Scientists link diabetes drugs to heart failure

[Al-khiyal]

July 27, 2007 -- Two of the most commonly used drugs for diabetes, which were taken by hundreds of thousands of mostly overweight people in the UK last year, are causing widespread heart failure, scientists warn today.

Use of the drugs, prescribed by doctors for type II diabetes, has doubled in the past three years as a consequence of a growing obesity problem. Last year 1.8m prescriptions were written across the UK, which scientists say equates to several hundred thousand patients taking the drugs which are recommended for use across the NHS by the National Institute for Health and Clinical Excellence (Nice).

But researchers today call on Nice to think again, revealing that as many as one in every 50 patients taking the drugs Avandia (rosiglitazone) and Actos (pioglitazone) over a period of 26 months will have to be hospitalised for heart failure.

The class of drugs, they say in the journal Diabetes Care, doubles the risk of heart failure, and even those with no history of heart problems are affected.

"This means that the diabetes drugs could have caused thousands of additional cases of heart failure, creating a substantial burden on hard-pressed NHS services," said Dr Yoon Loke, a clinical pharmacologist at the University of East Anglia who carried out the research with Wake Forest University in the US. "I think Nice should re-evaluate their decision to recommend these diabetes drugs."

Concerns about the safety of the drug were triggered in May when a leading US cardiologist published evidence of a link to heart attacks and death. The manufacturers strongly contested his study in the New England Journal of Medicine.

But today's evidence will add urgency to a special meeting of the US regulator, the Food and Drug Administration (FDA) which was already scheduled for Monday to discuss the safety of the drugs which are taken by 7 million people in the US.

Global sales of Avandia, made by the British company GlaxoSmithKline, have dropped by 22% in the US since the heart attack data was published in May, but are still worth £349m.

However, in Europe sales have continued to grow by 20% to £63m. Avandia is the company's second best-selling drug.

Dr Loke told the Guardian: "These drugs are no longer cost-effective by Nice's criteria. We spent about £70m a year on these two drugs. It is a huge amount ."

He and his American colleagues pooled data from 78,000 patients who have taken the drugs, some of them during the manufacturers' trials. They also looked closely at the cases of 200 people who suffered heart failure and found they were not people who were obviously at risk.

"Most patients in the studies did not have heart failure prior to starting on treatment with these drugs," said Dr Loke. "There doesn't seem to be a group of patients who are safe from these side-effects."

The European Medicines Agency (EMEA), which licensed the drugs, says it is reviewing the evidence and will not comment for the time being. Nice says it will take into account any new information when it updates its guidance on the diabetes treatment in February, but that any decision to limit prescribing of the drugs rested with the EMEA.

Alastair Benbow, European medical director for GlaxoSmithKline, said of the study: "It is well recognised that the class of drug can cause fluid retention. It is wholly different from the issue raised previously about heart attacks and cardiovascular deaths."

He said fluid retention could be resolved if the patient was well monitored and prescribed diuretics. Even heart failure could be treated in hospital. "What is missing here is the benefit these drugs provide." The drugs kept blood sugar levels low, preventing serious effects of the disease such as blindness and amputations, he said.

Takeda, manufacturers of Actos, last night declined to comment.

Scientists link diabetes drugs to heart failure

[amalgamate]

But researchers today call on Nice to think again, revealing that as many as one in every 50 patients taking the drugs Avandia (rosiglitazone) and Actos (pioglitazone) over a period of 26 months will have to be hospitalised for heart failure.

[Cheba_Mami]

Oh my God !!! That is shocking news!

[Al-khiyal]

WASHINGTON, July 30, 2007 — The widely used diabetes drug Avandia should be pulled from the market because of heart risks, a federal scientist said Monday.

Those risks, combined with no unique short-term benefits in helping diabetics control blood-sugar levels, fail to justify keeping Avandia on the market, according to a copy of a slide presentation by Food and Drug Administration scientist Dr. David Graham.

The document was distributed at the onset of a daylong meeting of a joint panel of outside experts convened to consider whether the drug should restricted to use in select patients and branded with prominent warnings or removed altogether from sale. Previously, the FDA said information from dozens of studies of the GlaxoSmithKline PLC drug points to an increased risk of heart attack.

Glaxo officials, meanwhile, disputed that conclusion, according to copies of company presentations to be given later Monday.

The FDA isn't required to follow the advice of its advisory committees but usually does.

The FDA moved up the date of Monday's meeting following the May publication of a study by The New England Journal of Medicine that generated new concerns about Avandia's safety. The pooled analysis of 42 studies revealed a 43 percent higher risk of heart attack for those taking Avandia compared with people taking other diabetes drugs or no diabetes medication.

Glaxo, meanwhile, says its own data show no increase in heart risks with Avandia compared with other diabetes drugs, including Actos.

About 1 million Americans with Type 2 diabetes use Avandia to control blood sugar by increasing the body's sensitivity to insulin. That sort of treatment has long been presumed to lessen the heart risks already associated with the disease, which is linked to obesity. News that Avandia, also called rosiglitazone, might actually increase those risks would represent a "serious limitation" of the drug's benefit, according to the FDA.

Expert warns against diabetes drug

[amalgamate]

you know, it's ironic now that i think about it- I've seen these drugs distributed more among the community's poor than in the middle-class or upper-class communities. Working in a CVS pharmacy, i rarely see Avandia and Actos being prescribed. But when working at a community clinic in a downtown area where most of the community is poor and from hispanic origin, we were filling prescriptions for Actos just as often as we were filling for Metformin.


makes you think doesn't it?

[Cheba_Mami]

yeah keep an eye on other prescibed drugs and i am sure you will see there is a difference per area...

[Cheba_Mami]

Health Canada investigates Losec, Nexium for heart risks
Last Updated: Thursday, August 9, 2007 | 11:07 AM ET
CBC News
Health Canada is alerting consumers who take Losec and Nexium, two prescription medications primarily used to treat acid-related stomach disorders, that it is investigating the drugs' links to serious cardiac problems.
Studies of the two medications reveal that patients using Losec or Nexium to treat gastroesophageal reflux disease (GERD) instead of surgery "may have experienced more heart attacks or cardiac deaths than patients who had the surgery," reads the advisory.

It also notes that many patients who developed cardiac problems had risk factors prior to beginning treatment.

The data being reviewed by Health Canada comes from a study that compares treatment with Losec to surgery in patients with severe GERD. Another continuing study comparing Nexium to surgery has five-year followup information on patients.

The study designs did not provide for a clear definition of cardiac problems or an adequate followup of patients. While both studies include some safety data, Health Canada said it is difficult to evaluate this data because of the way it was collected, reported and documented.

At this point, Health Canada's preliminary review finds the evidence provided does not confirm the existence of a possible cardiovascular risk. It plans to complete its analysis of the new information by the end of the year and will advise Canadians of its conclusions and recommendations at that time.

Health Canada is advising health professionals not to change their prescribing practices of the drugs for the time being.

Patients taking Losec or Nexium are also urged to consult with their doctors before making any change to their medication, as GERD can lead to other complications if left untreated.

Any adverse reactions to either drug should be reported to the Canadian Adverse Drug Reaction Monitoring Program, said Health Canada.

Continue reading article on website Health Canada investigates Losec, Nexium for heart risks