back

New Introductions - Internationally

US FDA Approves Combination of Valsartan & Aliskiren for Hypertension Management

US FDA has approved a single pill combination of aliskiren and valsartan, brand name Valturna, for the treatment of hypertension in patients likely to need multiple drugs to achieve their blood pressure goals. It is the first option that targets two key points of the RAAS, which may be overactive in many hypertensive patients.

The current approval was primarily based on a 8-week clinical trial in approximately 1,800 patients, which studied aliskiren 150 mg and 300 mg and valsartan 160 mg and 320 mg alone and in combination. Blood pressure reductions with the aliskiren/valsartan combination were significantly greater than with the monotherapies or placebo at the 8-week primary endpoint. Mean systolic and diastolic blood pressure reductions from baseline were 17.2/12.2 mmHg for aliskiren 300 mg/valsartan 320 mg, compared with 12.8/9.7 mmHg for valsartan 320 mg, 13.0/9.0 mmHg for aliskiren 300 mg, and 4.6/4.1 mmHg for placebo ( P < .05 for aliskiren/valsartan vs monotherapies or placebo).

US FDA Approves Triple Drug Combination Pill for Hypertension

US FDA has approved a once-daily triple combination pill consisting of amlodipine, valsartan, and hydrochlorothiazide (Exforge HCT) for the treatment of hypertension.

The approval is based on a study of over 2,000 patients with moderate to severe hypertension. In the study, the maximum dose of amlodipine/valsartan/ hydrochlorothiazide 10 mg/320 mg/25 mg demonstrated reductions of 18% to 29% in systolic blood pressure and reductions of 19% to 32% in diastolic blood pressure when compared with all dual combinations of its components at the same doses. The reductions in systolic/diastolic blood pressure with the triple combination pill were 7.6/5.0 mmHg greater than with valsartan/hydrochlorothiazide 320 mg/25 mg; 6.2/3.3 mmHg greater than with amlodipine/valsartan 10mg/320 mg; and 8.2/5.3 mmHg greater than with amlodipine/hydrochlorothiazide 10 mg/25 mg.

A patient may be switched to this single pill combination if blood pressure is not adequately controlled on any 2 of the following anti-hypertensive classes: calcium channel blockers, angiotensin receptor blockers, and diuretics.

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.