Page last updated: 2024-11-02

pioglitazone and Angina, Unstable

pioglitazone has been researched along with Angina, Unstable in 1 studies

Pioglitazone: A thiazolidinedione and PPAR GAMMA agonist that is used in the treatment of TYPE 2 DIABETES MELLITUS.
pioglitazone : A member of the class of thiazolidenediones that is 1,3-thiazolidine-2,4-dione substituted by a benzyl group at position 5 which in turn is substituted by a 2-(5-ethylpyridin-2-yl)ethoxy group at position 4 of the phenyl ring. It exhibits hypoglycemic activity.

Angina, Unstable: Precordial pain at rest, which may precede a MYOCARDIAL INFARCTION.

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
Green, JB	1
Bethel, MA	1
Paul, SK	1
Ring, A	1
Kaufman, KD	1
Shapiro, DR	1
Califf, RM	1
Holman, RR	1

Clinical Trials (1)

Trial Overview

Trial			Phase	Enrollment	Study Type	Start Date	Status
TECOS: A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes After Treatment With Sitagliptin in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control[NCT00790205]			Phase 3	14,671 participants (Actual)	Interventional	2008-12-10	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Percent Incidence of All-cause Mortality (Intent to Treat Population)

Percent incidence of all-cause mortality is reported as the percentage of participants who died due to any cause. (NCT00790205)
Timeframe: Up to 5 years

Intervention	Percentage of participants (Number)
Sitagliptin	7.5
Placebo	7.3

Percent Incidence of All-cause Mortality (Per Protocol Population)

Percent incidence of all-cause mortality is reported as the percentage of participants who died due to any cause. (NCT00790205)
Timeframe: Up to 5 years

Intervention	Percentage of participants (Number)
Sitagliptin	4.7
Placebo	4.3

Percent Incidence of CHF Requiring Hospitalization (Intent to Treat Population)

Percent incidence of CHF requiring hospitalization was reported as the percentage of participants who were admitted to the hospital for CHF. (NCT00790205)
Timeframe: Up to 5 years

Intervention	Percentage of participants (Number)
Sitagliptin	3.1
Placebo	3.1

Percent Incidence of Congestive Heart Failure (CHF) Requiring Hospitalization (Per Protocol Population)

Percent incidence of CHF requiring hospitalization was reported as the percentage of participants who were admitted to the hospital for CHF. (NCT00790205)
Timeframe: Up to 5 years

Intervention	Percentage of participants (Number)
Sitagliptin	2.8
Placebo	2.8

Percentage of Participants Who Initiated Chronic Insulin Therapy (Intent to Treat Population)

Chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months. (NCT00790205)
Timeframe: Up to 5 years

Intervention	Percentage of participants (Number)
Sitagliptin	9.7
Placebo	13.2

Percentage of Participants Who Initiated Chronic Insulin Therapy (Per Protocol Population)

Chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months. (NCT00790205)
Timeframe: Up to 5 years

Intervention	Percentage of participants (Number)
Sitagliptin	8.6
Placebo	11.9

Percentage of Participants With First Confirmed Cardiovascular (CV) Event of Major Adverse Cardiovascular Event (MACE) Plus (Per Protocol Population)

Primary composite CV endpoint of MACE plus which includes CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization. (NCT00790205)
Timeframe: Up to 5 years

Intervention	Percentage of participants (Number)
Sitagliptin	9.6
Placebo	9.6

Percentage of Participants With First Confirmed CV Event of MACE (Intent to Treat Population)

CV composite endpoint of MACE which includes CV-related death, nonfatal MI, or nonfatal stroke. (NCT00790205)
Timeframe: Up to 5 years

Intervention	Percentage of participants (Number)
Sitagliptin	10.2
Placebo	10.2

Percentage of Participants With First Confirmed CV Event of MACE (Per Protocol Population)

CV composite endpoint of MACE which includes CV-related death, nonfatal MI, or nonfatal stroke. (NCT00790205)
Timeframe: Up to 5 years

Intervention	Percentage of participants (Number)
Sitagliptin	8.4
Placebo	8.3

Percentage of Participants With First Confirmed CV Event of Major Adverse Cardiovascular Event (MACE) Plus (Intent to Treat Population)

Primary composite CV endpoint of MACE plus which includes CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization. (NCT00790205)
Timeframe: Up to 5 years

Intervention	Percentage of participants (Number)
Sitagliptin	11.4
Placebo	11.6

Percentage of Participants With Initiation of Co-interventional Agent (Intent to Treat Population)

In participants not receiving insulin at baseline, time to addition of first co-interventional agent (i.e., next oral AHA or chronic insulin, where chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.) (NCT00790205)
Timeframe: Up to 5 years

Intervention	Percentage of participants (Number)
Sitagliptin	21.7
Placebo	27.9

Percentage of Participants With Initiation of Co-interventional Agent (Per Protocol Population)

In participants not receiving insulin at baseline, time to addition of first co-interventional agent (i.e., next oral antihyperglycemic agent [AHA] or chronic insulin, where chronic insulin therapy is defined as a continuous period of insulin use of more than 3 months.) (NCT00790205)
Timeframe: Up to 5 years

Intervention	Percentage of participants (Number)
Sitagliptin	18.9
Placebo	24.5

Change From Baseline in HbA1c Over Time (Intent to Treat Population)

HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Estimated mean difference between sitagliptin and placebo controlling for baseline HbA1c and region. (NCT00790205)
Timeframe: Baseline and up to 4 years

Intervention	Percentage of HbA1c (Mean)
	Month 4: Sitagliptin, n= 6772; Placebo, n= 6738	Month 8: Sitagliptin, n= 6478; Placebo, n= 6414	Month 12: Sitagliptin, n= 6448; Placebo, n= 6384	Month 24: Sitagliptin, n= 6105; Placebo, n= 5975	Month 36: Sitagliptin, n= 3521; Placebo, n= 3439	Month 48: Sitagliptin, n= 1432; Placebo, n= 1383	Month 60: Sitagliptin, n= 123; Placebo, n= 128
Placebo	0.1	0.1	0.1	0.1	0.1	0.1	0.0
Sitagliptin	-0.3	-0.2	-0.2	-0.1	-0.1	0.0	0.0

Change From Baseline in HbA1c Over Time (Per Protocol Population)

Intervention	Percentage of HbA1c (Mean)
	Month 4; Sitagliptin, n=6632, Placebo, n=6588	Month 8; Sitagliptin, n=6294, Placebo, n=6197	Month 12; Sitagliptin, n=6217, Placebo, n=6092	Month 24; Sitagliptin, n=5668, Placebo, n=5475	Month 36; Sitagliptin, n=3227, Placebo, n=3083	Month 48; Sitagliptin, n=1271, Placebo, n=1224	Month 60; Sitagliptin, n=106, Placebo, n=108
Placebo	0.1	0.1	0.1	0.2	0.1	0.1	0.0
Sitagliptin	-0.3	-0.3	-0.2	-0.1	-0.1	0.0	-0.1

Change From Baseline in Renal Function Over Time (Intent to Treat Population)

Change in renal function based on eGFR using the MDRD method. (NCT00790205)
Timeframe: Baseline and up to 5 years

Intervention	mL/min/1.73 m^2 (Mean)
	Month 4; Sitagliptin, n=3949; Placebo, n=3977	Month 8; Sitagliptin, n=3687; Placebo, n=3648	Month 12; Sitagliptin, n=5082; Placebo, n=5015	Month 24; Sitagliptin, n=5157; Placebo, n=5071	Month 36; Sitagliptin, n=3037; Placebo, n=2942	Month 48; Sitagliptin, n=1237; Placebo, n=1210	Month 60; Sitagliptin, n=93; Placebo, n=106
Placebo	-0.8	-0.9	-0.5	-1.7	-1.6	-2.8	-5.7
Sitagliptin	-1.8	-2.4	-1.8	-3.2	-3.8	-4.0	-4.2

Change From Baseline in Renal Function Over Time (Per Protocol Population)

Change in renal function based on estimated glomerular filtration rate [eGFR] using the Modification of Diet in Renal Disease [MDRD] method. (NCT00790205)
Timeframe: Baseline and up to 5 years

Intervention	mL/min/1.73 m^2 (Mean)
	Month 4; Sitagliptin, n= 3859; Placebo, n= 3864	Month 8; Sitagliptin, n= 3562; Placebo, n= 3501	Month 12; Sitagliptin, n=4912, Placebo, n=4778	Month 24; Sitagliptin, n=4782, Placebo, n=4637	Month 36; Sitagliptin, n=2776, Placebo, n=2614	Month 48; Sitagliptin, n=1096, Placebo, n=1056	Month 60; Sitagliptin, n=79, Placebo, n=88
Placebo	-0.8	-0.9	-0.5	-1.7	-1.6	-2.8	-6.4
Sitagliptin	-1.9	-2.5	-1.8	-3.1	-3.7	-3.7	-3.5

Change From Baseline in Urine Albumin:Creatinine Ratio Over Time (Intent to Treat Population)

Change from baseline reflects the difference between the urine albumin:creatinine ratio reported time point and baseline value. (NCT00790205)
Timeframe: Baseline and up to 5 years

Intervention	g/mol Creatinine (Mean)
	Month 4; n=677, n=713	Month 8; n=658, n=624	Month 12; n=1167, n=1115	Month 24; n=1011, n=964	Month 36; n=537, n=553	Month 48; n=265, n=256	Month 60; n=14, n=18
Placebo	-1.4	0.5	1.2	3.1	3.9	1.6	6.4
Sitagliptin	-2.1	2.1	1.3	0.5	2.6	1.9	-2.5

Change From Baseline in Urine Albumin:Creatinine Ratio Over Time (Per Protocol Population)

Change from baseline reflects the difference between the urine albumin:creatinine ratio reported time point and baseline value. (NCT00790205)
Timeframe: Baseline and up to 5 years

Intervention	g/mol Creatinine (Mean)
	Month 4; Sitagliptin, n=664; Placebo, n=688	Month 8; Sitagliptin, n=635; Placebo, n=597	Month 12; Sitagliptin, n=1126; Placebo, n=1059	Month 24; Sitagliptin, n=930; Placebo, n=892	Month 36; Sitagliptin, n=488; Placebo, n=513	Month 48; Sitagliptin, n=238; Placebo, n=233	Month 60; Sitagliptin, n=13; Placebo, n=17
Placebo	-1.4	0.2	1.2	3.2	4.0	1.5	4.8
Sitagliptin	-2.2	1.7	0.8	0.7	2.5	1.3	-2.7

Trials

1 trial available for pioglitazone and Angina, Unstable

Article	Year
Rationale, design, and organization of a randomized, controlled Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) in patients with type 2 diabetes and established cardiovascular disease. American heart journal, 2013, Volume: 166, Issue:6 Topics: Aged; Aged, 80 and over; Angina, Unstable; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Doubl	2013