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.
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) |
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 | 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 |
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] |
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 |
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 |
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 |
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 |
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 cubed (mm3) (Mean) |
---|---|
Glipizide (GLP) 5 mg | 0.98 |
Rosiglitazone (RSG) 4 mg | -3.60 |
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 | -0.14 |
Rosiglitazone (RSG) 4 mg | -0.11 |
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 cubed (mm3) (Mean) |
---|---|
Glipizide (GLP) 5 mg | -4.91 |
Rosiglitazone (RSG) 4 mg | -4.59 |
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 (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 |
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 | -0.10 |
Rosiglitazone (RSG) 4 mg | -0.21 |
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 cubed (mm3) (Mean) |
---|---|
Glipizide (GLP) 5 mg | -4.56 |
Rosiglitazone (RSG) 4 mg | -8.13 |
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 |
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 cubed (mm3) (Mean) |
---|---|
Glipizide (GLP) 5 mg | -3.56 |
Rosiglitazone (RSG) 4 mg | -5.28 |
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 |
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 |
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 |
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 |
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 |
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 |
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
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 |
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 |
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
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 |
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
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 |
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 |
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 |
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 |
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 | 32.909 | 27.303 | 21.943 |
Rosiglitazone (RSG) 4 mg | 13.835 | 8.880 | 4.142 |
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 | 2.065 | -0.783 | -3.550 |
Rosiglitazone (RSG) 4 mg | 18.241 | 14.821 | 11.507 |
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 | 10.683 | 9.074 | 7.490 |
Rosiglitazone (RSG) 4 mg | 15.165 | 13.440 | 11.732 |
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 | 7.208 | 5.710 | 4.233 |
Rosiglitazone (RSG) 4 mg | 15.104 | 13.440 | 11.808 |
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 | -8.955 | -11.600 | -14.172 |
Rosiglitazone (RSG) 4 mg | 1.795 | -1.237 | -4.180 |
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 | -4.205 | -5.644 | -7.062 |
Rosiglitazone (RSG) 4 mg | 3.151 | 1.567 | 0.007 |
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 | -7.415 | -10.309 | -13.110 |
Rosiglitazone (RSG) 4 mg | -13.601 | -16.381 | -19.067 |
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 |
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 |
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 |
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).
Topics: Adult; Aged; Aged, 80 and over; Analysis of Variance; Angioplasty, Balloon, Coronary; Coronary Angio | 2012 |