Real World Effectiveness of Rosiglitazone Added to Maximal (Tolerated) Doses of Metformin and a Sulfonylurea Agent

Roy, Rajiv; Navar, Maria D.; Palomeno, Gladys; Davidson, Mayer B.

doi:10.2337/diacare.27.7.1741

Cited by 30 publications

(11 citation statements)

References 15 publications

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“…In this case, which is called ‘secondary failure’ to sulfonylureas, some investigators have proposed prescribing glitazones as third‐line therapy [23,24]. Such strategies, including a three‐drug treatment with metformin, sulfonylureas and one glitazone, remain partly efficient and result in a significant reduction of HbA1c levels [23–25]. These observations seem to be consistent with our own results and with the fact that insulin resistance is not stabilized at late stages of the disease and can be subject to further improvement or worsening.…”

Section: Discussionsupporting

confidence: 77%

Insulin secretion and sensitivity as determinants of HbA1c in type 2 diabetes

Monnier

Colette²,

et al. 2006

Eur J Clin Investigation

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Section: Discussionsupporting

confidence: 77%

Insulin secretion and sensitivity as determinants of HbA1c in type 2 diabetes

Monnier

Colette²,

et al. 2006

Eur J Clin Investigation

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“…We compared the above results to a prior study of rosiglitazone added to maximal (tolerated) doses of metformin and a sulfonylurea agent (8) in 48 patients with similar baseline characteristics (17 men and 31 women, aged 51 Ϯ 12.7 years, diabetes duration 7.7 Ϯ 6.1 years, and BMI 31.2 Ϯ 7.4 kg/m 2 ). Their baseline A1C level was 9.3 Ϯ 1.5%, which decreased to 7.5 Ϯ 1.5% 4 months later.…”

Section: Resultsmentioning

confidence: 92%

“…Comparisons were made in patients at 4 months, and those with successful outcomes (A1C Յ7.5%) were followed for 8 more months. The responses of 56 consecutively treated patients, in whom 45 mg pioglitazone was added, were compared with 48 patients receiving 8 mg rosiglitazone, as reported previously (8). (2 g) (3 had increased serum creatinine concentrations).…”

Section: Research Design Andmentioning

confidence: 99%

Comparison of the Glycemic Effects of Rosiglitazone and Pioglitazone in Triple Oral Therapy in Type 2 Diabetes

Tran

Navar²,

Davidson³

2006

Diabetes Care

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T o date, there have been few comparison studies between rosiglitazone and pioglitazone (1,2) and none of the two thiazolidinediones (TZDs) as a third agent in triple oral therapy. In February 2003, pioglitazone replaced rosiglitazone as the TZD on the pharmacy formulary at our hospital. This gave us the opportunity to compare the effectiveness of rosiglitazone and pioglitazone added to type 2 diabetic patients already on maximum (tolerated) doses of metformin and a sulfonylurea agent whose HbA 1c (A1C) levels did not meet the American Diabetes Association goal of Ͻ7.0%.RESEARCH DESIGN AND METHODS -Our diabetes clinic treatment algorithm mandates starting small doses of either a sulfonylurea agent or metformin and increasing the dose every 2 weeks until either a fasting plasma glucose (FPG) concentration of Ͻ130 mg/dl is attained or a maximal (tolerated in the case of metformin) dose is reached. If the FPG concentration remains Ͼ130 mg/dl, the alternate drug is added and also increased every 2 weeks. When the FPG goal is achieved, further therapeutic decisions are based on A1C levels measured 2-3 months later. Only when both agents are maximized and either the FPG concentration 2 weeks after the last increase remains Ͼ130 mg/dl or an A1C level is Ն7.0% 2-3 months after the FPG goal is reached, or at any time thereafter, is a maximal dose of a TZD added. The maximal dose is used because it can take up to 4 months to see a maximal response. If lower TZD doses are used initially and titrated upward, the patient can remain out of control for up to a year before insulin is started.Four months after adding the TZD, we decided whether triple oral therapy had been successful. We chose an A1C level of Յ7.5% to designate success and not start insulin (which necessitates significant lifestyle changes) because there was only a slight increase in the development or progression of retinopathy and/or nephropathy in patients with mean A1C levels between 7 and 8% (3-7). Only when A1C levels exceeded 7.5% (measured 4 months after starting the TZD or subsequently) was bedtime insulin started.The study design was a retrospective chart review of 104 adult type 2 diabetic patients followed in our diabetes clinic. The criterion for inclusion was taking a TZD for at least 4 months in patients who had failed maximal (tolerated) doses of metformin and a sulfonylurea agent. Comparisons were made in patients at 4 months, and those with successful outcomes (A1C Յ7.5%) were followed for 8 more months. The responses of 56 consecutively treated patients, in whom 45 mg pioglitazone was added, were compared with 48 patients receiving 8 mg rosiglitazone, as reported previously (8).RESULTS -Fifty-six patients on pioglitazone (24 men and 32 women, aged 54.1 Ϯ 7.7 years [mean Ϯ SD], diabetes duration 8.3 Ϯ 5.9 years, and BMI 33.2 Ϯ 7.4 kg/m 2 ) were studied. There were 42 Latinos, 11 African Americans, 2 Caucasians, and 1 Asian Pacific Islander. At baseline, 55 patients were taking maximal doses of glyburide (20 mg) or glipizide (40 mg), with 1 pati...

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“…The concept that oral blood-glucose-lowering therapy provides inadequate protection against hyperglycaemia is not new [22][23][24]. Epidemiological studies and preliminary intervention studies have shown that postprandial hyperglycaemia is a direct and independent risk factor for the development of cardiovascular disease [12].…”

Section: Discussionmentioning

confidence: 99%

Glycaemic instability is an underestimated problem in Type II diabetes

et al. 2006

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The aim of the present study was to assess the level of glycaemic control by the measurement of 24 h blood glucose profiles and standard blood analyses under identical nutritional and physical activity conditions in patients with Type II diabetes and healthy normoglycaemic controls. A total of 11 male patients with Type II diabetes and 11 healthy matched controls participated in a 24 h CGMS (continuous subcutaneous glucose-monitoring system) assessment trial under strictly standardized dietary and physical activity conditions. In addition, fasting plasma glucose, insulin and HbA(1c) (glycated haemoglobin) concentrations were measured, and an OGTT (oral glucose tolerance test) was performed to calculate indices of whole-body insulin sensitivity, oral glucose tolerance and/or glycaemic control. In the healthy control group, hyperglycaemia (blood glucose concentration >10 mmol/l) was hardly present (2+/-1% or 0.4+/-0.2/24 h). However, in the patients with Type II diabetes, hyperglycaemia was experienced for as much as 55+/-7% of the time (13+/-2 h over 24 h) while using the same standardized diet. Breakfast-related hyperglycaemia contributed most (46+/-7%; P<0.01 as determined by ANOVA) to the total amount of hyperglycaemia and postprandial glycaemic instability. In the diabetes patients, blood HbA(1c) content correlated well with the duration of hyperglycaemia and the postprandial glucose responses (P<0.05). In conclusion, CGMS determinations show that standard measurements of glycaemic control underestimate the amount of hyperglycaemia prevalent during real-life conditions in Type II diabetes. Given the macro- and micro-vascular damage caused by postprandial hyperglycaemia, CGMS provides an excellent tool to evaluate alternative therapeutic strategies to reduce hyperglycaemic blood glucose excursions.

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Real World Effectiveness of Rosiglitazone Added to Maximal (Tolerated) Doses of Metformin and a Sulfonylurea Agent

Cited by 30 publications

References 15 publications

Insulin secretion and sensitivity as determinants of HbA1c in type 2 diabetes

Insulin secretion and sensitivity as determinants of HbA1c in type 2 diabetes

Comparison of the Glycemic Effects of Rosiglitazone and Pioglitazone in Triple Oral Therapy in Type 2 Diabetes

Glycaemic instability is an underestimated problem in Type II diabetes

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