A large observational study found no increased risk for cardiovascular events associated with azithromycin (Zithromax, Pfizer) in a general population of young and middle-age adults. In a paper published in the New England Journal of Medicine, Danish investigators report the results of a large national observational study comparing people who took azithromycin with matched controls who took no antibiotics and with matched controls who took penicillin V for similar indications.
Although there was a significant increase in the risk of death from cardiovascular causes in people taking azithromycin compared with people taking no antibiotics (RR 2.85, CI 1.13 – 7.24), there was no increase in risk when compared to people taking penicillin V (RR 0.93, CI 0.56 to 1.55). The findings, write the authors, indicate “that the increased risk that was observed in the comparison with no antibiotic use was entirely attributable to the risk of death associated with acute infection (or some other adverse health characteristic in persons receiving antibiotic treatment, as compared with those not treated with antibiotics) rather than with its treatment.”
Click here to read the full story on Forbes.
Three substudies of the influential TNT (Treating to New Targets) trial have been retracted after the sponsor of the trial, Pfizer, discovered that blood samples from the study had been matched to the wrong participants.
The main results of TNT, published in 2005 in the New England Journal of Medicine, had a major impact on clinical practice and statin prescription patterns. The trial supported the increasingly aggressive use of statins and helped to solidify the enormous commercial success of atorvastatin (Lipitor, Pfizer).
The 3 newly-retracted substudies do not appear to affect the main finding of TNT. Two papers were published in the Journal of the American College of Cardiology. The third was published in the American Heart Journal. (The AHJ retraction notice has not yet been published, but the editors have confirmed the retraction.) Here are the 3 retracted articles:
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Merck has invested a substantial amount of money on the CETP inhibitor anacetrapib. Chemist and veteran pharma blogger Derek Lowe suspects that the company might as well have plunked the money down in a casino.
In a provocative new post, Lowe wonders if big pharma, in its desperation, has abandoned rational research in favor of, essentially, gambling. He notes that CETP is “a drug target that has incinerated a lot of money over the years” and wonders whether any of the compounds will “ever make it as a drug?” The failure of past CETP inhibitors, torcetrapib (Pfizer) and dalceptrapib (Roche), along with the recent failure of Tredaptive (Merck), “illustrate how little we know about this area [HDL].”
Read the rest of the post on Forbes.
The FDA has finally approved apixaban (Eliquis, Bristol Myers Squibb and Pfizer) to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. The action comes after the widely-anticipated drug had been plagued by delays at the FDA but well before the PDUFA deadline of March 17, 2013. Eliquis is the latest member of the new generation of oral anticoagulants, which also includes dabigatran (Pradaxa, Boehringer Ingelheim) and rivaroxaban (Xarelto, Johnson & Johnson).
The FDA said that apixaban should not be taken by patients with prosthetic heart valves or by patients with AF caused by a heart valve problem. (Recently the FDA added a contraindication to the dabigatran label against using the drug in patients with mechanical heart valves.) The FDA said that the most serious risk associated with apixaban, as with other anticoagulants, is bleeding, including life-threatening and fatal bleeding. Patients taking apixaban will receive a patient Medication Guide. The FDA is advising health care professionals to counsel patients about the signs of symptoms of possible bleeding.
The FDA approval was based largely on the results of the highly positive ARISTOTLE trial which found that apixaban was superior to warfarin in AF patients. The FDA will likely allow BMS and Pfizer to claim that apixaban is superior to warfarin, as the press release states that “patients taking Eliquis had fewer strokes than those who took warfarin.”
Click here to download a PDF of the package insert.
Click here to read the FDA press release…