Page last updated: 2024-10-28

glipizide and Neointima

glipizide has been researched along with Neointima in 1 studies

Glipizide: An oral hypoglycemic agent which is rapidly absorbed and completely metabolized.
glipizide : An N-sulfonylurea that is glyburide in which the (5-chloro-2-methoxybenzoyl group is replaced by a (5-methylpyrazin-2-yl)carbonyl group. An oral hypoglycemic agent, it is used in the treatment of type 2 diabetes mellitus.

Neointima: The new and thickened layer of scar tissue that forms on a PROSTHESIS, or as a result of vessel injury especially following ANGIOPLASTY or stent placement.

Research Excerpts

ExcerptRelevanceReference
"To determine (1) the medium-term effect of rosiglitazone and glipizide on intra-stent neointima hyperplasia, (2) restenosis pattern as assessed by intra-vascular ultrasound (IVUS) and quantitative coronary angiography (QCA) in patients with T2DM and coronary artery disease."5.16Evaluation of in-stent restenosis in the APPROACH trial (Assessment on the Prevention of Progression by Rosiglitazone On Atherosclerosis in diabetes patients with Cardiovascular History). ( Brugaletta, S; García-García, HM; Garg, S; Huang, C; Kolatkar, NS; Kravitz, BG; Miller, DM; Morocutti, G; Nesto, RW; Ratner, RE; Serruys, PW, 2012)

Research

Studies (1)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's1 (100.00)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
García-García, HM1
Garg, S1
Brugaletta, S1
Morocutti, G1
Ratner, RE1
Kolatkar, NS1
Kravitz, BG1
Miller, DM1
Huang, C1
Nesto, RW1
Serruys, PW1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase III, 18 Month, Multicenter, Randomized, Double-Blind, Active-Controlled Clinical Trial to Compare Rosiglitazone Versus Glipizide on the Progression of Atherosclerosis in Subjects With Type 2 Diabetes Mellitus and Cardiovascular Disease (APPROACH)[NCT00116831]Phase 3672 participants (Actual)Interventional2005-01-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Change From Baseline to Month 18 in LDL-c Peak Particle Density Measured by LDL Relative Flotation

From repeated measures analysis model: Change = baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit. (NCT00116831)
Timeframe: Baseline to Month 18

InterventionRatio (Mean)
Glipizide (GLP) 5 mg0.0040
Rosiglitazone (RSG) 4 mg0.0204

Change From Baseline to Month 18 in LDL-c/HDL-c Ratio

From repeated measures analysis model: Change = baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit. (NCT00116831)
Timeframe: Baseline to Month 18

Interventionratio (Mean)
Glipizide (GLP) 5 mg-0.365
Rosiglitazone (RSG) 4 mg-0.226

Change From Baseline to Month 18 in Total Cholesterol/HDL-c Ratio

From repeated measures analysis model: Change = baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit. (NCT00116831)
Timeframe: Baseline to Month 18

Interventionratio (Mean)
Glipizide (GLP) 5 mg-0.495
Rosiglitazone (RSG) 4 mg-0.377

Model Adjusted Change From Baseline in Atheroma Area to Month 18

IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication. (NCT00116831)
Timeframe: Baseline to Month 18

Interventionmillimeters square (mm2) (Mean)
Glipizide (GLP) 5 mg0.03
Rosiglitazone (RSG) 4 mg-0.10

Model Adjusted Change From Baseline in Atheroma Volume to Month 18

IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication. (NCT00116831)
Timeframe: Baseline to Month 18

Interventionmillimeters cubed (mm3) (Mean)
Glipizide (GLP) 5 mg0.98
Rosiglitazone (RSG) 4 mg-3.60

Model Adjusted Change From Baseline in Lumen Area to Month 18

IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication. (NCT00116831)
Timeframe: Baseline to Month 18

Interventionmillimeters square (mm2) (Mean)
Glipizide (GLP) 5 mg-0.14
Rosiglitazone (RSG) 4 mg-0.11

Model Adjusted Change From Baseline in Lumen Volume to Month 18

IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication. (NCT00116831)
Timeframe: Baseline to Month 18

Interventionmillimeters cubed (mm3) (Mean)
Glipizide (GLP) 5 mg-4.91
Rosiglitazone (RSG) 4 mg-4.59

Model Adjusted Change From Baseline in Normalized Atheroma Volume

IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Normalized atheroma volume is defined as mean atheroma area x median segment length in cohort. Model Adjusted Change = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication. (NCT00116831)
Timeframe: Baseline to Month 18

Interventionmillimeters cubed (mm3) (Mean)
Glipizide (GLP) 5 mg1.20
Rosiglitazone (RSG) 4 mg-3.92

Model Adjusted Change From Baseline in Percent Atheroma Volume (PAV) to Month 18

Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior Oral Anti-Hyperglycemic Diabetic Medications(s) (OAD). (NCT00116831)
Timeframe: Baseline to Month 18

Interventionpercent (absolute change) (Mean)
Glipizide (GLP) 5 mg0.43
Rosiglitazone (RSG) 4 mg-0.21

Model Adjusted Change From Baseline in Vessel Area to Month 18

IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication. (NCT00116831)
Timeframe: Baseline to Month 18

Interventionmillimeters square (mm2) (Mean)
Glipizide (GLP) 5 mg-0.10
Rosiglitazone (RSG) 4 mg-0.21

Model Adjusted Change From Baseline in Vessel Volume to Month 18

IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Model Adjusted Change (MAC) = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication. (NCT00116831)
Timeframe: Baseline to Month 18

Interventionmillimeters cubed (mm3) (Mean)
Glipizide (GLP) 5 mg-4.56
Rosiglitazone (RSG) 4 mg-8.13

Model Adjusted Change in Atheroma Area Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline

IVUS-derived endpoints measured within the same 10 mm segment of non-intervened coronary arteries with the greatest degree of atheroma volume at Baseline, from Baseline to Month 18, including the nominal change in atheroma volume and atheroma area. Model Adjusted Change = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication. (NCT00116831)
Timeframe: Baseline to Month 18

Interventionmillimeters squared (mm2) (Mean)
Glipizide (GLP) 5 mg-0.39
Rosiglitazone (RSG) 4 mg-0.50

Model Adjusted Change in Atheroma Volume Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline

IVUS-derived endpoints measured within the same 10 mm segment of non-intervened coronary arteries with the greatest degree of atheroma volume at Baseline, from Baseline to Month 18, including the nominal change in atheroma volume and atheroma area. Model Adjusted Change = Baseline + Region + Sex + Treatment + Cardiac Procedure + Prior OAD Medication. (NCT00116831)
Timeframe: Baseline to Month 18

Interventionmillimeters cubed (mm3) (Mean)
Glipizide (GLP) 5 mg-3.56
Rosiglitazone (RSG) 4 mg-5.28

Model Adjusted Change in Fasting Plasma Glucose (FPG) From Baseline to Month 18

From repeated measures analysis model: Change = Baseline + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit. (NCT00116831)
Timeframe: Baseline to Month 18

Interventionmillimole/Liter (mmol/L) (Mean)
Glipizide (GLP) 5 mg-0.46
Rosiglitazone (RSG) 4 mg-1.34

Model Adjusted Change in Glycated Hemoglobin (HbA1c) From Baseline to Month 18

From repeated measures analysis model: Change = Baseline + visit + sex + region + treatment + prior Oral Anti-Hyperglycemic Diabetic Medications(s) (OAD) + cardiac procedure + treatment x visit. (NCT00116831)
Timeframe: Baseline to Month 18

InterventionPercentage (Mean)
Glipizide (GLP) 5 mg-0.20
Rosiglitazone (RSG) 4 mg-0.30

Number of Participants With the Indicated Treatment Emergent Major Cardiovascular Events (MACE) for All-cause Death, Non-fatal MI, Non-fatal Stroke, Coronary Revascularization, or Hospitalization for Recurrent Myocardial Ischemia (MACE Composite 1)

This was 1 of 2 MACE composite endpoints and was a secondary efficacy endpoint. (NCT00116831)
Timeframe: Baseline to Month 21

InterventionParticipants (Number)
Glipizide (GLP) 5 mg38
Rosiglitazone (RSG) 4 mg39

Number of Participants With the Indicated Treatment Emergent Major Cardiovascular Events (MACE) for Cardiovascular Death, Nonfatal MI, or Nonfatal Stroke (MACE Composite 2)

This was 1 of 2 MACE composite endpoints and was a secondary efficacy endpoint. (NCT00116831)
Timeframe: Baseline to Month 21

InterventionParticipants (Number)
Glipizide (GLP) 5 mg10
Rosiglitazone (RSG) 4 mg14

Change From Baseline in Atheroma, Vessel, and Lumen Area to Month 18

IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18 (NCT00116831)
Timeframe: Baseline to Month 18

,
Interventionmillimeters squared (mm2) (Mean)
Atheroma Area, BaselineAtheroma Area, Month 18Change from Baseline in Atheroma AreaVessel Area, BaselineVessel Area, Month 18Change from Baseline in Vessel AreaLumen Area, BaselineLumen Area, Month 18Change from Baseline in Lumen Area
Glipizide (GLP) 5 mg5.9185.9280.01014.36414.261-0.1028.4478.335-0.113
Rosiglitazone (RSG) 4 mg5.7485.634-0.11414.16613.977-0.1898.4198.344-0.075

Change From Baseline in Atheroma, Vessel, and Lumen Volume to Month 18

IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18 (NCT00116831)
Timeframe: Baseline to Month 18

,
Interventionmillimeters cubed (mm3) (Mean)
Atheroma Volume, BaselineAtheroma Volume, Month 18Change from Baseline in Atheroma VolumeVessel Volume, BaselineVessel Volume, Month 18Change from Baseline in Vessel VolumeLumen Volume, BaselineLumen Volume, Month 18Change from Baseline in Lumen Volume
Glipizide (GLP) 5 mg249.747249.625-0.123609.378603.088-6.290359.726353.513-6.213
Rosiglitazone (RSG) 4 mg222.431218.576-3.854555.062547.186-7.876332.688328.676-4.012

Change From Baseline in Normalized Atheroma Volume

IVUS-derived endpoints measured within the same segment (in non-intervened coronary arteries) from Baseline to Month 18. Normalized atheroma volume is defined as mean atheroma area x median segment length in cohort. (NCT00116831)
Timeframe: Baseline to Month 18

,
Interventionmillimeters cubed (mm3) (Mean)
BaselineMonth 18Change from Baseline
Glipizide (GLP) 5 mg232.772233.1530.381
Rosiglitazone (RSG) 4 mg226.075221.599-4.476

Change From Baseline in Percent Atheroma Volume (PAV) to Month 18

The primary efficacy endpoint was change in PAV (defined as total atheroma volume divided by total vessel volume x 100) within a 40 mm segment in non-intervened coronary arteries from Baseline to Month 18, based upon Intravascular Ultrasound (IVUS) assessment. (NCT00116831)
Timeframe: Baseline to Month 18

,
Interventionpercent (absolute change) (Mean)
BaselineMonth 18Change from Baseline
Glipizide (GLP) 5 mg40.59341.0130.420
Rosiglitazone (RSG) 4 mg40.42240.182-0.240

Change in Atheroma Area Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline

IVUS-derived endpoints measured within the same 10 mm segment of non-intervened coronary arteries with the greatest degree of atheroma volume at Baseline, from Baseline to Month 18, including the nominal change in atheroma volume and atheroma area (NCT00116831)
Timeframe: Baseline to Month 18

,
Interventionmillimeters squared (mm2) (Mean)
BaselineMonth 18Change from Baseline
Glipizide (GLP) 5 mg7.5697.185-0.384
Rosiglitazone (RSG) 4 mg7.0936.625-0.468

Change in Atheroma Volume Within the 10 mm of the Non-intervened Vessel Segment With the Greatest Atheroma Volume at Baseline

IVUS-derived endpoints measured within the same 10 mm segment of non-intervened coronary arteries with the greatest degree of atheroma volume at Baseline, from Baseline to Month 18, including the nominal change in atheroma volume and atheroma area (NCT00116831)
Timeframe: Baseline to Month 18

,
Interventionmillimeters cubed (mm3) (Mean)
BaselineMonth 18Change from Baseline
Glipizide (GLP) 5 mg75.64972.225-3.424
Rosiglitazone (RSG) 4 mg70.96166.020-4.941

Model Adjusted Percent Change in Brain Natriuretic Peptide (BNP) From Baseline to Month 18

It was measured as ratio to baseline as percentage change based on log-transformed data : 100 x (exp(Mean change on log scale) - 1). Model Adjusted change based on ANCOVA: Log(value) - log(Baseline) = log(Baseline) + sex + region + treatment + prior OAD + cardiac procedure. (NCT00116831)
Timeframe: Baseline to Month 18

,
Interventionpercent change (Number)
Adjusted Geometric Mean + Standard ErrorAdjusted Geometric MeanAdjusted Geometric Mean - Standard Error
Glipizide (GLP) 5 mg-4.865-11.388-17.465
Rosiglitazone (RSG) 4 mg24.57615.7207.499

Number of Other Cardiovascular Events

This was one of the secondary endpoints of the study. (NCT00116831)
Timeframe: Baseline to Month 21

,
InterventionNumber of events (Number)
All-cause deathCardiovascular deathNon-fatal myocardial infarctionNon-fatal strokeCoronary revascularizationHospitalization for recurrent myocardial ischemiaNon-MACE congestive heart failure
Glipizide (GLP) 5 mg73612773
Rosiglitazone (RSG) 4 mg847526118

Percent Change From Baseline to Month 18 in Apoprotein B (apoB)

Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit. (NCT00116831)
Timeframe: Baseline to Month 18

,
Interventionpercent change (Number)
Adjusted Geometric Mean + Standard ErrorAdjusted Geometric MeanAdjusted Geometric Mean - Standard Error
Glipizide (GLP) 5 mg-6.588-8.320-10.021
Rosiglitazone (RSG) 4 mg-6.967-8.744-10.488

Percent Change From Baseline to Month 18 in Free Fatty Acids (FFA)

Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit. (NCT00116831)
Timeframe: Baseline to Month 18

,
Interventionpercent change (Number)
Adjusted Geometric Mean + Standard ErrorAdjusted Geometric MeanAdjusted Geometric Mean - Standard Error
Glipizide (GLP) 5 mg32.90927.30321.943
Rosiglitazone (RSG) 4 mg13.8358.8804.142

Percent Change From Baseline to Month 18 in HDL-2

Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit. (NCT00116831)
Timeframe: Baseline to Month 18

,
Interventionpercent change (Number)
Adjusted Geometric Mean + Standard ErrorAdjusted Geometric MeanAdjusted Geometric Mean - Standard Error
Glipizide (GLP) 5 mg2.065-0.783-3.550
Rosiglitazone (RSG) 4 mg18.24114.82111.507

Percent Change From Baseline to Month 18 in HDL-3

Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit. (NCT00116831)
Timeframe: Baseline to Month 18

,
Interventionpercent change (Number)
Adjusted Geometric Mean + Standard ErrorAdjusted Geometric MeanAdjusted Geometric Mean - Standard Error
Glipizide (GLP) 5 mg10.6839.0747.490
Rosiglitazone (RSG) 4 mg15.16513.44011.732

Percent Change From Baseline to Month 18 in High Density Lipoprotein Cholesterol (HDL-c)

Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit. (NCT00116831)
Timeframe: Baseline to Month 18

,
Interventionpercent change (Number)
Adjusted Geometric Mean + Standard ErrorAdjusted Geometric MeanAdjusted Geometric Mean - Standard Error
Glipizide (GLP) 5 mg7.2085.7104.233
Rosiglitazone (RSG) 4 mg15.10413.44011.808

Percent Change From Baseline to Month 18 in Low Density Lipoprotein Cholesterol (LDL-c)

Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit. (NCT00116831)
Timeframe: Baseline to Month 18

,
Interventionpercent change (Number)
Adjusted Geometric Mean + Standard ErrorAdjusted Geometric MeanAdjusted Geometric Mean - Standard Error
Glipizide (GLP) 5 mg-8.955-11.600-14.172
Rosiglitazone (RSG) 4 mg1.795-1.237-4.180

Percent Change From Baseline to Month 18 in Total Cholesterol (TC)

Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit. (NCT00116831)
Timeframe: Baseline to Month 18

,
Interventionpercent change (Number)
Adjusted Geometric Mean + Standard ErrorAdjusted Geometric MeanAdjusted Geometric Mean - Standard Error
Glipizide (GLP) 5 mg-4.205-5.644-7.062
Rosiglitazone (RSG) 4 mg3.1511.5670.007

Percent Change From Baseline to Month 18 in Triglycerides (TG)

Repeated measures analysis model: Log(value) - log (Baseline) = log(Baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit. (NCT00116831)
Timeframe: Baseline to Month 18

,
Interventionpercent change (Number)
Adjusted Geometric Mean + Standard ErrorAdjusted Geometric MeanAdjusted Geometric Mean - Standard Error
Glipizide (GLP) 5 mg-7.415-10.309-13.110
Rosiglitazone (RSG) 4 mg-13.601-16.381-19.067

Percent Change in Brain Natriuretic Peptide (BNP) From Baseline to Month 18

It was measured as ratio to baseline as percentage change based on log-transformed data : 100 x (exp(Mean change on log scale) - 1)It was measured as ratio to baseline as percentage change based on log-transformed data : 100 x (exp(Mean change on log scale) - 1). Ratio to baseline as %change mean (%) was used as the estimation parameter for both groups. (NCT00116831)
Timeframe: Baseline to Month 18

,
Interventionpercent change (Number)
Mean + Standard ErrorMeanMean - Standard Error
Glipizide (GLP) 5 mg1.141-6.608-13.764
Rosiglitazone (RSG) 4 mg30.18920.58211.683

Repeated Measures Analysis of Percent Change in hsCRP From Baseline to Month 18

Changes in cardiovascular biomarkers from Baseline to Month 18, such as high sensitivity C-reactive protein (hsCRP) . Repeated measures analysis model: Log(value) - log(baseline) = log(baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit. (NCT00116831)
Timeframe: Baseline to Month 18

,
Interventionpercent change (Number)
Adjusted Geometric Mean + Standard ErrorAdjusted Geometric MeanAdjusted Geometric Mean - Standard Error
Glipizide (GLP) 5 mg-62.82-65.18-67.40
Rosiglitazone (RSG) 4 mg-80.33-81.63-82.84

Repeated Measures Analysis of Percent Change in MMP 9 From Baseline to Month 18

Changes in cardiovascular biomarkers from Baseline to Month 18, such as matrix metalloproteinase-9 (MMP-9). Repeated measures analysis model: Log(value) - log(baseline) = log(baseline) + visit + sex + region + treatment + prior OAD + cardiac procedure + treatment x visit. (NCT00116831)
Timeframe: Baseline to Month 18

,
Interventionpercent change (Number)
Adjusted Geometric Mean + Standard ErrorAdjusted Geometric MeanAdjusted Geometric Mean - Standard Error
Glipizide (GLP) 5 mg-26.5-30.5-34.3
Rosiglitazone (RSG) 4 mg-38.8-42.2-45.5

Trials

1 trial available for glipizide and Neointima

ArticleYear
Evaluation of in-stent restenosis in the APPROACH trial (Assessment on the Prevention of Progression by Rosiglitazone On Atherosclerosis in diabetes patients with Cardiovascular History).
    The international journal of cardiovascular imaging, 2012, Volume: 28, Issue:3

    Topics: Adult; Aged; Aged, 80 and over; Analysis of Variance; Angioplasty, Balloon, Coronary; Coronary Angio

2012