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Phase 3 AVERROES trial reveals apixaban effective for atrial fibrillation patients unsuitable for warfarin

The phase 3 AVERROES (Apixaban Versus Acetylsalicylic acid (ASA) to Prevent Strokes) trial, designed to show the superiority of apixaban over aspirin for the prevention of stroke or systemic embolism in high-risk atrial fibrillation patients unsuitable for treatment with a vitamin K antagonist (warfarin), was terminated early following a recommendation from the Data Monitoring Committee.

31 Aug 2010

ANTIPAF trial reveals ARBs do not reduce number of AF episodes in paroxysmal AF patients

Atrial fibrillation (AF) is the most common cardiac arrhythmia, affecting about 7 million people in Europe. It is a progressive chronic disease in which episodes become more frequent and long-lasting over time. Conventional anti-arrhythmic therapy aims at halting progression and reducing symptoms, but the use of most anti-arrhythmic drugs is compromised by severe side effects, such as pro-arrhythmia or extra-cardiac organ toxicity.

31 Aug 2010

Data monitoring committee recommends early termination following impressive results of AVERROES study

The data monitoring committee of the AVERROES study, seeing overwhelming evidence of the success of apixaban in the prevention of stroke in patients with atrial fibrillation who are unsuitable for the conventional treatment of warfarin, has recommended early termination of this study. The decision came after repeated review and careful consideration of all efficacy and safety data.

31 Aug 2010

$Unfractionated heparin standard dose may be optimal treatment strategy in PCI patients on fondaparinux$

Unfractionated heparin standard dose may be optimal treatment strategy in PCI patients on fondaparinux

Results from the FUTURA/OASIS 8 study presented today at the ESC Congress provide initial evidence that a low dose of unfractionated heparin does not reduce the incidence of bleeding or vascular complications in PCI patients treated with the anticoagulant fondaparinux. Findings showed that the rates of peri-PCI major bleeding were 1.4% in those given low dose heparin and 1.2% the standard dose.

31 Aug 2010

Telmisartan and amlodipine combination therapy helps achieve high BP control/response rates

Data show that treatment with a single-pill combination of telmisartan, an angiotensin receptor blocker, (ARB) and amlodipine, a calcium channel blocker (CCB) results in significant reductions in blood pressure (BP) in patients with severe hypertension.

31 Aug 2010

Phase 3 EINSTEIN-DVT clinical trial data can transform deep vein thrombosis treatment

Johnson & Johnson Pharmaceutical Research & Development, announced today that the investigational, oral anticoagulant rivaroxaban successfully demonstrated non-inferiority compared to the standard of care for the prevention of recurrent venous thromboembolism (VTE) in patients with acute symptomatic deep vein thrombosis (DVT), with a comparable safety profile.

31 Aug 2010

Study: IV ibuprofen decreases pain, morphine use in pre and post-operative orthopedic surgery patients

Cumberland Pharmaceuticals Inc. today announced the publication of new data supporting the safety and efficacy of Caldolor® (ibuprofen) Injection in pre and post-operative orthopedic surgery patients. The study, which was published in the August edition of the peer-reviewed journal Pain Medicine, concludes that IV ibuprofen significantly decreased pain and morphine use when compared with placebo.

31 Aug 2010

Reduced heparin dose lowers bleeding risk after PCI without increasing risk of ischaemic complications

With both bleeding und thrombotic complications having a negative effect on PCI outcomes, increasing efforts have been made to improve PCI anticoagulation regimens. Although unfractionated heparin has been the standard anti-thrombotic agent in interventional cardiology for decades, there is still no solid evidence from large clinical trials to guide its dosing during PCI.

31 Aug 2010

J-LANCELOT trial finds E5555 may reduce MACE without increasing serious bleeding events

Aspirin and thienopyridine antiplatelet therapy (such as clopidogrel) are standard care in the treatment of acute coronary syndrome (ACS) and even in stable coronary artery disease (CAD) after coronary intervention with stent. However, effective antiplatelet agents are needed which do not increase the risk of bleeding.

31 Aug 2010

Tapentadol ER improves average intensity of chronic osteoarthritis knee pain: Study

Phase 3 safety and efficacy data comparing tapentadol extended release (ER) tablets, an investigational pain medication, to placebo in patients with moderate to severe chronic osteoarthritis knee pain have been published by Clinical Drug Investigation.

31 Aug 2010

$Heparin enoxaparin may provide better outcomes than unfractionated heparin$

Heparin enoxaparin may provide better outcomes than unfractionated heparin

Results from ATOLL, a phase 3 randomised trial comparing two anticoagulants in primary PCI for ST elevation MI, show that the low molecular weight heparin enoxaparin may provide better outcomes in such cases than the traditionally used unfractionated heparin.

30 Aug 2010

Phase 2 INNOVATE PCI trial results for elinogrel presented

Phase 2 trial results for elinogrel, a novel antiplatelet agent available in both intravenous and oral formulations, were presented here today.

30 Aug 2010

Smoked cannabis relieves chronic neuropathic pain

The medicinal use of cannabis has been debated by clinicians, researchers, legislators and the public at large for many years as an alternative to standard pharmaceutical treatments for pain, which may not always be effective and may have unwanted side effects. A new study by McGill University Health Centre (MUHC) and McGill University researchers provides evidence that cannabis may offer relief to patients suffering from chronic neuropathic pain.

30 Aug 2010

BioMarin's BMN-701 receives FDA orphan drug designation for treatment of Pompe disease

BioMarin Pharmaceutical Inc. announced today that it has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for BMN-701, a novel fusion of insulin-like growth factor 2 and alpha glucosidase (IGF2-GAA) in development for the treatment of Pompe disease. An investigational new drug application (IND) for BMN-701 has been submitted, investigational material has been manufactured and a Phase I/II study is expected to start in the first quarter of 2011.

30 Aug 2010

BDSI's Phase 2 study results of BEMA Buprenorphine selected for presentation at Pain Week 2010

BioDelivery Sciences International, Inc. announced today that its abstract showing the results of a Phase 2 clinical study of BEMA Buprenorphine in the treatment of pain has been selected for oral presentation at Pain Week 2010, a national conference educating frontline clinicians who are faced with treating patients with pain. The presentation will take place on Friday, September 10, as part of the 7:00 - 9:00 AM podium presentation session.

30 Aug 2010

Trius commences oral torezolid phosphate Phase 3 clinical study for ABSSSI

Trius Therapeutics, Inc. announced that the first patient has been dosed in its Phase 3 clinical study of the oral dosage form of torezolid phosphate for the treatment of acute bacterial skin and skin structure infections (ABSSSI). The double-blind, active control, pivotal study is designed to compare the efficacy and safety of once-daily oral administration of 200 milligrams of torezolid phosphate for six days of treatment with the efficacy and safety of twice-daily oral administration of 600 milligrams of linezolid (Zyvox®) for 10 days of treatment.

30 Aug 2010

Selective lowering of heart rate reduces risk of death and hospitalization: Study

The results of a major international study presented at the European Society of Cardiology Congress in Stockholm and published simultaneously in The Lancet show, for the first time, that selectively lowering heart rate with a novel medication, ivabradine, significantly reduces risk of death and hospitalization for patients with heart failure. This also resolves a longstanding debate about whether lowering heart rate itself can actually lower the risk of heart disease progression.

30 Aug 2010

Low doses of n-3 fatty acids do not reduce overall rate of major cardiovascular events

Results from the Alpha Omega Trial, a multicentre, placebo-controlled trial in men and women following myocardial infarction (MI), suggest that low doses of n-3 fatty acids given in the form of enriched margarines do not reduce the overall rate of major cardiovascular events.

30 Aug 2010

RLY5016 potassium binder helps to regulate hyperkalemia in heart failure patients

Results from a recent phase 2b clinical trial may provide a new approach to managing excess potassium levels in patients with heart failure and heart failure with chronic kidney disease.

30 Aug 2010

Large clinical trial does not confirm benefits of erythropoieitin for first ST-elevation myocardial infarction

Results from the HEBE III study, a prospective, randomised, multicentre trial performed in seven centres in the Netherlands, suggest that the promising effects of erythropoieitin seen in previous smaller studies cannot be confirmed for the improvement of clinical outcome in patients with a first ST-elevation myocardial infarction.

30 Aug 2010

Drug Trial News

Phase 3 AVERROES trial reveals apixaban effective for atrial fibrillation patients unsuitable for warfarin

ANTIPAF trial reveals ARBs do not reduce number of AF episodes in paroxysmal AF patients

Data monitoring committee recommends early termination following impressive results of AVERROES study

Unfractionated heparin standard dose may be optimal treatment strategy in PCI patients on fondaparinux

Telmisartan and amlodipine combination therapy helps achieve high BP control/response rates

Phase 3 EINSTEIN-DVT clinical trial data can transform deep vein thrombosis treatment

Study: IV ibuprofen decreases pain, morphine use in pre and post-operative orthopedic surgery patients

Reduced heparin dose lowers bleeding risk after PCI without increasing risk of ischaemic complications

J-LANCELOT trial finds E5555 may reduce MACE without increasing serious bleeding events

Tapentadol ER improves average intensity of chronic osteoarthritis knee pain: Study

Heparin enoxaparin may provide better outcomes than unfractionated heparin

Phase 2 INNOVATE PCI trial results for elinogrel presented

Smoked cannabis relieves chronic neuropathic pain

BioMarin's BMN-701 receives FDA orphan drug designation for treatment of Pompe disease

BDSI's Phase 2 study results of BEMA Buprenorphine selected for presentation at Pain Week 2010

Trius commences oral torezolid phosphate Phase 3 clinical study for ABSSSI

Selective lowering of heart rate reduces risk of death and hospitalization: Study

Low doses of n-3 fatty acids do not reduce overall rate of major cardiovascular events

RLY5016 potassium binder helps to regulate hyperkalemia in heart failure patients

Large clinical trial does not confirm benefits of erythropoieitin for first ST-elevation myocardial infarction

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