An Asian Multicenter Clinical Trial to Assess the Efficacy and Tolerability of Acarbose Compared With Placebo in Type 2 Diabetic Patients Previously Treated With Diet

Chan, Juliana C.N.; Chan, Kin Wei A; Ho, Larry L.T.; Fuh, Martin M.C.; Horn, Lee Chung; Sheaves, R.; Panelo, Araceli; Kim, Duk Kyl; Embong, Mustaffa

doi:10.2337/diacare.21.7.1058

Cited by 51 publications

(34 citation statements)

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“…Could the results obtained with voglibose in Japanese patients be extrapolated to other populations, in view of the well known good efficacy and safety profile of α-glucosidase inhibitors in Asians? 18 The answer might be yes because the reported results agree with those of the STOP-NIDDM trial with acarbose in Canadians and Europeans. 6 With the positive results obtained with metformin 1,8,12 and α-glucosidase inhibitors (today's study and references 8 and 19) on the one hand, and the rather high residual risk of developing type 2 diabetes with monotherapy on the other, treatment with a combination of the two types of drugs might be an option.…”

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confidence: 50%

“…16 α-glucosidase inhibitors seem to exert a good glucose-lowering effect (with an acceptable gastrointestinal tolerance) in Asian people, presumably because of specific food habits. 18 Therefore the results of the trial by Kawamori and colleagues in The Lancet today, in which the effect of voglibose (another α-glucosidase inhibitor) was assessed in Japanese patients with impaired glucose tolerance, raise much interest. 5 Analysis after almost 50 weeks of treatment showed that voglibose (0 .…”

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confidence: 99%

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Voglibose for prevention of type 2 diabetes mellitus

Scheen

2009

The Lancet

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Lifestyle interventions are effective for the prevention of type 2 diabetes in different populations with impaired glucose tolerance in the USA, 1 north Europe, 2 China, 3 and Japan. 4 Not only were the results impressive at the end of the intensive intervention trials, but long-term follow-up studies also confirmed the effect of lifestyle interventions for the prevention of diabetes in individuals at high risk of developing the disease. 2,3 Various drugs are efficacious in the prevention of type 2 diabetes in individuals with impaired glucose tolerance (figure). Glucose-lowering drugs preventedthe development of type 2 diabetes in placebo-controlled clinical trials. 1,3 Metformin reduced the relative risk of new-onset diabetes at the end of the US Diabetes Prevention Programme by 31%, 1 and a 26% reduction was seen inthe Indian Diabetes Prevention Programme. 8 Treatment with thiazolidinediones resulted in a greater risk reduction (60% with rosiglitazone in DREAM, 11 and 81% with pioglitazone in ACT-NOW 12-14 ). However, because both metformin and glitazones positively affect the pathophysiology of type 2 diabetes, 15 and because the main reported results were analysed without any washout period, the distinction between a masking and atrue preventive effect is almost impossible. 16 Another approach that would not directly affect insulin sensitivity or insulin secretion is to competitively inhibit intestinal α-glucosidase enzymes. 17 In the STOP-NIDDM trial, 6 done in Canada and various European countries, a 25% reduction was reported in the number of patients with new-onset diabetes and impaired glucose tolerance who were given acarbose (100 mg three times a day) compared with those given placebo after a 3-year followup. 6 Furthermore, acarbose significantly increased reversion of impaired glucose tolerance to normal. However, at the end of the study, treatment with placebo for 3 months was associated with an increase in conversion of impaired glucose tolerance to diabetes. Because acarbose does not interfere with the intestinal absorption of the monosaccharide glucose that is ingested during the oral glucose tolerance test, a masking effect seems unlikely compared with previous discussions about metformin or glitazones. 16 α-glucosidase inhibitors seem to exert a good glucose-lowering effect (with an acceptable gastrointestinal tolerance) in Asian people, presumably because of specific food habits. 18 Therefore the results of the trial by Kawamori and colleagues in The Lancet today, in which the effect of voglibose (another α-glucosidase inhibitor) was assessed in Japanese patients with impaired glucose tolerance, raise much interest. 5 Analysis after almost 50 weeks of treatment showed that voglibose (0 . 2 mg three times a day) reduced the risk of patients with impaired glucose tolerance developing type 2 diabetes by 40 . 5% and increased the proportion who achieved normoglycaemia by 53 . 9% compared with those given placebo. The underlying mechanism of action is not known. Unlike metformin and glitazones...

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Voglibose for prevention of type 2 diabetes mellitus

Scheen

2009

The Lancet

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“…Therefore, patients with dapagliflozin may have better medication adherence and fewer therapy discontinuations as compared with acarbose in some extent. In this study, according to the reports of included RCTs, therapy discontinuation rates were 8.6% and 14.6% in dapagliflozin and acarbose treatment, respectively, with reasons such as intolerance to therapy or adverse events, lost to follow-up, poor glycaemic control, poor medication adherence, or no longer met study criteria [41][42][43][55][56]. Potential better therapy adherence may be another advantage of dapagliflozin.…”

Section: Discussionmentioning

confidence: 99%

“…Title and abstract screening resulted in 52 papers for detailed review. After examination of full-text articles, four eligible studies were finally included in the meta-analysis (two on dapagliflozin versus placebo, and two on acarbose versus placebo) [41][42][55][56] (Fig 1).…”

Section: Literature Reviewmentioning

confidence: 99%

Cost-Effectiveness of Dapagliflozin Versus Acarbose as A Monotherapy in Type 2 Diabetes in China

2016

Value in Health

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ObjectiveTo estimate the long-term cost-effectiveness of dapagliflozin versus acarbose as monotherapy in treatment-naïve patients with type 2 diabetes mellitus (T2DM) in China. MethodsThe Cardiff Diabetes Model, an economic model designed to evaluate the cost-effectiveness of comparator therapies in diabetes was used to simulate disease progression and estimate the long-term effect of treatments on patients. Systematic literature reviews, hospital surveys, meta-analysis and indirect treatment comparison were conducted to obtain model-required patient profiles, clinical data and costs. Health insurance costs (2015¥) were estimated over 40 years from a healthcare payer perspective. Univariate and probabilistic sensitivity analyses were performed. ResultsThe model predicted that dapagliflozin had lower incidences of cardiovascular events, hypoglycemia and mortality events, was associated with a mean incremental benefit of 0.25 quality-adjusted life-years (QALYs) and with a lower cost of ¥8,439 compared with acarbose. This resulted in a cost saving of ¥33,786 per QALY gained with dapagliflozin. Sensitivity analyses determined that the results are robust. ConclusionDapagliflozin is dominant compared with acarbose as monotherapy for Chinese T2DM patients, with a little QALY gain and lower costs. Dapagliflozin offers a well-tolerated and cost-effective alternative medication for treatment-naive patients in China, and may have a direct impact in reducing the disease burden of T2DM.

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“…• an important manifestation in the early course of type 2 diabetes mellitus (T2DM) • a critical target for achieving glycemic control • a contributing factor in the pathogenesis of cardiovascular disease -Acarbose indirectly optimizes glucose metabolism during the day through adaptation of insulin secretion 2 • Numerous studies have shown beneficial effects of acarbose as a 1st-, 2nd-and 3rd-line treatment option, [10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28] for which it is recommended by both the International Diabetes Federation (IDF) and American Association for Clinical Endocrinologists (AACE) 29,30 • However, prescribing of acarbose varies around the world due to a perception that efficacy is limited in some ethnic and regional groups • We therefore analyzed pooled data from acarbose post-marketing studies (PMS) and non-interventional studies (NIS) to examine whether differences between patients of European Caucasian and Asian ethnicity exist based on a large body of evidence…”

Section: Introductionmentioning

confidence: 99%

Efficacy of acarbose in different geographical regions of the world: analysis of a real-life database

Kalra¹,

Soegondo²,

Schnell³

et al. 2014

EJEA

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An Asian Multicenter Clinical Trial to Assess the Efficacy and Tolerability of Acarbose Compared With Placebo in Type 2 Diabetic Patients Previously Treated With Diet

Abstract: In this multicenter study involving six ethnic groups, acarbose 100 mg t.i.d. was an effective, safe, and generally well-tolerated therapy in Asian type 2 diabetic patients with dietary failure. In some patients with troublesome gastrointestinal symptoms, a lower dosage may be necessary.

Cited by 51 publications

References 12 publications

Voglibose for prevention of type 2 diabetes mellitus

Voglibose for prevention of type 2 diabetes mellitus

Cost-Effectiveness of Dapagliflozin Versus Acarbose as A Monotherapy in Type 2 Diabetes in China

Efficacy of acarbose in different geographical regions of the world: analysis of a real-life database

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