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Dapagliflozin Propanediol Monohydrate

This article explores the use of Dapagliflozin Propanediol Monohydrate in clinical trials, specifically focusing on its potential benefits for patients with acute heart failure. The drug, known commercially as Dapagliflozin, is being studied in a multicenter, randomized, double-blind trial to assess its effects when initiated during hospitalization for acute heart failure. The research aims to determine if early administration of Dapagliflozin can improve cardiovascular outcomes and reduce the risk of worsening heart failure in stabilized patients.

Table of Contents

What is Dapagliflozin?

Dapagliflozin, also known by its full chemical name dapagliflozin propanediol monohydrate, is a medication that belongs to a class of drugs called SGLT2 inhibitors. It is primarily used to treat certain heart and kidney conditions, as well as type 2 diabetes[1]. The medication is available as a film-coated tablet, typically in a 10 mg strength, and is taken orally (by mouth)[1].

Medical Conditions Treated

Dapagliflozin is being studied for its effectiveness in treating acute heart failure[1]. Heart failure is a condition where the heart cannot pump blood effectively to meet the body’s needs. Acute heart failure refers to a sudden worsening of heart failure symptoms, often requiring hospitalization.

How Dapagliflozin Works

While the exact mechanism of action for heart failure is not fully explained in the provided information, SGLT2 inhibitors like dapagliflozin generally work by helping the kidneys remove excess sugar from the body through urine. This action can have beneficial effects on heart function and overall cardiovascular health[1].

Clinical Trial Overview

A large-scale clinical trial is being conducted to evaluate the effectiveness of dapagliflozin in patients with acute heart failure. The trial, named “DAPA ACT HF-TIMI 68,” aims to assess the impact of starting dapagliflozin treatment in the hospital for patients who have been stabilized after admission for acute heart failure[1].

The main objective of this trial is to determine if dapagliflozin, compared to a placebo (a substance with no active medication), can reduce the risk of cardiovascular death or worsening heart failure in these patients[1].

Eligibility Criteria

To participate in this study, patients must meet certain criteria. Some key inclusion criteria are:

  • Currently hospitalized for acute heart failure with symptoms like worsening breathlessness, fatigue, or swelling
  • Showing signs of fluid overload, such as swollen neck veins or fluid in the lungs
  • Receiving intensified heart failure treatment during the hospital stay
  • Having a measured left ventricular ejection fraction (LVEF) within the past 12 months
  • Showing elevated levels of certain heart failure markers in the blood (NT-proBNP or BNP)[1]

There are also several exclusion criteria, including:

  • Very low blood pressure in the past 24 hours
  • Certain severe heart rhythm problems
  • History of heart transplantation or being on a transplant list
  • Severely reduced kidney function
  • Current use of another SGLT2 inhibitor
  • History of type 1 diabetes or diabetic ketoacidosis (a serious complication of diabetes)[1]

Potential Benefits

The researchers hope that starting dapagliflozin treatment in the hospital for patients with acute heart failure might:

  • Reduce the risk of dying from cardiovascular causes
  • Decrease the chances of heart failure getting worse
  • Lower the risk of being readmitted to the hospital for heart failure
  • Reduce the need for urgent visits due to worsening heart failure[1]

Safety Considerations

The trial is also designed to evaluate the safety and tolerability of starting dapagliflozin treatment in the hospital. Some specific safety concerns being monitored include:

  • Low blood pressure that causes symptoms or requires hospitalization
  • Worsening kidney function
  • For patients with type 2 diabetes who are on insulin or certain diabetes medications, the risk of severe low blood sugar episodes[1]

Administration

Dapagliflozin is typically taken as a once-daily oral tablet. In this study, the maximum daily dose is 10 mg. The treatment period in the trial may last up to 2 months, but this could vary depending on individual patient needs and responses[1].

Aspect Details
Study Title Dapagliflozin and Effect on Cardiovascular Events in Acute Heart Failure -Thrombolysis in Myocardial Infarction 68 (DAPA ACT HF-TIMI 68)
Main Objective To assess the effect of in-hospital initiation of dapagliflozin on cardiovascular death or worsening heart failure in stabilized acute heart failure patients
Study Design Multicenter, randomized, double-blind, parallel group, placebo-controlled trial
Key Inclusion Criteria – Hospitalized for acute heart failure
– Left ventricular ejection fraction measured within past 12 months
– Elevated NT-proBNP or BNP during current hospitalization
– Stabilized patients (no increase in IV diuretics for 12 hours, no IV vasodilators/inotropes for 24 hours)
Key Exclusion Criteria – Symptomatic hypotension in past 24 hours
– eGFR <25 ml/min/1.73 m2
– Current use of SGLT2 inhibitor
– Type 1 diabetes or history of diabetic ketoacidosis
Primary Endpoints Time to first occurrence of cardiovascular death or worsening heart failure
Secondary Endpoints – Symptomatic hypotension leading to hospitalization or study drug discontinuation
– Worsening renal function
Drug Information Dapagliflozin Cipla 10 mg Film-coated Tablets

FAQ

  • What is the main purpose of the clinical trial using Dapagliflozin? The main purpose is to assess the effect of starting Dapagliflozin in the hospital on cardiovascular death or worsening heart failure in patients who have been stabilized during hospitalization for acute heart failure.
  • Who is eligible to participate in this clinical trial? Eligible participants include adults currently hospitalized for acute heart failure, with specific criteria such as worsening symptoms, objective signs of volume overload, and intensification of heart failure therapy during admission. Patients across various left ventricular ejection fractions and with or without type 2 diabetes may be included.
  • How is 'stabilization' defined for patients in this trial? Patients are considered stabilized when there's no increase in intravenous diuretics dose for 12 hours prior to randomization and no use of intravenous vasodilators or inotropes for 24 hours before randomization.
  • What are the main outcomes being measured in this trial? The primary outcome is the time to first occurrence of cardiovascular death or worsening heart failure, which includes events during the index admission, readmission for worsening heart failure, or urgent visits requiring intravenous diuretic therapy.
  • Are there any safety concerns being monitored in this trial? Yes, the trial is monitoring for safety issues such as symptomatic hypotension leading to hospitalization or study drug discontinuation, and worsening renal function that results in at least a doubling of serum creatinine, hospitalization, or other serious outcomes.

Ongoing Clinical Trials on Dapagliflozin Propanediol Monohydrate

  • A feasibility study of dapagliflozin for elderly patients hospitalized with chronic heart failure.

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study of dapagliflozin effects in patients hospitalized with acute heart failure

    Not recruiting

    3 1 1
    Investigated drugs:
    Czechia Hungary Poland

Glossary

  • Acute Heart Failure: A sudden worsening of heart function, often causing symptoms like severe breathlessness, rapid weight gain, and fluid buildup in the body.
  • Dapagliflozin: A medication belonging to the class of SGLT2 inhibitors, typically used to treat type 2 diabetes but being studied for its potential benefits in heart failure.
  • Left Ventricular Ejection Fraction (LVEF): A measurement of how much blood the left ventricle pumps out with each contraction, used to assess heart function.
  • NT-proBNP: A hormone released by the heart in response to stress or strain, often used as a marker for heart failure.
  • Inotropes: Medications that change the force of heart muscle contractions, often used to treat severe heart failure.
  • eGFR: Estimated Glomerular Filtration Rate, a test used to check how well the kidneys are working.
  • Cardiovascular Death: Death caused by heart disease or blood vessel problems.
  • Worsening Heart Failure: A deterioration in heart failure condition, often requiring additional treatment or hospitalization.
  • Randomized, Double-Blind Trial: A study where participants are randomly assigned to different treatment groups, and neither the participants nor the researchers know who is receiving which treatment.
  • SGLT2 Inhibitor: A class of medications that work on the kidneys to remove excess glucose from the body through urine.

References

  1. http://clinicaltrials.eu/trial/study-on-dapagliflozin-for-patients-stabilized-after-hospitalization-for-acute-heart-failure/