Onglyza (saxagliptin) gains European approval; demonstrates noninferiority to sitagliptin in phase 3b trial Reply

Following FDA approval in the US earlier this year, Onglyza (saxagliptin) received European marketing authorization, according to a press release issued by Bristol-Myers Squibb and AstraZeneca.

According to the companies, Onglyza is indicated as a once-daily 5 mg oral tablet dose in adult patients with type 2 diabetes mellitus to improve glycemic control:
Click to continue reading…

About these ads

First patient enrolled in study testing duration of antiplatelet therapy after DES Reply

Enrollment is finally underway in the much anticipated Dual Antiplatelet Therapy Study (DAPT), according to an announcement today from the Harvard Clinical Research Institute. DAPT is the product of a unique collaboration that includes the FDA, HCRI, and the following companies, which make stents and the antiplatelet drugs clopidogrel and prasugrel:
Click to continue reading…

Lancet review: will most babies born now live to 100? Reply

If current trends continue, most babies born in this century in developed countries will live to see their 100th birthday, according to an important new review appearing in the Lancet.

A key question is whether the increase in life expectancy will also bring an accompanying delay in functional limitations and disability. There is no clear answer to this question, but Kaare Christensen and coauthors find evidence suggesting that “people are living longer without severe disability.”

According to the authors, the increase in life expectancy shows no sing of deceleration: “The linear increase in record life expectancy for more than 165 years does not suggest a looming limit to human lifespan. If life expectancy were approaching a limit, some deceleration of progress would probably occur. Continued progress in the longest living populations suggests that we are not close to a limit, and further rise in life expectancy seems likely.” However, even if there are no further gains in health and life expectancy, three-fourths of babies born in this century will reach their 75th birthday.
Click to continue reading, including a comment from Harlan Krumholz…

REVERSE at 2 years: CRT may help prevent progression in early HF Reply

Two-year results from the REVERSE trial help support the proposition that cardiac resynchronization therapy may be beneficial in patients with class 1 and 2 heart failure. The results, which were presented initially last March at the American College of Cardiology meeting, have been published online as an expedited paper in the Journal of the American College of Cardiology. The major findings from the trial, the one year results, had been presented a year earlier at the ACC, and failed to demonstrate a benefit for CRT in this population, though trial investigators pointed to signs of reverse ventricular remodeling as an important hint of benefit.
Click to continue reading…

Invitation to Readers: My Mighty Team Reply

Dear CardioBrief Reader,

I am pleased to invite you to become one of the first users of an innovative new website, My Mighty Team, that has just entered beta testing. MIGHTY is a completely free social networking site designed to help people achieve goals such as losing weight, quitting smoking, or exercising more, by using small, focused teams to support and track their progress.
Click to continue reading…

FDA adds pancreatitis warning to Januvia label Reply

The FDA has revised the prescribing information for Januvia (sitagliptin) and Janumet  (sitagliptin/metformin), adding information about reported cases of acute pancreatitis in 88 cases. The FDA recommends that doctors monitor patients  for acute pancreatitis after initiating sitagliptin or increasing the dose.

Merck, which manufactures sitagliptin, released a statement saying it “believes these data do not demonstrate that a causal relationship exists between sitagliptin and pancreatitis.”
Click to read the FDA announcement and the statement from Merck…

Cholesterol prescriptions from Senators Schumer, Grassley, and Nelson 2

It’s only a very small moment within the enormous ongoing debate over health care reform, but a recent exchange in the US Senate over cholesterol remedies highlights the potential pitfalls when politicians talk about medicine.

As reported by David Herzenhorn in the New York Times, New York’s Senator Charles Schumer “said his doctor had directed him to take Lipitor… and then, after his cholesterol levels had dropped, suggested that he try a less expensive, generic medication instead. But he switched back after his cholesterol levels went back up. ‘I’m taking Lipitor even though it’s more expensive.’”
Click to continue reading…

TCT: Ticagrelor again shows benefits in PLATO invasive substudy 4

New results from a subset of the PLATO trial show that ticagrelor was more effective than clopidogrel in preventing events in ACS patients undergoing an invasive strategy.

Under development as Brilinta by AstraZeneca, ticagrelor is an oral, reversible antiplatelet drug with a rapid onset of action. The main results of PLATO in 18,624 ACS patients were presented last month at the ESC and published simultaneously in the New England Journal of Medicine. At TCT today, Chris Cannon presented results of the very large, planned substudy of the 72% of PLATO patients for whom an invasive strategy was intended.

Click to continue reading…

Gregg Stone no longer chairman of Cardiovascular Research Foundation Reply

UpdatedAccording to the website of the Cardiovascular Research Foundation, Gregg Stone is no longer the chairman of CRF. In addition, Stone is identified as the “immediate past chairman” of CRF in the press release for the SPIRIT IV trial issued by Abbott.

As CardioBrief reported yesterday, Stone’s predecessor as chairman, and the founder of the CRF, Martin Leon, was the subject of a letter from Senators Herb Kohl and Charles Grassley regarding potentially undisclosed conflict of interest statements.
Click to continue reading…

TCT: Xience outperforms Taxus in SPIRIT IV, but no difference in diabetics Reply

The Xience V outperformed the Taxus Express 2 in the SPIRIT IV Trial, but didn’t do any better or worse in the highly anticipated subset of diabetic patients. The results were presented at TCT 2009 during the Late Breaking Trials session on Wednesday by Gregg Stone.

At one year, the trial’s primary endpoint– the rate of target lesion failure (TLF)– in the 3,690 patients enrolled in the trial was 4.2% in the Xience V group versus 6.8% in the Taxus group, a highly significant difference. TLF is a combined endpoint of cardiac death, heart attack attributed to the target vessel (target vessel myocardial infarction), and ischemia-driven TLR (ID-TLR).
Click to continue reading…

Senators ask Columbia: did Martin Leon fail to disclose millions of dollars received from industry? 1

Updated– Senators Herb Kohl and Charles Grassley have once again raised the issue of potentially undisclosed conflicts of interest involving Martin Leon and the Cardiovascular Research Foundation he founded. The senators’ letter coincided with TCT 2009, the group’s well-known annual meeting for interventional cardiologists, which is now taking place in San Francisco.

The senators’ letter to Columbia University was first reported by Barry Meier in a story in the New York Times. Based on their review of information received in their investigation of medical device makers, the senators state that “Dr. Leon appears to have failed to report millions of dollars that he has received in outside income.” The senate letter is based on discrepancies between information received from industry and from the disclosure statements submitted by Leon.
Click to continue reading…

ACC/AHA publish new performance measures to prevent CV disease Reply

The ACC and the AHA have produced a joint scientific statment containing 13 key aspects of cardiovascular disease prevention. The statement is published simultaneously in Circulation and the Journal of the American College of Cardiology.

The performance measures translate existing guidelines, or principles important to disease prevention, into practical steps for healthcare providers, said Rita Redberg, the chair of the writing group, in an ACC/AHA press release.

Here are the 13 performance measures:
Click to continue reading…

Wall Street analyst calls prasugrel launch “muted” 1

It may be too soon for reliable predictions, but one Wall Street analyst sees signs of weakness in Lilly’s launch of Effient (prasugrel).

Seamus Fernandez, a Leerink Swann analyst, wrote in a research note that the number of new prescriptions for prasugrel were below the numbers observed during a similar period in successful new drug launches in recent years.
Click to continue reading…

Company and Wall Street disagree over trial results of diet drug lorcaserin Reply

If you only read the press release issued by Arena Pharmaceuticals you would think the results of BLOSSOM, the highly anticipated phase 3 trial of the diet drug locaserin, were overwhelmingly positive. But Wall Street has a different view of the trial and drove the stock price of the company down more than 10%. Update: By Friday afternoon Wall Street appeared to change its mind. By the end of the day the stock was up 5.5%.

Click to continue reading…

UK study: high risk associated with 10-15 year cut in life expectancy Reply

50-year-old men who smoked and had hypertension and hypercholesterolemia had a dramatic 10 year reduction in their life expectancy, according to a report in BMJ on long term followup of 19,000 men enrolled in the Whitehall Study. Even worse, men in the study with risk factor scores in the top 5% had a 15 year reduction in their life expectancy compared to men in the bottom 5%.
Click to continue reading…

Senate investigation uncovers huge expenditures for Vytorin CME 3

As part of its investigation into continuing medical education (CME), the Senate Special Committee on Aging has uncovered extensive records of the vast sums of money spent by Merck/Schering Plough on CME programs for Vytorin from 2004 through 2007. The document, which was first reported by Jared A. Favole on Dow Jones newswires, provide a fascinating glimpse into the $60 million CME program. The documents also shed light on company expenditures for academic physicians serving as advisory board members to the companies.

CardioBrief has been able to view the document submitted to the senate committee. The document is over 100 pages in length and contains detailed lists of the thousands of CME grants made by the companies. The vast majority of the grants are relatively small– in the $1,000 – 5,000 range– and generally cover grand rounds and other similar activities. But a substantial number of the grants are breathtaking in their size.
Click to continue reading…

Study sheds light on stroke following cardiac surgery Reply

Stroke following cardiac surgery occurs in about 2% of cases but does not necessarily occur  more frequently in patients with significant carotid stenosis, according to a single center study appearing in the Archives of Neurology.

Yuebing Li and colleagues followed 4335 patients undergoing coronary artery bypass grafting, aortic valve replacement, or both at Lehigh Valley Hospital and Health Network. More than three-quarters of the strokes occurred in patients with significant carotid stenosis. However, patients who underwent combined carotid and cardiac operations had a much higher risk of stroke (15%)  than patients with a similar degree of carotid stenosis who only had cardiac surgery (0%).
Click to continue reading…