Effects of Rosiglitazone on Plasma BNP Levels and Left Ventricular Dysfunction

Baskent University

Status and phase

Completed

Phase 4

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Rosiglitazone(drug), cardiac adverse effects

Study type

Interventional

Funder types

Other

Identifiers

NCT00300911

KA04/164

Details and patient eligibility

About

The present study aimed to evaluate the effect of rosiglitazone treatment on cardiac function compared with metformin

Full description

Large scale clinical trials have reported fluid retention and increase in plasma volume (6% to 7%) with glitazone therapy, with an increased incidence of peripheral edema occuring in 2% to 5% patients. Some evidence suggests that this effect may be related to increased endothelial cell permeability induced by glitazones therapy. Others report that glitazones may interfere with renal hemodynamics. In controlled clinical trials, the frequency of new onset congestive heart failure was very low in glitazones treated patients. The incidence of congestive heart failure is higher in patients receiving combination therapy with insulin and glitazones. Only few studies compared rosiglitazone and metformin on cardiac safety. Recently a study reported a reversible increase in endothelial cell permeability to albumin in cultured pulmonary arterial cells treated with rosiglitazone. To our knowledge, there is not any clinical study published for showing the reversibility of the cardiac adverse effects if the rosiglitazone treatment is continued.

Sex

All

Ages

45 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Type 2 diabetes mellitus treated with oral hypoglycemic agents or diet only
Without any symptom or finding of heart failure
Normal liver enzymes and renal functions

Exclusion criteria

Any known coronary artery disease, congestive hearth failure, renal disease or liver disease
Any treatment for heart failure or diuretics for any reasons.