Acarbose adverse effects

In a 2-year study of the tolerability and safety of acarbose in 2035 patients the incidence of adverse effects was 7.5% and of withdrawals 2.5% (11). Of 1907 patients, 444 (23%) reported one or more adverse events. In 143 patients the physician considered that there was a probable or possible relation between the adverse event (all gastrointestinal) and acarbose. There were 77 deaths, but none was considered to be related to acarbose 52 stopped taking acarbose because of an adverse event and 45 were considered to be related to acarbose. Laboratory analyses were all within the reference ranges. HbAlc fell by 1.92%. 

Of 1027 patients, 283 used acarbose as the treatment of choice (13). In 250 cases the physician was not sure of the benefit 124 of these patients took acarbose and 126 patients took placebo besides regular therapy. In those taking acarbose HbAlc fell. The adverse effects were bloating, flatulence, abdominal cramps, and diarrhea there were moderate increases in serum transaminases. 

In a comparison of voglibose and acarbose in 21 in-patients with type 2 diabetes who took part in a randomized crossover study of acarbose 150 mg/day and voglibose 0.9 mg/day, there was marked interindividual variation in response (18). For both drugs efficacy was better in those with gastrointestinal adverse effects, such as abdominal distention and flatulence. 

When acarbose or placebo was given to patients with type 1 diabetes taking insulin, acarbose reduced postprandial blood glucose but there was no difference in HbAic the only adverse effects were gastrointestinal (23). 

In a double-blind, placebo-controlled study in 74 patients for 2 years, acarbose 100 mg tds, after a stepwise increase in dosage over 5 weeks, improved HbAic (-1.71%) more than placebo (24). Two patients taking acarbose withdrew with drug-related adverse effects. 

Acarbose reduced insulin resistance in 192 patients over 65 years of age (mean age 70) in a double-blind, placebo-controlled study (27). HbAlc was significantly but modestly reduced. The most frequent adverse effect was flatulence, which caused 12 patients (9 taking acarbose and 3 taking placebo) to withdraw. 

In a multicenter, double-blind, placebo-controlled study, 81 patients, in whom treatment with metformin was inadequate, received extra acarbose or placebo during 24 weeks after a 4-week run-in period to establish the optimal dose of acarbose (28). HbAic was reduced by 1.02% and fasting blood glucose by 1.13 mmol/1. Gastrointestinal adverse effects were more common in the acarbose group. 

Acarbose and miglitol have been reviewed (17,32,33). Their major adverse effects are flatulence, abdominal discomfort, diarrhea, and bloating, particularly at the start of therapy, which sometimes prevent further use. They should not be given to patients with intestinal obstruction, malabsorption, inflammatory bowel disease, or hepatic impairment. 

In the STOP-NIDDM trial of acarbose cardiovascular risk and hypertension were reduced however, almost a quarter of the participants withdrew early, and the main cause of early withdrawal was gastrointestinal adverse effects (43). 

The author of a review of the use of acarbose concluded that acarbose is safe in both monotherapy and combination therapy (44). The most common adverse effects are mild to moderate gastrointestinal symptoms, such as flatulence, meteorism, diarrhea, soft stools, abdominal discomfort, and pain. As glucose oxidase increases in the small intestine during therapy, it is advisable to start with a low dose so that the gut can adapt to acarbose. 

In a post-marketing surveillance study of 1142 patients in whom acarbose was added to insulin therapy for type 2 diabetes mellitus, HbAlc improved by 0.9% and there were 108 adverse effects in 6.9% of the patients (45). Most of the complaints were gastrointestinal (flatulence, abdominal pain, diarrhea) and more than half were reported in the first week of acarbose therapy. 

A meta-analysis of seven double-bhnd, randomized, placebo-controlled studies in which acarbose was used for a minimum of 52 weeks for the management of type 2 diabetes has shown that the frequency of the most common adverse events of flatulence, diarrhea, and abdominal pain varied from country to country 53% of those taking acarbose reported symptoms in Germany compared with 73% in Canada (46). The frequency of adverse effects with placebo was also higher in Canada (39%) than in Germany (29%). 

Side Effects, Adverse Effects. Gastrointestinal disturbances in the form of flatulence, abdominal discomfort, and, to a lesser extent, diarrhea are common side effects of therapy with a-glucosidase inhibitors. Use of acarbose at higher doses (100 mg or greater) has been associated with a low incidence of elevated serum transaminase levels, most often in patients weighing less than 60 kg. 

Adverse effects of acarbose are abdominal discomfort and flamlence. 

Neomycin may increase the efficacy and the gastrointestinal adverse effects of acarbose. There is some indirect evidence that acarbose with alcohol may increase the hepatotoxicity of paracetamol (acetaminophen). Parafytic ileus has been reported in a Japanese patient treated with acarbose and promethazine, an an-timuscarinic drug. 

Neomycin alone can reduce postprandial blood glucose levels and may enhance the reduction in postprandial glucose levels associated with acarbose. Neomycin 1 g three times daily increased the unpleasant gastrointestinal adverse effects (flatulence, cramps and diarrhoea) of acarbose 200 mg three times daily in 7 healthy subjects. The manufacturers suggest that if these adverse effects are severe the dosage of acarbose should be reduced." ... 

Gastrointestinal In a prospective, randomised, open-label study with diabetic patients (n = 60) treated with human insulin plus acarbose, the most frequent adverse effect was abdominal distension (n = 22,36%). These adverse effects were acarbose-dose-related from acarbose 50 mg once daily to 50 mg three times daily. [18 ]... 

Kageyama S, Nakamichi N, Sekino H, Fujita H, Nakano S. Comparison of the effects of acarbose and voglibose on plasma glucose, endogenous insulin sparing, and gastrointestinal adverse events in obese subjects a randomized, placebo-controlled, double-blind, three-way crossover study. Curr Ther Res Clin Exp 2000 61 630-45. 

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