Page last updated: 2024-11-07

spironolactone and Airflow Obstruction, Chronic

spironolactone has been researched along with Airflow Obstruction, Chronic in 3 studies

Spironolactone: A potassium sparing diuretic that acts by antagonism of aldosterone in the distal renal tubules. It is used mainly in the treatment of refractory edema in patients with congestive heart failure, nephrotic syndrome, or hepatic cirrhosis. Its effects on the endocrine system are utilized in the treatments of hirsutism and acne but they can lead to adverse effects. (From Martindale, The Extra Pharmacopoeia, 30th ed, p827)
spironolactone : A steroid lactone that is 17alpha-pregn-4-ene-21,17-carbolactone substituted by an oxo group at position 3 and an alpha-acetylsulfanyl group at position 7.

Research Excerpts

Excerpt	Relevance	Reference
"This study sought to investigate sex differences in outcomes and responses to spironolactone in patients with heart failure with preserved ejection fraction (HFpEF)."	9.30	Sex Differences in Outcomes and Responses to Spironolactone in Heart Failure With Preserved Ejection Fraction: A Secondary Analysis of TOPCAT Trial. ( Kao, DP; Lindenfeld, J; Merrill, M; Sweitzer, NK, 2019)
"This study sought to investigate sex differences in outcomes and responses to spironolactone in patients with heart failure with preserved ejection fraction (HFpEF)."	5.30	Sex Differences in Outcomes and Responses to Spironolactone in Heart Failure With Preserved Ejection Fraction: A Secondary Analysis of TOPCAT Trial. ( Kao, DP; Lindenfeld, J; Merrill, M; Sweitzer, NK, 2019)

Research

Studies (3)

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	3 (100.00)	24.3611
2020's	0 (0.00)	2.80

Authors

Authors	Studies
Merrill, M	1
Sweitzer, NK	1
Lindenfeld, J	1
Kao, DP	1
Andersson, C	1
Hansen, PW	1
Steffensen, IE	1
Andreasen, C	1
Weeke, PE	1
Køber, L	1
Gislason, GH	1
Torp-Pedersen, C	1
Moret, M	1
Darbellay, P	1
Lebowitz, D	1
Alves, C	1
Sabeh, N	1
Carballo, S	1

Clinical Trials (1)

Trial Overview

Trial			Phase	Enrollment	Study Type	Start Date	Status
Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT)[NCT00094302]			Phase 3	3,445 participants (Actual)	Interventional	2006-08-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Aborted Cardiac Arrest

First incidence of aborted cardiac arrest (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Intervention	Events per 100 person-years (Number)
Placebo	0.09
Spironolactone	0.05

All-cause Mortality

(NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Intervention	Events per 100 person-years (Number)
Placebo	4.6
Spironolactone	4.2

Cardiovascular Mortality

(NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Intervention	Events per 100 person-years (Number)
Placebo	3.1
Spironolactone	2.8

Cardiovascular-related Hospitalization

Hospitalization for MI, stroke or the management of heart failure, whichever occurred first (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Intervention	Events per 100 person-years (Number)
Placebo	6.2
Spironolactone	5.5

Chloride

Average post-baseline Chloride, taking into consideration baseline Chloride, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual. (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Intervention	mEq/L (Least Squares Mean)
Placebo	102.33
Spironolactone	102.26

Composite Outcome of Cardiovascular Mortality or Cardiovascular-related Hospitalization (i.e., Hospitalization for Myocardial Infarction(MI), Stroke, or the Management of Heart Failure), Whichever Occurred First

(NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Intervention	Events per 100 person-years (Number)
Placebo	7.8
Spironolactone	7.2

Composite Outcome of Cardiovascular Mortality, Aborted Cardiac Arrest, or Hospitalization for the Management of Heart Failure, Whichever Occurred First

(NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Intervention	Events per 100 person-years (Number)
Placebo	6.6
Spironolactone	5.9

Composite Outcome of Sudden Death or Aborted Cardiac Arrest, Whichever Occurred First

(NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Intervention	Events per 100 person-years (Number)
Placebo	1.1
Spironolactone	1.0

Composite Outcome of Sudden Death, Aborted Cardiac Arrest, or Hospitalization for the Management of Ventricular Tachycardia, Whichever Occurred First

(NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Intervention	Events per 100 person-years (Number)
Placebo	1.1
Spironolactone	1.0

Depression Symptoms, as Measured by Patient Health Questionnaire.

"Average post-baseline depression, taking into consideration baseline depression, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.~The Patient Health Questionnaire (PHQ) is a 10-item, self-administered instrument for screening, diagnosing, monitoring and measuring the severity of depression. Scores can range from 0-27, in which lower scores reflect better mental health status. The PH-Q was administered at the following study visits: baseline, month 12 and annually thereafter. Valid translations of this questionnaire were only available for subjects enrolled in the United States and Canada." (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Intervention	units on a scale (Least Squares Mean)
Placebo	5.6
Spironolactone	5.1

Deterioration of Renal Function

First incidence of a deterioration of renal function. The TOPCAT protocol defines deterioration of renal function as occurring if a subject has a serum creatinine value which is at least double the baseline value for that subject, and is also above the upper limit of normal (assumed to be 1.0 mg/dL for females and 1.2 mg/dL for males.) (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Intervention	Events per 100 person-years (Number)
Placebo	2.2
Spironolactone	3.2

Development of Atrial Fibrillation, Among Subjects Without a History of Atrial Fibrillation at Baseline.

First incidence of atrial fibrillation among subjects without a history of atrial fibrillation at baseline (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Intervention	Events per 100 person-years (Number)
Placebo	1.4
Spironolactone	1.4

Estimated Glomerular Filtration Rate (GFR)

Average post-baseline GFR, taking into consideration baseline GFR, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual. (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Intervention	mL/min/1.73m2 (Least Squares Mean)
Placebo	67.50
Spironolactone	65.20

Hospitalization for Any Reason

First incidence of a hospitalization for any reason (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Intervention	Events per 100 person-years (Number)
Placebo	20.0
Spironolactone	18.8

Hospitalization for the Management of Heart Failure

First incidence of a hospitalization for the management of heart failure (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Intervention	Events per 100 person-years (Number)
Placebo	4.6
Spironolactone	3.8

Myocardial Infarction

First incidence of myocardial infarction (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Intervention	Events per 100 person-years (Number)
Placebo	1.1
Spironolactone	1.2

New Onset Diabetes Mellitus, Among Subjects Without a History of Diabetes Mellitus at Baseline.

First incidence of new onset diabetes mellitus among subjects without a history of diabetes mellitus at baseline. (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Intervention	Events per 100 person-years (Number)
Placebo	0.7
Spironolactone	0.7

Potassium

Average post-baseline Potassium, taking into consideration baseline Potassium, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual. (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Intervention	mEq/L (Least Squares Mean)
Placebo	4.32
Spironolactone	4.49

Quality of Life, as Measured by McMaster Overall Treatment Evaluation Questionnaire.

"Average post-baseline quality of life, taking into consideration baseline quality of life and treatment group.~The McMaster Overall Treatment Evaluation questionnaire is a self-administered 3-item instrument that measures a patient's perception of change in their health-related quality of life since the start of therapy. The questionnaire consists of a single question - Since treatment started, has there been any change in your activity limitation, symptoms and/or feelings related to your heart condition? Scores can range from -7 to +7, and higher scores reflect better health status. The questionnaire was administered at the following study visits: month 4 and month 12. Valid translations of this questionnaire were only available for subjects enrolled in the United States, Canada and Argentina." (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Intervention	units on a scale (Least Squares Mean)
Placebo	1.2
Spironolactone	1.2

Quality of Life, as Measured by the EuroQOL Visual Analog Scale.

"Average post-baseline quality of life, taking into consideration baseline quality of life, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.~The EuroQOL visual analog scale (EQ5D) is a single-item, self-administered instrument that quantifies current health status. Scores can range from 0-100, in which higher scores reflect better health status. The EQ5D was administered at the following study visits: baseline, month 4, month 12 and annually thereafter." (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Intervention	units on a scale (Least Squares Mean)
Placebo	65.9
Spironolactone	66.4

Quality of Life, as Measured by the Kansas City Cardiomyopathy Questionnaire.

"Average post-baseline quality of life, taking into consideration baseline quality of life, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.~The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. The KCCQ was administered at the following study visits: baseline, month 4, month 12 and annually thereafter." (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Intervention	units on a scale (Least Squares Mean)
Placebo	63.1
Spironolactone	64.4

Serum Creatinine

Average post-baseline serum creatinine, taking into consideration baseline serum creatinine, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual. (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Intervention	mg/dL (Least Squares Mean)
Placebo	1.11
Spironolactone	1.17

Sodium

Average post-baseline Sodium, taking into consideration baseline Sodium, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual. (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Intervention	mEq/L (Least Squares Mean)
Placebo	140.95
Spironolactone	140.33

Stroke

First incidence of stroke (NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Intervention	Events per 100 person-years (Number)
Placebo	1.1
Spironolactone	1.0

Total Hospitalizations (Including Repeat Hospitalizations) for the Management of Heart Failure

(NCT00094302)
Timeframe: Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.

Intervention	Events per 100 person-years (Number)
Placebo	8.3
Spironolactone	6.8

Trials

1 trial available for spironolactone and Airflow Obstruction, Chronic

Article	Year
Sex Differences in Outcomes and Responses to Spironolactone in Heart Failure With Preserved Ejection Fraction: A Secondary Analysis of TOPCAT Trial. JACC. Heart failure, 2019, Volume: 7, Issue:3 Topics: Age Factors; Aged; Aged, 80 and over; Atrial Fibrillation; Cardiovascular Diseases; Cause of Death;	2019

Other Studies

2 other studies available for spironolactone and Airflow Obstruction, Chronic

Article	Year
Mortality associated with cardiovascular drugs in patients with chronic obstructive pulmonary disease and right-sided heart failure - A danish nationwide registry-based study. European journal of internal medicine, 2019, Volume: 63 Topics: Adrenergic beta-Antagonists; Aged; Aged, 80 and over; Angiotensin-Converting Enzyme Inhibitors; Aspi	2019
[Internal medicine in the hospital setting]. Revue medicale suisse, 2015, Jan-21, Volume: 11, Issue:458 Topics: Adrenergic beta-Antagonists; Aminobutyrates; Angiotensin Receptor Antagonists; Asymptomatic Diseases	2015