Late-breaking data from the SPIRIT IV trial demonstrated that Abbott’s market-leading XIENCE V(R) Everolimus Eluting Coronary Stent System achieved superiority in the key safety and efficacy measures of target lesion failure (TLF) and target lesion revascularization (TLR) compared to the TAXUS(R) Express2(TM) Paclitaxel-Eluting Coronary Stent System (TAXUS) at one year. With 3,690 patients, the SPIRIT IV trial is one of the largest randomized clinical trials between two drug eluting stents.

In the trial’s primary endpoint, XIENCE V demonstrated a statistically significant 38 percent reduction in TLF compared to TAXUS (4.2 percent for XIENCE V vs. 6.8 percent for TAXUS, p-value = 0.001). TLF is defined as a composite measure of important efficacy and safety outcomes for patients and is defined as cardiac death, heart attack attributed to the target vessel (target vessel myocardial infarction), and ischemia-driven TLR (ID-TLR). The standard was established to harmonize the definition of major adverse cardiac events across various drug eluting stent trials. XIENCE V also demonstrated a statistically significant 46 percent reduction in TLR (repeat procedure) compared to TAXUS (2.5 percent for XIENCE V vs. 4.6 percent for TAXUS, p-value=0.001). TLR is one of the major secondary endpoints of the SPIRIT IV trial. The groundbreaking results were presented today by Gregg W. Stone, M.D., professor of medicine at Columbia University Medical Center, during the 2009 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco.

In addition to demonstrating superiority in the primary endpoint of TLF and major secondary endpoint of TLR, XIENCE V demonstrated an impressive low rate of stent thrombosis (blood clots) at one year. Per protocol definition, XIENCE V demonstrated an observed 80 percent reduction in stent thrombosis compared to TAXUS (0.17 percent for XIENCE V vs. 0.85 percent for TAXUS, p-value=0.004) at one year. Per Academic Research Consortium (ARC) definition of definite/probable stent thrombosis, XIENCE V demonstrated an observed 74 percent reduction in ARC definite/probable stent thrombosis at one year (0.29 percent for XIENCE V and 1.10 percent for TAXUS, p-value=0.004). The ARC definitions of stent thrombosis were developed to harmonize the definition of stent thrombosis across various drug eluting stent trials.

“SPIRIT IV represents one of the largest randomized trials of two drug eluting stents completed to date. Importantly, this study was performed without routine angiographic follow-up, which may result in a tendency to treat lesions which may not be causing symptoms, and potentially impact results,” said Dr. Stone, who is also immediate past chairman of the Cardiovascular Research Foundation, New York; and principal investigator of the SPIRIT IV trial. “The SPIRIT IV results show that XIENCE V significantly reduces a patient’s risk of experiencing a heart attack, the need for a repeat procedure or stent thrombosis.”

Event Rates in Complex Patients

The SPIRIT IV trial included multiple complex patient subgroups, including more than 1,100 patients with diabetes, who typically are sicker and have more challenging artery disease. In patients with diabetes, there was no difference in TLF between XIENCE V and TAXUS at one year (6.4 percent for XIENCE V vs. 6.9 percent for TAXUS, p-value=0.80). In patients without diabetes, XIENCE V demonstrated a 54 percent reduction in TLF compared to TAXUS at one year (3.1 percent for XIENCE V vs. 6.7 percent for TAXUS, p-value<0.0001). In the endpoint of ARC definite/probable stent thrombosis, XIENCE V demonstrated a 40 percent reduction compared to TAXUS in patients with diabetes (0.80 percent for XIENCE V vs. 1.33 percent for TAXUS, p-value=0.52), and a 94 percent reduction compared to TAXUS in patients without diabetes (0.06 percent for XIENCE V vs. 1.00 percent for TAXUS, p-value=0.0009).

In addition, XIENCE V demonstrated low event rates in multiple subgroup analyses, such as patients with smaller vessels (reference vessel diameter less than or equal to 2.75 mm), patients with longer lesions (lesion length greater than 13.3 mm) and patients with multi-vessel disease. In patients with smaller vessels, XIENCE V demonstrated a 43 percent reduction in TLF compared to TAXUS at one year (3.9 percent for XIENCE V vs. 6.8 percent for TAXUS). In patients with longer lesions, XIENCE V demonstrated a 35 percent reduction in TLF compared to TAXUS at one year (4.5 percent for XIENCE V vs. 6.9 percent for TAXUS). In patients with two or more lesions treated, XIENCE V demonstrated a 49 percent reduction in TLF compared to TAXUS at one year (5.1 percent for XIENCE V vs. 10.0 percent for TAXUS).

Key Results from the SPIRIT IV Trial

In the SPIRIT IV trial of 3,690 patients, XIENCE V demonstrated the following key results at one year:

– A 38 percent reduction in TLF compared to TAXUS (4.2 percent for XIENCE V vs. 6.8 percent for TAXUS, p-value=0.001).

– A 39 percent reduction in major adverse cardiac events (MACE) compared to TAXUS (4.2 percent for XIENCE V vs. 6.9 percent for TAXUS, p-value=0.0009). MACE is a composite clinical measure of safety and efficacy outcomes for patients, defined as cardiac death, heart attack (myocardial infarction or MI), or ID-TLR driven by lack of blood supply.

– A 46 percent reduction in TLR compared to TAXUS (2.5 percent for XIENCE V vs. 4.6 percent for TAXUS, p-value=0.001).

– A 31 percent reduction in cardiac death or target vessel myocardial infarction (MI) compared to TAXUS (2.2 percent for XIENCE V vs. 3.2 percent for TAXUS, p-value=0.09).

– A 38 percent reduction in heart attacks (MI) attributed to the target vessel compared to TAXUS (1.8 percent for XIENCE V vs. 2.9 percent for TAXUS, p-value=0.04).

– Comparable rates in cardiac death compared to TAXUS (0.4 percent for XIENCE V vs. 0.4 percent for TAXUS, p-value=1.00).

– An observed 80 percent reduction in stent thrombosis per protocol definition compared to TAXUS (0.17 percent for XIENCE V vs. 0.85 percent for TAXUS, p-value=0.004).

– An observed 74 percent reduction in stent thrombosis per ARC definition of definite/probable stent thrombosis compared to TAXUS (0.29 percent for XIENCE V and 1.10 percent for TAXUS, p-value=0.004).

“In SPIRIT IV, XIENCE V demonstrated superiority to TAXUS in the clinically driven endpoint of target lesion failure, which links the results more closely to real-world practice,” said Charles A. Simonton, M.D., FACC, FSCAI, vice president, Medical Affairs, and chief medical officer, Abbott Vascular. “The SPIRIT IV results confirm the consistent and outstanding performance of the XIENCE V stent. We believe these results have the potential to be practice-changing based on the strength of the data.”

About XIENCE V

XIENCE V is used to treat coronary artery disease by propping open a narrowed or blocked artery and releasing the drug, everolimus, in a controlled manner to prevent the artery from becoming blocked again following a stent procedure. XIENCE V is built upon Abbott’s market-leading bare metal stent, the MULTI-LINK VISION(R) Coronary Stent System. The VISION platform is designed to facilitate ease of delivery, making it easier for physicians to maneuver the stent and treat the diseased portion of the artery.

The XIENCE V stent is available on both over-the-wire (OTW) and rapid exchange (RX) delivery systems. Rapid exchange is the most widely used type of delivery system because it provides physicians additional flexibility to work as single operators during stent procedures.

Abbott’s market-leading XIENCE V drug eluting stent is commercially available in the United States, Europe and other international markets. XIENCE V is an investigational device in Japan and is currently under review by Japan’s Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency.

Abbott also supplies a private-label version of XIENCE V to Boston Scientific called the PROMUS(R) Everolimus-Eluting Coronary Stent System. PROMUS is designed and manufactured by Abbott and supplied to Boston Scientific as part of a distribution agreement between the two companies.

Everolimus, developed by Novartis Pharma AG, is a proliferation signal inhibitor, or mTOR inhibitor, licensed to Abbott by Novartis for use on its drug eluting stents. Everolimus has been shown to inhibit in-stent neointimal growth in the coronary vessels following stent implantation, due to its anti-proliferative properties.

About Abbott Vascular

Abbott Vascular, a division of Abbott, is one of the world’s leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development, and advancing medicine through training and education. Headquartered in Northern California, Abbott Vascular offers a comprehensive portfolio of vessel closure, endovascular and coronary products.

About Abbott

Abbott (NYSE: ABT) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 72,000 people and markets its products in more than 130 countries.

Source: Abbott

Boston Scientific Corporation (NYSE: BSX) welcomed one-year data from the SPIRIT IV clinical trial comparing the XIENCE V((R)) (PROMUS((R))) Everolimus-Eluting Coronary Stent System to the TAXUS((R)) Express2(TM) Paclitaxel-Eluting Coronary Stent System. The results support the benefits of paclitaxel-eluting stents in diabetic patients. The trial enrolled 3,690 patients, including 1,140 diabetics, the largest diabetic subset ever studied in a drug-eluting stent clinical trial.

The Company also announced that on October 1 it will begin its previously planned, phased discontinuation of the TAXUS Express Stent used in the SPIRIT IV trial. The TAXUS Express Stent has been replaced by the thinner-strut TAXUS((R)) Liberte((R)) Stent worldwide. The TAXUS Liberte Stent was approved in Europe in 2005, in the U.S. in 2008 and in Japan in 2009.

The SPIRIT IV results were presented at the 21(st) annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium by Gregg W. Stone, M.D., Professor of Medicine and the Director of Research and Education at the Center for Interventional Vascular Therapy at the Columbia University Medical Center/New York-Presbyterian Hospital, and Principal Investigator of the trial.

“We welcome the positive SPIRIT IV results reaffirming the safety and efficacy of our two drug-eluting stent platforms,” said Donald S. Baim, M.D., Chief Medical and Scientific Officer at Boston Scientific. “The strong outcomes among diabetic patients treated with TAXUS Express were impressive, particularly the rates of target lesion failure (TLF) at one year, which were equivalent for PROMUS and TAXUS Express. These rates were actually lower for TAXUS Express in diabetic patients requiring insulin.”

The TLF rates for diabetic patients at one year were 6.4% for the XIENCE V (PROMUS) Stent and 6.9% for the TAXUS Express Stent (p=0.80). For diabetic patients requiring insulin, the TLF rates were 8.0% for the XIENCE V (PROMUS) Stent and 7.0% for the TAXUS Express Stent (p=0.83).

SPIRIT IV is a prospective, single-blinded, multicenter clinical trial in which patients with up to three native coronary artery lesions were randomized 2:1 to the XIENCE V (PROMUS) Stent or the TAXUS Express Stent at 66 U.S. sites. The primary endpoint is the rate of ischemia-driven TLF at one year, which is a composite measure of safety and efficacy consisting of cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization (TLR).

The results showed the trial met its endpoint of TLF non-inferiority with rates of 4.2% for the XIENCE V (PROMUS) Stent and 6.8% for the TAXUS Express Stent (p<0.0001). Contributing to this result was a significant difference in TLR (2.5% for XIENCE V (PROMUS) versus 4.6% for TAXUS Express, p<0.001), including a large subgroup of patients (n=1,352) with vessels smaller than or equal to 2.75 mm. As announced yesterday, the TAXUS ATLAS Small Vessel Trial reported a statistically significant reduction in the rate of TLR in small vessels treated with the 2.25 mm diameter TAXUS Liberte Atom(TM) Stent compared to the older 2.25 mm diameter TAXUS Express Atom Stent.

SPIRIT IV safety results demonstrated comparable rates of death (1.0% for XIENCE V (PROMUS) versus 1.3% for TAXUS Express, p=0.61) and a non-significant difference in Myocardial Infarction (1.9% for XIENCE (PROMUS) versus 3.1% for TAXUS Express, p=0.02). The overall major adverse cardiac events (MACE) rate was 4.2% for XIENCE (PROMUS) and 6.9% for TAXUS Express (p=0.0009). Stent thrombosis under the ARC (Academic Research Consortium) definite/probable definition was 0.29% for XIENCE (PROMUS) versus 1.1% for TAXUS Express (p=0.004). This difference is inconsistent with results seen in the SPIRIT II and III trials where rates of ARC stent thrombosis were comparable at one year and remained similar out to three years.

“We are pleased that our thinner-strut TAXUS Liberte Stent has proved so appealing to clinicians as a replacement for the TAXUS Express Stent,” said Hank Kucheman, Senior Vice President and Group President, Cardiovascular for Boston Scientific. “We continue to be the only manufacturer offering both everolimus- and paclitaxel-based drug-eluting stent platforms, and we look forward to introducing our upcoming family of platinum chromium Element(TM) Stents, which will be offered in everolimus, paclitaxel and bare-metal versions.”

The TAXUS stent systems — both Liberte and Express — have been evaluated by the industry’s most extensive randomized, controlled clinical trial program, with follow-up to five years in some cases. These trial results have been supplemented by data on more than 50,000 patients enrolled in post-approval registries. To date, approximately 4.6 million TAXUS stents have been implanted globally, making them the world’s most frequently used drug-eluting stents.

The PROMUS Stent is a private-labeled XIENCE V Everolimus-Eluting Coronary Stent System manufactured by Abbott and distributed by Boston Scientific. SPIRIT IV is sponsored by Abbott. TAXUS, TAXUS Express2, Express, Liberte, PROMUS and Element are trademarks of Boston Scientific Corporation or its affiliates. XIENCE is a trademark of Abbott Laboratories Group of Companies.

The TAXUS Liberte Stent has received an indication for use in diabetic patients in CE-Marked countries. In the United States, the TAXUS Express, TAXUS Liberte and PROMUS Stents are not specifically indicated for use in diabetic patients.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like “anticipate,” “expect,” “project,” “believe,” “plan,” “estimate,” “intend” and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding clinical trials, regulatory approvals, product performance and competitive offerings. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.

Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and, future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A- Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A - Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file thereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document.

Source: Boston Scientific Corporation

Versartis, Inc. today presented preclinical data demonstrating the potential for monthly dosing of its lead product, VRS-859 (exenatide-XTEN), for the treatment of type 2 diabetes. The data were presented by Jeffrey Cleland, Ph.D., Founder and Chief Executive Officer of Versartis, at the IBC Protein Engineering & Design Conference in San Diego.

In his talk, “Half-life Extension and In Vivo Biological Activity of Peptide and Protein Therapeutics,” Dr. Cleland presented VRS-859 preclinical data in models of diabetes and pharmacokinetics in mice, rats, dogs and monkeys. Versartis has begun development activities for VRS-859 including manufacturing and regulatory meetings. A clinical study of VRS-859 in patients with type 2 diabetes is planned for the first half of 2010.

Versartis is also finalizing lead selection for VRS-317 (human growth hormone-XTEN), a monthly dosage form. Dr. Cleland presented preclinical proof of concept and pharmacokinetic data. Versartis plans to begin Phase I clinical trials of VRS-317 in patients with growth hormone deficiency in the second half of 2010.

In addition to the reduced dosing frequency, Versartis’ XTEN products enable room temperature stability and low cost manufacturing. The XTEN properties allow for co-formulation and co-administration of proteins and peptides that are normally incompatible. Versartis is conducting research on combination products for metabolic disease to exploit these novel properties.

“Versartis is focusing on treatments for metabolic and endocrine diseases that currently require daily or weekly dosing,” explained Dr. Cleland. “Our results to date demonstrate the potential for monthly dosing of our compounds. The potential for improved convenience along with other XTEN properties provide a distinct advantage for Versartis’ products over other products on the market or in development.”

Source
Versartis, Inc.

Researchers in the Memory Disorders Program at Georgetown University Medical Center are now recruiting volunteers for a national gene therapy trial - the first study of its kind for the treatment of patients with dementia due to Alzheimer’s disease.

The phase II study examines the safety and possible benefits of CERE-110. CERE-110 contains a gene and is injected during surgery into a part of the brain affected by Alzheimer’s disease. The gene will instruct brain cells to produce more of a protein, called Nerve Growth Factor or NGF, which helps nerve cells survive and function properly. The transfer of this gene into the brain is a medical technique called gene therapy.

“Our goal is to stop the progression of Alzheimer’s disease,” explains R. Scott Turner, MD, PhD, director of Georgetown’s Memory Disorders Program. “This is our first study of a gene therapy injected into brain, and thus the trial requires close collaboration with our neurosurgery colleagues at GUMC, in particular Dr. Chris Kalhorn.”

Turner says Kalhorn, an associate professor of the department of neurosurgery at Georgetown University Hospital, routinely performs neurosurgical procedures similar to the one being utilized in this study.

About 50 people with Alzheimer’s disease will participate in this study at fewer than 10 hospitals nationwide. Only persons with a mild form of Alzheimer’s Disease, who are evaluated and deemed competent to consent for themselves, will be permitted to participate in the study. The study requires each patient select a study partner for the length of the study. All patients in the study will undergo surgery to drill two small holes in the skull. Only those patients randomly assigned to receive CERE-110 will have the gene therapy injected into the brain. Those subjects randomized to the placebo group will not have the gene therapy injected.

This study is a phase II, double-blind, placebo-controlled study.

Phase II means the investigational agent has been studied in a small number of patients and this study is being conducted to determine its safety and possible benefits.

Double-blind means that the patients, clinical coordinators and treating physicians will not know if the patient received the investigational agent until the end of the study. Only the neurosurgeon and operating team delivering the gene therapy will know if the patient received the active agent.

Placebo-controlled means that patients will be selected randomly to either receive the active agent or not, but all patients will undergo surgery. This study has been approved by the FDA and the Institutional Review Board at GUMC.

This study is sponsored by the Alzheimer’s Disease Cooperative Study (ADCS) through a grant from the National Institute on Aging (a part of the NIH) in association with Ceregene, Inc, which will provide the active agent used in this study. GUMC will be reimbursed for the costs of performing the study by the ADCS. Turner, the study’s lead investigator at Georgetown, has no financial interests to disclose.

The Memory Disorders Program is conducting several clinical studies for patients in the early stages of dementia due to Alzheimer’s disease. Depending on the person’s medical status, he or she may qualify and wish to participate in other studies. To learn more about this or other studies, visit memory.georgetown.edu.

Source:
Karen Mallet

Georgetown University Medical Center

Physical therapist-directed exercise counseling combined with fitness center-based exercise training can improve muscular strength and exercise capacity in people with type 2 diabetes, with outcomes similar to those of supervised exercise, according to a randomized clinical trial published in the September issue of Physical Therapy, the scientific journal of the American Physical Therapy Association (APTA).

Type 2 diabetes is associated with numerous health complications, including a decline in muscular strength and exercise capacity. Studies show that a decline in muscular strength increases the risk of loss of physical function and that a decline in exercise capacity increases the risk of cardiovascular and all-cause mortality. “Improving muscular strength and exercise capacity in people with type 2 diabetes is crucial to preventing loss of physical function and decreasing comorbidity and mortality in these patients,” said lead researcher J. David Taylor, PT, PhD, CSCS, assistant professor in the Department of Physical Therapy at the University of Central Arkansas.

Supervised exercise programs improve both muscular strength and exercise capacity in people with type 2 diabetes; however, Medicare and other health insurance programs do not currently reimburse physical therapists and other clinicians for these exercise programs.

In this study, 24 people with type 2 diabetes were randomly allocated to either an experimental group that received two months of physical therapist-directed exercise counseling and fitness center-based exercise training or a comparison group that received two months of laboratory-based, supervised exercise. Exercise training for all participants consisted of resistance training (chest press, row, and leg press exercises) and aerobic training (walking or jogging on a treadmill) as recommended for people with type 2 diabetes by the American Diabetes Association and the American College of Sports Medicine. Participants in the experimental group received a face-to-face counseling session at baseline and one month after baseline, weekly 10-minute telephone calls, and seven-day-per-week access to a local fitness center. Each participant in the comparison group received the same prescribed exercise program as the experimental group, but in a supervised environment.

Although both groups had significant improvements in muscular strength and exercise capacity following exercise training, the results showed no significant differences in improvements between these two groups. “The fact that there were no significant differences in improvements between patients who received exercise counseling and those in a supervised program suggests that physical therapists may make an evidence-based choice of prescribing either exercise counseling combined with fitness center-based training or supervised exercise training for patients with type 2 diabetes,” said Taylor.

Source:
Jennifer Rondon

American Physical Therapy Association

The FDA has requested that label information for the diabetes drug sitagliptin (Januvia) caution users about a heightened risk of acute pancreatitis.

“Eighty-eight postmarketing cases of acute pancreatitis, including two cases of hemorrhagic or necrotizing pancreatitis in patients using sitagliptin, were reported to the agency between Oct. 16, 2006 and Feb. 9, 2009,” the FDA said in an alert today.

The agency said it’s working with sitagliptin’s manufacturer, Merck & Co., on revisions to its prescribing information. The change also covers Janumet, which combines the sitagliptin with metformin. The revisions will include:

• Information regarding postmarketing reports of acute pancreatitis, including the severe forms, hemorrhagic or necrotizing pancreatitis
• Recommendations that healthcare professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases of sitagliptin or sitagliptin/metformin, and to discontinue sitagliptin or sitagliptin/metformin if pancreatitis is suspected while using these products
• Information noting that sitagliptin has not been studied in patients with a history of pancreatitis

The FDA noted that in the absence of such studies, it’s unclear whether these patients are at increased risk for developing recurrent pancreatitis while on the drug.

A statement indicating that sitagliptin or sitagliptin/metformin “should be used with caution and with appropriate monitoring in patients with a history of pancreatitis” will likely be included, the FDA said.

Acute pancreatitis is beginning to look like a class effect for the newer drugs against diabetes that act through the glucagon-like peptide-1 pathway.

Two years ago, the FDA demanded a similar label change for the incretin mimetic exenatide (Byetta), after 30 pancreatitis cases were reported. (See FDA Wants Pancreatitis Caution Added to Exenatide (Byetta) Label)

Both exenatide and sitagliptin act through receptors for GLP-1 — exenatide is a synthetic mimic of the peptide, while sitagliptin inhibits the dipeptidyl peptidase-4 enzyme that degrades GLP-1 in vivo.

Another DPP-4 inhibitor, saxagliptin (Onglyza), was approved in July. Its label does not mention pancreatitis risk.

Following the FDA announcement, Merck issued a statement saying its own analysis did not confirm an excess risk.

“Merck has thoroughly reviewed the safety data for sitagliptin, and sitagliptin was not associated with an increase in the incidence of pancreatitis in preclinical studies or in clinical trials of up to two years in duration with more than 6,000 patients,” the company said.

“Merck has also carefully reviewed postmarketing adverse experience reports, and Merck believes these data do not demonstrate that a causal relationship exists between sitagliptin and pancreatitis.”

The statement added that pancreatitis is a known complication of type 2 diabetes and pointed out that the FDA had previously acknowledged the difficulty in attributing the condition to antidiabetic drugs.

Related Article(s):

• FDA Wants Pancreatitis Caution Added to Exenatide (Byetta) Label

Researchers from the Memory and Cognition Center at University Hospitals Case Medical Center will begin testing an intriguing new approach to slowing down the progression of Alzheimer’s Disease (AD) using Intravenous Immune Globulin (IGIV), also known as gammaglobulin. IGIV is traditionally used to treat primary immunodeficiency disorders, but is not currently approved for treating AD, which is one of the leading causes of dementia in the elderly.

Initial research in experimental models and patients suggests that immunotherapy targeting beta amyloid (the protein that forms the core of plaques in the brain) may provide a more effective way to treat AD. Antibodies that bind to beta amyloid are present in IGIV, which is made from the blood of several thousand healthy adults.

One of the hallmarks of AD pathology is an abundance of beta-amyloid deposits in the brain. While it is not yet known if beta amyloid plaques cause AD or are a byproduct of the disease, scientists are interested in finding ways to reduce the toxic effects of beta amyloid on the brain. Antibodies against beta amyloid may do so by binding to toxic forms of beta amyloid, thereby neutralizing them and/or promoting their elimination.

“We are investigating whether IGIV, which contains naturally occurring human anti-amyloid antibodies, will defend the brain of AD patients against the damaging effects of beta amyloid. If it does, giving IGIV to patients with mild to moderate Alzheimer’s may potentially slow the rate of progression of the disease,” says Alan Lerner, M.D., principal investigator for the study in Cleveland and director of the Memory and Cognition Center.

“In our initial studies in AD patients, IGIV provided significant cognitive benefits, improved brain metabolism and reduced beta amyloid levels in the spinal fluid,” says Norman Relkin, M.D., project director and director of the Weill Cornell Alzheimer’s Disease and Memory Disorders Program. In a Phase II trial at Weill Cornell, Dr. Relkin reported that participants undergoing several months of continuous IGIV therapy also demonstrated improvement in their activities of daily living. He added, “These findings, as well as IGIV’s long established record of safe use for treating other diseases, provide a strong rationale for further study in AD patients on a larger scale.”

The GAP (Gammaglobulin Alzheimer’s Partnership) Study will examine the safety, effectiveness and tolerability of IGIV in patients with mild to moderate AD. GAP is recruiting 360 participants at 36 sites nationwide. This large Phase III clinical trial expands on earlier testing, is one of two Phase III trials and is part of the final phase in studying IGIV as a potential treatment for AD before seeking regulatory approval.

The trial is being conducted by the Alzheimer’s Disease Cooperative Study (ADCS), a nationwide consortium of research centers and clinics coordinated by the University of California at San Diego and directed by Paul Aisen, M.D.

“As many as five million Americans may be afflicted now and with the numbers growing rapidly, ADCS clinical trials such as the GAP study are essential to finding new and more effective treatments for Alzheimer’s disease,” Aisen commented.

The ADCS is primarily supported by the National Institute on Aging (NIA), part of the National Institutes of Health. The GAP study is jointly funded by Baxter International Inc. and the NIA.

Source:
George Stamatis

University Hospitals Case Medical Center

At least 124,000 new body weight, according to estimates from a new modelling study. The proportion of cases of new cancers attributable to a body mass index of 25kg/m2 or more were highest among women and in central European countries such as the Czech Republic, Latvia, Slovenia and Bulgaria.

The lead author of the study [1], Dr Andrew Renehan, told Europe’s largest cancer congress, ECCO 15 - ESMO 34 [2], in Berlin: “As more people stop smoking and fewer women take hormone replacement therapy, it is possible that obesity may become the biggest attributable cause of cancer in women within the next decade.”

Dr Renehan, who is a senior lecturer in cancer studies and surgery at the University of Manchester (UK), and his colleagues in the UK, The Netherlands and Switzerland, created a sophisticated model to estimate the proportion of cancers that could be attributed to excess body weight in 30 European countries. Using data from a number of sources including the World Health Organisation and the International Agency for Research on Cancer, they estimated that in 2002 (the most recent year for which there are reliable statistics on cancer incidence in Europe) there had been over 70,000 new cases of cancer attributable to excess BMI out of a total of nearly 2.2 million new diagnoses across the 30 European countries.

The percentage of obesity-related cancers varied widely between countries, from 2.1% in women and 2.4% in men in Denmark, to 8.2% in women and 3.5% in men in the Czech Republic. In Germany it was 4.8% in women and 3.3% in men, and in the UK it was 4% in women and 3.4% in men.

Then, the researchers projected the figures forward to 2008, taking into account what was known about shifts in the distribution of BMI, the dramatic decline in women’s use of hormone replacement therapy (HRT) from 2002 onwards following research that showed it increased the risk of breast cancer, and the wider use of PSA screening for prostate cancer in men.

They found that the number of cancers that could be attributed to excess body weight increased to 124,050 in 2008. In men, 3.2% of new cancers could be attributed to being overweight or obese and in women it was 8.6%. The largest number of obesity-related new cancers was for endometrial cancer (33,421), post-menopausal breast cancer (27,770) and colorectal cancer (23,730). These three accounted for 65% of all cancers attributable to excess BMI.

“I must emphasise that we are trying not to be sensationalist about this,” said Dr Renehan. “These are very conservative estimates, and it’s quite likely that the numbers are, in fact, higher.”

The number of new cases of obesity-related oesophageal cancer was particularly high in the UK relative to the rest of Europe. “This country accounts for 54% of new cases across all 30 countries,” said Dr Renehan. “This may be due to synergistic interactions between smoking, alcohol, excess body weight and acid reflux - and is currently an area where research is required.”

Until 2002 when HRT use dropped dramatically following the results of the Women’s Health Initiative Trial (USA) that showed an increased risk of breast cancer in women taking HRT, Dr Renehan said that HRT masked and diluted the effects of obesity on the incidence of breast cancer. “In women who used HRT it wasn’t clear what proportions of breast cancers were caused by HRT or by obesity. In women who don’t take HRT, the effect of obesity was much clearer. Now that far fewer women are using HRT, it is much easier to see the effect of obesity on the incidence of breast cancer, and also on endometrial cancer. Consequently, the proportions of these cancers attributable to obesity have increased.”

Dr Renehan said that although European countries were taking steps to tackle the obesity epidemic, this study underlined the urgency of the task and the scale of the problems caused by increasingly overweight populations.

“The overall size of the burden of increasing cancer incidence should inform health policy. For example, it is clear that, in both relative and absolute terms, obesity-related cancer is a greater problem for women than for men. At a country level, it is a greater problem for central European countries like the Czech Republic, whereas it is less of a problem in France and Denmark. Similarly, obesity-related oesophageal cancer seems to be a substantial and unique problem in the UK.

“The study also identifies priorities for research into certain cancers, namely endometrial, breast and colorectal cancers. In the face of an unabating obesity epidemic, and apparent failure of public health policies to control weight gain, there is a need to look at alternative strategies, including pharmacological approaches.”

Dr Renehan’s own research is trying to relate these epidemiological findings back to the biological mechanisms that are at work. His research uses the observed interactions between excess BMI and cancer risk to guide questions in the laboratory.

Abstract no: 327, Oncopolicy session: Drug and lifestyle mediated prevention initiatives in Europe.

[1] “Incident cancer burden attributable to excess body mass index in 30 European countries”. International Journal of Cancer, 2009, in press.

[2] ECCO 15 - ESMO 34 is the 15th congress of the European CanCer Organisation and the 34th congress of the European Society for Medical Oncology.

Source:
Emma Mason

ECCO-the European CanCer Organisation

The pharmacy profession’s most prestigious and sought-after awards, the
Pharmaceutical Society of Australia Awards for Excellence, will be announced at the
Pharmacy Congress Australia being held at the Sydney Hilton from 15-18 October.

The PSA’s Pharmacist of the Year, Young Pharmacist of the Year and Lifetime
Achievement Awards are the profession’s pinnacles of achievement and are held in the
highest esteem both within and outside the profession. These will be announced on
Friday 16 October.

In addition, the PSA’s Pharmacy Student of the Year will be announced at the gala
dinner on Saturday 17 October.

The President of the PSA, Warwick Plunkett, said the awards were very significant for
the profession and Pharmacist of the Year and Young Pharmacist Awards recognized
the special individual contributions to the professional advancement of pharmacy.

“These awards are for achievements in 2009 while the Lifetime Achievement Award
recognises an individual’s contribution over a much greater period of time,” he said.
“These awards are a very concrete recognition of the extremely high standards that the
profession maintains in Australia, and of the efforts by individuals to maintain and
improve on those standards.
“They also give recipients a special standing and status among their many peers
throughout the pharmacy profession, as well as among other health professionals
across the country.
“They reflect the commitment and dedication the recipients have shown to their
profession in 2009.”

Mr Plunkett said the PSA held the annual awards to recognise individual achievement
and the important contribution that the pharmacy profession makes to the whole of
Australian society.

“These awards acknowledge the achievers of the profession. They acknowledge those
involved in innovative practice; those lifting practice standards; and pharmacists who
present a model of service and advice for others to follow,” he said.

Mr Plunkett said the awards were made possible through the sponsorship of Symbion
Pharmacy Services, whose retail brands include Chemmart, and Terry White Chemists.

Source
Pharmaceutical Society of Australia

Standards for pharmacy’s various practice activities are the cornerstone of its profession
and compliance with such standards in the day-to-day practice setting guarantees a quality
outcome for the public, President of the Pharmaceutical Society of Australia, Warwick
Plunkett, said today.

He stressed that ensuring such standards exist and are in line with contemporary practice is
a major responsibility for PSA on behalf of the profession.

The Standards are developed by the profession, for the profession, and are a reflection of
the profession’s responsibility to consumers.

Mr Plunkett said pharmacists were being urged to respond to a specially designed
questionnaire about the Standards, the results of which would help shape the direction of
version 4 of the Standards.

“The Professional Practice Standards version 4 will be completed and ready for distribution
by June 2010,” Mr Plunkett said.

“To ensure that the new version of the Standards meet the needs of all sectors of the
profession and consumers, PSA is undertaking this review which will depend greatly on
input from pharmacists from all sectors.

“This review will look at the content of the Standards as well as the design and presentation
with the aim of making the Standards easier to use and to incorporate into everyday
pharmacy practice.

“As part of the review process, pharmacists are invited to complete an online questionnaire
asking about their use and understanding of the current version of the Standards.”

Mr Plunkett said the Standards were designed for use by individual pharmacists to assess
their own profession practice.

“While they are intended to serve as a guide for desired standards of practice, it is ultimately
the responsibility of each individual pharmacist to determine whether a higher standard is
required in areas relating to their own individual circumstances as practitioners,” he said.

“Thus the input from pharmacists into the future development and implementation of the
Standards is imperative.”

Source
Pharmaceutical Society of Australia

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