe the activity of the bacteria damages and weakens the barrier that protects the stomach and duodenum, eventually causing the ulcer. In some people, the infection persists lifelong. Infection with H. pylori has also been linked to a number of other gastrointestinal diseases, including stomach cancer.

An ulcer is a sore or lesion that forms in the lining of the stomach or duodenum where acid and pepsin are present. Symptoms of ulcers include a gnawing or burning pain in the upper abdomen (often occurring between meals and early in the morning), and, sometimes, nausea, vomiting, loss of appetite and weight. Although ulcers can develop at any age, they are most prevalent in people over the age of 30.

Prilosec is currently indicated as first-line therapy for erosive esophagitis, for the maintenance of healed erosive esophagitis, for symptomatic gastroesophageal reflux disease (GERD) that is poorly responsive to customary medical treatment, and for short-term treatment of active duodenal ulcer and active benign gastric ulcer. It is also indicated for the treatment of certain pathological hypersecretory conditions. Biaxin is indicated for the treatment of mild-to-moderate infections, including upper-respiratory tract infections, lower-respiratory tract infections, and uncomplicated skin and skin-structure infections.

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