Espero Pharmaceuticals will donate its GoNitro (nitroglycerin) sublingual powder to be used in two clinical trials in patients with stable ischemic heart disease, and in a subgroup of patients who also have chronic kidney disease (CKD). Both clinical trials are recruiting patients.
GoNitro sublingual powder was approved in June by the U.S. Food and Drug Administration (FDA) for acute relief of an attack or prevention of angina pectoris (chest pain) due to stable ischemic heart disease, also called coronary artery disease. It is the first and only short-acting nitrate in a stabilized crystal granule form available in single-dose packets (400 msg), according to Espero.
ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches, NCT01471522) is an international comparative effectiveness study funded by the National Heart, Lung, and Blood Institute (NHLBI). Its aim is to determine the best way to manage stable ischemic heart disease. A total of 8,000 patients with moderate or severe ischemia will be recruited from 336 sites in 35 countries worldwide, including 126 sites in the U.S.
Patients participating in the trial will be randomized into two treatment groups: Patients in the routine invasive (INV) management group will undergo a cardiac catheterization. If significant coronary artery disease is present, a coronary revascularization procedure will be performed. In addition, study participants in this group will receive optimal medical therapy (OMT) involving diet, physical activity, treatment with GoNitro as a short-acting nitrate and, if deemed appropriate, other medications.
Patients assigned to a conservative strategy (CON) of OMT will receive OMT alone with catheterization and possibly revascularization if they do not respond to the therapy.
The ISCHEMIA trial primarily intends to establish if an INV strategy of cardiac catheterization, followed by stent or bypass surgery, if appropriate, plus OMT can reduce cardiovascular death or nonfatal myocardial infarction, as compared with a conservative strategy.
“We are excited GoNitro has been selected to participate in the landmark ISCHEMIA trial to determine the optimal way to manage SIHD,” Quang Pham, chief executive officer of Espero Pharmaceuticals said in a press release. “The current practice guidelines state that all patients suffering from SIHD should be prescribed a short-acting nitrate for angina.”
“We are appreciative of the donation made by Espero Pharmaceuticals,” said Judith S. Hochman, MD, chair of the ISCHEMIA trial. “Short-acting nitrates are important to our patients and trial,” added David Maron, MD, the trial’s co-chair and principal investigator.
Patients with CKD are at increased risk of death from cardiovascular causes, 15 to 30 times higher than age-matched patients without CKD.
The ISCHEMIA-CKD (NCT01985360) is a study that aims to determine the best way to manage stable ischemic heart disease in a subgroup of approximately 500 to 700 patients who have advanced CKD (estimated glomerular filtration rate, eGFR, of less than 30, or who are on dialysis). Patients will be treated with one of the two disease management options, as in the ISCHEMIA trial.
Ischemic heart disease is present when a patient has one or more symptoms, signs, or complications from an inadequate supply of blood to the myocardium (the heart musculature). This is usually is due to obstruction of the epicardial coronary arteries due to atherosclerosis.