About diabetic gastroparesis
About diabetic gastroparesis
Gastroparesis, also known as delayed gastric emptying, is a condition in which the stomach empties slower than normal or food stops moving through the digestive tract.
Gastroparesis occurs in approximately 4% of the general population and in up to 12% of patients with diabetes.4,5 The disorder occurs as a result of a disruption in the normal digestive process. With gastroparesis, muscular contractions in the esophagus, stomach, and small intestine may be too slow or out of rhythm, resulting in food emptying slowly from the stomach or stopping in the digestive tract. When food stays in the stomach for too long, it can cause many uncomfortable symptoms and eventually may lead to more serious complications.
Metozolv ODT* is a prescription medicine used in adults for 4 to 12 weeks to relieve symptoms of diabetic gastroparesis. If you have diabetic gastroparesis, talk with your healthcare professional about Metozolv ODT.
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Diabetic gastroparesis symptoms
People who do not receive treatment for gastroparesis can experience a variety of uncomfortable symptoms. Without treatment, gastroparesis can cause complications with diabetic medicine, making it difficult for people with diabetes to control blood glucose levels. Diabetic gastroparesis symptoms may include
- Nausea
- Vomiting—Many people with diabetic gastroparesis vomit repeatedly several hours after eating
- Bloating immediately after a meal—These feelings of fullness may develop even after eating small amounts of food
- Weight loss and dehydration—Feeling full after eating small amounts of food may make it difficult to consume healthy amounts of food and water. This can lead to weight loss and dehydration
- Early satiety—Feeling full soon after you start eating or after eating a small amount of food
- Decreased appetite
- Heartburn
- Abdominal pain
If you have diabetes and are experiencing any of these symptoms, talk to your healthcare professional. He or she can perform tests to determine if you have diabetic gastroparesis and prescribe the right medicine for you.
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Diabetic gastroparesis risk factors
Many diabetic gastroparesis risk factors stem from problems related to controlling the level of glucose (sugar) in the blood. For people with diabetes, gastroparesis causes may include
- High glucagon levels—Glucagon is a hormone that increases the amount of glucose in the blood
- Vagus nerve neuropathy—Complications in the vagus nerve can disrupt muscle contraction in the digestive system
- Reduced number and density of interstitial cells of Cajal—Interstitial cells of Cajal act as pacemakers to time muscle contractions in the digestive system
- Stress—A corticotrophin-releasing hormone that the body releases in response to stress can also reduce digestion speed
- Taking certain medications—Some medicines may delay the speed at which the stomach empties
- Duration of diabetes—People with diabetic gastroparesis often have had diabetes for at least 10 years
There is no guaranteed plan for acute and recurrent diabetic gastroparesis prevention, but controlling blood sugar levels and regularly visiting your healthcare professional can help. If prevention efforts fail, ask your healthcare professional about Metozolv ODT, a treatment option for acute and recurrent diabetic gastroparesis.
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IMPORTANT SAFETY INFORMATION
Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with the duration of treatment and the total cumulative dose.
Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia. In some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped.
Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia.
METOZOLV® ODT (metoclopramide HCl) is indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy and for the relief of symptoms associated with acute and recurrent diabetic gastroparesis (diabetic gastric stasis) in adults. Therapy should not exceed 12 weeks in duration. Take on an empty stomach up to four times daily, at least 30 minutes before eating and at bedtime.
METOZOLV ODT is contraindicated in patients with intestinal obstruction, hemorrhage, or perforation; pheochromocytoma; known sensitivity or intolerance to metoclopramide; epilepsy; or are receiving concomitant medications with extrapyramidal reactions.
Extrapyramidal symptoms (EPS), manifested primarily as acute dystonic reactions, occur in approximately 1 in 500 patients treated with the usual adult dosages of 30 to 40 mg/day of metoclopramide. These usually are seen during the first 24 to 48 hours of treatment with metoclopramide, occur more frequently in pediatric patients and adult patients less than 30 years of age and are even more frequent at higher doses.
Drug-induced Parkinsonism can occur during metoclopramide therapy, more commonly within the first 6 months after beginning treatment, but also after longer periods. Patients with a history of Parkinson’s disease should be given metoclopramide cautiously, if at all, since such patients can experience exacerbation of Parkinsonian symptoms when taking metoclopramide.
There have been rare reports of an uncommon but potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) associated with metoclopramide. Clinical manifestations of NMS include hyperthermia, muscle rigidity, altered consciousness, and evidence of autonomic instability. The management of NMS should include immediate discontinuation of metoclopramide and other drugs not essential to concurrent therapy.
Depression associated with metoclopramide use has occurred in patients with and without a history of depression. For those patients with a prior history of depression, metoclopramide should only be given if the expected benefits outweigh the potential risks.
In one study in hypertensive patients, intravenously administered metoclopramide was shown to release catecholamines; hence, caution should be exercised when metoclopramide is used in patients with hypertension. Any rapid rise in blood pressure associated with METOZOLV ODT use should result in immediate cessation of metoclopramide use in those patients.
Since metoclopramide produces a transient increase in plasma aldosterone, patients with cirrhosis or congestive heart failure may be at risk of developing fluid retention and volume overload. If these side effects occur at any time in any patients during metoclopramide therapy, the drug should be discontinued.
Adverse reactions, especially those involving the nervous system, may occur after stopping the use of METOZOLV ODT.
In clinical studies, the most frequently reported adverse events (≥2% occurrence) were headache, nausea, fatigue, somnolence, and vomiting.
Full Prescribing Information for METOZOLV ODT, including BOXED WARNING.
References: 1. METOZOLV ODT [package insert]. Morrisville, NC: Salix Pharmaceuticals, Inc; 2009.
2. Overview. US Food and Drug Administration. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Overview&DrugName=REGLAN. Accessed May 6, 2009.
3. Overview. US Food and Drug Administration. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Overview&DrugName=METOCLOPRAMIDE%20HYDROCHLORIDE. Accessed May 6, 2009.
4. Abell TL, Bernstein RK, Cutts T, et al. Treatment of gastroparesis: a multidisciplinary clinical review. Neurogastroenterol Motil. 2006;18:263-283. 5. Haans JJL, Masclee AAM. Review article: the diagnosis and management of gastroparesis. Aliment Pharmacol Ther. 2007;26(suppl 2):37-46.