ACARBOSE

Ann Neurol 2002 May;51(5):604-12
Risk of Developing Type 2 Diabetes Reduced in Acarbose Clinical Trial Results from the landmark STOP-NIDDM trial published in Lancet
WEST HAVEN, CT, June 15, 2002 - Results from the Study to Prevent Non-Insulin Dependent Diabetes Mellitus (STOP-NIDDM), a landmark international trial in patients with impaired glucose tolerance (IGT), demonstrated that the use of acarbose (Precose®, acarbose tablets) reduced the risk of developing type 2 diabetes mellitus and increased the number of patients who reverted to having normal glucose tolerance. The study was published in the June 15 2002 edition of the medical journal, Lancet:
Chiasson J-L, Gomis R, Hanefeld M, Josse RG, Karasik A, Laakso M, for the STOP-NIDDM Trial Research Group. Acarbose can prevent the progression of impaired glucose tolerance to type 2 diabetes mellitus: results of a randomised clinical trial: the STOP-NIDDM Trial. Lancet 2002; 359(9323).

Before individuals develop type 2 diabetes, they almost always have a period of impaired glucose tolerance (IGT) during which glucose levels are above normal but not sufficiently elevated to be diagnosed as diabetes. The ADA has now adopted the term, prediabetes, to describe this condition. A person is generally considered to have prediabetes if a fasting plasma glucose is between 110 and 125 mg/dL or an oral glucose tolerance test similar to the one used in STOP-NIDDM is between 140 and 199 mg/dL. About 16 million Americans are thought to have prediabetes.
In the study, 1429 male and female patients with IGT (mean age of 54.5 years) were randomized to either placebo or acarbose 100 mg 3 times a day for a mean follow-up time of 3.3 years. All subjects were given dietary instruction and were encouraged to exercise.

After 3.3 years of treatment in the STOP-NIDDM trial, the risk of developing type 2 diabetes was reduced by 25% in patients receiving acarbose. In those subjects receiving the study drug whose IGT was confirmed by a second 2-hour glucose load, the risk of type 2 diabetes was reduced by 36.4%.
"The number of individuals who are at risk of developing type 2 diabetes -- a costly condition -- is reaching epidemic proportions in the United States and the rest of the world," said Dr. Paul MacCarthy, Vice President, US Medical Science at Bayer. "The STOP-NIDDM trial is part of an evolving body of work that suggests intervention in patients with IGT may reduce the risk of developing type 2 diabetes."
The results observed in the study were consistent regardless of the age, gender and body mass index (BMI) of the study participants. Body weight decreased by 0.5 kg in the acarbose treated group and increased by 0.3 kg the placebo group.
Side effects observed in the clinical trial were described as mild to moderate in severity by the investigators. Gastrointestinal symptoms including flatulence, diarrhea, and abdominal pain were the most common side effects and were more frequently seen in the acarbose treated group. No serious adverse events were determined to be related to the study medication.

Braz J Med Biol Res 2002 Aug;35(8):877-84
Improved glycemic control by acarbose therapy in hypertensive diabetic patients: effects on blood pressure and hormonal parameters
Rosenbaum P, Peres RB, Zanella MT, Ferreira SR
Divisao de Endocrinologia, Universidade Federal de Sao Paulo, Sao Paulo, SP, Brasil

A double-blind, randomized, placebo-controlled study was carried out on 44 hypertensive type 2 diabetic subjects previously treated by diet associated or not with sulfonylurea to assess the effects of acarbose-induced glycemic control on blood pressure (BP) and hormonal parameters. Before randomization and after a 22-week treatment period (100 to 300 mg/day), the subjects were submitted to a standard meal test and to 24-h ambulatory BP monitoring (ABPM) and had plasma glucose, glycosylated hemoglobin, lipid profile, insulin, proinsulin and leptin levels determined. Weight loss was found only in the acarbose-treated group (75.1 +/- 11.6 to 73.1 +/- 11.6 kg, P<0.01). Glycosylated hemoglobin decreased only in the acarbose group (6.4 +/- 1.7 to 5.6 +/- 1.9%, P<0.05). Fasting proinsulin decreased only in the acarbose group (23.4 +/- 19.3 to 14.3 +/- 13.6 pmol/l, P<0.05), while leptin decreased in both (placebo group: 26.3 +/- 6.1 to 23.3 +/- 9.4 and acarbose group: 25.0 +/- 5.5 to 22.7 +/- 7.9 ng/ml, P<0.05). When the subset of acarbose-treated patients who improved glycemic control was considered, significant reductions in diurnal systolic, diastolic and mean BP (102.3 +/- 6.0 to 99.0 +/- 6.6 mmHg, P<0.05) were found. Acarbose monotherapy or combined with sulfonylurea was effective in improving glycemic control in hypertensive diabetic patients. Acarbose-induced improvement in metabolic control may reduce BP in these patients. Our data did not suggest a direct action of acarbose on insulin resistance or leptin levels.

GENERIC NAME: acarbose
BRAND NAME: Precose

DRUG CLASS AND MECHANISM: Acarbose is an oral medication that is used to control blood glucose (sugar) levels in type II diabetes. It belongs to a class of drugs called alpha-glucosidase inhibitors which also includes miglitol (Glyset). Acarbose was approved by the FDA for use in 1995.

Carbohydrates that are eaten are digested by enzymes in the intestine into smaller sugars which are absorbed into the body and increase blood sugar levels. The process of carbohydrate digestion requires the pancreas to release into the intestine alpha-amylase enzymes which digest the large carbohydrates into smaller carbohydrates called oligosaccharides. The cells lining the small intestine then release alpha-glucosidase enzymes that further digest the oligosaccharides into smaller sugars, like glucose, that can be absorbed. Acarbose is a man-made oligosaccharide designed to slow down the actions of alpha-amylase and alpha-glucosidase enzymes thereby slowing the appearance of sugar in the blood after a meal.

PREPARATIONS: Tablets: 25, 50 and 100 mg.

STORAGE: Acarbose should be stored at room temperature, 15-30°C(59-86°F) in a tight container.

PRESCRIBED FOR: It is believed that strict sugar control in diabetics decreases the risk of eye, kidney, and nerve damage. Alpha-glucosidase inhibitors are used to help lower blood sugar levels that are not controlled by diet and exercise. Acarbose can be used alone to treat type II diabetes or can be combined with sulfonylureas such as glyburide (Diabeta) or metformin (Glucophage) or with insulin.

DOSING: The initial acarbose dose may start 25 mg three times daily and then increase after four to eight weeks to 50-100 mg three times daily. Acarbose should be taken at the first bite of each meal.

Smaller doses may be adequate for patients with severe kidney dysfunction or liver disease. Acarbose is not recommended if cirrhosis is present. Acarbose therapy is not advised in the presence of certain medical conditions such as inflammatory bowel disease or intestinal obstruction and chronic intestinal diseases that interfere with digestion or absorption such as Crohn's disease.

Acarbose doses should be adjusted based upon blood glucose levels taken one hour after a meal and blood HbA1c levels taken about three months after starting or changing the dose. (HbA1c is a chemical in the blood that is a good indicator of blood glucose control.)

DRUG INTERACTIONS: Acarbose may interfere with digoxin absorption thereby decreasing digoxin blood levels and its effect. Therefore, the digoxin dose may need to be increased if acarbose is begun.

Since adding insulin or a sulfonylurea to acarbose therapy may lower blood glucose more than acarbose alone, the risk for developing hypoglycemia is greater when these drugs are combined. Caution should be used when combining these drugs.

If mild to moderate hypoglycemia occurs while taking acarbose in combination with another anti-diabetic agent, the hypoglycemia should be treated with oral glucose (dextrose) instead of sucrose (table sugar) because acarbose blocks the digestion of sucrose to glucose, and hypoglycemia will not be corrected rapidly with sucrose. Acarbose alone does not produce hypoglycemia.

PREGNANCY: There are no studies of acarbose treatment during pregnancy in humans. Insulin therapy is recommended in pregnancy.

NURSING MOTHERS: Acarbose is excreted in the milk of lactating animals, but no human studies have been conducted. Acarbose use is not recommended for nursing mothers.

SIDE EFFECTS: The most common side effects with acarbose therapy are abdominal pain, diarrhea and flatulence. There is a rare possibility that these gastrointestinal side effects may become severe and progress to paralytic ileus.

Other possible but rare side effects are an increase in liver enzymes, and decreases in hematocrit, calcium or vitamin B6 levels.

Caution! Before starting to take this medicine, it is vital that you should consult your doctor! Do not use it on your own initiative, without medical advice.
Also, you should read carefully important health information about this drug given here:

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