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Health & Medicine for Senior Citizens

Tradjenta Effective Fighting Diabetes for Long-Term: International Study

The drug linagliptin is marketed in U.S. as Tradjenta and as Trajenta in other countries

July 24, 2012 - An extended trial involving older people of a drug for type 2 diabetes has confirmed that the oral DPP-4 inhibitor Tradjenta (linagliptin) is a safe and effective means of lowering glucose levels for up to 102 weeks, either on its own or in combination with other selected oral anti-diabetic medication.

The 32-country study, published in the August issue of IJCP, the International Journal of Clinical Practice, followed 2,121 individuals who had taken part in four previous 24-week randomised, double-blind, placebo controlled trials, in order to monitor them for a further 78 weeks. Linagliptin is marketed in U.S. as Tradjenta, and as Trajenta in other countries.

Those subjects who had previously received linagliptin (1,532) continued to do so and those who had received the placebo during the earlier trials (589) were also given the drug during the 78-week trial extension.

The participants who took part in the extended trial came from 231 sites in 32 countries: Argentina, Austria, Belgium, Canada, China, Croatia, the Czech Republic, Finland, Germany, Greece, Hungary, India, Israel, Italy, Japan, Korea, Malaysia, Mexico, the Netherlands, New Zealand, the Philippines, Poland, Romania, Russia, Slovakia, Spain, Sweden, Taiwan, Thailand, Ukraine, the United Kingdom and the United States.

"Initial 24-week trials showed that linagliptin, either on its own or with other glucose-lowering agents, was effective in improving glycaemic control without weight gain or an independent increased risk of hypoglycaemia (reduced blood sugar levels)" says co-author David R Owens, Professor Emeritus, Centre for Endocrinology and Diabetes Sciences at Cardiff University, Wales, UK.

"Linagliptin works by blocking the action of DPP-4, an enzyme that destroys the hormone GLP-1, which helps the body produce more insulin when it is needed." Linagliptin was administered orally once a day in all cases, either on its own, or in combination with metformin or metformin plus a sulphonylurea or pioglitazone.

Key findings of the extended study included:

 

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Links to more archived stories below this news report


 
 

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   >> The study participants had an average age of 57.5 years, 75% were younger than 65 years, 51.8% were male and 52.5% had been diagnosed more than five years ago.

   >> The majority had a body mass index of less than 30 kg/m2 (62.4%), a normal or mildly impaired kidney function (95.6%) and glycated hemoglobin levels of less than 8% (71.2%). The mean baseline glycated haemoglobin and fasting plasma glucose levels were significantly lower in those subjects who had received linagliptin rather than the placebo in the previous 24-week trials.

   >> 1,880 people (88.6%) completed the trial. The main reasons for discontinuing were adverse side effects (3.7%), refusal to continue medication (2.6%) and lack of therapeutic effect (1.1%).

   >> 1,718 subjects (81%) reported at least one adverse episodes during the extension phase. The highest incidence were in people receiving the combination of linagliptin plus metformin and a sulphonylurea (84.2%), followed by those receiving linagliptin plus metformin (81.6%). When linagliptin was taken on its own, the adverse side effects rate was lower at 78.8%, similar to those on linagliptin plus pioglitazone (76%).

   >> Most adverse side effects were mild or moderate and the incidence of severe adverse side effects was low at 3.8%, with 3.4% discontinuing the drug as a result. Overall, 14.3% of participants experienced drug-related adverse incidents.

   >> The investigators determined that 13.9% of participants experienced hyploglycaemic (low blood sugar) events and that about half of these (6.9%) were drug-related.

   >> The highest level of drug-related hypoglycaemic events occurred in persons receiving metformin with a sulophonylurea (11%), with much lower rates for those receiving linagliptin plus metformin (2.1%), lingaliptin on its own (0.5%) and lingaliptin plus pioglitazone (0.2%).

   >> Serious adverse events were reported in 9.9% of the trial subjects, with eight deaths reported during the study period. However, these were not related to the drug.

   >> Long-term lingagliptin use was not associated with a clinically relevant change in body weight, with individuals previously on the drug losing an average of 0.03kg and those previously on the placebo gaining an average of 0.47 kg.

"This is the largest data set of long-term clinical evidence for linagliptin to date" concludes Professor Owens.

"Findings from the 78-week open-label extension involving 2,121 people with type 2 diabetes demonstrate sustained glycaemic control for up to 102 weeks treatment duration.

"They also provide evidence that supports the efficacy and tolerability profile seen in previously reported 24-week studies. Therefore this extension study shows that linagliptin is an effective and well tolerated therapy for the long-term management of type 2 diabetes."

Notes:

The commercial drugs are marketed by Boehringer Ingelheim and Lilly

IJCP, the International Journal of Clinical Practice, was established in 1946 and is edited by Dr Graham Jackson. It provides its global audience of clinicians with high-calibre clinical papers, including original data from clinical investigations, evidence-based analysis and discussions on the latest clinical topics. http://wileyonlinelibrary.com/journal/IJCP, www.twitter.com/IJCPeditors. It is published by John Wiley & Sons, Inc. http://www.wiley.com

More at Wikipedia



Links to Archived Reports on Diabetes

Should YOU be tested for diabetes?

Anyone 45 years old or older should consider getting tested for diabetes. If you are 45 or older and overweight-see the BMI chart -getting tested is strongly recommended. If you are younger than 45, overweight, and have one or more of the risk factors, you should consider getting tested. Ask your doctor for a fasting blood glucose test or an oral glucose tolerance test. Your doctor will tell you if you have normal blood glucose, prediabetes, or diabetes.

   ● Among U.S. residents ages 65 years and older, 10.9 million, or 26.9 percent, had diabetes in 2010.

   ● Diabetes affects 25.8 million people of all ages - 8.3 percent of the U.S. population
       > DIAGNOSED - 18.8 million people
       ●> UNDIAGNOSED - 7.0 million people

   ● About 215,000 people younger than 20 years had diabetes—type 1 or type 2—in the United States in 2010.

   ● About 1.9 million people ages 20 years or older were newly diagnosed with diabetes in 2010 in the United States.

   ● In 2005–2008, based on fasting glucose or hemoglobin A1C (A1C) levels, 35 percent of U.S. adults ages 20 years or older had prediabetes - 50 percent of adults ages 65 years or older. Applying this percentage to the entire U.S. population in 2010 yields an estimated 79 million American adults ages 20 years or older with prediabetes.

   ● Diabetes is the leading cause of kidney failure, nontraumatic lower-limb amputations, and new cases of blindness among adults in the United States.

   ● Diabetes is a major cause of heart disease and stroke.

   ● Diabetes is the seventh leading cause of death in the United States.

Heart Disease, Stroke Deaths Drop for People with Diabetes: Often Seniors

Healthier lifestyles, better disease management are helping people live longer; Among U.S. seniors 65 and older, 10.9 million, or 26.9% had diabetes in 2010. - May 23, 2012

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‘…with the exception of patients over age 76 with the poorest health status, all showed strong survival rates’ - U-M study - May 2, 2012


Lifestyle Changes Reduced Type 2 Diabetes Risk 58%; Highly Effective for Seniors

Over 10 years, the lifestyle and metformin interventions resulted in health benefits and reduced the costs of inpatient and outpatient care and prescriptions…

March 22, 2012


Diabetes Drug TAX-875 Improves Glucose Control Without Increasing Hypoglycemia

Researchers say it is as effective as glimepiride with lower risk of drop in blood sugar - good news for about 11 million seniors with type 2 diabetes

Feb. 27, 2012


Older Women with Diabetes Have Greater Hearing Loss as They Age

Men lose even more hearing regardless of diabetes or age; women lose less if diabetes controlled

Jan. 26, 2012


Statins of Any Kind May Increase Risk of Diabetes in Postmenopausal Women

Researchers say current recommendations by diabetes association nor statin guidelines should change - Jan. 10, 2012


Diabetes Drugs, Blood Thinners Cause 2/3 of Senior Citizen Adverse Events, Hospitalizations

Almost half of cases are in elderly aged 80 plus; overdoses, stronger than expected effect most common causes - Nov. 26, 2011


Raising 'Good' Cholesterol Reduces Heart Attack, Stroke Risk in Diabetes Patients

And, risks of heart attack and stroke increase when 'good' cholesterol levels go down - Oct. 7, 2011


Dieting Beats Exercise for Diabetes Prevention in Older Women, Combo Is Best

Strengthening exercise appears to have greater benefits for insulin resistance than aerobic exercise - Sept. 2, 2011


Older Diabetes Patients with Very Low Glucose Have Slightly Higher Risk of Death

Well controlled blood sugar level lowers risk of heart attack, amputation, kidney disease - April 18, 2011


Senior Citizens Lead the Way as Diabetes Spreads to 26 Million in New U.S. Estimate

Estimates in U.S. have risen since CDC estimated in 2008 that 23.6 million (7.8) had diabetes and 57 million adults had prediabetes - Jan. 27, 2011


Older Women with Diabetes and Depression Have Twice the Risk of Death

Both problems linked to unhealthy behaviors such as smoking, poor diet and a sedentary lifestyle - Jan. 3, 2011


Fat Distribution Plays Key Role in Weight Loss Success in Patients at Risk of Diabetes

‘Abdominal and liver fat are the two most important factors in predicting whether a lifestyle intervention will be successful’

Aug. 24, 2010


An Old Antibiotic Appears to Reduce Stroke Risk, Injury for Diabetics

Almost 70% of Americans dying with diabetes found to show a major vascular event such as a stroke or heart attack as a cause of death

Aug. 23, 2010


Getting Fat After Age 50 Greatly Increases Diabetes Risk that Already Escalates for Seniors

‘Participants with a greater than 4 inch increase in waist size from baseline to the third follow-up visit had a 70 percent higher risk of type 2 diabetes…’

June 22, 2010


Study Pinpoints Atrial Fibrillation Risk at 40 Percent for Those with Diabetes, Maybe Higher

Nearly nine in 100 people over age 80 - have atrial fibrillation; risk rises by 3% for each additional year patients have diabetes – watch video

April 23, 2010


Considering Type 2 Diabetes Treatment, Experts Say 1 Size Does Not Fit All

International group recommends individualized therapies; Almost one of every four senior citizens has diabetes

April 5, 2010


Senior Women at High Risk of Bone Fractures After Taking Diabetes Drugs Avandia or Actos

TZDs have previously been linked to bone loss, increasing fracture risk; type 2 diabetes and insulin also increase risk for fractures

Feb. 10, 2010


Victoza (liraglutide) Gets FDA Approval as New Treatment for Type 2 Diabetes

Seniors aged 60 with type 2 diabetes are about one-third of all adults with this chronic disease

Jan. 27, 2010


Harvard Scientists Move Closer to Correcting Cellular Defects That Lead to Diabetes

Report says the G6PD protein, which produces essential antioxidant NAPDH, could prevent the death of pancreatic beta cells, the root cause of diabetes

Jan. 4, 2010


Seniors May Reduce Risk of Type 2 Diabetes by Half with More Exercise, Less Weight

Modest weight loss or taking anti-diabetic drug for 10 years lowers risk of type 2 diabetes in high risk people of all ages

Nov. 2, 2009


Diabetes Patients May Have Wrong Idea About Taking Insulin: Should be Front-Line Defense

Common fears of weight gain, developing low blood-sugar, decline in quality of life are largely unfounded, researchers find

Aug. 11, 2009

 

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