Pfizer announced that new statin users who took Lipitor® (atorvastatin calcium) were significantly more likely to stay on their medication compared to those who took simvastatin, according to an observational study of more than 186,000 patients in one of the largest U.S. managed care claims databases. The results were published in the July issue of Current Medical Research and Opinion.

“It is important for patients to remain on their medications, especially those with chronic conditions such as high cholesterol, which when uncontrolled may increase a patient’s risk for heart attacks and strokes,” said Dr. JoAnne M. Foody, study lead author, associate professor of medicine at Harvard Medical School and director of the Cardiovascular Wellness Center at Brigham and Women’s/Faulkner Hospitals, Boston. “In patients who take statins to manage their cholesterol levels, poor persistence has been linked with an increase in heart attacks and strokes in addition to higher healthcare costs.”

According to the results:

- Of patients without prior cardiovascular events (n=175,322), those treated with Lipitor were a significant 15 percent less likely to discontinue therapy in the first year than those treated with simvastatin.

- Of patients who had at least one prior cardiovascular event (n=11,331), those treated with Lipitor were a significant 22 percent less likely to discontinue therapy than those treated with simvastatin.

A subanalysis examined the persistence rates of patients aged 65 years and older, who are at a higher risk for cardiovascular events and are known to have lower persistence rates than younger patients. In this retrospective database analysis, persistence rates were defined as the number of days a patient remained on treatment in the first year following medication start date.

According to the results:

– Overall, persistence was worse in elderly patients than in younger patients for both statins, but the relative difference between Lipitor and simvastatin users was similar to that of the overall patient population.

– Elderly patients without prior cardiovascular events (n=8,278) treated with Lipitor were a significant 22 percent less likely to discontinue therapy than those treated with simvastatin.

– Elderly patients with at least one prior cardiovascular event (n=980) treated with Lipitor were a significant 26 percent less likely to discontinue therapy than those treated with simvastatin.

“Today, physicians face increasing pressure to switch from established statin therapy to generics, based on the perception that all statins are equivalent,” said Dr. Rochelle Chaiken, vice president of Pfizer’s global cardiovascular and metabolic medical team. “This observational study provides important real-world insights into statin usage patterns and suggests that the choice of statin may have a significant effect on whether a patient remains on their prescribed medication. When choosing a medication, it is critical for clinicians to consider all of the factors that may influence the long-term effectiveness of therapy.”

About the study

This Pfizer-funded study was a retrospective analysis using anonymous patient-level health plan data from IMS Health, a healthcare information and consulting company. At the time of the analysis, the IMS database included fully adjudicated medical and pharmacy claims for 52 million individual patients from 92 health plans across the U.S. A total of 186,653 primary and secondary prevention patients with at least one complete year of follow up were included in this study; 136,652 patients received atorvastatin, and 50,001 received simvastatin.

As with all observational studies, this study has some limitations. For example, the reasons for medication discontinuation were not tracked in the database. Although the analysis accounted for a range of important variables, differences in persistence after adjusting for all known baseline imbalances could still be due in part to unmeasured confounding factors such as differences in effectiveness, side-effects, cost or other attributes of the statins. Further studies are required to explore these factors.

Important U.S. Prescribing Information

Lipitor is a prescription medication. It is used in patients with multiple risk factors for heart disease such as family history, high blood pressure, age, low HDL (“good” cholesterol) or smoking to reduce the risk of a heart attack and stroke, certain kinds of heart surgery and chest pain.

Lipitor is also used in patients with type 2 diabetes and at least one other risk factor for heart disease such as high blood pressure, smoking or complications of diabetes, including eye disease and protein in urine, to reduce the risk of heart attack and stroke.

Lipitor is used in patients with existing coronary heart disease to reduce the risk of heart attack, stroke, certain kinds of heart surgery, hospitalization for heart failure, and chest pain.

When diet and exercise alone are not enough, Lipitor is used along with a low-fat diet and exercise to lower cholesterol.

Lipitor is not for everyone. It is not for those with liver problems. And it is not for women who are nursing, pregnant or may become pregnant.

Patients taking Lipitor should tell their doctors if they feel any new muscle pain or weakness. This could be a sign of rare but serious muscle side effects. Patients should tell their doctors about all medications they take. This may help avoid serious drug interactions. Doctors should do blood tests to check liver function before and during treatment and may adjust the dose. The most common side effects are gas, constipation, stomach pain and heartburn. They tend to be mild and often go away.

Lipitor
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Women with anti-SSA/Ro antibodies and a previous child who has heart block a condition where the electrical signal that makes the heart beat is damaged may potentially decrease their risk of delivering another child with life threatening heart disease by taking hydroxychloroquine (Plaquenil®), according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in Atlanta.

Systemic lupus erythematosus, also called SLE or lupus, is a chronic inflammatory disease that can affect the skin, joints, kidneys, lungs, nervous system, and/or other organs of the body. The most common symptoms include skin rashes and arthritis, often accompanied by fatigue and fever. Lupus occurs mostly in women, typically developing in individuals in their twenties and thirties prime child-bearing age. Sj?¶gren’s syndrome is an inflammatory disease that can affect many different parts of the body, but most often affects the tear and saliva glands. Patients with this condition may notice irritation, a gritty feeling, or painful burning in the eyes. Dry mouth or difficulty eating dry foods, and swelling of the glands around the face and neck are also common. Some patients experience dryness of other mucous membranes (such as the nasal passages, throat, and vagina) and skin.

Anti-SSA/Ro antibodies are present in about one-third of women with systemic lupus erythematosus, almost all with Sjogren’s syndrome, and even in some healthy women. Pregnancy in mothers with anti-SSA/Ro antibodies whether they have a disease or not can be challenging for patients and the doctors who treat them since, despite weekly monitoring, some children born to these women can have the heart complications of neonatal lupus, which are associated with additional diseases and even death. In addition, some children are born with the transient skin rash of cutaneous neonatal lupus.

Previous research suggested that fetal exposure to hydroxychloroquine may decrease the risk of heart problems associated with neonatal lupus in mothers with lupus and anti-SSA/Ro antibodies. Recently, researchers have taken this one step further and have studied the use of hydroxychloroquine as a way to lower the chances of these cardiac complications in subsequent pregnancies of women who have already given birth to a child with neonatal lupus.

Women who have one child with cardiac neonatal lupus are 10 times more likely to experience the same complications with additional children than women who have not had an affected child.

According to data from the Research Registry for Neonatal Lupus (a U.S. registry dedicated to collecting and analyzing neonatal lupus data) the recurrence rate of cardiac neonatal lupus after giving birth to one child is 18 percent and the occurrence of cardiac neonatal lupus after giving birth to one child with cutaneous neonatal lupus is 13 percent. Based on this information, researchers tried to find out whether this recurrence rate was lower in women taking hydroxychloroquine.

Twenty-four pregnancies of 22 women who had previously given birth to one child with lupus (either with or without cardiac complications) were followed. Sixty-eight percent of the mothers were Caucasian, 41 percent were diagnosed with lupus, and 32 percent were diagnosed with Sjogren’s syndrome. Nineteen of the 22 mothers had previously given birth to a child with cardiac neonatal lupus, and eight of those infants died of complications.

Researchers studied the effects of taking hydroxychloroquine daily (with an average dose of 352.6mg) started by six weeks of, and continued throughout the entire, pregnancy to determine if this would positively affect the outcomes of the pregnancies. In addition to taking hydroxychloroquine, 25 percent of the mothers received low dose intravenous immune globulin, 75 percent received non-fluorinated steroids (17 of these women were on prednisone), and 8.3 percent received fluorinated steroids (one of these women started taking these after the diagnosis of congenital heart block).

Based on the above recurrence/occurrence rates, researchers expected the rate of recurrent cardiac neonatal lupus among the study’s participants to be 17.2 percent. Of the 24 pregnancies where the mothers took hydroxychloroquine, only one child was born with cardiac neonatal lupus a recurrence/occurrence rate of only 4.2 percent, about 75.7 percent less than expected.
These results led researchers to conclude that, in these high-risk pregnancies, hydroxychloroquine may decrease the risk for delivering a second child with cardiac neonatal lupus.

“This case series, made possible by the U.S. Research Registry for Neonatal Lupus and our collaborators in Europe, suggests that for women with anti-SSA/Ro antibodies who have had a previous child with neonatal lupus, the use of hydroxychloroquine during a subsequent pregnancy may reduce the risk of having a child with serious life-threatening heart disease,” explains Peter M. Izmirly, MD assistant professor, New York University School of Medicine, New York and lead investigator in the study who also notes that additional studies should be completed to confirm this observation.

Patients should talk to their rheumatologists to determine their best course of treatment.

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Results from a 24-week Phase III study presented at the 68th American Diabetes Association Annual Scientific Sessions demonstrated that saxagliptin, a selective, reversible inhibitor of the dipeptidyl peptidase (DPP-4) enzyme in development by Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN), produced significant reductions in key measures of glucose control (glycosylated hemoglobin level [A1C], fasting plasma glucose [FPG] and postprandial glucose [PPG]) in treatment na??ve people with type 2 diabetes compared to placebo (PBO). Over 24 weeks, saxagliptin had an adverse event profile that appeared similar to placebo. The companies have proposed the trade name ONGLYZA™ for saxagliptin if approved by the U.S. Food & Drug Administration.

“Diabetes is a serious and chronic condition that affects nearly 21 million people in the U.S. and, unfortunately, this number is only going to rise,” said Julio Rosenstock, MD, Director of Dallas Diabetes & Endocrine Center at Medical City, and also Clinical Professor of Medicine at University of Texas Southwestern Medical Center, Dallas, USA.

About the Study

The data represent findings from a multicenter, randomized, double-blind, placebo-controlled, parallel-group study of 401 people with type 2 diabetes (ages 18-77) who were treatment na??ve and whose A1C level was greater than or equal to 7 percent and less than or equal to 10 percent. Individuals were randomized to one of four separate treatment arms: saxagliptin 2.5 mg (n=102), 5 mg (n=106) or 10 mg (n=98) or placebo (n=95), once daily. The primary endpoint of the study was the change from baseline to Week 24 in A1C. The secondary endpoints of the study included achievement of A1C of less than 7 percent and changes from baseline in FPG (a measure of a person’s blood glucose after at least 8 hours of fasting). PPG (a measure of a person’s blood glucose, measured during an oral glucose tolerance test [OGTT]) was also evaluated.

Study Results

After 24 weeks, individuals receiving ONGLYZA™ (saxagliptin) 2.5 mg, 5 mg and 10 mg demonstrated a significant mean change in A1C from baseline of -0.4 percent, -0.5 percent and -0.5 percent, respectively, which resulted in a placebo-adjusted change of -0.6 percent, -0.6 percent and -0.7 percent, respectively (p-value less than 0.0001). Reductions in A1C levels were seen as early as four weeks after initiation of saxagliptin treatment, the first scheduled A1C measurement point. The percentage of individuals receiving saxagliptin 2.5 mg, 5 mg and 10 mg or placebo who achieved the American Diabetes Association’s recommended A1C of less than 7 percent at Week 24 was 35 percent, 38 percent and 41 percent, respectively, compared to 24 percent of individuals treated with PBO (p-value not significant at the 2.5 mg dose; p-value at the other doses less than 0.05 versus PBO). Saxagliptin demonstrated significant reductions versus placebo in FPG and PPG at all doses from baseline to Week 24.

Over 24 weeks, saxagliptin had an adverse event profile that appeared similar to placebo. Across all treatment groups, the percentage of individuals who experienced at least one adverse event was slightly higher in individuals treated with saxagliptin (75.5 percent) compared to PBO (71.6 percent). The most commonly reported (greater than or equal to 5 percent) adverse events from the saxagliptin treatment arms and PBO, respectively, were: upper respiratory tract infection [8.8 percent (27/306), 11.6 percent (11/95)]; headache [8.2 percent (25/306), 7.4 percent (7/95)], urinary tract infection [6.9 percent (21/306), 4.2 percent (4/95)], nasopharyngitis [5.9 percent (18/306), 6.3 percent (6/95)] and sinusitis [5.6 percent (17/306), 3.2 percent (3/95)].

No cases of confirmed hypoglycemia (symptoms of hypoglycemia with a fingerstick glucose less than or equal to 50 mg/dL) were reported. The proportion of reported hypoglycemic events was similar in the saxagliptin-treatment arms (5.2 percent) and PBO (6.3 percent).

Saxagliptin was not associated with weight gain in any of the treatment groups. Mean change from baseline in body weight at Week 24 was -1.2 kg, -0.1 kg and -0.1 kg at the 2.5 mg, 5 mg and 10 mg doses, respectively, and -1.4 kg for PBO.

About ONGLYZA™ (saxagliptin)

Saxagliptin, a DPP-4 inhibitor, is an investigational drug under joint development by Bristol-Myers Squibb and AstraZeneca for the treatment of type 2 diabetes. Saxagliptin is being studied in clinical trials as a once-daily therapy to determine its efficacy and safety. Saxagliptin was specifically designed to be a selective, reversible inhibitor of the DPP-4 enzyme, with dual routes of clearance. Phase III data has previously been presented in combination with metformin, the most commonly prescribed OAD, and further Phase III data, including saxagliptin added to a sulfonylurea, a thiazolidinedione and as initial combination therapy with metformin, will be disclosed later this year. The Companies plan to submit a New Drug Application (NDA) in the United States in mid 2008.

About DPP-4 Inhibitors

DPP-4 inhibitors are a class of compounds that work by affecting the action of natural hormones in the body called incretins. Incretins decrease elevated blood sugar levels (glucose) by increasing the body’s utilization of sugar, mainly through increasing insulin production in the pancreas, and by reducing the liver’s production of glucose.

About Type 2 Diabetes

Diabetes (diabetes mellitus) is a chronic disease in which the body does not produce or properly use insulin. Insulin is a hormone that is needed to convert sugar, starches (carbohydrates) and other nutrients into energy needed for daily life. The cause of diabetes continues to be investigated, and both genetic and environmental factors such as obesity and lack of exercise appear to play a role. Diabetes is associated with long-term complications that affect almost every part of the body. The disease may lead to blindness, heart and blood vessel disease, stroke, kidney failure, amputations, and nerve damage.

There are two primary underlying causes associated with type 2 diabetes: the body does not produce enough insulin (insulin deficiency), or the cells ignore the insulin (insulin resistance). Symptoms of type 2 diabetes develop gradually, and their onset is not as sudden as in type 1 diabetes. Symptoms may include fatigue, frequent urination, increased thirst and hunger, weight loss, blurred vision, and slow healing of wounds or sores. Some people, however, have no symptoms. Type 2 diabetes is most often associated with older age, obesity, family history of diabetes, previous history of gestational diabetes, physical inactivity and certain ethnicities. People with type 2 diabetes often are characterized with: insulin resistance, abdominal obesity, a sedentary lifestyle, having low HDL-C (“good”) cholesterol levels and high triglyceride levels and hypertension. Type 2 diabetes accounts for approximately 90 to 95 percent of all diabetes. This equates to roughly 221 million people with type 2 diabetes globally, and 18.7 million people in the U.S. alone. The American Diabetes Association recommends a hemoglobin A1C measurement of less than 7 percent for most people with type 2 diabetes. Hemoglobin A1C is a measurement of a person’s average blood glucose level over a two-to-three month period and is considered an important marker of long-term glucose control. Other important markers for type 2 diabetes include fasting plasma glucose, a measure of a person’s blood glucose after at least 8 hours of fasting and postprandial glucose, a measure of a person’s blood glucose after a meal.

Bristol-Myers Squibb and AstraZeneca Partnership

Bristol-Myers Squibb and AstraZeneca entered into a collaboration in January 2007 to enable the companies to research, develop and commercialize two investigational drugs for type 2 diabetes ??” ONGLYZA™ (saxagliptin) and dapagliflozin. The Bristol-Myers Squibb/AstraZeneca Diabetes collaboration is dedicated to global patient care, improving patient outcomes and creating a new vision for the treatment of type 2 diabetes.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to extend and enhance human life. For more information, visit bms.

Bristol-Myers Squibb Forward-Looking Statement This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that an NDA submitted to the FDA will be approved or that the timing of any NDA submission will occur as described in this release. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol-Myers Squibb’s business, including those identified in Bristol-Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2007, particularly under “Item 1A. Risk Factors”. Bristol- Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world’s leading pharmaceutical companies with healthcare sales of $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. In the United States, AstraZeneca is a $13.35 billion dollar healthcare business with 12,200 employees committed to improving people’s lives. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
For more information about AstraZeneca, please visit astrazeneca-us.

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Ethicon Endo-Surgery today announced that the Anesthesiology and Respiratory Therapy Devices Advisory Committee of the U.S. Food and Drug Administration (FDA) voted in favor of approval of the SEDASYS(R) System for use by physician/nurse teams to administer minimal-to-moderate propofol sedation during screening and diagnostic procedures for colorectal cancer (colonoscopy) and the upper gastrointestinal tract (EGD). The SEDASYS(R) System, the first computer-assisted personalized sedation (CAPS) system, integrates drug delivery and patient monitoring to enable propofol sedation personalized to each patient’s needs.

The Anesthesiology and Respiratory Therapy Devices Advisory Committee voted 8 to 2 in favor of approval. Conditions of approval recommended by the Panel included that the SEDASYS(R) System only be used in adult patients age 70 and under, a comprehensive training program, definition of the sedation delivery team and a post-approval study. The final decision regarding approval of the device is made by the FDA.

“There is strong clinical support that the SEDASYS(R) System reduces the risk of over-sedation, which may help make sedation more predictable and reliable for physician/nurse teams,” said Kenneth Sumner, Ph.D., Vice President, Clinical and Regulatory Affairs, Ethicon Endo-Surgery, Inc. “We look forward to continuing discussions with the FDA during the regulatory review process.”

The Advisory Committee reviewed results from a recent pivotal trial, which were included in the company’s Pre-Market Approval (PMA) application for the SEDASYS(R) System. In the study, patients who received sedation with the SEDASYS(R) System experienced fewer and less significant oxygen desaturation events, a clinical sign of over-sedation, than patients sedated with the current standard of care drugs — benzodiazepines and opioids.

The SEDASYS(R) System automatically detects and responds to signs of over-sedation (oxygen desaturation and low respiratory rate/apnea), guided by continual monitoring and recording of critical patient vital signs, including oxygen saturation, respiratory rate, heart rate, blood pressure, end-tidal carbon dioxide and patient responsiveness.

Propofol (also known as DIPRIVAN(R)) is considered by physicians to be a preferred sedative due to its rapid onset and quick, clear-headed recovery, which enables patients to promptly return to normal activities following a colonoscopy or EGD procedure. Current propofol labeling states only persons trained in the administration of general anesthesia should administer the drug. In the majority of practice settings, gastroenterologists do not have broad access to anesthesiologists.

About the SEDASYS(R) System

The SEDASYS(R) System is the first computer-assisted personalized sedation (CAPS) system designed for physician/nurse teams to provide minimal-to-moderate sedation levels with propofol. By integrating drug delivery and patient monitoring, the SEDASYS(R) System enables physician/nurse teams to deliver personalized sedation. It automatically detects and responds to signs of over-sedation (oxygen desaturation and low respiratory rate/apnea) by stopping or reducing delivery of propofol, increasing oxygen delivery and automatically instructing patients to take a deep breath. The device is currently an investigational device limited by U.S. law to investigational use only.

About Ethicon Endo-Surgery

Ethicon Endo-Surgery, a Johnson & Johnson company, develops and markets advanced medical devices for minimally invasive and open surgical procedures, focusing on procedure-enabling devices for the interventional diagnosis and treatment of conditions in general and bariatric surgery, as well as gastrointestinal health, gynecology and surgical oncology.

(C)2009 Ethicon Endo-Surgery

SEDASYS(R) is a trademark of Ethicon Endo-Surgery.

DIPRIVAN(R) is a registered trademark of the AstraZeneca group of companies.

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Genzyme Corp. (NASDAQ: GENZ) and Isis Pharmaceuticals Inc. (NASDAQ: ISIS) announced that the phase 3 study of mipomersen in patients with heterozygous familial hypercholesterolemia (heFH) met its primary endpoint with a highly statistically significant 28 percent reduction in LDL-cholesterol after 26 weeks of treatment, compared with an increase of 5 percent for placebo.

All of the 124 patients in the study had pre-existing coronary artery disease, were taking a maximally tolerated dose of a statin and in many cases additional lipid-lowering drugs. Patients’ average LDL-C at baseline was 150 mg/dL. Patients treated with mipomersen had an average LDL-C level of 104 mg/dL at the end of the study. Forty-five percent of the mipomersen-treated patients achieved LDL-C levels of less than 100 mg/dL, a recognized treatment goal for high-risk patients. The reductions observed in the study were in addition to those achieved with the patients’ existing therapeutic regimens.

“The average reduction in LDL-C of 28 percent in these high-risk, difficult-to-treat patients with severe inherited high cholesterol is very encouraging,” said Evan A. Stein, M.D., Ph.D., Director of the Metabolic & Atherosclerosis Research Center, Cincinnati, Ohio, and an investigator on the study. “The nearly 50 mg/dL additional decrease in LDL-C when added to maximally tolerated statin therapy is above what we have seen with any other agent in this population, and the side effect profile of mipomersen continues to be acceptable.”

The trial also met each of its three secondary endpoints with statistically significant reductions in apo-B, total cholesterol, and non-HDL-cholesterol. Study results are based on an intent-to-treat analysis (full analysis set). Data will be submitted for presentation at a future medical meeting.

“We are excited by these strong data in the second phase 3 trial of mipomersen,” said Genzyme Chief Medical Officer Richard A. Moscicki, M.D. “This therapy has the potential to make a major difference in the lives of patients who are in great need of new treatment options. With these data, we remain on-track with our development plan for mipomersen.”

There were no new areas of safety concerns identified in the trial. Of the 83 patients treated with mipomersen, 73 completed the study; nine of the discontinuations were related to adverse events. Consistent with previous studies evaluating mipomersen, the most commonly observed adverse events were injection site reactions and flu-like symptoms.

As in other mipomersen trials, elevations in liver transaminases were observed that were similar in magnitude and duration to those seen in other studies. None of these patients had changes in other laboratory tests to indicate hepatic dysfunction, and there were no Hy’s Law cases.

“Mipomersen has again delivered positive results with this second phase 3 study, and continues to make progress toward the market,” said Stanley Crooke, Chairman and Chief Executive Officer of Isis Pharmaceuticals. “Mipomersen represents the power of antisense technology and reflects our commitment to innovation and technological advancement to create potent and specific drugs to help people lead healthier and more hopeful lives.”

The study was a randomized, double-blind, placebo-controlled trial that enrolled 124 heFH patients, aged 18 and older with LDL-C levels greater than 100 mg/dL. Patients were randomized 2:1 to receive a 200 mg dose of mipomersen or placebo weekly for 26 weeks. The trial was conducted at 26 sites in the United States and Canada.

Late-Stage Development Plan

Genzyme’s initial U.S. and E.U. regulatory filings for mipomersen will seek marketing approval for the treatment of patients with homozygous FH (hoFH). The phase 3 study of mipomersen in hoFH met its primary endpoint with a 25 percent reduction in LDL-C, and results were presented at the annual American Heart Association meeting in November. In the first half of 2011, Genzyme expects to file for U.S. and E.U. approval of the treatment and to have made progress toward filing in other major international markets.

These two filings may also include patients with severe hypercholesterolemia. A phase 3 study of mipomersen in patients with severe hypercholesterolemia is fully enrolled with 58 patients and data are anticipated in mid-2010. The companies have also completed enrollment in a phase 3 trial involving 158 hypercholesterolemic patients at high risk for coronary heart disease, and data are anticipated in mid-2010.

About Mipomersen

Mipomersen is a first-in-class apo-B synthesis inhibitor currently in late-stage development. It is intended to reduce LDL-C by preventing the formation of atherogenic lipids. It acts by decreasing the production of apo-B, which provides the structural core for all atherogenic lipids, including LDL-C, which carry cholesterol through the bloodstream.

About Familial Hypercholesterolemia

FH is a genetic disorder that results in elevated LDL cholesterol levels. FH patients are unable to properly metabolize LDL-C due to dysfunctional LDL receptors, which are responsible for clearing LDL from plasma. These patients experience a markedly increased risk of premature cardiovascular disease (CVD) and CVD-related death.

There are two forms of FH: homozygous (hoFH), where a defective gene is inherited from both parents, or heterozygous (heFH), where a defective gene is inherited from only one parent so that some LDL receptor function is preserved. HoFH is a very rare condition estimated to affect approximately one in a million people worldwide. HeFH is a more common form of the disorder, with a prevalence of approximately one in 500.

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Among eligible Medicare beneficiaries, increased use of carotid arterial stenting (CAS) procedures to treat carotid stenosis – the narrowing of the carotid artery – is associated with higher rates of mortality and adverse clinical outcomes, including heart attack and stroke, according to researchers from the University of Pennsylvania School of Medicine.

Published in the November 2009 issue of the Journal of Vascular Surgery, the study adds to a growing body of research about the effectiveness of stenting for preventing heart attack, stroke, and death. Findings lend further insight into factors influencing how medical technology performs when integrated as treatment among the general Medicare population as opposed to in a controlled clinical trial setting.

For treatment of moderate to severe carotid stenosis, CAS is an alternative to carotid endarterectomy (CEA), a surgical procedure that opens blocked arteries that supply the brain. Introduced in the 1990s, CAS was initially available to Medicare patients only when they were enrolled in clinical trials testing the effectiveness of the minimally invasive procedure. When Medicare expanded coverage of the procedure in 2005, the rate of CAS utilization nearly quadrupled – from 266 to 1,015 procedures per month – as the procedure was available for the first time to the general Medicare population, including elderly patients deemed too ill for surgery who would have had no other treatment option.

“Our study showed that in areas where CAS was used more commonly during the coverage era, the clinical outcomes from the combined population of CAS and CEA patients worsened. Nevertheless, stenting should remain a viable and effective treatment option that doctors and patients consider judiciously,” says lead author Peter Groeneveld, MD, MS, assistant professor of medicine at the University of Pennsylvania School of Medicine. “CAS is often the only option for patients who are not healthy enough to undergo surgery. However, this state of health may inevitably affect clinical outcomes from the procedure.”

Using a national sample of 46,784 Medicare patients older than 66 years of age, the study examined clinical outcomes of both methods in the two ‘eras’ – when CAS was covered only in clinical trials and after it became widely covered under Medicare. For each ‘era,’ researchers assessed clinical outcomes at 90 and 270 days after the procedure in patients who had received either procedure for the first time over a twelve-month period. Key findings showed that in geographic areas that widely adopted CAS during the coverage era, the rate of heart attack, stroke, and death was greater in the 90 and 270 days following the procedure than in the pre-coverage era.

“Key findings from the retrospective study included:
When adjusted statistically, more 270-day adverse outcomes in the era of Medicare coverage.

In geographic areas with higher adoption rates of CAS during the expanded coverage era, there was a higher rate of 90-day mortality and adverse outcomes, and a higher rate of 270-day mortality and adverse outcomes.

No difference in mortality or adverse outcome rates between eras in locations with lower CAS adoption.

Groeneveld, who is also affiliated with the Philadelphia Veterans Affairs Medical Center, has researched the impact of cardiac devices, including drug-eluting stents and implantable cardioverter-defibrillators, for more than 15 years, notes that in a time of healthcare reform, clinical trials and comparative effectiveness research may influence policymakers’ decisions about which procedures receive coverage. “Some procedures may receive coverage because clinical trials show them to be more effective, even if by a small percentage, than the current standard treatment. But that rate of effectiveness can change drastically as more patients with unique medical characteristics begin to receive the procedure, and as more doctors with varying skill levels perform it.”

In the study, researchers used propensity scoring to match patients across eras and locations in order to reduce bias arising from variables such as sex, race, age, clinical comorbidities, and hospital characteristics, among others. The ‘pre-coverage era’ was defined as October 1, 2002, through September 30, 2004, and the ‘coverage era’ was defined as August 1, 2005, through March 31, 2006, after the Centers for Medicare and Medicaid Services implemented a national coverage decision expanding patient eligibility criteria for CAS.

The University of Pennsylvania School of Medicine research was supported by a grant from the Institute for Health Technology Studies (InHealth). The coauthors of this study are Lin Yang, MS; Alexis Greenhut, MPH; and Feifei Yang, MS.

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Naprapathy works better on back and neck trouble than recommended and proven effective advice from doctors, according to a new study from Swedish medical university Karolinska Institutet. The study is the first major investigation into naprapathy – and opens up possibilities for its integration into regular treatments.

Naprapathy is a special system for restoring functionality and reducing pain in muscles and joints. The therapy is manual, with the naprapath using manipulation and mobilisation of the spine and other joints, and muscle treatments such as stretching and massage. Treatments are often complemented with different kinds of physical exercise and advice.

Eva Skillgate, postgraduate student at the Department of Environmental Medicine, Karolinska Institutet, has compared the efficacy of naprapathy with that of medical advice in accordance with the guidelines that had previously proved most effective against back and neck pain. The results, published in the Clinical Journal of Pain, show distinct differences in favour of naprapathy.

In the study of 409 patients, the researchers compared two groups of people with back and neck problems. Following a medical examination to eliminate serious conditions, the patients were randomly assigned to two therapeutic alternatives. Half of the patients were treated by a naprapath and half received advice and support from doctors with the aim of strengthening their belief in their own ability to deal with the complaint. The advice encouraged the patients to move, despite any pain, and to live as normal a life as possible.

Twelve weeks after study start, 57% in the naprapathy group stated that were ‘very much better’ compared with 13 % in the control group. 69% in the naprapathy and 42% in the control group had a clinically important decrease in pain, and 19% in the naprapathy group and 7% in the control group was totally recovered twelve weeks after the study had started. Separate analysis of neck pain and back pain patients showed similar results. For the majority of the patients the pain/disability had lasted for more than one year.

“The study looked at a very common type of back and neck complaint,” says Eva Skillgate. “The trial adds to the knowledge that recommending a combination of manual therapies, as naprapathic manual therapy, may be an alternative to consider in primary healthcare for patients with back and neck pain.”

Publication:
“Naprapathic Manual Therapy or Evidence-Based Care for Back and Neck Pain; A Randomized, Controlled Trial”
Eva Skillgate, Eva Vingard, Lars Alfredsson
Clinical Journal of Pain, May 2007, 23:431-439

For more information, please contact:

Eva Skillgate

Karolinska Institutet is one of the leading medical universities in Europe. Through research, education and information, Karolinska Institutet contributes to improving human health. Each year, the Nobel Assembly at Karolinska Institutet awards the Nobel Prize in Physiology or Medicine. For more information, visit info.ki.se/ki

Contact: Katarina Sternudd

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In a
presentation yesterday at the American Heart Association Scientific
Sessions 2008, scientists from deCODE genetics (Nasdaq:DCGN) presented data
from large scale case-control studies in multiple populations that
underscore the clinical utility of the deCODE AF(TM) test for improving the
diagnosis and treatment of atrial fibrillation as a means to prevent
stroke. deCODE AF(TM) is a DNA-based reference laboratory test that detects
two single-letter variations (SNPs) in the human genome that deCODE has
shown double the risk of atrial fibrillation (AF). It is an important tool
for physicians because atrial fibrillation (AF), a common cardiac
arrythmia, is often intermittent and therefore under diagnosed. Detecting
AF frequently requires more extensive cardiac monitoring than is feasible
on all patients who have suffered stroke or transient ischemic attack
(TIA).

deCODE’s newly presented data demonstrate that the SNPs measured by
deCODE AF(TM) are the most significant known genetic risk factors not only
for AF, but also for ischemic stroke. But most surprisingly, these same
markers were also shown to confer risk of cryptogenic and large vessel
stroke as well. The strong connection between AF and non-cardiogenic
subtypes led the deCODE team to estimate that 20-30% of these subtypes is
likely due to undiagnosed, intermittent AF. This means that AF causes an
even larger proportion of stroke than previously believed, making tools
like deCODE AF(TM) all the more important for helping doctors to target
monitoring to those at risk and to tailor therapy accordingly.

“Through an analysis of the SNPs in deCODE AF(TM) we have expanded our
understanding of the role of AF in causing stroke, and physicians can
immediately take this new information into the clinic through the use of
the same test. This has implications for the prevention of recurrent
stroke, because most patients who have suffered a cryptogenic or large
vessel event are discharged and put on Plavix or aspirin, which have little
impact in preventing AF. Testing all of their stroke and TIA patients with
deCODE AF(TM), doctors can identify those who should be monitored for AF.
And for those who evidence AF, warfarin may be the best therapy. With our
partner Medicomp we are now planning a multicenter study pairing the use of
deCODE AF(TM) with ambulatory digital cardiac monitors, in order to
demonstrate the impact that improving the detection of AF cna have on the
prevention of stroke,” said Dr. Kari Stefansson, M.D., Dr. Med., CEO of
deCODE, a board-certified neurologist and neuropathologist.

About deCODE AF(TM) and this study

In 2007, deCODE discovered two SNPs on chromosome 4q25 that double the
risk of atrial fibrillation, and later that year launched deCODE AF(TM) to
enable doctors to detect these SNPs in their patients. In the study
discussed above, deCODE conducted a genome-wide association study to
identify risk variants for stroke. The deCODE team analyzed more than
300,000 single latter variations (SNPs) across the genomes of more than
35,000 stroke patients and control subjects from several discovery and
replication cohorts from the United States and Europe. The 4q25 SNPs in the
deCODE AF test – called rs10033464 and rs2200733 – were the only markers
found to confer significantly increased risk of ischemic stroke in general
and carioembolic stroke in particular. This was not unexpected, because AF
is such a major risk for ischemic stroke. However rs2200733 was also
strongly associated with increased risk of non-cardiogenic stroke as well.

How to order deCODE AF(TM)

Additional information and physician order forms for deCODE AFr(TM) can
be found at decodediagnostics. The price of the test is $200
dollars and deCODE facilitates filing for reimbursement with commercial
insurers. Testing is performed in deCODE’s CLIA-registered laboratory,
which has analyzed the genomes of hundreds of thousands of people from
around the globe.

About deCODE

deCODE is a bio-pharmaceutical company developing drugs and DNA-based
tests to improve the treatment, diagnosis and prevention of common
diseases. Its lead therapeutic programs, which leverage the company’s
expertise in chemistry and structural biology, include DG041, an
antiplatelet compound being developed for the prevention of arterial
thrombosis; DG051 and DG031, compounds targeting the leukotriene pathway
for the prevention of heart attack; and DG071 and a platform for other PDE4
modulators with therapeutic applications in Alzheimer’s disease and other
conditions. deCODE is a global leader in human genetics, and has identified
key variations in the genome (SNPs) conferring increased risk of major
public health challenges from cardiovascular disease to cancer. Based upon
these discoveries deCODE has brought to market a growing range of DNA-based
tests for gauging risk and empowering prevention of common diseases.
Through its CLIA-registered laboratory, deCODE is offers deCODE T2(TM) for
type 2 diabetes; deCODE AF(TM) for atrial fibrillation and stroke; deCODE
MI(TM) for heart attack; deCODE ProCa(TM) for prostate cancer; deCODE
Glaucoma(TM) for a major type of glaucoma; and deCODE BreastCancer, for the
common forms of breast cancer. deCODE is delivering on the promise of the
new genetics.(SM) Visit us on the web at decode; on our
diagnostics site at decodediagnostics; for our pioneering
personal genome analysis service, integrating the genetic variants included
in these tests and those linked to another twenty common diseases, at
decodeme; and on our blog at decodeyou.

Any statements contained in this presentation that relate to future
plans, events or performance are forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. These
forward-looking statements are subject to a number of risks and
uncertainties that could cause actual results, and the timing of events, to
differ materially from those described in the forward-looking statements.
These risks and uncertainties include, among others, those relating to our
ability to obtain financing and to form collaborative relationships, the
effect of a potential delisting of our common stock from The Nasdaq Global
Market, uncertainty regarding potential future deterioration in the market
for auction rate securities which could negatively affect our cash position
and result in additional permanent impairment charges, our ability to
develop and market diagnostic products, the level of third party
reimbursement for our products, risks related to preclinical and clinical
development of pharmaceutical products, including the identification of
compounds and the completion of clinical trials, the effect of government
regulation and the regulatory approval processes, market acceptance, our
ability to obtain and protect intellectual property rights for our
products, dependence on collaborative relationships, the effect of
competitive products, industry trends and other risks identified in
deCODE’s filings with the Securities and Exchange Commission, including,
without limitation, the risk factors identified in our most recent Annual
Report on Form 10-K and any updates to those risk factors filed from time
to time in our Quarterly Reports on Form 10-Q or Current Reports on Form
8-K. deCODE undertakes no obligation to update or alter these
forward-looking statements as a result of new information, future events or
otherwise.

deCODE genetics Inc
decode

View drug information on Plavix; Warfarin Sodium tablets. Continue reading →

Patients with ulcerative
colitis (UC) treated with Asacol(R) (mesalamine) delayed-release tablets
demonstrated a statistically significant improvement in overall quality of
life in as early as three weeks according to a new data analysis by Procter
& Gamble Pharmaceuticals, Inc., which provides quantified evidence to
support a long-held assumption.

“The goals of UC therapy are to treat active disease and prevent
relapse in order to improve quality of life, and now the data tell us that
Asacol does, in fact, improve quality of life for patients, as quickly as
three weeks from the start of therapy,” said lead author E. Jan Irvine, MD,
Head, Division of Gastroenterology, St. Michael’s Hospital, Toronto,
Ontario. The data were presented at the Crohn’s and Colitis Foundation’s
national research and clinical conference, “Advances in the Inflammatory
Bowel Diseases.”

UC is a form of inflammatory bowel disease (IBD). Asacol is indicated
for the treatment of mildly to moderately active UC and for the maintenance
of remission of UC. Improved quality of life with Asacol had not previously
been evaluated.

This data analysis was based on results from the ASCEND I and II
studies — sponsored by Procter & Gamble Pharmaceuticals. The ASCEND
studies were two Phase III, multi-center, double-blind, randomized,
active-control, 6-week studies of patients with active UC. Patients
received oral Asacol 2.4 g/day, the indicated dose for treatment, in the
active control arm. Quality of life was assessed using the Inflammatory
Bowel Disease Questionnaire (IBDQ) at baseline, three weeks and six weeks.

The IBDQ is a reliable tool for measuring health-related quality of
life in patients with UC. The 32-item questionnaire examines four aspects
of patients’ lives: bowel symptoms, systemic symptoms, emotional function,
and social function. The change in IBDQ score from baseline in each group
was assessed. Total IBDQ scores range from 32-224 with a higher score
indicating a better quality of life.

The studies included a randomized total of 687 patients, of whom, 349
received Asacol 2.4 g/day and were included in the quality of life
analysis. The mean age was 43.1 years; 53.3 percent of patients were
female; and mean baseline IBDQ score was 143. Treatment with Asacol
provided a significant improvement in the overall IBDQ scores at both three
weeks and six weeks (28.3 and 38.1 point improvement respectively, p

UC causes flares followed by periods of remission. During a flare, in
which the rectum or colon become inflamed, people experience symptoms such
as diarrhea, rectal bleeding, abdominal cramping and an urgent need to go
to the bathroom. Flares can vary in duration and intensity. While UC is a
lifelong condition, medication may help control flares.

UC affects people of all ages, but is often diagnosed during early
adulthood. The causes of this condition are unknown, but may involve
heredity, infection or the immune system.

About Asacol(R) (mesalamine) Delayed-Release Tablets 400 mg

Asacol is indicated for the treatment of mildly to moderately active UC
(the indicated dosage is two 400 mg tablets tid for 6 weeks) and for the
maintenance of remission of UC (the indicated dosage is 1.6 g/day in
divided doses).

Asacol was well-tolerated in clinical studies. Overall, the incidence
of adverse events with Asacol was comparable to placebo.

In pivotal clinical studies of mildly to moderately active UC, the most
frequent adverse events reported for Asacol and placebo, respectively, were
headache (35% vs. 36%), abdominal pain (18% vs. 14%), eructation (16% vs.
15%), pain (14% vs. 8%) and nausea (13% vs. 15%); for the maintenance of
remission of UC, the most frequent adverse events were headache (50% vs.
50%), rhinitis (42% vs. 36%), diarrhea (35% vs. 50%), abdominal pain (32%
vs. 44%) and flatulence (24% vs. 30%).

Asacol is contraindicated in patients with hypersensitivity to
salicylates. Caution should be exercised when using Asacol in patients with
known renal dysfunction or history of renal disease. It is recommended that
all patients have an evaluation of renal function prior to initiation of
Asacol tablets and periodically while on Asacol therapy. As with other
mesalamine-containing products, serious adverse events may occur with
Asacol. Please visit pgpharma/pi/US-Asacol.pdf for full
prescribing information.

About Procter & Gamble (NYSE: PG)

Three billion times a day, P&G brands touch the lives of people around
the world. The company has one of the strongest portfolios of trusted,
quality, leadership brands, including Actonel, Asacol, Enablex, Prilosec
OTC, Metamucil, Fibersure, Align, Pepto-Bismol, Vicks, ThermaCare, PUR,
Crest and Oral-B. The P&G community consists of almost 140,000 employees
working in over 80 countries worldwide. Please visit pg for
the latest news and in-depth information about P&G and its brands.

Procter & Gamble
pg

View drug information on Actonel; Asacol; Prilosec. Continue reading →

Phase II data presented at the annual meeting of the American Urology Association (AUA) indicate that men suffering from an enlarged prostate may benefit from BOTOX(R) injections.

The two-stage, multi-center, double-blind, randomized study showed that two different dose levels of Botulinium Neurotoxin Type A (BOTOX) injected into the prostate was both safe and efficacious for the management of benign prostatic hyperplasia (BPH), a common noncancerous enlargement of the prostate that can cause difficulty in urination.

“People often underestimate the significant impact BPH can have on a man’s quality of life,” said Dr. E. David Crawford, one of the principal investigators of the study and head of the Urologic Oncology Department at the University of Colorado Health Sciences Center. “These data indicate that BOTOX is an effective, fast-acting treatment option that does not require daily dosage. We are excited to see what the long-term data will show us.”

A renowned urologist and clinician, Dr. Crawford is a lead investigator on 17 abstracts presented at the AUA regarding both BPH and prostate cancer screening, including the prostate arm of the Prostate, Lung, Colorectal, and Ovarian (PLCO) study.

Study results included data from 125 men with BPH, aged 50 years and older, and treatment success was defined in terms of efficacy and safety over a 12 week timeframe. Patients were assigned to receive either 100 units or 300 units of BOTOX. Seventy-three percent of patients taking 100 units and 81 percent taking 300 units passed the cut offs for efficacy, defined as 30 percent or more improvement from baseline. Both doses also passed the safety criteria. Specifically, there were no grade four or five toxicity events observed in either dose, and only 17 percent in the 100 dose and 18 percent in the 300 dose reported grade two or three events.

“A condition that effects more than half of men in their sixties and nearly 90 percent of those over the age of seventy, new treatment options and greater awareness are needed to help support men suffering from this condition,” said Wendy Poage, president of the Prostate Conditions Education Council. “We applaud Dr. Crawford and his colleagues for their research of innovative new treatment options for the thousands of men with BPH.”

BPH occurs commonly in men over the age of 60. While experts do not know what causes BPH, many believe that the condition may be related to hormone changes that occur during the aging process. BPH is not life threatening, but can cause bothersome urinary symptoms, including difficulty urinating, the need to urinate quite frequently, or awaking during the night to urinate.

About the Prostate Conditions Education Council

A national organization committed to men’s health, the Prostate Conditions Education Council (PCEC) – formally the Prostate Cancer Education Council – is the nation’s leading resource for information on prostate health. The PCEC is dedicated to saving lives through awareness and the education of men, the women in their lives, as well as the medical community about prostate cancer prevalence, the importance of early detection, and available treatment options, as well as other men’s health issues. The Council – comprised of a consortium of leading physicians, health educators, scientists and prostate cancer advocates – aims to conduct nation wide screenings for men and perform research that will aid in the detection and treatment of prostate conditions.

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