Showing posts from August, 2010

AVERROES: Apixaban yields significant reductions in stroke, no increased bleeding

Patients with atrial fibrillation unable to take  warfarin  who are treated with  apixaban  (Pfizer/Bristol-Myers Squibb), an investigational oral factor Xa inhibitor, had a significantly lower risk of stroke and systemic embolic events compared with patients treated with aspirin. Importantly, the benefits of apixaban did not come at a cost of increased bleeding, with no observed increases in the risk of major bleeding, minor bleeding, or intracranial hemorrhage, among other end points, in those treated with apixaban.   Outcomes   Apixaban (n=2809)   Aspirin (n=2791)   Relative risk   (95%CI)   Stroke or systemic embolic event   1.6 3.6 0.46 (0.33-0.64) Stroke, embolic event, MI, or vascular death   4.1 6.2 0.66 (0.53-0.83) MI 0.7 0.8 0.85 (0.48-1.50) Vascular death 2.5 2.9 0.86 (0.

INNOVATE PCI: Elinogrel, a new antiplatelet agent, passes initial hurdles

  A novel antiplatelet agent tested in a phase 2 trial passed safety and clinical hurdles this week when investigators showed that treatment with oral and intravenous (IV) elinogrel   (Novartis) had more rapid antiplatelet effects than   clopidogrel   (Plavix, Bristol Myers-Squibb/Sanofi-Aventis) in the acute and chronic phases of therapy. "I think, at this point, we're talking about potential advantages, remembering this is a phase 2 trial, with this drug," said lead investigator   Dr Sunil Rao   (Duke University Medical Center, Durham, NC). "Remember that, based on recent clinical-trial data, there is a suggestion that greater platelet inhibition is associated with better ischemic outcomes, but that comes with a cost of increased bleeding risk. The platelet trials suggest reversible platelet inhibition may mitigate some of those risks and further improve outcomes. So, in that sense, elinogrel has properties of reversible inhibition of the CYP12 receptor, so it

New class of antiplatelet agents in clinical trials

  A new investigational antiplatelet agent,   atopaxar   (E5555; Eisai)—which acts via a different pathway from that of aspirin and drugs such as   clopidogrel   and   ticagrelor —has shown promising results in a two-arm phase 2 trial in Japan, one part in ACS patients and the other in people with high-risk CAD.   The findings, which were published simultaneously in the   European Heart Journal, were presented in a hot-line session here at the   European Society of Cardiology 2010 Congress   by   Dr   Shinya Goto   (Tokai University School of Medicine, Japan). He said atopaxar showed the potential to reduce major adverse cardiovascular events (MACE) in both populations, although he stressed this was not the main focus of the trial, known as   Japanese Lesson from Antagonizing the Cellular Effect of Thrombin   (J-LANCELOT). Atopaxar, a protease-activated receptor 1 (PAR-1) inhibitor that targets thrombin-induced platelet activation, also looks to have a good safety profile—there

ART: Early results for bilateral IMA in CABG offer some promises, some concerns

One-year data from what the lead investigator characterized as one of the largest-ever randomized clinical trials of two CABG surgery techniques has found no differences in major clinical events between patients treated with either single internal mammary artery (SIMA) grafts or bilateral internal mammary arteries (BIMA). Presenting the results here at the   European Society of Cardiology 2010 Congress ,   Dr David Taggart   (University of Oxford, UK) emphasized that the primary end point of the study is 10-year survival, so results for the overall trial won't be available until 2015 at the earliest. But 30-day and one-year results, presented today, provide reassurances that BIMA during CABG is feasible. Of note, however, BIMA grafts were associated with a small but statistically significant increase in need for sternal-wound reconstruction. After studies during the 1980s first reported that internal mammary arteries rather than saphenous vein grafts improved survival and fre

ATOLL seen as supporting enoxaparin over standard heparin in primary PCI

More than two decades into the era of primary PCI, alternatives to unfractionated heparin   (UFH) as the procedure's antithrombin adjuvant have been explored far less thoroughly than, say, what form of antiplatelet therapy might be best during the procedure. Now a prospective, randomized trial appears to strengthen observational evidence that the low-molecular-weight heparin (LMWH)   enoxaparin   (Lovenox, Sanofi-Aventis) may be superior to the heparin "classic" in PCI for STEMI. The   STEMI Treated With Primary Angioplasty and Intravenous Lovenox or Unfractionated Heparin   (ATOLL) study, presented here today at the   European Society of Cardiology 2010 Congress , randomized about 900 patients undergoing PCI for acute STEMI to receive either IV enoxaparin or UFH with the procedure. The two groups' subsequent 30-day rates of a complex composite primary end point that included death and major bleeding were not significantly different, although the enoxaparin group

Two-part reversible anticoagulant performs well with PCI in small trial

Researchers believe they may have found a truly reversible anticoagulant system to control bleeding during PCI that consists of one agent to anticoagulate and another to halt the first drug's effects. The product, known for the time being as REG1 (Regado Biosciences, Basking Ridge, NJ) includes two nuclease-stabilized RNA aptamers: an aptamer inhibiting coagulation factor IXa called RB006 ( pegnivacogin ) and its matched active control agent, RB007 ( anivamersen ). "Having a reversible anticoagulant or an anticoagulant you can control has been the holy grail of anticoagulant therapy, especially in PCI,"   Dr Mauricio Cohen   (University of Miami, FL) said. "We understand that while we need intense anticoagulation during the procedures, we also need to be in control and make sure we don't overshoot anticoagulation, because if the patient bleeds, they are at a higher risk of mortality." Currently, the only reversal agent available now is protamine, whi

Stem cells associated with improved long-term hemodynamics and reduced mortality in chronic heart failure

The largest clinical trial so far of intracoronary autologous stem-cell transplantation in patients with chronic heart failure has shown that such treatment was associated with multiple hemodynamic and functional benefits as well as a reduction in mortality, benefits that were maintained out to five years of follow-up. The   STAR-heart   study was presented today at the first clinical-trial hot-line session here at the   European Society of Cardiology (ESC) 2010 Congress . However, the same results were published in February this year in the   European Journal of Heart Failure , leading some to question their inclusion as a "hot-line" paper. Presenter   Dr Bodo-Eckehard Strauer   (Heinrich-Heine University, Düsseldorf, Germany) explained   that the study was submitted to the journal with the intention of it being published "in parallel" with the ESC presentation, but the journal published it early. The study involved 391 patients with chronic heart failure fol

10 surgeries, 7 hours and one anaesthesia

Imagine 10 surgeries at one sitting with a single anaesthesia within seven hours. This is precisely what doctors at Manipal Hospital did. The result: Fifty-nine-year-old Nagamma, who suffered from 15 years of chronic crippling disabilities, is now able to walk without pain. The surgery is believed to be the first of its kind in India, if not globally. A team of three doctors conducted the surgeries. “The amount of blood loss expected in this kind of a surgery is two to three litres. This was a surgery with minimal blood loss of 800 ml. She was shifted to the ward directly without any ICU care,” said Dr RD Chakravarthy, HoD, orthopaedic department, Manipal Hospital. Bharat Electronics Limited, where Nagamma’s son is an employee, sponsored the surgeries which came for a cost of Rs6 lakh. Nagamma’s first check-up was done in June. “It was found that Nagamma’s both hip joints were directed differently. Her knee joints were also bent. A surgery was planned on August 11,” said Dr Chak

At 101, Patient is Nation's Oldest Transcatheter Heart Valve Replacement

When   Doris Snyder   celebrated her 102nd birthday on   August 10 , she was that much closer to the expected birth of her first great-granddaughter who's due to arrive early September. She is very excited about the milestone, which might not have been possible were it not for a cutting-edge, experimental procedure that replaced one of Doris' heart valves weeks earlier when she was 101. The valve had been rendered useless by aortic valve stenosis—hardening from calcium deposits that restrict the flow of blood from the heart.   "This procedure could be a major breakthrough for these patients, as they're generally told that nothing can be done for them," said   Patrick M. McCarthy , MD, chief of the division of cardiothoracic surgery for Northwestern Memorial Hospital and director of the hospital's Bluhm Cardiovascular Institute and the Heller-Sacks professor of Surgery at   Northwestern University 's Feinberg School of Medicine.   McCarthy is a co

A 2-Year-Old Is First in U.S., and Youngest in World to Use Artificial Lung

Doctors at St. Louis Children’s Hospital say Owen Stark, a 2-year-old from Eldon, MO, is alive today because of an artificial lung. St. Louis Children’s Hospital is the first hospital in the country to use the device, the German-made Novalung® sLA Membrane Lung, as an artificial lung. Owen is the youngest person in the world to receive one. Originally approved to help adults through cardiac surgery for intervals up to six hours, the Washington University physicians on the Children’s Hospital medical team requested permission from the FDA to use the sLA for Owen to oxygenate his blood in place of his failing lungs until donor organs became available. This temporary use is commonly referred to as a “bridge to transplant.” Surprisingly, Owen rehabilitated so significantly on the Novalung®sLA, that when doctors removed it after 23 days — expecting a need to replace it right away — Owen’s lungs were strong enough to function on their own. Owen was diagnosed with idiopathic pulmonary

Antibiotic sponge 'ineffective' in cardiac surgery

Inserting a sponge containing gentamicin antibiotic at the time of surgical closure following cardiac surgery does not reduce the rate of sternal wound infections after three months, according to US researchers. The findings contradict evidence from previous studies. Use of the sponges is currently approved in 54 countries. The trial included 1,502 cardiac surgical patients at high risk for sternal wound infection due to diabetes and   obesity. Patients were randomised to either insertion of two gentamicin-collagen sponges between the sternal halves at surgical closure or no intervention. The authors found no significant difference in infection rates between the two groups.  

In a rare surgery, doctors unclog 11-year-old's heart

In a pathbreaking cardiac surgery, doctors at a city hospital have successfully removed over 20gm of muscle bulge from the outlet of the heart of an 11-year-old boy.   The bulge was obstructing the flow of blood from   Ravi   Ramola's heart to other parts of the body due to which his physical growth was affected. Doctors at Sir Ganga Ram Hospital, who performed the surgery, said such an obstruction could even lead to sudden heart failure.   According to doctors, the treatment procedure extended septal myectomy applied to remove the muscle bulge in Ravi's case was performed for the first time in   India . "In the standard procedure for removal of muscle bulge, the resection is partial. But through this surgery we have been able to completely resect the muscle bulge. Now, Ravi can live a healthy life,'' said Dr   Sujay Shad, senior consultant cardiac surgeon, Sir Ganga Ram Hospital, where Ravi was referred from a hospital in his hometown in   Uttarakhand.   &

Vyteris and Georgia Tech partner for transdermal drug delivery technologies

Vyteris, a developer of transdermal drug delivery technology, has announced an agreement with the Georgia Tech Research Corporation of the Georgia Institute of Technology, or Georgia Tech, granting Vyteris the option to exclusively license Georgia Tech's patented thermal ablation and microdevice fabrication technologies for transdermal drug delivery. Under terms of the agreement, Georgia Tech will be entitled to royalty and milestone payments connected to the development and potential commercialization of products which incorporate the technologies. Specific financial terms of the agreement were not disclosed. Vyteris plans to work closely with Georgia Tech to identify therapies that would be appropriate for the application of the new transdermal drug delivery technologies.  

Cipla acquires Meditab Specialities for Rs 133.35 crore

Cipla, the third largest pharma company in India with net sales of Rs 5,300 crore plus, has acquired Meditab Specialities Pvt Ltd for a total consideration of Rs 133.35 crore. Meditab has small and mid-sized formulation manufacturing facilities at multiple locations. Entities controlled by the relatives of the promoters are major shareholders in Meditab. The aggregate consideration for this acquisition was determined on the basis of the valuation report provided by Grant Thornton and fairness opinion provided by Kotak Mahindra Capital Company Ltd. In addition to control over Meditab's aforesaid manufacturing facilities which would result in improvements in operational and cost efficiencies, the company will benefit from Meditab's investments. Meditab is implementing expansion of API/intermediates international business through the manufacturing facility in China and entering into the high growth Chinese domestic formulations market through the local manufacturing facility i

Pakistani Flood Disaster Relief

I would like to comment that in the times of adversity there is no religion; Hindu, Sikh, Muslim, Christan and No Country whether it is India or Pakistan. The only religion which Should prevail at these trying times is that of Humanity….   Keeping this tradition alive, Indian government has extended a relief package of US$5.0 million which is far more than any help extended by any Western nation. Then why is the Pakistani government not accepting the same. On one side they say that there could be another wave of deaths because of unavailability of clean food & water, which they are not able to provide because of financial constraints and ironically on the other side they are NOT accepting AID from INDIA. Why????   I request Pakistani government to rise above the politics and accept the aid and save lives of innocent people.