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

Excerpt	Relevance	Reference
"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."	5.16	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). ( 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)

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	0 (0.00)	29.6817
2010's	1 (100.00)	24.3611
2020's	0 (0.00)	2.80

Authors

Authors	Studies
García-García, HM	1
Garg, S	1
Brugaletta, S	1
Morocutti, G	1
Ratner, RE	1
Kolatkar, NS	1
Kravitz, BG	1
Miller, DM	1
Huang, C	1
Nesto, RW	1
Serruys, PW	1

Clinical Trials (1)

Trial Overview

Trial			Phase	Enrollment	Study Type	Start Date	Status
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 3	672 participants (Actual)	Interventional	2005-01-31	Completed
[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

Intervention	Ratio (Mean)
Glipizide (GLP) 5 mg	0.0040
Rosiglitazone (RSG) 4 mg	0.0204

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

Intervention	ratio (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

Intervention	ratio (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

Intervention	millimeters square (mm2) (Mean)
Glipizide (GLP) 5 mg	0.03
Rosiglitazone (RSG) 4 mg	-0.10

Model Adjusted Change From Baseline in Atheroma Volume to Month 18

Intervention	millimeters cubed (mm3) (Mean)
Glipizide (GLP) 5 mg	0.98
Rosiglitazone (RSG) 4 mg	-3.60

Model Adjusted Change From Baseline in Lumen Area to Month 18

Intervention	millimeters 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

Intervention	millimeters 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

Intervention	millimeters cubed (mm3) (Mean)
Glipizide (GLP) 5 mg	1.20
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

Intervention	percent (absolute change) (Mean)
Glipizide (GLP) 5 mg	0.43
Rosiglitazone (RSG) 4 mg	-0.21

Model Adjusted Change From Baseline in Vessel Area to Month 18

Intervention	millimeters 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

Intervention	millimeters 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

Intervention	millimeters 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

Intervention	millimeters 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

Intervention	millimole/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

Intervention	Percentage (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

Intervention	Participants (Number)
Glipizide (GLP) 5 mg	38
Rosiglitazone (RSG) 4 mg	39

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

Intervention	Participants (Number)
Glipizide (GLP) 5 mg	10
Rosiglitazone (RSG) 4 mg	14

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

Intervention	millimeters squared (mm2) (Mean)
	Atheroma Area, Baseline	Atheroma Area, Month 18	Change from Baseline in Atheroma Area	Vessel Area, Baseline	Vessel Area, Month 18	Change from Baseline in Vessel Area	Lumen Area, Baseline	Lumen Area, Month 18	Change from Baseline in Lumen Area
Glipizide (GLP) 5 mg	5.918	5.928	0.010	14.364	14.261	-0.102	8.447	8.335	-0.113
Rosiglitazone (RSG) 4 mg	5.748	5.634	-0.114	14.166	13.977	-0.189	8.419	8.344	-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

Intervention	millimeters cubed (mm3) (Mean)
	Atheroma Volume, Baseline	Atheroma Volume, Month 18	Change from Baseline in Atheroma Volume	Vessel Volume, Baseline	Vessel Volume, Month 18	Change from Baseline in Vessel Volume	Lumen Volume, Baseline	Lumen Volume, Month 18	Change from Baseline in Lumen Volume
Glipizide (GLP) 5 mg	249.747	249.625	-0.123	609.378	603.088	-6.290	359.726	353.513	-6.213
Rosiglitazone (RSG) 4 mg	222.431	218.576	-3.854	555.062	547.186	-7.876	332.688	328.676	-4.012

Change From Baseline in Normalized Atheroma Volume

Intervention	millimeters cubed (mm3) (Mean)
	Baseline	Month 18	Change from Baseline
Glipizide (GLP) 5 mg	232.772	233.153	0.381
Rosiglitazone (RSG) 4 mg	226.075	221.599	-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

Intervention	percent (absolute change) (Mean)
	Baseline	Month 18	Change from Baseline
Glipizide (GLP) 5 mg	40.593	41.013	0.420
Rosiglitazone (RSG) 4 mg	40.422	40.182	-0.240

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

Intervention	millimeters squared (mm2) (Mean)
	Baseline	Month 18	Change from Baseline
Glipizide (GLP) 5 mg	7.569	7.185	-0.384
Rosiglitazone (RSG) 4 mg	7.093	6.625	-0.468

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

Intervention	millimeters cubed (mm3) (Mean)
	Baseline	Month 18	Change from Baseline
Glipizide (GLP) 5 mg	75.649	72.225	-3.424
Rosiglitazone (RSG) 4 mg	70.961	66.020	-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

Intervention	percent change (Number)
	Adjusted Geometric Mean + Standard Error	Adjusted Geometric Mean	Adjusted Geometric Mean - Standard Error
Glipizide (GLP) 5 mg	-4.865	-11.388	-17.465
Rosiglitazone (RSG) 4 mg	24.576	15.720	7.499

Number of Other Cardiovascular Events

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

Intervention	Number of events (Number)
	All-cause death	Cardiovascular death	Non-fatal myocardial infarction	Non-fatal stroke	Coronary revascularization	Hospitalization for recurrent myocardial ischemia	Non-MACE congestive heart failure
Glipizide (GLP) 5 mg	7	3	6	1	27	7	3
Rosiglitazone (RSG) 4 mg	8	4	7	5	26	11	8

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

Intervention	percent change (Number)
	Adjusted Geometric Mean + Standard Error	Adjusted Geometric Mean	Adjusted 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)

Intervention	percent change (Number)
	Adjusted Geometric Mean + Standard Error	Adjusted Geometric Mean	Adjusted Geometric Mean - Standard Error
Glipizide (GLP) 5 mg	32.909	27.303	21.943
Rosiglitazone (RSG) 4 mg	13.835	8.880	4.142

Percent Change From Baseline to Month 18 in HDL-2

Intervention	percent change (Number)
	Adjusted Geometric Mean + Standard Error	Adjusted Geometric Mean	Adjusted Geometric Mean - Standard Error
Glipizide (GLP) 5 mg	2.065	-0.783	-3.550
Rosiglitazone (RSG) 4 mg	18.241	14.821	11.507

Percent Change From Baseline to Month 18 in HDL-3

Intervention	percent change (Number)
	Adjusted Geometric Mean + Standard Error	Adjusted Geometric Mean	Adjusted Geometric Mean - Standard Error
Glipizide (GLP) 5 mg	10.683	9.074	7.490
Rosiglitazone (RSG) 4 mg	15.165	13.440	11.732

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

Intervention	percent change (Number)
	Adjusted Geometric Mean + Standard Error	Adjusted Geometric Mean	Adjusted Geometric Mean - Standard Error
Glipizide (GLP) 5 mg	7.208	5.710	4.233
Rosiglitazone (RSG) 4 mg	15.104	13.440	11.808

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

Intervention	percent change (Number)
	Adjusted Geometric Mean + Standard Error	Adjusted Geometric Mean	Adjusted Geometric Mean - Standard Error
Glipizide (GLP) 5 mg	-8.955	-11.600	-14.172
Rosiglitazone (RSG) 4 mg	1.795	-1.237	-4.180

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

Intervention	percent change (Number)
	Adjusted Geometric Mean + Standard Error	Adjusted Geometric Mean	Adjusted Geometric Mean - Standard Error
Glipizide (GLP) 5 mg	-4.205	-5.644	-7.062
Rosiglitazone (RSG) 4 mg	3.151	1.567	0.007

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

Intervention	percent change (Number)
	Adjusted Geometric Mean + Standard Error	Adjusted Geometric Mean	Adjusted 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

Intervention	percent change (Number)
	Mean + Standard Error	Mean	Mean - Standard Error
Glipizide (GLP) 5 mg	1.141	-6.608	-13.764
Rosiglitazone (RSG) 4 mg	30.189	20.582	11.683

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

Intervention	percent change (Number)
	Adjusted Geometric Mean + Standard Error	Adjusted Geometric Mean	Adjusted 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

Intervention	percent change (Number)
	Adjusted Geometric Mean + Standard Error	Adjusted Geometric Mean	Adjusted 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

Article	Year
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