June 11th, 2013
People with Sleep Apnea at Increased Risk for Sudden Cardiac Death
Larry Husten, PHD
Although people with obstructive sleep apnea (OSA) have an increased risk for death and cardiovascular disease, the relationship between OSA and sudden cardiac death (SCD) has not been clear. Now a new study published in the Journal of the American College of Cardiology provides evidence that OSA is in fact associated with an increase in the risk […]
June 10th, 2013
Dramatic Increase in Use of Radial Artery Access for PCI in the U.S.
Larry Husten, PHD
In the last six years interventional cardiologists have dramatically increased their use of radial access for PCI, according to a retrospective study published in Circulation. Using data from the CathPCI registry on more than 2.8 million procedures between January 2007 and September 2012, Dmitriy Feldman and colleagues found that radial access PCI increased 13-fold, from a negligible 1.2% at the beginning of the study […]
June 7th, 2013
FDA Advisory Panel Backs Looser Restrictions on Avandia
Larry Husten, PHD
After two days of deliberation an FDA advisory panel has recommended that the severe restrictions (REMS) placed on rosiglitazone (Avandia, GlaxoSmithKline [GSK]) be modified. The vote constitutes a modest revival in fortune for the embattled drug and its maker after many years of controversy and bad news. Only 5 panel members voted to continue the current severe restrictions. […]
June 4th, 2013
Study Finds More Musculoskeletal Problems in People Who Take Statins
Larry Husten, PHD
An observational study published in JAMA Internal Medicine provides new evidence suggesting that people who take statins are more likely to develop musculoskeletal problems. Ishak Mansi and colleagues analyzed data from 6,967 statin users and an equal number of propensity-matched nonusers who were active-duty soldiers, veterans, and their families in the San Antonio Military Area. They found that the […]
June 4th, 2013
With One Big Exception FDA Reviewers Back More Benign View of Avandia Trial
Larry Husten, PHD
The FDA has released a 538-page briefing document for an advisory panel meeting on Wednesday and Thursday that will reassess a key clinical trial and reconsider the fate of the now-tarnished former blockbuster diabetes drug rosiglitazone (Avandia, GlaxoSmithKline). (Click here for the FDA documents.) As reported last week, the re-adjudication of the RECORD safety trial performed by […]
May 31st, 2013
Two FDA Officials Quarrel Over Safety of Angiotensin-Receptor Blockers
Larry Husten, PHD
Two FDA officials are quarreling in public about their different views about the safety of angiotensin-receptor blockers (ARBs), according to a story by Thomas Burton in Friday’s Wall Street Journal. One official, Thomas Marciniak, contends that ARBs may increase the risk for cancer. Marciniak has been a vocal critic of FDA’s efforts to assess drug safety. In the […]
May 30th, 2013
Large Meta-Analysis Quantifies Risks Posed by Coxibs and Traditional NSAIDs
Larry Husten, PHD
Findings from a very large meta-analysis of clinical trials of NSAIDs may now allow physicians to quantify the cardiovascular and gastrointestinal risks associated with these drugs. The results of the Coxib and traditional NSAID Trialists’ (CNT) Collaboration, employing data from more than 350,000 randomized patients, have been published in the Lancet. Here are some of the key findings: The risk […]
May 29th, 2013
Report on the RECORD Trial Released
Larry Husten, PHD
An independent re-adjudication of the RECORD trial has confirmed the trial’s original finding that rosiglitazone does not increase cardiovascular risk. But critics of the trial and the drug are unlikely to be appeased by the new result. The re-adjudication of RECORD will be the subject of an extraordinary 2-day FDA advisory committee meeting next week on […]
May 28th, 2013
Interpretations Differ Over Study of Coenzyme Q10 in Heart Failure
Larry Husten, PHD
Coenzyme Q10 (CoQ10) may be beneficial in heart failure (HF), according to the results of the Q-SYMBIO study presented this past weekend at the Heart Failure 2013 meeting in Lisbon, Portugal. But the results should be viewed with a critical eye, say experts. A possible role for CoQ10 in the treatment of HF has long been proposed. A recent […]
May 24th, 2013
Rivaroxaban Gains Approval in Europe for ACS Indication
Larry Husten, PHD
Rivaroxaban (Xarelto, Bayer) has been approved in Europe for the prevention of atherothrombotic events (cardiovascular death, myocardial infarction, or stroke) following an acute coronary syndrome (ACS). The drug was approved at a dose of 2.5 mg twice-daily and should be used in combination with standard antiplatelet therapy. Rivaroxaban is now the only oral anticoagulant to receive […]