Boehringer Ingelheim Canada Ltd. today announced that Health Canada has granted marketing authorization of PRADAX™ (dabigatran etexilate), a novel oral direct thrombin inhibitor (DTI) for the prevention of venous thromboembolism (VTE) in adult patients who have undergone elective total hip or total knee replacement surgery. The approval of PRADAX™ makes it the first new oral anticoagulant to be approved in Canada in more than 40 years.
Venous thromboembolism (VTE) is comprised of both deep vein thrombosis (DVT), a blood clot that forms in a deep vein of the calf, upper leg or pelvis and pulmonary embolism (PE), a potentially fatal blood clot that has broken loose and traveled to the lungs. Venous thromboembolism (VTE) kills more people each year than breast cancer, AIDS and motor vehicle crashes combined.[ii]
“For many years, we have needed an equally effective oral anticoagulant to what is currently available, but with a good safety profile and without a need for routine monitoring,” says Dr. David Backstein, orthopaedic surgeon at Mount Sinai Hospital in Toronto. “Now, with the approval of PRADAX™, we have an attractive alternative to protect our patients from VTE - a serious condition that many refer to as a ’silent killer’.”
PRADAX™ is a novel, once-daily anticoagulant that differs from commonly used anticoagulants in Canada. Unlike warfarin, a commonly used anticoagulant, PRADAX™ does not require extensive anticoagulation monitoring (regular blood tests to measure for blood clotting activity). PRADAX™ is taken orally and no injections are needed. PRADAX™ does not interact with food and has a low potential for drug-drug interactions.[iii]
“We hear daily the concerns of orthopaedic patients, and the risk of blood clots post-surgery is among the most prominent,” says Angelique Berg, Executive Director, Canadian Orthopaedic Foundation. “As Canadians age and the demand for hip and knee replacements skyrockets, the incidence of these potentially life-threatening clots could rise accordingly. Orthopaedic patients need safe, effective and convenient therapeutic option, and the arrival of the first innovation in 40 years is encouraging indeed.”
Expert guidelines recommend the use of preventative blood thinning medication (thromboprophylaxis) for patients undergoing knee replacement surgery for at least 10 days, and extended thromboprophylaxis of 28 to 35 days for patients undergoing hip replacement surgery.[iv] However, there is evidence that in certain patient populations, less than one in five patients discharged from hospital following hip and knee replacement surgery received a thromboprophylaxis.[v] Without the use of preventative therapy as many as 60 per cent of patients will develop DVT.4
“Because patients are spending less time in hospital there is a greater need for safe and convenient treatment options like PRADAX™ as patients are discharged,” says Dr. Michael Tanzer, orthopaedic surgeon at the Montreal General Hospital. “The average hospital stay following hip and knee replacement surgery has been substantially shortened, which means that the care and management of patients has shifted from in-hospital to at-home. Because there is little to no blood monitoring required with PRADAX™ and no food interactions, patients are now able to conveniently and safely continue therapy in an out-of-hospital setting.”
About PRADAX™
The Canadian approval of PRADAX™ is based on data from the RE-NOVATE, RE-MOBILIZE and RE-MODEL trials.
With all anticoagulant agents it is important to optimize the balance of efficacy and safety. In addition to the critically important bleeding profile, liver safety needs to be considered. In the three pivotal trials, a low incidence and severity of major bleeding (including those occurring at the surgical site) was reported in patients treated with PRADAX™, which was similar to those treated with enoxaparin (a commonly used injectable anticoagulant).3,[vi],[vii]
Rates of liver enzyme alanine aminotransferase (ALT) elevations greater than three times the upper limit of normal (3x ULN) were also low and comparable to enoxaparin at any time post-baseline with PRADAX™, supporting liver safety.3,6,7
PRADAX® is approved in all 27 European Union member states, most recently in the United Kingdom.
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and 39,800 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine. In 2007, Boehringer Ingelheim posted net sales of 10.9 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.
http://www.boehringer-ingelheim.com
References:
[i] Canadian Institute for Health Information, Canadian Joint Replacement Registry (CJJR) 2007 Annual Report. - Hip and Knee Replacements in Canada (Ottawa: CIHI, 2008)
[ii] Canadian Patient Safety Institute Getting started kit: Venous thromboembolism prevention how-to guide., March 2008
[iii] PRADAX Product Monograph, June 10, 2008
[iv] Geerts WH, Pineo GF, Heit JA, et al. Prevention of venous thromboembolism. The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004; 126:338S-400S
[v] Rahme E, Dasgupta K, et al. Postdischarge thromboprophylaxis and mortality risk after hip-or-knee replacement surgery. CMAJ 2008;178(12)1545-1554
[vi] Eriksson BI, Dahl OE, Kurth AA et al. Oral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial. J Thromb Haemost 2007;5:2178-2185
[vii] Eriksson BI, Dahl OE, Rosencher N et al. Dabigatran etexilate compared with enoxaparin for the extended prevention of venous thromboembolism following total hip replacement. Lancet 2007;370:949-956
View drug information on Warfarin Sodium tablets.
Study Results Provide Further Evidence That Early Treatment of Rheumatoid Arthritis With Enbrel(R) Plus Methotrexate in Moderate to Severe Patients can Stop the Disease From Progressing, and Helps Patients Return to More Normal and Productive Lives
Data presented today show that 80% of patients with early active rheumatoid arthritis achieved radiographic remission (or non-progression defined as a change in TSS is less than or equal to 0.5) at one year when treated with Enbrel (etanercept) and methotrexate, compared to 59% when treated with methotrexate alone(1). COMET* (COmbination of Methotrexate and ETanercept in Active Early Rheumatoid Arthritis) is the first major trial to use remission as its primary endpoint in patients with early active rheumatoid arthritis treated with a biologic. Data from the landmark COMET study were presented at the European League Against Rheumatism (EULAR) Annual Meeting in Paris.
The COMET trial also showed that 50% of patients taking this Enbrel combination achieved clinical remission (DAS28
“Until recently, we did not know whether remission was a realistic or even achievable goal”, said Professor Paul Emery, lead COMET trial investigator and Professor of Rheumatology, University of Leeds, UK. “We now have results which show that not only is clinical remission achievable in a significant number of patients, but radiographic and functional remission are also achievable. These exciting results lead to the next therapeutic step in aiming for multiple measures of remission as our treatment goal, no longer just one. Given that these levels of remission have not previously been seen and represent the optimal goal, these results will lead to the need for treatment of RA with an anti-TNF treatment option such as etanercept at the earliest appropriate opportunity to halt disease progression.”
Enbrel’s ability to achieve remission in many of the patients treated, irrespective of how it is measured, provides real-life benefits for the patient by stopping the disease from progressing whilst at the same time helping them to continue normal day-to-day functioning. Further data from the COMET trial show that the number of lost work days in patients treated with the Enbrel combination was approximately half that of patients receiving methotrexate alone(2).
No differences were observed in rates of serious infections or malignancies among patients in the Enbrel plus methotrexate group compared with the methotrexate-only group.
The economic data from another study called DART** were also presented at the EULAR Annual Meeting(3), complementing the results from the COMET study. DART trial investigator Professor Robert Moots, Professor of Rheumatology, University of Liverpool, United Kingdom commented: “The DART study confirms that whilst all of the TNF inhibitors are highly effective in reducing disease activity in RA, in normal clinical usage there may be a need to increase the dose of infliximab and adalimumab, but not etanercept, to maintain this beneficial effect. Similarly, the COMET results also demonstrate Enbrel’s value by enabling more patients to stay at work than those taking methotrexate alone. In conclusion, these results, coupled with previous studies, demonstrate that Enbrel can not only protect joints from further damage but also permit optimisation of the long-term management of patients with RA, due to a predictable dosing and hence more predictable cost.”
To access further media information relating to this press release, additional information on Enbrel and future media announcements, please log on to the media centre at http://www.wyeth.eu.
About ENBREL(4)
ENBREL is a fully human soluble tumour necrosis factor (TNF) receptor antagonist. ENBREL was first approved in 1998 for moderate to severe rheumatoid arthritis and has since been used in nearly 500,000 patients worldwide across indications.
ENBREL in the EU is approved for the following indications:
Rheumatoid arthritis
Enbrel in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate. Enbrel can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Enbrel is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Enbrel, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.
Polyarticular juvenile idiopathic arthritis
Treatment of active polyarticular juvenile idiopathic arthritis in children and adolescents aged 4 to 17 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Enbrel has not been studied in children aged less than 4 years.
Psoriatic arthritis
Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Enbrel has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease.
Ankylosing spondylitis
Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Plaque psoriasis
Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA
*COMET study details
This study was designed to compare the clinical efficacy and safety of ENBREL and methotrexate combination therapy with methotrexate alone in patients with early active rheumatoid arthritis. Patients in this study had disease duration of less than or equal to 2 years, had not previously received methotrexate, and had active disease based on DAS28 (more than or equal to 3.2) and elevation of erythrocyte sedimentation rate (more than or equal to 28 mm/hr) or C-reactive protein levels (more than or equal to 20 mg/L). Patients were randomised to receive either ENBREL plus methotrexate (n = 274) or methotrexate alone (n = 268). Primary efficacy endpoints were:
1) The radiographic change at week 52 from baseline assessed by using an X-ray measurement of changes in joint damage, the modified Total Sharp Score (mTSS). Radiographic remission was assessed with the TSS, with non-progression defined as a change in TSS less than or equal to 0.5. Patients receiving Enbrel with methotrexate experienced significantly less progression of joint damage with a 0.27 unit mean change from baseline at one year in TSS, compared with a 2.44 unit mean change in those treated with methotrexate alone which translates into nine times less joint damage with the Enbrel combination versus methotrexate alone (1).
2) The proportion of patients achieving clinical remission, as measured by disease activity score (DAS28 less than 2.6). DAS28 is a measure of joint swelling and tenderness (based on 28 joints), as well as overall disease activity measured by a global health assessment and an objective marker of inflammation (erythrocyte sedimentation rate). DAS28 is a validated tool used in clinical trials.
Other endpoints included low disease activity (DAS28 less than or equal to 3.2), radiographic non-progression (mTSS less than or equal to 0.5), and the number of patients achieving functional remission as measured by Health Assessment Questionnaire (HAQ). This double-blind, randomised, multicenter study consists of two 12-month periods. The data presented at EULAR is from the first 12-month period (52 weeks).
**DART study details:
The DART (Anti-TNF Drug utilization and dosing patterns Assessment: a Retrospective observational study of subjects Treated for rheumatoid arthritis) study is a retrospective observational study involving 739 patients in 44 European centres treated with monoclonal antibodies to TNF-alpha or soluble TNF-alpha receptor over is greater than or equal to 12 month period. The study was designed to assess potential dose escalation and other associated treatment costs on routine clinical practice. Eligible subjects were required to be continuously treated with prescribed anti-TNF agent (ATA) for is greater than or equal to 12 months and have no concurrent diagnosis of any other TNF-mediated conditions.
About WYETH
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women’s health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.
Wyeth is one of the world’s largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products, nutritionals and non-prescription medicines that improve the quality of life for people worldwide. The Company’s major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health. http://www.wyeth.com
References
(1) Abstract OP-0008 from the European League Against Rheumatism (EULAR) congress, 12 June 2008. Emery P. et al. Clinical Remission, Radiographic Non-Progression, And Normalized Function With The Combination Of Etanercept And Methotrexate In The Treatment Of Early Active Rheumatoid Arthritis: 1-Year Results Of The COMET Trial
(2) Abstract OP-0096 from the European League Against Rheumatism (EULAR) congress, 12 June 2008. Anis. A. et al. Work-Related Outcomes In Early Active Rheumatoid Arthritis: Results From The COMET Trial
(3) Abstract FRI0139 from the European League Against Rheumatism (EULAR) congress, 13 June 2008. Moots, R. et al. Dose Escalation Accounts For Differences In Cost Of Care In 739 Patients With Rheumatoid Arthritis (RA) Treated With Anti-TNF Agents (ATAs): Results From The DART Study
(4) Enbrel EMEA SPC (eMC last accessed 25/05/08)
http://www.wyeth.com
View drug information on Enbrel.
In its latest report on bone mineral densitometry equipment, MD Buyline, an independent medical technology and informatics intelligence firm, has ranked GE Healthcare number one for the second consecutive quarter. Not only did GE Healthcare’s GE Lunar bone mineral densitometry products achieve the highest overall user satisfaction composite rating from MD Buyline’s member network of more than 3,200 hospitals, but it also improved its previous scores in all eight categories:
- Systems performance
- System reliability
- Installation and implementation
- Applications training
- Service response time
- Service repair quality
- Overall composite score.
This achievement is consistent with GE Healthcare’s own customer satisfaction efforts, including its own customer advisory board, periodic surveys, and using feedback to seek continuous improvement. Latest scores reveal a 97-percent rate for customers who are not only satisfied, but often willing to recommend GE Healthcare Lunar Service to a peer.
GE Healthcare Lunar, the leading densitometry equipment partner worldwide, helps physicians measure bone mineral density in patients, as well as enabling licensed medical practitioners to simultaneously assess body composition and ascertain fat distribution in adults. This X-ray technology, called Dual-Energy X-ray Absorbtiometry or DXA scanning, measures and calculates bone, fat and muscle mass. Another Lunar technology uses quantitative ultrasound to measure the heel to assess fracture risk.
Key GE Healthcare Lunar service features that contributed to its improvement in MD Buyline scores are:
- A dedicated bone mineral densitometry online support center staff in Madison, Wis. who answers customer calls in approximately less than 20 seconds.
- An ability to diagnose and support service and applications queries remotely with the GE InSite ExC platform’s connectivity, which allows GE to deliver remote fixes in 15 minutes or less, up to 87 percent of the time.
- Dedicated field engineers who are certified annually on the equipment hardware and software applications.
“We are very proud of this steady increase in scores from those who use the product every day. This reflects the GE Healthcare Lunar’s commitment to focus on the customer experience,” said David Schlack, general manager of GE Healthcare’s Lunar Services. “Our investments in people, processes and our infrastructure are enabling us to exceed customers’ expectations, and making our ‘Early Health’ model a reality through helping to achieve earlier disease detection and prevention in osteoporosis. We are committed to maintaining our number one ranking with our customers.”
About Md Buyline
MD Buyline, based in Dallas, Texas, maintains the largest online database on medical capital and informatics purchasing, discounting, user feedback, and vendor information. Since 1983, the firm has been creating a level playing field for hospitals and medical technology vendors, empowering its members to make sound technology and financial decisions. Hospital members have instant online access to tools and services that can assist them in evaluating and selecting technologies, budgeting and financial planning, negotiating the best deal, and maintaining their purchases. Data comes from vendor quotations submitted by members; interviews with real users; clinical site visits; trade shows; factory tours; and vendor demonstrations. For more information about MD Buyline, visit its Web site at: http://www.mdbuyline.com
About GE Healthcare
GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform, treat and monitor disease, so patients can live their lives to the fullest.
GE Healthcare’s broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier. Our vision for the future is to enable a new “early health” model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries.
GE Healthcare
Join orthopedic experts at Rush University Medical Center for a free informational discussion about advanced options in treating chronic knee pain. The free program will be held from 6 to 8:30 p.m., Tuesday, June 24 in Room 542 of the Searle Conference Center, located on the Rush campus, at 1725 W. Harrison St., Chicago.
The discussion will include information about nonsurgical treatments and innovative surgical approaches for chronic knee pain that can yield excellent outcomes and minimize tissue trauma, allowing for accelerated rehabilitation and a faster return to work or sport.
Dr. Kathleen Weber, sports medicine specialist, will talk about nonsurgical options for recurring and chronic knee problems. Weber is a team physician for the Chicago Bulls and the Chicago White Sox.
Dr. Brian Cole, an orthopedic surgeon who specializes in cartilage restoration, will talk about cartilage repair for young and active patients, using new techniques that make it possible to regenerate and replace cartilage before more advanced degeneration occurs. Cole is a team physician for the Chicago Bulls and the Chicago White Sox.
Dr. Scott Sporer, and orthopedic surgeon specializing in joint replacement surgery, will discuss current advances in knee replacement surgery including minimally invasive procedures.
To register for “Nonsurgical and Minimally Invasive Treatments for Chronic Knee Pain”, please call (888) 352-RUSH (7874) or visit http://www.rush.edu. Free parking in the Rush garage and refreshments are available for registered attendees.
Rush University Medical Center
Osteoporosis is a disease that can be crippling, leaving bones brittle, weak and easily broken. There are already some 8 million women in the U.S. who suffer from osteoporosis* and experts say that number could soon skyrocket.
She may not quite understand the language yet, or the technology behind the test, but Sandra Ramos knows the importance of a simple heel scan.
“I’m told with time, my bones can get weaker,” says Ramos.
If they are, a quick 5 minute heel scan can tell her. In many ways, Sandra is lucky. She never heard much about osteoporosis in her native Mexico, and experts fear millions more Hispanic women will not hear enough about it after settling in this country - leading to a serious health issue in the near future.
“We are facing, as a country I think, a potential epidemic for osteoporosis if we don’t do something proactively,” says Kevin Evans, PhD at Ohio State University Medical Center.
That’s just what Dr. Evans is doing. He’s conducting studies on hundreds of Hispanic women to see how brittle their bones might be. Treating broken bones in Hispanics due to osteoporosis already costs more than 750 million dollars a year in the U.S.* That number is expected to skyrocket to more than 2 billion dollars* unless programs like these can get the word out early about prevention.
“We really want to see if we can do something to affect them building bone mass. Osteoporosis is considered a disease classically for people over the age of 50 or 60. We want to do something before they get there,” says Evans.
He says Hispanic women are rarely included in studies looking at osteoporosis. By doing more heel scans, that might change, and so might their risk of falling to this crippling disease. Evanssays another challenge is to get more calcium products into the Hispanic diet. Things like milk and broccoli have high calcium levels, but they are not staples in the diets of some Hispanics.
*Osteoporosis Facts, National Osteoporosis Foundation, retrieved from http://www.nof.org/osteoporosis/diseasefacts.htm, May 2008
Ohio State University Medical Center
Located in Columbus, Ohio, The Ohio State University Medical Center is one of the largest and most diverse academic medical centers in the country and the only academic medical center in central Ohio.
State University Medical Center
The US Food and Drug Administration (FDA) has broadened the US indication for once-yearly Reclast® (zoledronic acid) Injection 5 mg[1] to include the prevention of new clinical fractures in patients who have recently had a low-trauma hip fracture1.
No other osteoporosis treatment has demonstrated a reduction of new clinical fractures in patients who have recently had a low-trauma hip fracture (e.g. due to a fall from standing height or less).
The FDA decision is based on safety and efficacy data from the landmark Recurrent Fracture Trial, published in The New England Journal of Medicine, showing a significant 35% reduction in the risk of new clinical fractures in patients treated with Reclast3.
“The consequences of osteoporosis can be devastating, particularly hip fractures. However, few patients actually receive treatment for the prevention of additional fractures after a hip fracture2,” said Kenneth G. Saag, MD, MSc, Professor of Medicine and Epidemiology, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham. “In the first large-scale clinical trial of its kind, these data support an efficacious therapeutic option for patients after a hip fracture.”
Osteoporosis is a condition in which the bones become weak and can break more easily4. Around 10 million people in the US are affected by osteoporosis and another 34 million are at risk from the disease, which caused an estimated 297,000 hip fractures in the US in 20074. Of those patients who experience a hip fracture, almost a quarter of people over the age of 50 die from complications within one year4.
Among those who survive a year after experiencing a hip fracture, 50% need help walking, 25% require long-term nursing care, and all remain at high risk of further fracture5. Yet few hip fracture patients are currently treated for osteoporosis2.
The Recurrent Fracture Trial involved more than 2,100 men and women aged 50 and older3 with osteoporosis who had experienced a hip fracture. Results showed that Reclast increased bone mineral density (BMD) and reduced the risk of new clinical fractures by 35% compared to patients treated with placebo3. The risk of new spine fractures was reduced by 46% and new non-spine fractures (e.g. hip, wrist and rib) by 27%3.
In the Recurrent Fracture Trial, the incidence of all-cause mortality was 9.6% in the Reclast group versus 13.3% in the placebo group3. This reduction in mortality is multifactorial and the groups were not randomized for risk of mortality at entry into the study3.
The updated US label further reinforces the safety and efficacy of Reclast, the only once-yearly treatment for postmenopausal osteoporosis approved in the US and EU (under the name Aclasta®) to reduce the risk of fractures in all key areas of the body typically affected by this disease, including the hip, spine and non-spine1. Regulatory approval is also being sought for Aclasta in the European Union for the prevention of clinical fractures after a recent low-trauma hip fracture.
Unlike oral bisphosphonate therapies that are taken daily, weekly or monthly, Reclast/Aclasta is given as a once-yearly 15-minute intravenous infusion1. This means with a single treatment, along with daily calcium and vitamin D supplements, a patient can receive a full year’s fracture protection against the consequences of osteoporosis.
“The new label reinforces the potential of Reclast/Aclasta for treating a range of osteoporosis patients,” said Trevor Mundel, MD, Head of Global Development Functions at Novartis Pharma AG. “These data support the clear need to treat patients after hip fracture who are at risk of the potentially devastating and life-threatening consequences of osteoporosis.”
Reclast/Aclasta is already approved in more than 50 countries for the treatment of postmenopausal osteoporosis and in more than 70 countries for the treatment of Paget’s disease of bone, the second most common metabolic bone disorder6.
Reclast/Aclasta has a demonstrated tolerability profile. The most common adverse events associated with Reclast/Aclasta were transient post-dose symptoms such as fever and muscle pain. Most of these symptoms occurred within the first three days following Reclast/Aclasta administration and resolved within three days. The incidence of post-dose symptoms can be reduced with the administration of paracetamol or ibuprofen shortly after Reclast/Aclasta infusion.
The active ingredient in Reclast/Aclasta is zoledronic acid, which is also available in a different dosage under the brand name Zometa® (zoledronic acid) Injection 4 mg for use in certain oncology indications.
Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as “risk,” “can,” “potential,” “potentially,” or similar expressions, or by express or implied discussions regarding potential future revenues from Reclast. Such forward-looking statements reflect the current views of the Company regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Reclast to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Reclast will achieve any particular levels of revenue in the future. In particular, management’s expectations regarding Reclast could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; competition in general; unexpected regulatory actions or delays or government regulation generally; the company’s ability to obtain or maintain patent or other proprietary intellectual property protection; government, industry and general public pricing pressures, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Novartis
Novartis AG provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on growth areas in healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, and consumer health products. Novartis is the only company with leading positions in these areas. In 2007, the Group’s continuing operations (excluding divestments in 2007) achieved net sales of USD 38.1 billion and net income of USD 6.5 billion. Approximately USD 6.4 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 98,000 full-time associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.
References
1.Reclast® (zoledronic acid) Injection [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; June 2008.
2.Cadarette SM, et al. Trends in drug prescribing for osteoporosis after hip fracture, 1995-2004. Journal of Rheumatology. 2007; 35:319-326.
3.Lyles KW, Colon-Emeric CS, Magaziner JS, et al. for the HORIZON Recurrent Fracture Trial. Zoledronic acid and clinical fractures and mortality after hip fracture. N Engl J Med. 2007:537:1799-1809.
4.National Osteoporosis Foundation. Fast Facts on Osteoporosis Brochure. February 2008.
5.Edwards BJ, Perry HM III. Age-related osteoporosis. Clin Geriatr Med. 1994; 10:575-587.
6.US Department of Health and Human Services. Bone Health and Osteoporosis: A Report of the Surgeon General. 2004, p. 88.
http://www.novartis.com
View drug information on Reclast; Zometa.
Tufts University researcher Bess Dawson-Hughes, M.D., chaired the committee that recently updated the National Osteoporosis Foundation (NOF) Clinician’s Guide to Prevention and Treatment of Osteoporosis. The new Clinician’s Guide incorporates the World Health Organization (WHO) absolute fracture prediction algorithm (FRAX®), a computer-based tool expected to increase the identification of patients at risk for osteoporosis.
“The introduction of the WHO’s fracture prediction algorithm necessitated the revision of the Clinician’s Guide,” says Dawson-Hughes, director of the Bone Metabolism Laboratory at the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University. “The algorithm tells clinicians how likely a patient is to fracture a bone due to osteoporosis or low bone mass in the 10 years following examination, also known as 10-year fracture risk. This can help clinicians decide whether a patient needs to be treated or simply monitored.”
Writing in the April 2008 issue of the journal Osteoporosis International, corresponding author Dawson-Hughes and colleagues describe how to apply FRAX® in the United States. Clinicians estimate a patient’s 10-year fracture risk using a computer program that considers bone mineral density (BMD) score, or T-score, and nine clinical risk factors including personal fracture history, family fracture history, weight, race and gender. Notably, FRAX® and the new Clinician’s Guide now apply to men over 50 and post-menopausal non-Caucasian women, including African-Americans, Asians and Latinas. Previous versions applied only to post-menopausal Caucasian women, the group at highest-risk for osteoporosis.
In their analysis, Dawson-Hughes and colleagues highlight the inclusion of men in the guide. “Post menopausal women remain the most vulnerable to osteoporotic fractures, yet clinicians should not overlook men because their fracture risk may be lower,” says Dawson-Hughes, who is also a professor at Tufts University School of Medicine. “The new U.S.-adapted FRAX® will help identify high-risk subgroups of men and non-Caucasian women and, we hope, a wider population of patients at risk for osteoporosis will be treated. Use of FRAX® in men and non-Caucasian women will require adjustments in their T-scores that currently appear on bone density reports. “
Additionally, FRAX® and the new Clinician’s Guide address the cost-effectiveness of prescribing medication to patients with low bone mass, but not osteoporosis. Dawson-Hughes and colleagues performed an economic analysis that calls for treating patients with a 10-year hip fracture risk of 3 percent or greater or a major fracture risk of 20 percent or greater. That would include; patients with fragility fractures or osteoporosis, older patients at risk for osteoporosis and younger patients presenting additional clinical risk factors for fracture. FRAX® is applicable to men and women over age 50, but not to younger people.
“The ability to estimate 10-year fracture risk is a crucial development in osteoporosis care, but it is still important for clinicians to review patient cases on an individual basis,” says Dawson-Hughes. “Ten-year fracture risk should be used as a guideline.”
The following are some recommendations from the new Clinician’s Guide:
“We continue to stress the importance of taking calcium and vitamin D for optimal bone health,” says Dawson-Hughes, who has published several papers on the subject. “Previous studies suggest these nutrients help strengthen bones which is beneficial for all adults, even those who show no signs of osteoporosis.”
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Dawson-Hughes, B, Tosteson, ANA, Melton, LJ III, Baim, S, Favus MJ, Khosla, S, Lindsay RL. Osteoporosis International. 2008 (April); 19: 449-458.
*Select information in this news release was provided by the National Osteoporosis Foundation, which also funded a portion of the study.
About Tufts University School of Medicine
Tufts University School of Medicine and the Sackler School of Graduate Biomedical Sciences at Tufts University are international leaders in innovative medical education and advanced research. The School of Medicine and the Sackler School are renowned for excellence in education in general medicine, special combined degree programs in business, health management, public health, bioengineering and international relations, as well as basic and clinical research at the cellular and molecular level. Ranked among the top in the nation, the School of Medicine is affiliated with six major teaching hospitals and more than 30 health care facilities. The Sackler School undertakes research that is consistently rated among the highest in the nation for its impact on the advancement of medical science. For two decades, the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University has studied the relationship between good nutrition and good health in aging populations. Tufts research scientists work with federal agencies to establish the USDA Dietary Guidelines, the Dietary Reference Intakes, and other significant public policies.
Source: Andrea Grossman
Tufts University, Health Sciences
Alcohol consumption has been linked with a decrease in risk ofdeveloping rheumatoid arthritis, according to an article released onJune 5, 2008 in the BMJ specialist journal Annals of theRheumatic Diseases.
Arthritis is a disease that involves damage to the joints of the body.Rheumatoid arthritis is specifically a type of damage caused byautoimmune attack resulting in inflammation of the protectivecartilage. It commonly affects multiple joints at once, and can resultin severe deformation of the joints themselves.
More than 2,750 subjects were examined in two separate studiesregarding various environmental and genetic risk factors for rheumatoidarthritis. These included survey questions about lifestyle,specifically, how much they smoked and drank. Separately, blood sampleswere taken and examined for genetic risk factors. Nearly half of theparticipants (1650 subjects) suffered fromrheumatoid arthritis, and their non-arthritic counterparts weresimilarly distributed in terms of sex, age, and residential location.
Drinking alcohol was associated with a significantly lower risk ofdeveloping rheumatoid arthritis. In face, it was found that the morealcohol a subject consumed, the better their chances were to escapethis disease. The top one quarter of regular drinkers were 50% lesslikely to develop the disease in comparison with the half of thepopulation drinking the least. This effect was true for both males andfemales. However, it was more pronounced in subjects who alreadycarried risk factors for the disease. Among the other factors examined,smoking has already been shown to increase the risk of rheumatoidarthritis — this was confirmed and magnified by genetic riskfactors.
According to the authors, this strengthens the idea that lifestylefactors are of great importance in the development of this disease.Other researchers have also observed this connection between alcoholarthritis prevention. Additionally, this is similar to other studieslinking alcohol consumption to a reduced risk of other inflammatoryprocesses including cardiovascular disease. They note that, despitethese new results, giving up smoking is still this disease’s singlemost effective preventative measure.
Alcohol consumption is associated with decreased risk ofrheumatoidarthritis: results from two Scandinavian case-control studies
H Kallberg, S Jacobsen, C Bengtsson, M Pedersen, L Padyukov, P Garred,M Frisch, E W Karlson, L Klareskog, L Alfredsson
OnlineFirst Ann Rheum Dis
10.1136/ard.2007.086314
Click Here For Journal
Written by Anna Sophia McKenney
Copyright: Medical News Today
Researchers are developing a monitoring system similar to those used by earthquake seismologists to detect tiny cracks in bones, a technology that could help prevent fractures in humans and racehorses.The new monitoring system records “acoustic emission data,” or sound waves created by the tiny bone fissures. The same sorts of acoustic emissions are used to monitor the integrity of bridges, other structures and mechanical parts like helicopter turbine blades, said Ozan Akkus, an associate professor in Purdue University’s Weldon School of Biomedical Engineering.
“When a microcrack occurs in a bone it generates sound waves similar to those created by earthquakes,” Akkus said. “The goal is to create a wearable device that would alert the person when a stress fracture was imminent so that they could stop rigorous physical activity long enough for the bone to heal.”
Researchers at Purdue have designed wearable acoustic emission sensors, which could be used to monitor the formation of these “microcracks” in bones that can lead to hairline stress fractures unless detected in time. The technology might help prevent serious fractures in racehorses that could cause lameness and lead to more serious catastrophic bone failure.
Catastrophic injuries are rare in racehorses but still remain a major concern to horse owners and racing fans. This problem was highlighted by the recent tragedy involving this year’s Kentucky Derby second-place finisher Eight Belles. The 3-year-old filly broke both ankles as she was slowing down at the end of the race and had to be euthanized. Big Brown won both the Kentucky Derby and Preakness Stakes and is favored to win the Belmont Stakes on Saturday (June 7).
“The need for new technologies to prevent stress fractures and the many other causes of catastrophic injury to racehorses is great,” said Stephen Adams, a veterinarian and professor in the Purdue School of Veterinary Medicine.
“There is a huge investment in thoroughbred and standardbred horses, and a thoroughbred racehorse can cost between $4,000 to $10 million and cost thousands more each month for training. About 70 percent of young thoroughbreds develop microcracks in their cannon bones known as bucked shins. About 10 percent of horses with bucked shins will have radiographic evidence of stress fractures. One of our goals is to prevent stress fractures and curtail catastrophic fractures.”
Estimated losses attributed to bone fractures in thoroughbred or standardbred horses used in the horse racing industry exceed $10 million annually.
“While it is still in the early stages, this technology holds great promise for horses,” said Adams, who specializes in equine lameness and surgery and is collaborating with Akkus in testing the system on horses. “These horses are running 40 miles an hour, and if there is a microfracture in the animal there is danger it will become a catastrophic failure. Currently, microfractures are not visible on an X-ray, and we need a viable way to detect tiny fractures before they become stress fractures or catastrophic fractures.”
Shane Fimbel, technology transfer manager for the Purdue Research Foundation’s Office of Technology Commercialization, is working with Adams and Akkus to move the technology to the market.
“This technology is important in many ways, but in particular with horses and other animals because they cannot articulate why they are in pain,” Fimbel said.
Such a technology also might protect soldiers, athletes and dancers. Akkus will be visiting West Point this summer to test the monitoring system on cadets going through basic training.
“Strenuous military exercises subject soldiers to prolonged physical activity in which relatively small forces are repeatedly exerted on bones,” Akkus said. “The forces are not initially strong enough to break a bone, but it’s the repetition that poses the most danger by causing microscopic cracks to accumulate over time and eventually result in stress fractures.”
Depending on the service branch and type of training, 5 percent to 20 percent of U.S. basic training recruits experience stress fractures of the lower extremities, with the highest incidence in women recruits, Akkus said.
About 5 percent to 10 percent of athletes experience stress fractures.
A stress fracture occurs because cracks form when mineralized collagen fibers in bone fail, producing sound waves that cause a rippling motion on the skin’s surface.
“This is the same thing that happens during an earthquake, but on a microscopic scale and at a higher frequency,” Akkus said. “Instead of an earthquake-size opening, these cracks are about a tenth of a millimeter wide.”
Accumulating cracks sometimes cause “spontaneous fractures” that occur without warning, afflicting the young and old alike, including athletes and elderly people suffering from osteoporosis.
A major factor in the crack formation is the dynamic process bones use to continually rebuild themselves. When bone is damaged, specialized cells bore tunnel-like holes to remove the damaged tissue and then fill in the resulting cavity with new bone.
Hard physical activity without rest increases the stress in these porous areas that are under repair.
One reason it’s difficult to diagnose the hairline fractures is because they are caused by the gradual accumulation of microscopic cracks, which are not detectable with conventional imaging technologies.
“It’s really hard to measure stresses in bone without cutting open the bone to study it,” Akkus said. “And there is very little warning because you don’t have horrible pain. You might have some discomfort, but you can keep exercising or whatever activity you are doing.”
As hard as it is for humans to discern the pain due to developing stress fractures, it is relatively impossible for a horse to overtly display its discomfort, making this technology all the more valuable for equine applications.
“Ultimately, we would like to do real-time monitoring of damage activity and learn how to distinguish between a small crack and a more structurally threatening defect,” Akkus said. “There are different types of cracks that occur, and it’s important to be able to distinguish among them so that we can determine how serious the damage is.”
To differentiate the various types of cracks, researchers are integrating “pattern recognition” software and earthquake models, working with Robert Nowak, a Purdue professor of earth and atmospheric sciences. The multidisciplinary research involves biomedical and electrical engineering, veterinary medicine, and earth and atmospheric sciences.
Bones most affected in horses are the cannon bones of the front limb, which are the equivalent of human finger bones. The most commonly affected bones in humans are those in the feet, legs and hips, particularly the ball-and-socket joints that connect the legs to the pelvis.
Researchers at Purdue and the University of Toledo have jointly filed patents on the discovery through the Purdue Research Foundation Office of Technology Commercialization.
The Purdue Research Park is part of the Purdue Research Foundation, a private, nonprofit foundation created to assist Purdue University in the area of economic development. In addition to the Purdue Research Park in West Lafayette, the foundation has established or is currently constructing technology parks in other locations around Indiana including Merrillville, New Albany and Indianapolis.
Writers: Cynthia Sequin and Emil Venere
http://www.purdue.edu
A new study from the University of Alabama at Birmingham indicates that the OtisKnee Custom Fit Knee™ Replacement system may have a positive impact on length of hospital stay, range of motion, pain level and patient satisfaction immediately following total knee replacement surgery. The study abstract, titled “MRI-Guided Custom-Fit Total Knee Replacement: The First Six Weeks,” was presented at the joint Alabama Orthopedic Society and Mississippi Orthopedic Society annual meeting on May 3, 2008 in Sandestin, Fla. by Herrick Siegel, M.D., associate professor of surgery at the University of Alabama at Birmingham and lead investigator of the study.
Designed to evaluate the impact of OtisKnee on the early success of total knee replacement, the study involved 25 total knee replacements performed in 19 patients using the custom-fit OtisKnee technology. Each patient was followed for six weeks, a crucial period for predicting ultimate satisfaction with the procedure. Results showed that OtisKnee had a positive influence on length of hospital stay, range of motion, pain and patient satisfaction, as seen by the following data.
-Average length of hospital stay for single and bilateral (both knees) OtisKnee patients was 2.2 and 3.5 days, respectively.
-At two weeks, 17 of the 19 OtisKnee patients were walking with only a cane, and by 6 weeks all patients were walking without assistance.
-Sixteen of the 19 OtisKnee patients reported that they only needed prescription pain medication for 10 to 14 days post-op, and all patients were off prescription pain medication completely by four weeks post-op.
In addition, the study results indicated that OtisKnee is useful to the surgeon in pre-determining ideal implant size as well as defining proper rotation and positioning during the total knee replacement procedure.
“While total knee replacement has been a successful surgery historically, studies have shown that nearly 14 percent of patients have reported being dissatisfied or very dissatisfied with their surgery,” said Dr. Siegel. “Preliminary results with OtisKnee indicate that this unique, custom-fit approach may lead to a more predictable, reproducible and optimal result for patients.”
Since its limited U.S. launch in June of 2007, the OtisKnee technique has been performed by more than 400 surgeons on more than 7,000 patients. Initial clinical data demonstrating the value of OtisKnee in total knee replacement has been presented at the American Academy of Orthopaedic Surgeons annual meeting and has been accepted for publication in a peer-reviewed orthopedic trade journal.
About OtisMed Corporation
OtisMed Corporation is a privately held orthopedic technology company dedicated to providing new solutions for complex clinical problems in joint replacement. OtisMed’s focus is on developing and commercializing highly accurate and cost effective surgical solutions that are customized to each patient. OtisMed’s initial offering is the OtisKnee™, a groundbreaking new product that enables surgeons to offer custom fit total knee replacement. With OtisKnee, surgeons can for the very first time match the size and placement of the implant to the patient’s unique and normal (non-diseased) knee anatomy.
Founded in 2007, the company has received funding from Kleiner Perkins Caufield & Byers. For more information, call 888-OTISMED or visit http://www.otismed.com.
OtisMed Corporation