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Treatment for Dysmotility-type of Dyspepsia

Dyspepsia, Novartis

Stomach ulcer or acid reflux (When stomach acid backs up into the esophagus. The tube leading from the mouth to the stomach.) and medications (anti-inflammatory ibuprofen, aspirin, naproxen and ketoprofen) cause dyspepsia or dysmotility – type (One of three subgroups of functional dyspepsia) of dyspepsia. Symptoms are pain, bloating, and uncomfortably feeling in the upper middle part of the stomach (common digestive condition). The pain is transient – comes and goes, but it’s usually present most of the time. Other signs of dyspepsia include heartburn, vomiting, burping, severe vomiting, excessive and uncomfortable feeling of fullness after eating, and extreme fullness, soon after the start of a meal. Also, symptoms include unexplainable loss of weight, and trouble swallowing. Both men and women could develop this condition at any age. Approximately one of every four persons gets dyspepsia some time in life or twenty-five percent of the adult population (Fifty-two million Americans). Rarely, dyspepsia is caused by stomach cancer. Sometimes no cause can be found. Annual direct and indirect healthcare average cost is $2.5 billion.

Treatment for dyspepsia depends on the cause. Otherwise, no prescription medication approved to treat dysmotility-type of dyspepsia. Stomach ulcers can be treated, taking acid-blocking medicine. Infection in the stomach treatable by an antibiotic. Discontinue taking medications that cause the symptoms of dyspepsia. Common approach taken to avoid dyspepsia: Stop smoking, avoid foods that upset the stomach, reducing stress, and don’t eat before bedtime (Increases acid reflux). Also, raising the head of the bed with blocks under both legs may help. If none of these suggestions stops dyspepsia, a physician would recommend undergoing an Endoscopy examination: A small tube with a camera inserted into the mouth and down into the stomach. The doctor would examine the inside of the stomach for any cause of pain.

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Presented at the American College of Gastroenterology (AOG), Annual Scientific Meeting in Las Vegas, October 20 – 25, 2006, Zelnorm (tegaserol maleate) demonstrated potential treatment for multiple symptoms of dysomotility , supported by Phase three data of Novartis AG. During clinical studies, a total of 2,667 women, at least 18 years age, Zelnorm had relieved dyspepsia symptoms. Significant results observed by severe baseline dyspepsia symptoms, compared to taking a placebo. Moderate to severe diarrhea side effect developed in 13.6% of treated patients. Recommended discontinue use of the medication when diarrhea side effect develops. James Shannon, MD, Global Head of Development at Novartis Pharma AG said:
” Millions of patients currently rely on Zelnorm to relieve IBS (irritable bowl syndrome) with Constipation and Chronic Constipation and these new study results may offer hope of relieve to those living with symptoms of dysmotility-type of dyspepsia.” Previously, the treatment of Zelnorm for men and women less than 65 years of age with Chronic Idiopathic Constipation (No known cause and lasting over six months.) proved successful. Zelnorn is approved in fifty-five countries for treatment of irritable bowl syndrome with constipation and in 20 countries for treatment of chronic idiopathic constipation.

Concerned reasons to consider before taking Zelnorm: The effectiveness of the Zelnorn has not been established in patients 65 years or older with Chronic Idiopathic Constipation. Also, the efficacy beyond twelve weeks has not been studied. Some patients taking the medication developed Ischemic Colitis (A disorder in which, part of colon (large intestine) becomes inflamed or injured. Usually attributed, decline in blood flow to the colon, which can interfere with its normal functions) and other forms of intestinal ischemia (Result of a blood clot, blocking the flow of blood to or from the intestine)