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Amgen's Sensipar/Mimpara fails to meet endpoint in CV events for dialysis patients - The Pharma Letter

Keywords: Amgen, Sensipar, Mimpara, Cardiovascular events, Dialysis patients, Ph III

Article | 11 June 2012

Amgen (Nasdaq: AMGN), the world’s largest independent biotech company, announced top-line results on Friday of the Phase III ...

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Patients' praise kidney unit's 10 years of care - Halifax Evening Courier


Published on Monday 11 June 2012 10:19

Hospital staff, patients and their families past and present came together to celebrate the 10th anniversary of the dialysis unit at Calderdale Royal Hospital.

Set up as a satellite unit by the Leeds Teaching Hospitals NHS Trust it marked a major step forward for local renal patients.

It avoided the need for patients to travel to Leeds three times a week for treatment.

More than a 100 people attended a lunch at the Shay stadium and shared stories and thanked the unit’s staff.

Denise Ford, 49, of Wheatley, told the Courier of her four-way “live paired donor transplant” which involved her father, Terence Hartley, 69, of Mixenden.

Just before her 40th birthday she suffered renal failure brought on by high blood pressure.

By 2005 the teaching assistant at Luddenden Foot Academy was having dialysis treatment in Leeds.

She later got a place at the Halifax unit and in 2007 her father was tested to see if he was a suitable match to donate a kidney to her.

He wasn’t, but after extensive tests was found to be an acceptable donor and in December 2008 father and daughter were matched with a couple in Manchester.

Mr Hartley’s healthy kidney was transplanted into the ill woman and her husband’s healthy kidney was transplanted into Denise’s body.

Denise said it was normal for a family loved one to want to donate a kidney under such circumstances rather than waiting - without guarantees - for a deceased donor.

“It’s another route,” she said.

“We both now feel fantastic and it has given me my life back.”

Terence said he was subjected to stringent medical tests.

“And, I have not looked back since,” he said.

Both praised staff at Calderdale and the Leeds General Infirmary.

“They are absolutely fantastic and without their support patients’ could not get through the treatment,” said Denise.

Chris Smith, 26, of Sowerby Bridge, was born with Fanconi Syndrome, a rare disease which attacked his kidneys and by the time he was 18 he needed dialysis.

He did receive a kidney transplant but it failed after a year and he has now been on a waiting list again for several years.

His mother Theresa Smith is currently having tests to see if she is a suitable match for him or a “live pair donor transplant.”

“I can’t faul the Halifax unit, it is really good,” said Chris, who has a son, Harry, five months, with partner Clare Beckham.


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Post-hoc analysis of linagliptin phase 3 data in… - Pharmaceutical Processing

RIDGEFIELD, Conn. and INDIANAPOLIS , June 9, 2012 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) today announced results from a post-hoc analysis, which explored the clinical effect of linagliptin on albuminuria in patients with type 2 diabetes who had early diabetic nephropathy (renal disease).  The primary endpoint of the analysis was changes to the urinary albumin-to-creatinine ratio (UACR), which is a measure of renal function in patients with type 2 diabetes and diabetic nephropathy. 

This post-hoc analysis, which is being presented at the American Diabetes Association 's (ADA's) 72nd Scientific Sessions®, included 227 patients with type 2 diabetes and diabetic nephropathy from four randomized, 24-week trials who were on stable treatment with one of two types of blood pressure medicines that are the standard treatment for diabetic renal disease — angiotensin-converting enzyme inhibitors (ACEs) and angiotensin receptor blockers (ARBs).[1]  The post-hoc analysis showed a 29 percent reduction in UACR with linagliptin plus ACE/ARBs, versus ACE/ARBs alone at 24 weeks (p=0.0305).[1]  Since this was a post-hoc analysis, it did not control for other contributing factors.  In addition, the linagliptin treatment group reduced glucose levels (as measured by a 0.71 percent change in hemoglobin A1c [HbA1c or A1C] versus the placebo treatment group at 24 weeks; p < 0.0001).  A1C is measured in people with diabetes to provide an index of blood glucose control for the previous two to three months.    

"As these results are based on a post-hoc analysis, this interesting observation warrants further investigation," said John Smith , M.D., Ph.D., senior vice president for clinical development and medical affairs, Boehringer Ingelheim Pharmaceuticals, Inc.

About the Post -hoc Analysis
Data from four randomized, double-blind, 24-week, placebo-controlled trials of linagliptin monotherapy, linagliptin with add-on to metformin, linagliptin with add-on to metformin and sulfonylurea and a factorial study of linagliptin in initial combination with metformin were pooled for the analysis (n=2472) to explore the clinical effect of linagliptin on albuminuria in patients with type 2 diabetes who had early diabetic nephropathy.  The primary objectives of these four trials were to evaluate the reduction in A1C from baseline at 24 weeks.[1]

UACR was collected in the four trials as safety data.  The endpoint of this post-hoc analysis was the percentage change in the average (mean) UACR.  In this analysis, 492 (19.9 percent) patients met UACR (30 to 3,000 mg/g creatinine) and estimated glomerular filtration rate (eGFR; > 30 mL/min/1.73 m2) thresholds, of whom 46 percent received stable ACE/ARB therapy (linagliptin n=168; placebo n=59).  Mean baseline A1C was 8.2 percent versus 8.5 percent and median baseline UACR was 76 versus 78 mg/g creatinine for the linagliptin and placebo groups, respectively.[1]

The incidence of hypoglycemia was higher in the linagliptin treatment group (14.3%) compared with the placebo treatment group (0%).

Linagliptin is marketed as Tradjenta® 5mg tablets in the U.S.

To learn more about TRADJENTA and for full prescribing information visit: www.TRADJENTA.com, or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257.

What are Tradjenta® (linagliptin) tablets?[2]

TRADJENTA is a prescription medicine that is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

TRADJENTA is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

It is not known if TRADJENTA is safe and effective when used with insulin.

Important Safety Information

Who should not take TRADJENTA?

Do not take TRADJENTA if you are allergic to linagliptin or any of the ingredients in TRADJENTA. 

Symptoms of a serious allergic reaction to TRADJENTA are rash, raised red patches on your skin (hives), swelling of your face, lips, and throat that may cause difficulty breathing or swallowing.  If you have any symptoms of a serious allergic reaction, stop taking TRADJENTA and call your doctor right away.

What should I tell my doctor before taking TRADJENTA?

TelI your doctor if you take other medicines that can lower your blood sugar, such as a sulfonylurea or insulin.

TRADJENTA may cause serious side effects, including low blood sugar (hypoglycemia). If you take TRADJENTA with another medicine that can cause low blood sugar, such as sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take TRADJENTA. 

Signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, or feeling jittery.

Also tell your doctor if you take rifampin (Rifadin®, Rimactane®, Rifater®, Rifamate®), an antibiotic that is used to treat tuberculosis.

TRADJENTA may affect the way other medicines work, and other medicines may affect how TRADJENTA works.

Tell your doctor if you are pregnant or planning to become pregnant or are breast-feeding or plan to breast-feed.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

What are the possible side effects of TRADJENTA?

The most common side effects of TRADJENTA include stuffy or runny nose and sore throat.

You are encouraged to report negative side effects of prescription drugs to the FDA.  Visit www.fda.gov/medwatch or call 1-800- FDA -1088.

For more safety information, please see Patient Information and full Prescribing Information.

To learn more about TRADJENTA visit: www.TRADJENTA.com.  For full prescribing information visit: http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Tradjenta/Tradjenta.pdf or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257.

Please report any unexpected effects or product problems to the Boehringer Ingelheim Drug Information Unit by calling 1-800-542-6257.

About Diabetes
Approximately 25.8 million Americans[3] and an estimated 366 million people worldwide[4] have type 1 or type 2 diabetes. Type 2 diabetes is the most common type, accounting for an estimated 90 to 95 percent of all diabetes cases.[3] Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin.[5]

Boehringer Ingelheim and Eli Lilly and Company
In January 2011 , Boehringer Ingelheim and Eli Lilly and Company announced an alliance in the field of diabetes that centers on four pipeline compounds representing several of the largest treatment classes. This alliance leverages the companies' strengths as two of the world's leading pharmaceutical companies, combining Boehringer Ingelheim's solid track record of research-driven innovation and Lilly's innovative research, experience, and pioneering history in diabetes. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs. Find out more about the alliance at www.boehringer-ingelheim.com or www.lilly.com.

About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany , it operates globally with 145 affiliates and more than 44,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.

In 2011, Boehringer Ingelheim achieved net sales of about $17.1 billion ( 13.2 billion euro ). R&D expenditure in the business area Prescription Medicines corresponds to 23.5% of its net sales.

For more information, please visit http://us.boehringer-ingelheim.com and follow us on Twitter at http://twitter.com/boehringerus.

About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, IN , Lilly provides answers — through medicines and information — for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.

About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we work to meet the diverse needs of people with diabetes through research and collaboration, a broad and growing product portfolio and a continued commitment to providing real solutions—-from medicines to support programs and more—-to make lives better.

For more information, visit www.lillydiabetes.com.

This press release contains forward-looking statements about TRADJENTA tablets for the treatment of type 2 diabetes. It reflects Lilly's current beliefs; however, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialization. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that TRADJENTA will be commercially successful. For further discussion of these and other risks and uncertainties, please see Lilly's latest Forms 10-Q and 10-K filed with the U.S. Securities and Exchange Commission . Lilly undertakes no duty to update forward-looking statements.

P-LLY
TJ310500

 

 

[1] Groop P-H, Cooper M, Perkovic V, et al.  Linagliptin Lowers Albuminuria on Top of Recommended Standard Treatment for Diabetic Nephropathy.  Abstract #953-P. Presented at the American Diabetes  Association's (ADA's) 72nd Scientific Sessions®. June 8-12 , Philadelphia, PA.

[2] Tradjenta® (linagliptin) tablets. Highlights of Prescribing Information. Initial US Approval: 2011.

[3] Centers for Disease Control and Prevention . National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States , 2011. Atlanta, GA : U.S. Department of Health and Human Services , Centers for Disease Control and Prevention , 2011.

[4] International Diabetes Federation . IDF Diabetes Atlas, 5th Edition: The Global Burden. 2011. http://www.idf.org/diabetesatlas/5e/the-global-burden. Accessed on: May 18, 2012 .

[5] International Diabetes Federation . IDF Diabetes Atlas, 5th Edition: What is Diabetes? http://www.idf.org/diabetesatlas/5e/what-is-diabetes. Accessed on: May 18, 2012 .

(Logo:  http://photos.prnewswire.com/prnh/20031219/LLYLOGO )

(Logo:  http://photos.prnewswire.com/prnh/20110825/DE57898LOGO )

 

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Abhishek Pal's kin meet Mamata Banerjee - Times of India

KOLKATA: Relatives of Abhishek Pal, the youth from Barrackpore who had collapsed during a constable recruitment drive at Race Course and later died, met chief minister Mamata Banerjee at her residence on Sunday. The CM assured that she will provide a job to his sister.

Abhishek, 22, was a candidate for the constable recruitment drive at Race Course. He fainted after completing the 1.6-km sprint and died on Wednesday night at SSKM hospital. after he collapsed after completing his test. The youth from Barrackpore had fainted during the recruitment drive, after completing the 1.6 km sprint.

On Sunday, when Abhishek's relatives met Mamata, she not only assured the victim's sister a job, but also asked her to come down to Writers' Buildings on Monday afternoon with her CV. Abhishek's mother is also likely to meet the CM on Monday.

Suresh Bhujel, who had also dreamt of a job in Kolkata Police as a constable, is now battling for his life at SSKM Hospital. Despite efforts by doctors, the youth's condition continues to be critical and is said to be deteriorating.

Suresh had undergone dialysis due to his renal failure. But there has been no improvement of his condition, doctors said. Doctors fear that the Kalimpong youth might develop multi-organ failure.

"The patient had undergone dialysis also. But his condition continues to be critical. He is on ventilation support," said Dr Tamal Ghosh, medical superintendent and vice principal of SSKM hospital.

Suresh had collapsed while trying to complete a 1.6-km sprint during the Kolkata Police recruitment process on Wednesday. The police had come under strong criticism for making the candidates go through such physical endurance tests in the sweltering heat. He was rushed to the hospital and was shifted to the ICU on Thursday.

Chief minister Mamata Banerjee on Sunday assured relatives of Abhishek Pal to provide a job to his sister. 22-year old Pal was a candidate for the constable recruitment test at Race Course and died on Wednesday night at SSKM hospital after he collapsed after completing his test. The youth from Barrackpore had fainted during the recruitment drive, after completing the 1.6 km sprint.

His relatives came down to meet the CM at her residence. The CM assured them to provide his sister with a job and for that she has asked the sister to come down to Writers' Buildings on Monday afternoon with a bio-data. Abhishek's mother is also likely to meet the CM on Monday.

While Suresh Bhijbal, who had also dreamt of a job in Kolkata Police as a constable is now fighting for life at SSKM Hospital. Despite efforts by doctors, the youth's condition continues to be critical and is said to be deteriorating. Suresh had undergone dialysis due to his critical renal failure. But there has been no improvement of his condition, doctors said. Doctors feared that the Kalimpong youth might develop multi organ failure.

"The patient had undergone dialysis also. But his condition continues to be critical. He is on ventilation support," said Dr Tamal Ghosh medical superintendent and vice principal of SSKM, hospital.

Suresh had collapsed while trying to complete a 1.6 km sprint during the Kolkata Police recruitment process on Wednesday. The police had come under strong criticism for making the candidates go through the physical endurance test in the sweltering heat. He was rushed to the hospital and has been shifted to the ICU on Thursday.

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Aspirin before heart surgery reduces the risk of post-operative acute kidney ... - Medical Xpress

Professor Jianzhong Sun (MD, PhD), professor and attending anaesthesiologist at Jefferson Medical College, Thomas Jefferson University (Philadelphia, USA), told the meeting that in a study of 3,219 , pre-operative was associated with a reduction in of about three in every 100 patients undergoing (CABG), valve surgery or both.

The patients were divided into two groups: those taking within five days before their operation (2,247 patients) and those not taking it (972 patients) [1]. Although the researchers had no record of the precise dose taken, doses of between 80-325mg per day is the normal dose for aspirin that is taken over a period of time.

After adjusting their results for various differing characteristics such as age, disease, and other medications, the researchers found that pre-operative aspirin was associated with a significant decrease in the incidence of post-operative : acute renal failure occurred in 86 out of 2247 patients (3.8%) taking aspirin, and in 65 out of 972 patients (6.7%) not taking it [1]. This represented an approximate halving in the risk of acute renal failure.

Prof Sun said: "Thus, the results of this clinical study showed that pre-operative therapy with aspirin is associated with preventing about an extra three cases of acute renal failure per 100 patients undergoing CABG or/and valve surgery."

Acute renal failure or injury is a common post-operative complication and has a significant impact on the survival of patients undergoing . "It significantly increases hospital stay, the incidence of other complications and mortality," said Prof Sun. "From previous reports, up to 30% of patients who undergo develop acute renal failure. In our studies, about 16-40% of cardiac surgery patients developed it in various degrees, depending upon how their kidneys were functioning before the operation. Despite intensive studies we don't understand yet why kidney failure can develop after cardiac surgery, but possible mechanisms could involve inflammatory and neurohormonal factors, reduced blood supply, reperfusion injury, kidney toxicity and/or their combinations."

He continued: "For many years, aspirin as an anti-platelet and anti-inflammatory agent has been one of the major medicines in prevention and treatment of cardiovascular disease in non-surgical settings. Now its applications have spread to surgical fields, including cardiac surgery, and further, to non-cardiovascular diseases, such as the prevention of cancer. Looking back and ahead, I believe we can say that aspirin is really a wonder drug, and its wide applications and multiple benefits are truly beyond what we could expect and certainly worthy of further studies both in bench and bedside research."

Prof Sun said that more observational and randomised controlled clinical trials were required to investigate the role played by aspirin in preventing post-operative kidney failure, but he believed that the effect might also be seen in patients undergoing non-cardiac surgeries.

"For instance, the PeriOperative ISchemic Evaluation-2 trial (POISE-2) [2] is ongoing and aims to test whether small doses of aspirin, given individually for a short period before and after major non-cardiac surgeries, could prevent major cardiovascular complications such as heart attacks and death, around the time of surgery."

Other findings from Prof Sun's research showed that diabetes, high blood pressure, heart disease, heart failure, and diseases of the vascular system were all independent risk factors for post-operative .

More information: Abstract no: 4AP6-8

[1] These figures are slightly different to those in the abstract as they have been updated since the abstract was submitted.

[2] Details of the POISE-2 trial can be found at: http://clinicaltri … /NCT01082874

[3] This research received no funding.

Provided by European Society of Anaesthesiology search and more info website

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