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New Introductions - Internationally

US FDA approves Enoxaparin for STEMI

The US FDA has approved enoxaparin for treatment of acute ST-segment elevation MI (STEMI). This approval was made on the basis of the Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment-Thrombolysis In Myocardial Infarction study 25 ( EXTRACT-TIMI 25) , in which enoxaparin reduced the rate of recurrent MI or death in patients receiving either thrombolysis or PCI.

EXTRACT-TIMI 25 enrolled more than 20,000 STEMI patients scheduled to undergo fibrinolysis. Patients randomized to enoxaparin experienced significantly less death/MI, driven primarily by a 33% reduction in nonfatal MI, as compared with patients randomized to unfractionated heparin.

US FDA Approves Atorvastatin In Patients With CHD

The US Food and Drug Administration (FDA) has approved the use of atorvastatin in patients with clinically evident coronary heart disease (CHD) to reduce the risk of non-fatal myocardial infarction, fatal and non-fatal stroke, revascularization procedures, angina and hospitalization for CHF. Atorvastatin is the first cholesterol-lowering drug to be approved for reducing the risk of heart failure.

This approval is based on results from the Treating to New Targets (TNT) trial and supported by findings from the Incremental Decrease in Endpoints through Aggressive Lipid Lowering (IDEAL) trial. The five-year TNT study involved 10000 patients with heart disease and elevated LDL levels. Those taking atorvastatin 80 mg had a significant 22% reduction in the risk of major cardiovascular events compared with patients taking atorvastatin 10 mg. In addition, patients treated with high-dose atorvastatin had a significant 26% reduction in the risk of hospitalization for heart failure. 

Source: www.medscape.com As accessed on March 9, 2007

US FDA approves Clopidogrel in STEMI patients not undergoing coronary angioplasty

The US Food and Drug Administration (FDA) has approved the use of Clopidogrel for patients with acute ST-segment elevation myocardial infarction (STEMI), who are not going to undergo coronary angioplasty.

Two studies support the effectiveness of clopidogrel in treating patients with STEMI. A large trial, the Clopidogrel and Metoprolol in Myocardial Infarction Trial (COMMIT) study, was a randomized, double-blind, placebo-controlled trial of 46,000 patients. Results of this trial demonstrated that clopidogrel, when combined with other standard treatments including thrombolysis, reduced mortality and also reduced the combined number of recurrent heart attacks, strokes and deaths.

The findings in COMMIT are supported by the results of the Clopidogrel as Adjunctive Reperfusion Therapy- Thrombolysis in Myocardial Infarction 28 (CLARITY- TIMI 28) study. CLARITY- TIMI 28 was a clinical trial of 3,500 patients undergoing thrombolysis for STEMI. This study showed that clopidogrel improved the patency rate of the infarct-related artery and reduced ischemic complications as compared to placebo.

FDA approves concomitant use of ezetimibe and fenofibrate

The U.S. Food and Drug Administration (FDA) has approved ezetimibe for use in combination with fenofibrate, as an adjunctive therapy to diet for the reduction of elevated total cholesterol, LDL cholesterol, Apo B, and non-HDL cholesterol in patients with mixed hyperlipidemia.

Coadministration of ezetimibe and fenofibrate offer complementary lowering of LDL and total cholesterol in patients with mixed hyperlipidemia. The use of ezetimibe with fibrates other than fenofibrate is not recommended until use in patients is studied.

This approval was based on the results from a clinical trial which showed that combination therapy of 10 mg of ezetimibe co-administered with 160 mg of fenofibrate significantly reduced LDL cholesterol levels when compared to either treatment alone ( p <0.001). Patients with mixed hyperlipidemia in a 12-week study who were co-administrated ezetimibe 10 mg and fenofibrate 160 mg showed a 20% reduction in LDL cholesterol compared to a 6% reduction in LDL cholesterol with 160 mg fenofibrate monotherapy and a 13% reduction in LDL cholesterol with 10 mg ezetimibe monotherapy. In this study, ezetimibe co-administered with fenofibrate appeared to be well tolerated and the rates for cholecystectomy were 0.6% for fenofibrate alone and 1.7% for ezetimibe and fenofibrate together.

For patients taking ezetimibe and fenofibrate in whom cholelithiasis is suspected, physicians should perform gallbladder studies and consider alternative lipid-lowering therapy.

Ranolazine gets FDA approval for use in Angina

On January 31, 2006 , the US Food and Drug Administration (FDA) approved ranolazine for treating chronic angina. Ranolazine, a new molecular entity, is the first drug approved to treat chronic angina in over ten years. Although several pharmacological activities of ranolazine have been described, the precise way the drug works is not fully understood. Since ranolazine affects electrical conduction in the heart (prolong the QT interval), it should only be used by patients who have not responded to other anti-anginal (long-acting nitrates, calcium channel blockers and beta blockers) drugs.

"Chronic angina limits people's activities," said Dr. Steven Galson, MD, Director of FDA's Center for Drug Evaluation and Research. "The approval of ranolazine provides a new treatment option for patients who continue to suffer symptoms of angina despite using other angina drugs."

Ranolazine was studied in patients with chronic angina who still had symptoms despite being treated with other anti-anginal drugs. Two clinical trials, ERICA (Efficacy of Ranolazine in Chronic Angina) and CARISA (Combination Assessment of Ranolazine In Stable Angina) were conducted. In ERICA, 565 patients who were experiencing about 4.5 angina attacks per week while taking a full dose of a calcium channel blocker were randomized to ranolazine or placebo for 6 weeks. Patients receiving ranolazine had a reduction in angina attacks of about 1 attack per week, compared with those in the placebo group. In CARISA, 823 patients on either a calcium channel blocker or beta-blocker (atenolol) were randomized to ranolazine or placebo and followed for 12 weeks using a formal exercise treadmill test. Patients in the ranolazine group had a mean exercise improvement similar to that seen with other anti-anginal therapies.

In both studies, ranolazine appeared to be less effective in women than in men.

In clinical studies, common side effects included dizziness, headache, constipation and nausea.

FDA approves Atorvastatin to reduce risk of strokes and heart attacks in patients with Type 2 Diabetes and for reduction of the risk of stroke in people who are at a risk of developing heart disease

The U.S. Food and Drug Administration (FDA) has approved Atorvastatin to reduce the risk of stroke and heart attack in people with type 2 diabetes without evidence of heart disease but with other risk factors. Atorvastatin was also approved for reducing the risk of stroke in people without evidence of heart disease but with multiple risk factors other than diabetes. Common risk factors for heart disease include high cholesterol, high blood pressure, family history, age over 55, smoking, diabetes and obesity.

This decision was based on the findings of the Collaborative Atorvastatin Diabetes Study (CARDS)- a landmark trial of more than 2,800 patients with type 2 diabetes, near normal cholesterol, and at least one other risk factor, such as high blood pressure or smoking- which showed that patients on atorvastatin experienced nearly 50 percent fewer strokes than those on placebo. The CARDS trial was stopped nearly two years earlier than planned because of the strong benefits among patients who took atorvastatin.

The additional approval of atorvastatin to reduce the risk of stroke in patients with multiple risk factors reflects findings from the Anglo-Scandinavian Cardiac Outcomes Trial: Lipid-Lowering Arm (ASCOT-LLA) another landmark trial which was also halted nearly two years earlier than planned. The trial found that atorvastatin reduced the relative risk of stroke by 26% percent compared to placebo. The study involved more than 10,300 people with normal or borderline cholesterol and no prior history of heart disease, but with controlled high blood pressure and at least three other risk factors for heart disease, such as family history, age over 55, smoking, diabetes and obesity.

Patients with multiple risk factors, including diabetes, face a greater threat of heart attack and stroke, so reducing their risk is critical. The fact that one can reduce the risk of heart attack and stroke even in this high-risk population with atorvastatin assumes great importance.

Reference:
www.medscape.com As accessed on September 30 th 2005 .

BNP Test for Assessment of Rehospitalization, Mortality Risks in HF Patients

September 2005. The FDA approved a new indication for a plasma B-type natriuretic peptide (BNP) test, allowing its use as an aid in the assessment of rehospitalization and mortality risks in patients with heart failure.

The approval was based on a systematic review of studies showing that the relative risk of death increased by 35% for every 100 pg/mL increase in BNP concentration, and that admitted heart failure patients whose BNP values did not decrease over the course of treatment were at a particularly high risk of death or a cardiovascular event.

The test was previously approved by the FDA for use as an aid in the diagnosis of congestive heart failure (CHF), assessment of CHF severity, and in the risk stratification of patients with acute coronary syndromes.

Perindopril Erbumine for Stable Coronary Artery Disease

On Aug. 23, the FDA approved a new indication for perindopril erbumine allowing its use in reducing the risk of cardiovascular mortality or nonfatal myocardial infarction (MI) in patients with stable coronary artery disease.

The approval was based on data from the European Trial on Reduction of Cardiac Events with Perindopril in Patients with Stable Coronary Artery Disease (EUROPA) that involved 12,218 patients randomized to receive perindopril or placebo for an average of 4.2 years. Results showed that the addition of once-daily perindopril yielded a 20% decrease in risk for the combined primary end points of cardiovascular mortality, nonfatal MI, and cardiac arrest compared with standard therapy alone ( P = .0003). The risk of myocardial infarction (fatal or nonfatal) was reduced by 24% ( P < .001) and the risk of heart failure by 39% ( P = .002).

In patients with coronary artery disease, perindopril should be initiated at a dose of 4 mg daily (2 mg/day in patients aged > 70 years) for two weeks, and then increased as tolerated to a maintenance dose of 8 mg/day.

Treprostinil Sodium Allowed for PAH in 23 EU Countries

On Aug. 10, the European Mutual Recognition Procedure was completed for treprostinil sodium allowing its use in 23 member states of the European Union. Treprostinil is indicated for the subcutaneous treatment of primary pulmonary arterial hypertension (PAH) in patients with New York Heart Association (NYHA) class III left ventricular dysfunction.

The indication was initially approved by France 's regulatory agency in February 2005. Recently released interim results of a phase 4 postmarketing study have shown that 13 of 14 treprostinil-treated patients were able to successfully transition from epoprostenol sodium therapy compared with one of seven patients receiving placebo (93% vs 14%; P = .0006).

Treprostinil sodium was previously approved by the FDA for intravenous and subcutaneous administration to diminish symptoms associated with exercise in patients with NYHA class II to IV PAH.

US FDA has Approved Valsartan to Reduce Post-MI Risk of Cardiovascular Death

August 3, 2005

The FDA approved a new indication for valsartan, allowing its use to reduce the risk of cardiovascular mortality in clinically stable patients with left ventricular dysfunction/failure following myocardial infarction.

The agency also removed the restriction limiting heart failure indications to patients intolerant of angiotensin-converting enzyme (ACE) inhibitors.

The approval was based on data from the VALsartan In Acute myocardial iNfarcTion (Valiant) trial in 14,703 patients, showing that valsartan was similarly effective to captopril in reducing mortality ( P = .004) and the overall incidence of cardiovascular events ( P < .001) for a median of 24.7 months in post-MI patients. Also, the addition of captopril to valsartan therapy did not increase its efficacy and was associated with an increased rate of adverse events. Valsartan was well-tolerated and adverse events were generally related to underlying disease.