Cardiometabolic disease staging predicts effectiveness of weight-loss therapy to prevent type 2 diabetes

Pooled results from phase III clinical trials assessing phentermine/topiramate extended release

Fangjian Guo, W. Timothy Garvey

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Objective: To assess the ability of medication-assisted weight loss to prevent diabetes as a function of the baseline weighted Cardiometabolic Disease Staging (CMDS) score. Research Design and Methods We pooled data from 3,040 overweight and obese participants in three randomized controlled trialsdCONQUER, EQUIP, and SEQUELdassessing efficacy and safety of phentermine/topiramate extended release (ER) for weight loss. In these doubleblind phase III trials, overweight/obese adult patients were treated with a lifestyle intervention and randomly assigned to placebo versus once-daily oral phentermine/ topiramate ER. The weighted CMDS score was calculated using baseline quantitative clinical data including waist circumference, blood glucose, blood pressure, and blood lipids. Incident diabetes was defined based on serial measures of fasting glucose, 2-h oral glucose tolerance test glucose, and/or HbA1c. Results: The absolute decrease in 1-year diabetes incidence rates in subjects treated with medication versus placebo was greatest in those with high-risk CMDS scores at baseline (10.43-6.29%), intermediate in those with moderate CMDS risk (4.67-2.37%), and small in the low-risk category (1.51-0.67%). The number of participants needed to treat to prevent one new case of diabetes over a 56-week period was 24, 43, and 120 in those with baselineCMDS scores of≥60, 30-59, and 0-29, respectively. Conclusions: Numbers needed to treat to prevent one case of type 2 diabetes are markedly lower in patients with high-risk scores. CMDS can be used to quantify risk of diabetes in overweight/obese individuals and predict the effectiveness ofweight-loss therapy to prevent diabetes.

Original languageEnglish (US)
Pages (from-to)856-862
Number of pages7
JournalDiabetes Care
Volume40
Issue number7
DOIs
StatePublished - Jul 1 2017

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Phentermine
Phase III Clinical Trials
Type 2 Diabetes Mellitus
Weight Loss
Numbers Needed To Treat
Placebos
Therapeutics
Glucose
Aptitude
Waist Circumference
Glucose Tolerance Test
Blood Glucose
Life Style
Fasting
Research Design
topiramate
Blood Pressure
Lipids
Safety
Incidence

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Advanced and Specialized Nursing

Cite this

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title = "Cardiometabolic disease staging predicts effectiveness of weight-loss therapy to prevent type 2 diabetes: Pooled results from phase III clinical trials assessing phentermine/topiramate extended release",
abstract = "Objective: To assess the ability of medication-assisted weight loss to prevent diabetes as a function of the baseline weighted Cardiometabolic Disease Staging (CMDS) score. Research Design and Methods We pooled data from 3,040 overweight and obese participants in three randomized controlled trialsdCONQUER, EQUIP, and SEQUELdassessing efficacy and safety of phentermine/topiramate extended release (ER) for weight loss. In these doubleblind phase III trials, overweight/obese adult patients were treated with a lifestyle intervention and randomly assigned to placebo versus once-daily oral phentermine/ topiramate ER. The weighted CMDS score was calculated using baseline quantitative clinical data including waist circumference, blood glucose, blood pressure, and blood lipids. Incident diabetes was defined based on serial measures of fasting glucose, 2-h oral glucose tolerance test glucose, and/or HbA1c. Results: The absolute decrease in 1-year diabetes incidence rates in subjects treated with medication versus placebo was greatest in those with high-risk CMDS scores at baseline (10.43-6.29{\%}), intermediate in those with moderate CMDS risk (4.67-2.37{\%}), and small in the low-risk category (1.51-0.67{\%}). The number of participants needed to treat to prevent one new case of diabetes over a 56-week period was 24, 43, and 120 in those with baselineCMDS scores of≥60, 30-59, and 0-29, respectively. Conclusions: Numbers needed to treat to prevent one case of type 2 diabetes are markedly lower in patients with high-risk scores. CMDS can be used to quantify risk of diabetes in overweight/obese individuals and predict the effectiveness ofweight-loss therapy to prevent diabetes.",
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N2 - Objective: To assess the ability of medication-assisted weight loss to prevent diabetes as a function of the baseline weighted Cardiometabolic Disease Staging (CMDS) score. Research Design and Methods We pooled data from 3,040 overweight and obese participants in three randomized controlled trialsdCONQUER, EQUIP, and SEQUELdassessing efficacy and safety of phentermine/topiramate extended release (ER) for weight loss. In these doubleblind phase III trials, overweight/obese adult patients were treated with a lifestyle intervention and randomly assigned to placebo versus once-daily oral phentermine/ topiramate ER. The weighted CMDS score was calculated using baseline quantitative clinical data including waist circumference, blood glucose, blood pressure, and blood lipids. Incident diabetes was defined based on serial measures of fasting glucose, 2-h oral glucose tolerance test glucose, and/or HbA1c. Results: The absolute decrease in 1-year diabetes incidence rates in subjects treated with medication versus placebo was greatest in those with high-risk CMDS scores at baseline (10.43-6.29%), intermediate in those with moderate CMDS risk (4.67-2.37%), and small in the low-risk category (1.51-0.67%). The number of participants needed to treat to prevent one new case of diabetes over a 56-week period was 24, 43, and 120 in those with baselineCMDS scores of≥60, 30-59, and 0-29, respectively. Conclusions: Numbers needed to treat to prevent one case of type 2 diabetes are markedly lower in patients with high-risk scores. CMDS can be used to quantify risk of diabetes in overweight/obese individuals and predict the effectiveness ofweight-loss therapy to prevent diabetes.

AB - Objective: To assess the ability of medication-assisted weight loss to prevent diabetes as a function of the baseline weighted Cardiometabolic Disease Staging (CMDS) score. Research Design and Methods We pooled data from 3,040 overweight and obese participants in three randomized controlled trialsdCONQUER, EQUIP, and SEQUELdassessing efficacy and safety of phentermine/topiramate extended release (ER) for weight loss. In these doubleblind phase III trials, overweight/obese adult patients were treated with a lifestyle intervention and randomly assigned to placebo versus once-daily oral phentermine/ topiramate ER. The weighted CMDS score was calculated using baseline quantitative clinical data including waist circumference, blood glucose, blood pressure, and blood lipids. Incident diabetes was defined based on serial measures of fasting glucose, 2-h oral glucose tolerance test glucose, and/or HbA1c. Results: The absolute decrease in 1-year diabetes incidence rates in subjects treated with medication versus placebo was greatest in those with high-risk CMDS scores at baseline (10.43-6.29%), intermediate in those with moderate CMDS risk (4.67-2.37%), and small in the low-risk category (1.51-0.67%). The number of participants needed to treat to prevent one new case of diabetes over a 56-week period was 24, 43, and 120 in those with baselineCMDS scores of≥60, 30-59, and 0-29, respectively. Conclusions: Numbers needed to treat to prevent one case of type 2 diabetes are markedly lower in patients with high-risk scores. CMDS can be used to quantify risk of diabetes in overweight/obese individuals and predict the effectiveness ofweight-loss therapy to prevent diabetes.

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