Imagine Avandia safety as an old-fashioned balance scale. Data on one side upholding the contention that the benefits of the GlaxoSmithKline diabetes med are worth its risks. Data on the other supporting the argument that the drug isn’t safe and should be withdrawn. Well, two newly published studies are adding their weight to the latter–just two weeks before the FDA’s advisory panel meeting on Avandia safety.

One study concludes that Avandia boosted the risk of death, heart failure, stroke or heart attack by 18 percent compared with its Takeda-made competitor Actos. You may recall that this research was done by the FDA’s David Graham, who’s been a frequent critic of Avandia and of the FDA’s response to safety concerns. ”If you treated 60 people for a year with Avandia, you would cause one extra case of heart attack, stroke, heart failure or death,” Graham tells NPR, “compared to if you had treated 60 patients with Actos.”

The other, an update of the first study that found heart-attack risks associated with Avandia, found that one of every 52 patients using the drug suffered. ”I think what we can say confidently is, looking at the totality of data in 2010, Avandia increases the risk of heart attack compared to other diabetes drugs by about a third,” Dr. Steve Nissen of the Cleveland Clinic says.

GSK released a statement contending that data from randomized clinical trials–rather than these analyses of clinical data and records–shows that Avandia is, in fact, safe. “[T]hese trials show that Avandia does not increase the overall risk of heart attack, stroke or death,” the company says. And as PharmaTimes reports, another new study hit at the American Diabetes Association meeting yesterday, showing no increased risk of death, stroke or heart attack (but does boost fracture risk).

FDA Deputy Commissioner Joshua Sharfstein tells the New York Times that the newly published studies “will be part of the discussion that FDA has as we consider the important question of Avandia’s safety.” The FDA is also planning to release its own research on the drug. That advisory panel meeting is coming up July 13-14.

Source: FiercePharma

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After initially tapping taspoglutide as the latest in a string of likely blockbusters-to-be from Roche, analysts are turning sour on the drug’s prospects after gaining a close look at the side effect data presented by researchers over the weekend.

The once highly touted diabetes drug prospect was put through the ringer earlier in the month when Roche said that it needed to amend trials to watch for side effects like vomiting and nausea, delaying any app for up to 18 months. But a look at the data presented over the weekend at the American Diabetes Association meeting left analysts doubtful that the drug can ever gain marketing approval.

“The full data presentation suggest that taspoglutide’s side-effect profile may be worse,” said Annie Cheng, an analyst for Bryan, Garnier. Cheng, once bullish about the therapy’s blockbuster potential, reduced her estimate on the likelihood of an FDA approval from 60 percent to only 10 percent. That’s also bad news for Ipsen, which licensed the drug to Roche.

“We rate the possibility that Roche hands the drug back to Ipsen at around 50 percent,” noted Morgan Stanley, according to a report from Dow Jones. “Roche’s sub-optimal development for taspoglutde raises questions about the integrity of the development programs for their other large phase III programs.”

Source: FierceBiotech

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MannKind CEO Alfred Mann said Monday that the company has held talks with “a number of very significant” drugmakers about a potential partnership to market its inhaled insulin product Afresa, which is currently under review by the FDA. Mann indicated that the interested companies are “very qualified to take this to market.”

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Rodman & Renshaw analyst Simos Simeonidis commented that he expects MannKind to enter into a worldwide partnership for Afresa during the summer, and he said it is likely the product will be approved by the FDA next spring. In addition, the analyst stated that late-stage results for Afresa presented recently at the annual meeting of the American Diabetes Association “solidify our view that Afresa can be a product that could take market share away from injectable insulins and become [a] significant player in the diabetes space.” Simeonidis suggested that Afresa has the potential to achieve sales of $1 billion or more.

Shares in MannKind rose as much as 15 percent on the news.

Source: FirstWord

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The American Diabetes Association’s Scientific Sessions were center stage this weekend in New Orleans. A few items of note:

Stents and certain branded drugs were no better at preventing death in some diabetic patients than a regimen of older, cheaper drugs, according to a randomized, federally funded study of more than 2,000 patients, the WSJ reports.

The study was constructed to answer several questions, largely related to cardiovascular health (diabetes raises the risk of cardiovascular problems such as heart attacks). Besides the stent question, the study found that for diabetics with severe heart disease, bypass surgery reduced the risk of death more than drug treatment alone.

It also found that Avandia and Actos, made by GlaxoSmithKline and Takeda, respectively, didn’t reduce deaths more than insulin. (On the other hand, Actos and Avandia are pills, which are easier to take than insulin, and they don’t carry insulin’s risk of causing dangerously low blood sugar.

A few small drug makers are seeing their stocks rise in pre-market trading after releasing promising data at the ADA conference, Dow Jones Newswires reports. Orexigen is up on data that showed its experimental drug Contrave improved eating control. Arena rose after researchers said a drug called lorcaserin helped patients lose weight and keep it off over a two-year period. And shares of Amylin and Alkermes were up on results that a once-a-week version of the diabetes drug Byetta helped patients control blood-glucose levels and lose weight.

Source: The Wall Street Journal

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GlaxoSmithKline announced that type 2 diabetes drug Avandia showed no increased cardiovascular risk compared with commonly prescribed treatments, according to long-term study results presented at the annual meeting of the American Diabetes Association. The findings were also published in The Lancet and in an editorial accompanying the study, the authors stated that “definitive conclusions about the relation between [Avandia] and cardiovascular disease remain elusive, owing to study limitations.”

In the randomised RECORD trial, 2220 patients with type 2 diabetes were treated with Avandia as an add-on to metformin or sulphonylurea, and 2227 patients were treated with a combination of metformin and sulphonylurea. GlaxoSmithKline said the findings indicated that “cardiovascular hospitalisation and cardiovascular death (which includes heart attack, congestive heart failure, and stroke) was not statistically different between the two groups after an average of 5.5 years of therapy.” In addition, the company noted that glycaemic control was significantly better in the Avandia group after the average 5.5 years of treatment.

“The findings essentially are that, in overall cardiovascular terms, the drug is safe,” noted lead investigator Philip Home. “There’s no decreased risk, and that includes the heart failure element,” Home indicated, adding that “if anything, deaths were reduced with [Avandia] compared to those in the control group. It doesn’t reach statistical significance, but it’s on the right side of benefit.” Nonetheless, study researchers also stated that the data were “inconclusive about any possible effect on myocardial infarction,” and that results from the trial demonstrated that “the addition of rosiglitazone…is confirmed to increase the risk of heart failure.”

Bernard Zinman, co-author of the editorial appearing in The Lancet alongside the RECORD study, said that “it’s good there isn’t a strong negative signal but it doesn’t tell us it’s safe.” Zinman also indicated that the study “doesn’t tell us anything” about the drug’s propensity for causing heart attacks. Meanwhile, Cleveland Clinic cardiologist Steven Nissen described the trial as “seriously flawed.” He stated that not enough patients remained in the study to determine conclusively that the drug does not pose a higher risk for heart attacks and other cardiovascular problems.

GlaxoSmithKline spokesperson Mary Anne Rhyne commented that most patients who stopped taking Avandia did so near the trial’s end, which allowed researchers to make conclusions. The company released figures showing that 61 percent of patients in the Avandia arm and 51 percent patients in the control group remained on their medicines at the end of the study. Rhyne said that the numbers were not unusual for a trial where patients were followed for more than five years.

Nissen further remarked that the trial was made “worthless” by the fact that patients in the Avandia arm took 10 percent more cholesterol-lowering drugs. However, Home replied that the use of the lipid-lowering drugs could only have had a minor impact on the data.

In further reaction to the news, the chief scientific and medical officer of the American Diabetes Association, Richard Kahn, indicated that the association will evaluate the data and consider reversing its recommendation against using GlaxoSmithKline’s thiazolidinedione drug. The ADA’s recommendation came after the release of Nissen’s meta-analysis in 2007, which showed that Avandia increased the risk of heart attack by 43 percent and the risk of cardiovascular death by 64 percent, when compared with placebo or other treatment regimens.

Source: FirstWord

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Findings presented at the American Heart Association scientific sessions on Wednesday demonstrated that GlaxoSmithKline’s Avandia (rosiglitazone) failed to significantly slow progression of atherosclerosis in patients with type 2 diabetes, compared with the sulphonylurea glipizide, marketed by Pfizer as Glucotrol.

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Participants in the 672-patient APPROACH trial were randomly assigned either Avandia or glipizide. After 18 months of treatment, results showed that patients who took Avandia achieved a 0.21-percent reduction in atherosclerotic plaque, while those in the glipizide group experienced a 0.43-percent increase. The company indicated that the difference between the groups did not reach statistical significance.

However, the drug did demonstrate benefit in a secondary measure, which showed that the volume of atherosclerotic plaque was 5.12 cubic millimetres less among Avandia patients than among those administered glipizide. Lead author Richard Nesto suggested that the data “[place] these drugs side by side when it comes to the arteries.”

Commenting on the results, Cleveland Clinic cardiologist Steven Nissen remarked that the findings provide “one more reason” for physicians to be cautious about prescribing GlaxoSmithKline’s product. Nissen also suggested that APPROACH is “too small to confirm or refute the safety issues previously raised” about the drug. A larger study designed to assess the treatment’s safety is not expected to be completed for another two years.

Last month, the American Diabetes Association and the European Association for the Study of Diabetes issued new treatment guidelines recommending that doctors not use Avandia.

Source: FirstWord

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Findings from research by the Centers for Disease Control and Prevention indicate that the incidence of new diabetes cases among adults in the US nearly doubled over the past 10 years.

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The data, published in the CDC’s Morbidity and Mortality Weekly Report, are based on records from 33 states and show that the rate of new cases of diagnosed diabetes among adults rose from 4.8 per 1000 people during 1995-1997 to 9.1 per 1000 people in 2005-2007. The highest age-adjusted incidence was predominantly in the southern states, led by West Virginia where the rate was 12.7 per 1000 people.

Karen Kirtland, lead author of the study, noted that “this report documents the geographic distribution of new cases of diabetes and is consistent with previous studies showing an increase in new diabetes cases.” Commenting on the trend, Matt Petersen, a spokesperson with the American Diabetes Association, suggested that “some day we’ll see a levelling off of diabetes incidence if the obesity rate levels out. But clearly it hasn’t started yet. We won’t see the plateau in type 2 diabetes for quite a while.”

Source: FirstWord

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A consumer advocacy group announced on Thursday that it filed a petition with the FDA to ban GlaxoSmithKline’s Avandia (rosiglitazone), citing concerns the diabetes drug could result in death from liver failure and carries several other life-threatening risks that outweigh its benefits.

In the petition, Public Citizen reported that it identified 14 cases of “Avandia-induced” liver failure, including 12 deaths, following a review of adverse event reports filed with the US regulator. “The evidence for this unique combination of toxicities is compounded by the accompanying lack of evidence of any clinical benefit, compared to other approved drugs for diabetes,” the petition said.

GlaxoSmithKline spokesperson Mary Anne Rhyne commented that the company does “not believe there is a connection between liver toxicity and this medicine.” She added that the drug is safe “for appropriate type 2 diabetes patients, when used according to the label.” Meanwhile, FDA spokesperson Rita Chappelle said the agency will review the petition and issue a response.

Last week, the American Diabetes Association and the European Association for the Study of Diabetes issued updated treatment guidelines recommending that doctors not use the drug.

Source: FirstWord

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