Template:WikiDoc News: Today in Medicine

February 19, 2009: New Analysis Casts Doubt on HDL as Target for Therapy

• (CardioBrief) - The SYNTAX trial, which compared CABG to PCI in patients with 3-vessel or left main coronary disease, has been published in the New England Journal of Medicine. The trial found that CABG was superior to PCI at one year, but the results have generated considerable controversy. As always, the devil is in the details. An editorial by Richard Lange and L. David Hillis concludes that patient data needs to be reviewed by both a cardiac surgeon and an interventional cardiologist “to determine the likelihood of safe and effective revascularization with PCI and with CABG.” The implication here, then, is that “revascularization should not be performed at the time of diagnostic angiography.” This of course would entail an enormous change in standard clinical practice, at least in the United States. The SYNTAX score, which is largely an assessment of complex coronary anatomy, should play an important role in the decision in most patients who do not have a clear indication or contraindication for either procedure. The NEJM also posted an online discussion about SYNTAX with Betsy Nabel and David Hillis moderated by Thomas Lee. Nabel notes that the difference in the primary endpoint of SYNTAX was driven largely by an increase in the need for revascularization in the PCI group, while in the CABG group there was a higher incidence of stroke. (New England Journal of Medicine)

February 19, 2009: OAT: No Improved Quality of Life Found for Late Opening of Occluded Arteries

• (CardioBrief) - Despite a marginal advantage at 4 months, after two years PCI does not improve the quality of life when compared to medical therapy after late opening after MI, according to a new report from the Occluded Artery Trial (OAT) Investigators published in the New England Journal of Medicine. In addition, PCI, as expected, is more expensive than the medical approach. In a separate report, published in Circulation earlier this week, OAT investigators reported the electrophysiologic effects of late PCI in their trial. They found that late PCI had no effect on heart rate variability, signal-averaged ECG, or T-wave variability.(New England Journal of Medicine)

February 19, 2009: Pharmacogenetics: A Better Path to Warfarin Dosing?

• (CardioBrief) - Using a pharmacogenetic algorithm to estimate the initial warfarin dose is better than using the usual clinical or fixed-dose approaches, according to a new study from the Imternational Warfarin Pharmacogenetics Consortium published in the New England Journal of Medicine. (New England Journal of Medicine)

February 18, 2009: New Analysis Casts Doubt on HDL as Target for Therapy

• (CardioBrief) - Raising HDL, by itself, has no effect on coronary heart disease rates, according to a large new analysis in the British Medical Journal. An international team analyzed 108 clinical trials including nearly 300,000 patients and found no correlation between changes in HDL and outcome. By contrast, changes in LDL were strongly associated with outcome. The authors write: “Raising high density lipoprotein cholesterol without considering effects on high density lipoprotein function seem to have little promise for the prevention of cardiovascular events.” (British Medical Journal)

February 17, 2009: New Data on Sudden Death in Young Athletes Published

• (CardioBrief) - Barry Maron and colleagues have now provided the most clear and comprehensive perspective yet available on the rate and cause of sudden death in young athletes in the US. Examining data from 1980-2006, the investigators found, in a report published online in Circulation, that cardiovascular disease accounted for 56% of all cases, with more than a third of these caused by hypertrophic cardiomyopathy. Over the last six years an average of 66 deaths have occurred each year. The authors conclude that “the absolute number of cardiovascular sudden deaths in young US athletes was somewhat higher than previous estimates but relatively low nevertheless.” (Circulation)

February 17, 2009: PFO and Migraine: The Next Chapter

• (CardioBrief) - A new study in JACC: Cardiovascular Interventions may revive interest in the idea of PFO closure for the treatment of migraines. This area has been highly controversial in recent years. Now a new study from Italy suggests that closure of large PFOs may in fact be beneficial in these patients. (JACC: Cardiovascular Interventions)

February 17, 2009: Elderly in Cardiogenic Shock Benefit from Early PCI

• (CardioBrief) - Elderly patients in cardiogenic shock may benefit from early use of PCI, according to a new study in JACC: Cardiovascular Interventions. “Although mortality occurs in roughly half of patients in these high risk situations, without this aggressive treatment, the prospect of survival is very poor,” said David Clark, in an ACC press release. “A patient’s age in and of itself should not be used to deny someone more aggressive, invasive care with angioplasty for cardiogenic shock,” commented Judith Hochman, who is the author of an accompanying editorial. (JACC: Cardiovascular Interventions)

February 17, 2009: Researchers Identify First Common Genes Variants that Regulate Blood Pressure

• (CardioBrief) - Two gene variants that encode for natriuretic peptides are associated with significant differences in blood pressure, according to a new study published in Nature Genetics. (Nature Genetics)

February 17, 2009: SALT II: Letter Writers React to Alderman’s NY Times Op-Ed Piece

• (CardioBrief) - Letter writers to the New York Times, angry at Michael Alderman’s op-ed critique of proposed low salt regulations, are ready to turn him into a pillar of salt. Dr. Steven Havas notes that high sodium consumption causes at least 150,000 prematures deaths each year in the United States. Nephrologist Sheldon Hirsch responds to Alderman’s point that most people would not benefit from sodium restrictions: “But public policy is meant to advance the general welfare. It does not necessarily provide all individuals with equal (or even any) benefit, nor must it necessarily impinge on individual medical decisions.” But at least one writer expressed strong approval for Alderman’s position: “I’m not sure I like the idea of the government’s telling me what to eat. No, let me rephrase that: I do not want the government in my kitchen.”

February 17, 2009: Stent Wars: Abbott Wins and Medtronic Loses

• (CardioBrief) - A year after the launch of the second generation drug-eluting stents the clear winners and losers are emerging, according to a Dow Jones story by Jon Kamp.Medtronic’s Endeavor stent seems stuck with only a 10% market share, while Abbot’s Xience stent (also marketed by Boston Scientific) holds about half the market.

February 13, 2009: FDA Advisory Committee to Consider Dronedarone in March

• (CardioBrief) - Following fast on the heels of the publication of the ATHENA trial in the NEJM, the FDA announced it will hold a hearing of the Cardiovascular and Renal Drugs Advisory Committee on March 18 to consider “the proposed indication in patients with a history of, or current atrial fibrillation or atrial flutter, for the reduction of the risk of cardiovascular hospitalization or death.”

February 13, 2009: Judge Who Ruled in Favor of Medtronic Failed to Disclose Family Link to Company

• (CardioBrief) - The judge who ruled in Medtronic’s favor by dismissing a big lawsuit against the company didn’t disclose that his son is a partner in a law firm that has Medtronic as a client, according to a story in Friday’s Wall Street Journal. Applying the principle of preemption, which has recently received strong support from the Supreme Court, the judge dismissed seeking damages from Medtronic for harm caused by the company’s Sprint Fidelis defibillator leads. Despite the disclosure, the plaintiffs will have a difficult time overturning the decision according to a NYU law professor quoted in the Journal story.

February 13, 2009: Women With NSTE ACS Don't Benefit From Invasive Procedures

• (WikiDoc) - Routine invasive procedures do not seem to benefit women with non-ST-elevation (NSTE) acute coronary syndromes (ACS), according to a substudy of the OASIS 5 trial published in the European Heart Journal. Instead, the study found, those women are more likely to die and more often experience significant bleeding. The study suggests research done on invasive procedures in men may not apply to women, and vice-versa. The study looked at 185 women and its author admits more studies may be needed. (European Heart Journal)
• Download the slides here
• Read the article here

February 12, 2009: Registry Sheds Light on Takotsubo Cardiomyopathy

• (CardioBrief) - Stress-induced cardiomyopathy, otherwise known as Takotsubo cardiomyopathy, is now regarded as a genuine clinical entity. Data from a Rhode Island registry, published online in the American Journal of Cardiology, sheds light on its “characteristics, treatment strategies, and natural history”. In a cohort of 70 patients, 95% were postmenopausal women. The authors observed a spike of cases in the summer months and concluded that “overall long-term prognosis and recovery of left ventricular function were excellent.” (American Journal of Cardiology)

February 12, 2009: After FAME: New Study Offers Clues to Utility of FFR

• (CardioBrief) - The recent publication of FAME in the NEJM drew attention to FFR (fractional flow reserve) to guide PCI during angiography. Now, a new study published online in the American Journal of Cardiology may shed some light on its practical clinical utility. In a study of 142 patients with intermediate LMCA stenosis, the researchers concluded that “FFR measurement is helpful in guiding the decision whether to revascularize patients with intermediate LMCA stenosis. (American Journal of Cardiology)

February 12, 2009: Stem Cell Drug for Heart Attacks Shown Safe in Early Testing

• (WikiDoc) - An experimental stem cell drug has been shown to improve heart function in an early stage trial. Prochymal, by Osiris Therapeutics, is made from adult stem cells and was tested in a 53-patient trial. It will now advance to a larger mid-stage trial focused on patients who have had a heart attack.

February 12, 2009: Genetic Code of Cold Virus Mapped

• (WikiDoc) - Scientists at the Universities of Maryland and Wisconsin-Madison have mapped the genetic code of the common cold, or at least the 99 most-common strains of it. According to the journal Science, the genetic mapping of the the common cold, or human rhinovirus, could be a great step toward full genome-based epidemiologic studies and antiviral or vaccine development. (Science)

February 12, 2009: ATHENA Published in NEJM: Dronedarone Benefits AF Patients

• (CardioBrief) - The ATHENA trial, originally presented last May at the Heart Rhythm Society meeting, has been published in the New England Journal of Medicine. The trial found that “dronedarone reduced the incidence of hospitalization due to cardiovascular events or death in patients with atrial fibrillation.” (New England Journal of Medicine)

February 12, 2009: Contrast Echo Found Useful in Technically Difficult Cases

• (CardioBrief) - The precise role of contrast echocardiography in clinical practice has been difficult to determine. Now a new study in JACC from Methodist Hospital in Houston, TX, has found that CE can dramatically reduce the percentage of uninterpretable studies and technically difficult studies in a series of 632 patients. (JACC)

February 11, 2009: Prasugrel: Now the Real Work Starts

• (CardioBrief) - The spotlights have turned elsewhere, but it’s only now the real work on prasugrel will take place. As a brief item in Inside Indiana Business notes, Lilly officials will now begin “a period of intense discussions” with the FDA over labeling of the drug. In an accompanying video interview, Lilly VP Tony Ware said that approval of prasugrel could help prevent 23,000 heart attacks, 7,000 stent thromboses, and 4,000 cardiovascular deaths, at the expense of 2,300 major bleeds. Ware said that Lilly supported appropriate cautions on the use of the drug in stroke patients or patients with a history of stroke, patients over 75 years of age, and patients weighing less than 130 lbs. When asked when he expected prasugrel to be approved, Ware said “it’s very hard to predict the timing on the FDA…. if I had a crystal ball to know when exactly it would be available I’d have to say it’s been a little cloudy of late.”

February 10, 2009: David Sabiston Jr, Pioneering Surgeon, Dead at 84

• (CardioBrief) - David Sabiston Jr, who performed an early version of coronary bypass surgery in 1962 while at Johns Hopkins, died last month. Sabiston’s early work helped pave the way for the ascension of CABG as a mainstay of modern medicine. Sabiston went on to become the head of Duke’s department of surgery. Sabiston’s textbook is a standard in the field.

February 10, 2009: PCI for MI: Experienced Hospitals and Physicians are Best

• (CardioBrief) - Practice makes perfect. A new study in JACC shows that high-volume hospitals and high-volume physicians do far better for their patients than their low-volume counterparts. The data is taken from the New York State PCI registry. “When rare but severe complications arise, a team experienced in its recognition and treatment may be the difference between life and death,” comments James Jollis in an accompanying editorial. (JACC)

February 10, 2009: Expensive Urine: Multivitamins Have No Effect on Major Endpoints

• (CardioBrief) - Women who take multivitamins have the same risk for cancer, cardiovascular disease, and death as women who don’t take vitamins, according to a new study in the Archives of Internal Medicine. “These results suggest that multivitamin use does not confer meaningful benefit or harm in relation to cancer or cardiovascular disease risk in postmenopausal women,” say the study’s authors. (Archives of Internal Medicine)

February 10, 2009: Study Finds Lower Risk of Death for Primary Prevention Use of Statins

• (CardioBrief) - Patients who take statins for primary prevention have a lower risk of death, according to a large new observational study published in Archives of Internal Medicine. “The observed benefits from statins were greater than expected from randomized clinical trials, emphasizing the importance of promoting statin therapy and increasing its continuation over time for both primary and secondary prevention," write the study authors.(Archives of Internal Medicine)

February 9, 2009: No Connection Between Vaccines & Autism, Original Data Faked in Lancet

• (WikiDoc) - A new review published in the February 15 edition of Clinical Infectious Diseases shows no link between vaccines and autism. Furthermore, a reporter from London's Times has shown the doctor who first proposed the link faked his data. That research was originally published in the February 1998 edition of Lancet and has led to an extraordinarily widespread belief in such a connection. Click to read the Times story.

February 9, 2009: Mass General Under Scrutiny for High Mortality Rate in Cath Lab

• (CardioBrief) - The Boston Globe is reporting that Massachusetts General Hospital and St Vincent Hospital in Worcester are being monitored by state officials for high death rates in 2007 in cardiac catheterization patients. At MGH, 43 or 1,543 patients died. In response, the hospitals claim the high rates are due to aggressive treatment of exceptionally sick patients.

February 9, 2009: Doctors Too "Cavalier" in Prescribing Narcotics: FDA

• (WikiDoc) - The FDA plans to add further restrictions to two dozen narcotics because they're overprescribed, officials said in a meeting Monday. Prescriptions for schedule II narcotics, or extended-release opioids like OxyContin, fenanyl patches, and methadone and morphine tablets, are under increased scrutiny. The FDA says hundreds of patients die and thousands are injured each year because doctors inappropriately prescribe the drugs.

February 9, 2009: Increased Mortality and Cardiovascular Morbidity Associated with the Use of Nonsteroidal Anti-Inflammatory Drugs in Chronic Heart Failure by Dr. Michael W. Tempelhof

• (WikiDoc) - "Use of nonsteroidal anti-inflammatory drugs (NSAIDs) and COX-2 inhibitors in patients with known cardiovascular disease has been demonstrated to increase the risk for cardiovascular events and mortality. NSAIDS and COX-2 inhibitors have been associated with increased retention of sodium retention, endothethial dysfunction and renal toxicity. Consequently, the administration of these agents to patients with heart failure is not recommended."

February 9, 2009: 5 New Studies Shed New Light on the Genetics of MI

• (CardioBrief) - Nature Genetics has published 5 new genome wide association studies that may help unravel the genetic tangle behind heart attacks. From the study: "While the effects of these variants on risk of disease are small, further study should provide new biological insight into the mechanisms underlying coronary artery disease, particularly those involving inflammation and lipids." (Nature Genetics)

February 9, 2009: FDA Approves 2 Ablation Catheters for AF

• (CardioBrief) - The FDA today approved the first ablation catheters for the treatment of atrial fibrillation. The devices approved today are the NaviStar ThermoCool saline irrigated radio-frequency ablation catheter and the EZ Steer ThermoCool Nav. The FDA previously approved other ablation catheters to treat arrhythmias such as atrial flutter and ventricular tachyarrhythmia, but not atrial fibrillation.

February 6, 2009: Do beta blockers inhibit the anti-inflammatory effect of statins?

• (CardioBrief) - A new study in the American Journal of Cardiology raises the possibility that beta blockers might blunt the CRP-reducing effects of statins. Franz Messerli provided a comment on this provocative study to CardioBrief...

February 6, 2009: Alderman questions NYC efforts to cut salt in NY Times opinion piece

• (CardioBrief) - In an opinion piece in today’s New York Times, hypertension expert and salt skeptic Michael Alderman questions the wisdom of a New York City public health campaign to reduce salt content in processed food by 40% over the next 10 years. Given the lack of randomized clinical trials, and the ambiguity of the observational evidence, Alerman believes “ there is a possibility that such a big change in one element of their diet might have unintended harmful consequences. Prudence requires that logic and good intentions also be supported by strong evidence that such an action would be safe.”

February 6, 2009: Early study finds anacetrapib safe and effective

• (CardioBrief) - Anacetrapib, Merck’s CETP inhibitor, was safe and effective in a study of 589 patients. The results are in sharp contrast to those for torcetrapib, the Pfizer CETP inhibitor that was pulled from development after it was found to raise blood pressure. In the new study, anacetrapib had no discernible effect on blood pressure. The full text of the study, from the February issue of the American Heart Journal, is available for free at the AHJ site. You can read a good discussion of the study, with useful commentary from Roger Blumenthal, Christie Ballantyne, and John Kastelein, in an excellent Heartwire news story by Sue Hughes.

February 6, 2009: Sir James Black, pioneer of propranolol, pans state of pharma

• (CardioBrief) - Sir James Black, the Scottish scientist who developed two blockbusters that transformed the pharmaceutical industry and modern medicine, propranolol and cimetidine, laments the state of research at big pharma. Of the Pfizer-Wyeth merger he says: “Will they never learn? They will completely exhaust each others’ energies for two years.” Read the interview in the Financial Times.

February 5, 2009: New DES studies add new understanding about clopidogrel duration, LAD usage, and ISR

• (CardioBrief) - Clopidogrel duration: In a study of nearly 3,000 DES patients, stopping clopidogrel at 30 days or 6 months, but not 12 months, was associated with stent thrombosis, “thus suggesting,” according to Waksman’s group at the Washington Hospital Center in an article in press in the American Journal of Cardiology, “the optimal duration of therapy for the prevention of ST to be 6 to 12 months.”

• (CardioBrief) - DES versus BMS for proximal LAD: One-year clinical outcome in 136 BMS and 350 DES patients were the same, according to another study by Waksman’s group in the February 15 issue of the American Journal of Cardiology.

• (CardioBrief) - DES for the treatment of BMS vs DES ISR: The advent of DES has not eliminated the problem of in-stent restenosis. According to yet another study from Waksman’s group in the February 15 issue of the American Journal of Cardiology, “DES ISR continues to be a therapeutic challenge because patients with DES ISR treated using DESs experience higher rates of recurrence compared with patients with BMS ISR treated using DESs. The optimal treatment of patients with DES restenosis remains to be defined.”

• (CardioBrief) - DSCT to detect in-stent restenosis: Dual source computed tomography may help in thenoninvasive detection of ISR, according to a German study published online in the American Journal of Cardiology.

February 5, 2009: Google & IBM Partner to Improve Online Health Records

• (WikiDoc) - Today, technology giants Google and IBM released new software that allows patients to upload the data generated by home-health monitoring products to their personal health record in Google Health. The two companies hope that the software will help patients provide healthcare providers with a more current and complete view of their medical records. The software release represents an early step towards instituting industry wide electronic healthcare records, which is a top priority of the Obama administration. (Wall Street Journal)

February 4, 2009: Many Diabetics Ignore Doctor's Orders

• (WikiDoc) - One third of diabetics never fill their doctor's prescription for antidiabetic meds, according to a study in this month's Journal of General Internal Medicine. The researchers looked at 1,132 adult patients treated at Geisinger Clinic in Danville, PA. They were all members of its health plan and were prescribed antihyperglycemic medication. The study's authors then matched their patients' electronic health records to insurance claims to see who followed their doctors' advice. (Journal of General Internal Medicine)

February 4, 2009: Tomaselli Named Director of Cardiology at Johns Hopkins

• (WikiDoc) - Dr. Gordon Tomaselli is taking the helm of the cardiology division at Johns Hopkins University School of Medicine. A cardiac electrophysiologist, Tomaselli's been at Johns Hopkins since 1986, concentrating primarily on arrhythmias. He will continue on as co-director of the school's Heart and Vascular Institute. Tomaselli is taking over for Eduardo Marbán, M.D., Ph.D., who has led the cardiac division since 2002.

February 4, 2009: BIDMC Physician Opens Mail, Finds $1 Million

• (WikiDoc) - $1 Million was not what Beth Israel Deaconess primary care physician Jerry Smetana expected to find in his mail recently, but there it was: an extraordinary gift from his former friend and philanthropist Harvey Picker. Smetana was Picker's primary care physician, and over the course of the last two decades Picker had developed an interest in his doctor's research. In time, he made a couple donations to Smetana and his projects. When Picker died last year, Smetana wondered what would happen to his research. Then he got a strange letter in the mail. Click here to read the rest of the story...

February 3, 2009: FDA Panel Unanimously Recommends Approval of Prasugrel

• (CardioBrief) - The FDA’s cardiorenal advisory committee has unanimously recommended approval of prasugrel. Stay tuned to CardioBrief for more details.

February 3, 2009: The Uninvited: Sanjay Kaul Removed from Prasugrel’s FDA Advisory Panel

• (CardioBrief) - CardioBrief has learned from multiple sources that Sanjay Kaul will not be a member of the FDA advisory panel on Tuesday’s hearing to evaluate prasugrel. Kaul has been a sharp critic of recent drug trials, and has raised public concerns about prasugrel and other cardiovascular agents in recent years. Kaul’s name appeared on the FDA roster posted on the FDA website last Friday. Although his name still appeared on the document at the time of this posting, Kaul was removed late last week from the committee for having an intellectual conflict of interest, though it is unclear exactly what this means or what it implies. Certainly the FDA had to have known that Kaul was an outspoken critic– just google “Kaul and prasugrel” to see what I mean. So this raises the question: what prompted this last minute dramatic move on the part of the FDA?

February 3, 2009: Amid Washington Uncertainty, Califf Reportedly Still in Running to be FDA Commissioner

• (CardioBrief) - Robert Califf is still in the running to be the next FDA commissioner, according to the InVivo blog. Califf’s bid is apparently backed by Senator Ted Kennedy, while Sharfstein, the other often-named contender for the job, is backed by Henry Waxman, a powerful figure in the House. One important word of caution: the blog post appeared before Tom Daschle withdrew his name as the Obama administration’s nominee for secretary of HHS.

February 3, 2009: AHA: Doctors Should Avoid Unnecessary Heart Scans

• (WikiDoc) - The American Heart Association is urging doctors to avoid unneeded heart imaging tests, citing the link between ionizing radiation exposure and cancer. The AHA science advisory panel is issuing guidelines for physicians on the use of such tests in the Feb. 2 issue of Circulation. Medical imaging is the biggest source of controllable radiation exposure for Americans, according to the panel, and doctors should be judicious in its use. (Circulation)

• (CardioBrief) - In addition, a new study in JAMA has found a wide variation in radiation dose between different institutions and different devices. “Effective strategies to reduce radiation dose are available but some strategies are not frequently used,” say the authors. (JAMA)

February 3, 2009: T-wave alternans may help identify some patients who don’t need an ICD

• (CardioBrief) - T-wave alternans (TWA) is still on the long and winding road to widespread clinical acceptance, and there’s no end to its journey in sight right now. The ABCD (Alternans Before Cardioverter Defibrillator) Trial has been published in JACC. The study investigators, and the editorialists, agree that TWA has promise, but that it can not yet be used to identify patients who don’t need an ICD. (JACC)

February 3, 2009: Erectile Dysfunction-Heart Disease Link Shown

• (WikiDoc) - A definitive link between erectile dysfunction and heart disease exists, and has been shown by Mayo Clinic researchers. A new study of 1,402 men found those with ED are 80 percent more likely to develop HD than the men without ED. Researchers are unsure why ED is a harbinger of HD but have investigated the link since two preliminary studies in 2005 pointed to the same conclusion. (Mayo Clinic)

February 2, 2009: Atorvastatin Gets Its Own Planetoid

• (CardioBrief) - It’s certainly not a gas giant on the scale of JUPITER, but a new study published in Clinical Therapeutics has found that high dose atorvastatin is more effective at reducing CRP than low dose atorvastatin. With only 340 patients, the trial was not large enough to detect any differences in clinical outcomes, of course.

February 2, 2009: Synthetic HDL Molecules Feature Heart of Gold

• (WikiDoc) Researchers at Northwestern University have successfully created synthetic HDL molecules - "good" cholesterol - featuring gold nanoparticles at their core. The molecules' surface so closely mirrors real HDL that, like the real thing, they latch on to LDL and don't let go. While the molecule holds promise for treatment of cardiovascular disease, it has yet to be tested in living bodies. While drugs are currently available to help lower LDL levels, it is very difficult to raise HDL.

February 2, 2009: Noisy Traffic Can Hurt Your Heart

• (WikiDoc) - If constant honking, blaring sirens and noisy traffic stress you out, they could really be doing a number on your heart. Swedish researchers found folks who live with constant road noise are 40 percent more likely to suffer a myocardial infarction. Researchers say those most at risk live with a steady backdrop of about 50 decibels, or the the equivalent of a moderate rainfall. The researchers say the noise-heart attack link was independent of other factors like air pollution.

January 30, 2009: Prasugrel’s FDA Outlook Appears Brighter

• (CardioBrief) - Next Tuesday the FDA’s Cardiovascular and Renal Drugs Advisory Committee will help decide the fate of prasugrel (Effient), Lilly’s highly anticipated and somewhat controversial antiplatelet drug that many have predicted could be the next clopidogrel. The FDA has released its briefing documents for the meeting, and the bottom line is that prasugrel’s path to approval appears less bumpy than some had expected. On the other hand, the document recommends a boxed warning for the drug. According to a Dow Jones Newswire story, analysts are predicting the drug will receive approval, but only for a narrow indication.

January 30, 2009: NT-proBNP Guided vs. Symptom-Guided Heart Failure Therapy by Michael W. Tempelhof

• (WikiDoc) - Cardiologists using N-terminal proBNP (NT-proBNP) levels to guide treatment of heart failure patients may not see significant improvement over more standard symptom-guided therapy. A study, printed in JAMA, looked at 499 patients aged 60 or older who had been recently hospitalized for heart failure. It found that after 18 months, patients whose therapy was guided by N-terminal BNP did not experience a better quality of life or see improved overall clinical outcomes.

January 30, 2009: Lancet editorial: OTC Orlistat Not in the Public Interest

• (CardioBrief) - Orlistat should not be available over-the-counter, according to a Lancet editorial. Orlistat recently received OTC approval in Europe and is already available OTC in the USA. According to the editorial, ”better accessibility to orlistat may not necessarily be in the best interests of the public. Orlistat has limited effect in the management of obesity—the average weight loss per year is only 2.5 kg. Making this drug available OTC will add false credibility to the notion that there is an easy pill-popping solution to obesity rather than long-term lifestyle changes.” (Lancet)

January 29, 2009: Heartburn Drugs May Interfere with Plavix, Lead to 2nd Heart Attack

• (WikiDoc) - Clot-preventing drug Plavix, taken with heartburn drugs after a heart attack, dramatically increases a patient's chances of having a second heart attack, according to the Canadian Medical Association Journal. Plavix and Proton pump inhibitors like Prilosec and Prevacid are among the most widely prescribed drugs in the world, so these findings could have an enormous public health impact. The Canadian study looked at 13,636 people who had heart attacks between 2002 and 2007. They found those who took Plavix along with a proton pump inhibitor had a 40 percent increased chance of having a second heart attack. Scientists believe the heartburn meds interfere with body's ability to metabolize the clot-preventing drug. (Canadian Medical Association Journal)

January 29, 2009: Generic Metoprolol Succinate Shortage Causing Problems

• (CardioBrief) - The Wall Street Journal Health Blog is reporting that a shortage of generic metoprolol succinate is causing trouble for some patients. Following an FDA warning last year, Sandoz recalled 6 millions bottles of the generic drug. Then, earlier, this month, KV Pharmaceutical stopped making its version of the drug. Some insurers won’t reimburse for AstraZeneca’s brand name Toprol XL and some patients are being switched to metoprolol tartrate (Lopressor).(Wall Street Journal)

January 29, 2009: Urine Test for CAD in the Future?

• (CardioBrief) - A group of European and Australian researchers have taken the first step toward developing a urine test to detect coronary artery disease (CAD). In a new study in the Journal of Proteome Research, the team performed a urine proteomic analysis to identify a combination of 17 proteins associated with angiographically detected CAD. Don’t go looking for a clinical test anytime soon, but this may be a hint of the future. (Journal of Proteome Research)

January 29, 2009: Outpatient Surgery Skyrockets

• (WikiDoc) - Outpatient clinics now perform two out of every three surgeries in America. According to a new study by the National Center for Health Statistics, improvements in pain medication and anesthesia, along with less invasive procedures, kept patients from having to stay overnight in a hospital. Insurance also played its part, with insurance companies pushing hospitals and doctors to perform more outpatient procedures. Some doctors worry about the rise of outpatient clinics, though, because they may not stay maintain 24-hour emergency rooms. (National Center for Health Statistics)

January 28, 2009: SPECT-MPI May Be Useful in New Onset HF

• (CardioBrief) - SPECT-MPI may be useful in ruling out coronary artery disease in patients with new onset heart failure, according to a non-randomized, observational, cohort study published in the Journal of Nuclear Cardiology. Click to read the press release from Lantheus Medical, which makes Cardiolite. (Journal of Nuclear Cardiology)

January 28, 2009: FDA Warning: Dietary Supplement Contains Sibutramine

• (CardioBrief) - The FDA is warning consumers that Venom HYPERDRIVE 3.0, marketed by Applied Lifescience Research Industries Inc, contains significant amounts of sibutramine. Click to read the FDA press release. (FDA)

January 28, 2009: CV Therapeutics Rejects Buyout Offer From Astellas Pharma (Updated)

• (CardioBrief) - CV Therapeutics, which markets Ranexa (ranolazine), has rejected a buyout bid from Astellas Pharma. Click to read the Astellas press release and the response from CV Therapeutics.

January 28, 2009: New Slides on ClinicalTrialResults.org

• Thrombus Aspiration During Primary Percutaneous Coronary Intervention Improves Myocardial Reperfusion and Reduces Infarct Size (EXPIRA Trial) by Dr. Gennaro Sardella

January 28, 2009: Medicare Increasing Unable to Tamp Down Cancer Costs

• (WikiDoc) - The price of cancer drugs has ballooned over the past 15 years and Medicare is increasingly unable to do anything about it, according to a report in the New England Journal of Medicine. Spending on cancer drugs is also rising faster than many other areas of health care and it may be up to policymakers to stem its mounting costs. The author's article contends Medicare seems to have less freedom to contain those expenses because of the "unique legislative and regulatory framework" that surrounds cancer drugs.(NEJM)

January 27, 2009: TIME-CHF: BNP-guided therapy misses the boat

• (CardioBrief) - BNP was no better than symptoms in guiding therapy for elderly CHF patients, according to a new study published in JAMA (2009;301(4):383-392). The study was originally presented last summer at the European Society of Cardiology meeting in Munich. In an accompanying editorial in JAMA, Ileana Pina and Christopher O’Connor conclude...(JAMA)

January 27, 2009: Uric acid and insulin levels linked to risk of hypertension

• (CardioBrief) - Small increases in uric acid and insulin levels, even at levels usually considered “normal,” are linked to an increased risk of hypertension, according to a new study in the Archives of Internal Medicine. Commenting on the report for CardioBrief, Franz Messerli… (Archives of Internal Medicine)

January 27, 2009: Tech-Savvy Hospitals, Better Hospitals?

• (WikiDoc) - Hospitals that “go digital” with electronic medical records and data systems experience fewer deaths and lower costs, according to a study published in the Archives of Internal Medicine. President Obama has declared digital health records a key focus of his health care reforms, and has proposed spending $50 billion a year for five years to get it done. The Archives study looked at how 41 Texas hospitals used technology and found patients had a 15% lower chance of dying in the most tech-savvy hospitals. But the researchers admit they couldn’t rule out the possibility that those hospitals with fewer deaths were generally “better” hospitals to begin with. Which is exactly what another study just found…

• The group HealthGrades took a look at more than 150,000 Medicare patients and found the odds of dying in a top-rated hospital are much lower than at other hospitals. Patients in a top five percent of hospitals had a 27 percent lower death rate than patients in the bottom 95 percent. The researchers also found the top-rated hospitals had an eight percent lower risk of complications. (Archives of Internal Medicine, HealthGrades)

January 26, 2009: Larry Husten, the former editor of TheHeart.Org, will serve as WikiDoc's first Director of Medical Journalism

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  The exact nature and scope of the position have yet to be fully defined, but Husten said that he hopes to "encourage and facilitate the development of high quality medical journalism in this new medium." Husten was the editor of TheHeart.Org from its inception in 1999 until December 2008. Before that he was a freelance medical journalist who wrote for The Lancet, The New York Times, Discover, and a large number of other medical and computer publications. In 1994-1995 he was a Knight Science Journalism Fellow at MIT. He received a PHD in English from the State University of New York at Buffalo and drove a taxicab in New York City before embarking on a career in medical journalism. Larry's blog, www.cardiobrief.com, is a one-stop source for information about new and interesting events in the cardiology universe. The content will also appear on clinicaltrialresults.com and wikidoc.org.

January 26, 2009: FDA Announces Ongoing Safety Review of Clopidogrel

• In an “early communication” posted on its website, the FDA announced today that it was examining the safety of clopidogrel. The review is a response to recent studies showing widespread variability in the efficacy of clopidogrel, based on genetic differences in the metabolism of the drug, or when it is administered with other drugs, such as PPIs. Eric Topol told CardioBrief that “pending work that needs to be done,” he believes that “genotyping for CYP2C19 will be indicated if it is shown that increasing the dose of clopidogrel overrides the lack of anti-platelet action.” He was more skeptical about the PPI story, noting that “the same scare with some statins proved a non-issue,” but agreed that the issue required further study. The FDA told Dow Jones that it was working with Bristol-Myers to update the drug’s label and that it was in discussions with Bristol-Myers and its partner on the drug, Sanofi-Aventis, about new clinical trials concerning this issue. (CardioBrief)

January 26, 2009: Danish Researchers Recommend Avoiding NSAIDs in HF

• NSAIDs are associated with significant increases in death and cardiovascular morbidity, according to a large, new registry study from Denmark in the Archives of Internal Medicine. Danish researchers found dose-dependent elevated risk levels for death and risk of hospitalization with use of rofecoxib, celecoxib, ibuprofen, diclofenac, naproxen, and other NSAIDs. They conclude that “patients with HF should, if possible, avoid using any NSAIDs at any dosage for most NSAIDS and at high dosages for ibuprofen and naproxen.” Dr. Steven Nissen agrees with the recommendation of the researchers but fully acknowledges the limitations of this type of research. He told CardioBrief: “Like all observational studies, this one has important weaknesses. There are many known and unknown confounders for which adjustment is not possible. All NSAIDs increase sodium retention and these drugs have long been associated with increased risk of heart failure. With regard to the effects on MI and mortality, the results suggest a class effect, but this can only be verified by a well-designed, prospective randomized trial. We are conducting such as study, the PRECISION trial in 20,000 patients using three of these drugs, naproxen, ibuprofen, and celecoxib. Until the results are available, prudent practitioners should use NSAIDs in high risk patients only when absolutely necessary and should always use the lowest effective dosage for the least duration possible.”(CardioBrief)

January 26, 2009: Innovative stent company seeks emergency intervention

• Xtent, a small company developing an innovative drug-eluting stent system featuring customized lengths and diameters, is being seriously threatened by the financial crisis. The company has announced that it will fire 112 of its 121 employees unless it can strike some sort of deal. Click to see the press release.(CardioBrief)

January 26, 2009: Evidence-Based Treatment for HF Sees Improvements

• Australian researchers have seen long-term improvement in heart attack patients undergoing evidence-based treatments. The study, printed in the British Medical Journal, did a 12-year follow-up on 4,500 Australians who survived 28 days after a myocardial infarction. The researchers noted improving trends for those treated with a progressive regime of evidence-based treatments and coronary revascularization in their initial admission to the hospital and over the following year. (British Medical Journal)

January 26, 2009: Follow-Up: Surgeons Adopting Strict Rules on Payments

• The North American Spine Society now requires its members to disclose all ties to medical device companies - including dollar amounts. Two weeks ago we told you about a University of Wisconsin researcher who raked in more than $19 million over five years from spinal device maker Medtronic. After coming under fire from lawmakers, the NASS made its disclosure policy dramatically stricter. The Wisconsin researcher had only been required to report earning "more than $20,000" in donations from medical companies. (Wall Street Journal)

January 26, 2009: Measuring Fractional Flow Reserve During PCI Improves 1-Year Outcomes

• Percutaneous coronary intervention (PCI) for treatment of NSTEMI and/or STEMI from ischemia has been associated with improvements in short-term and long-term clinical outcomes. However, in ischemic patients with multiple vessel disease, determination of which lesion is the culprit stentoic lesion requiring intervention is often difficult.

January 23, 2009: Citing Costs, Younger Americans Skipping Meds

• One in seven Americans under the age of 65 passed on medication last year because it was too expensive. Not surprisingly, those with low incomes, chronic conditions and the uninsured were most likely to go without. But having insurance didn’t always help. According to the Center for Studying Health System Change, rising drug costs, more-frequent prescription-writing and expensive specialty meds all played a role. The researchers believe as the recession in America lengthens even more people will skip their meds, leading to more health-related complications. (Center for Studying Health System Change)

January 23, 2009: Women with Heart Problems Often Left Waiting

• Emergency medical personnel seem to delay women with signs of heart failure longer than men. Researchers at Tufts University examined nearly 6,000 emergency calls from Dallas County, Texas and found patients spent an average of 34 minutes with emergency personnel. But women were 52 percent more likely to be delayed by 45 minutes or more. Researchers weren’t able to say why that was the case but suggest heart problems in women aren’t as recognizable as those in men. (Circulation: Cardiovascular Quality and Outcomes)

January 23, 2009: 4,000-Person Drug Trial Scrapped After Sponsor Declares Bankruptcy

• In a clear sign of how the economic downturn is affecting research, phase 3 drug trial COGENT 1 has been scrapped after its sponsor declared bankruptcy. The trial would have tested a single-pill combination of clopidogrel and omeprazol to reduce gastrointestinal side effects in heart patients. Cogentus Pharmaceuticals, based in Palo Alto, CA, was the sponsor behind the trial. (TheHeart.org)

January 23, 2009: MA State Ethics Law Scuttles Plans for Medical Meeting

• A Massachusetts state law regulating medical industry marketing has wrecked plans for a medical group meeting to be held in Boston. The American Academy of Allergy, Asthma and Immunology was planning on holding its 2015 meeting in Boston but pulled out after deciding the new law would not allow it to offer Continuing Medical Education credit. Some presenters at the meeting work for drug and device companies, and as such would not meet the requirements for CME under the new law. (MedPage Today)

January 22, 2009: Gifts to Doctors Must Be Disclosed

• Any gifts made to doctors exceeding $100 per year would need to be disclosed under legislation introduced in the U.S. Senate Thursday. Companies that fail to disclose such gifts could see fines as high as $1 million, according to the Physician Payment Sunshine Act introduced by Senators Charles Grassley (R) and Herb Kohl (D). A similar bill failed in congress last year but Grassley says he feels this version has a good chance of passing the current Democrat-controlled houses. (Reuters)

January 22, 2009: Stroke Survivors with AF Have Greater Risk of Death

• Atrial fibrillation greatly increases stroke survivors’ chances of death, according to a study in the International Journal of Cardiology. Survivors with the arrhythmia showed a 50% greater chance of all-cause mortality versus those without it. The study showed patients older than 75 are at greatest risk, followed by those with congestive heart failure, prior stroke and diabetes. The researchers used patients’ CHADS2 scores to accurately determine how at risk they were for dying after ischemic stroke. (International Journal of Cardiology)

January 22, 2009: Women Make Better Heart Care Doctors?

• A European study demonstrates women are better at treating patients with chronic heart failure than their male counterparts. Female doctors are more likely to play by the book, following recommended guidelines for drug choice and dosage. Their male colleagues are less likely to prescribe drugs for CHF patients, and more likely to lower the dose if treating women. The researchers note, though, that women patients don’t necessarily have worse outcomes even though they get fewer drugs. Female CHF patients are also more likely to be misdiagnosed. (European Journal of Heart Failure)

January 22, 2009: American Journal of Clinical Nutrition

• Lowering salt intake improves endothelial function, according to researchers in the American Journal of Clinical Nutrition. They studied 29 overweight and obese patients with normal blood pressure and found those that cut salt in their diets had improved vessel dilation and blood flow. Scientists say further study is needed but it seems lowered blood pressure is not the only benefit of decreasing salt intake. (American Journal of Clinical Nutrition)

January 21, 2009: Pictures of a Bleeding Heart

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  Scientists in London have captured dramatic images of heart muscle bleeding immediately following heart attacks. The researchers used MRI machines to scan 15 people who had just suffered attacks. They found a direct correlation between the amount of heart damaged and the amount the heart bled. Recent research has shown some hearts bleed after blood restarts pumping through damaged tissue. The amount of bleeding that occurs after infarction may also indicate how well the patient recovers. (Radiology)

January 21, 2009: More Doctors E-Mailing It In

• The number of doctors prescribing medicine electronically has more than doubled in the past year thanks to a number of new incentives. Now about 70,000, or 12% of office-based doctors, have ditched pen and paper for software. Some studies have shown medicines are less likely to get mixed up if they’re e-prescribed, and starting this month Medicare’s going to give doctors a bonus if they make the digital switch. E-prescriptions may just be a start; the Obama administration wants to spend $50 billion in the next five years to adopt health-information technology. (Wall Street Journal)

January 21, 2009: Problems Pumping Iron? Maybe You’ve Got a Problem Pumping Blood

• Problems in the left ventricle are a good indicator of whether a person will have problems exercising. Researchers at the Mayo Clinic studied a group of people undergoing exercise echocardiography and found a strong inverse correlation between diastolic dysfunction and exercise capacity. They saw that those with mild and moderate/severe resting diastolic dysfunction had reduced exercise capacity. They also noted similar correlations with increased age, femaie sex and high body mass index. (JAMA)

January 21, 2009: Bill Gates, Others Pledge $630 Million to End Polio

• Should the U.S. start stockpiling antibiotics? Five years ago the last American plant to manufacture crucial ingredients for a number of drugs like penicillin closed its doors. On the heels of China's third reported case of human bird flu this year, some are asking whether President Obama’s administration should start storing more medicine at home. (Rotary International)

January 20, 2009: With a New President, a New Worry

• Retired Microsoft founder Bill Gates is teaming with a group of donors to give $630 million to eradicate polio. The Gates Foundation is teaming with Rotary International and the British and German governments. Polio remains a serious problems in parts of Africa, India and the Middle East. Despite the $630 million, the World Health Organization believes another $2 billion is needed to eliminate the disease by 2013, one of its goals.(New York Times by Gardiner Harris)

January 20, 2009: First Time Heart Attacks Not as Severe

• First time heart attacks aren’t as bad as they once were. Researchers in the current issue of Circulation think that may help explain why the heart attack death rate has declined by 1.5% over the past two decades. Since 1987, studies have shown those first attacks are doing less damage to the heart - though it’s unclear why. (HealthDay by Ed Edelson)

January 20, 2009: The “Sure Thing” Gene

• One percent of the world’s population carries a gene mutation nearly guaranteed to lead to heart problems. If those odds aren’t bad enough, they’re even worse for Indians. One in 25 people in India carry the gene, which means by next year India will have 60% of the world’s heart patients. It’s rare a common mutation has such a huge negative effect, according to scientists. (BBC News)

January 20, 2009: Men Better at Resisting Temptation

• Men’s brains may be better at resisting food cravings than women’s. A small study may shed some light on why greater numbers of women are obese. Twenty-three test subjects went without eating for 17 hours. Then researchers asked them to control their desire as they were taunted by plates of their favorite meals. Brain scans showed men fared better. (Time by Jeffrey Kluger)

January 20, 2009: Drug-Resistant Staph Infections Rising in Kids

• An “alarming” increase in children’s ear, nose and throat infections caused by drug-resistant staph, or MRSA, has a number of scientists worried. In the five year period between 2001 and 2006, the percentage of MRSA infections more than doubled, to 28 percent. These superbugs were once thought to only come from hospitals; now they’re being found in the community. (AP by Lindsey Tanner)

January 16, 2009: Brian Blank has joined WikiDoc as its inaugural Scholar in Medical Journalism

• Blank will be heading WikiDoc's international news bureau. Blank graduated from the University of Missouri-Columbia in 2003 with a degree in broadcast journalism. After working in local TV and radio, he moved to CNN in Atlanta as a researcher. There he assisted reporters and producers in CNN’s duPont award-winning coverage of the 2004 South Asia tsunami disaster and Peabody award-winning coverage of 2005’s Hurricane Katrina. He went on to do some reporting for CNN Radio in New York before moving to FOX in 2007. There he helped start the FOX Business Network as anchor Neil Cavuto’s producer. In 2008 he left that and moved to Cambridge, MA to complete a post-baccalaureate pre-med program at Harvard University in hopes of attending medical school in the future.

January 16, 2009: Popular Health Risk Tools Don’t Find Heart Disease

• Traditional risk assessment tools like the Framingham and National Cholesterol Education Program, NCEP, do not accurately predict coronary heart disease. In a Yale University School of Medicine study of 1,654 patients, some with no history of the disease and some taking statins, doctors used the tests to calculate the patients’ risk of heart disease. Researchers compared those results to the amount of plaque actually found in the patients’ arteries. The results: One in five patients thought to need statins before the test actually didn’t. And one in four taking statins had no plaque whatsoever.(ScienceDaily)

• Looking at cholesterol levels may not be any better. In another study, researchers found that nearly 75% of people hospitalized for heart attacks had normal levels of LDL cholesterol, the “bad” kind. The study’s author contends current cholesterol level guidelines should be changed, a topic the National Heart, Lung and Blood Institute is likely to look into soon.(HealthDay News by Ed Edelson)

January 16, 2009: Heparin-Induced Antibodies Point To Thrombosis Risk

• Cardiac patients with antibodies that resist heparin are more likely to develop thrombosis after surgery. Some of the patients studied developed the antibodies during surgery while others already had some resistance. But either way, researchers found the patients were more likely to develop deep vein thrombosis, a pulmonary embolism or myocardial infarction.(American Heart Journal by Anna Vittoria Mattioli, et al.)

January 16, 2009: Superbugs Vs. Cancer Drugs

• So-called “superbugs” that haunt some hospitals may have an enemy in cancer drugs. Some antibiotic-resistant bacteria “play dead,” or go dormant to avoid attack, then reawaken later. Scientists have discovered a protein called Hip A that enables the cells to go dormant is actually a protein kinase. Because several cancer drugs work by inhibiting protein kinases, it’s thought they might be able to treat some forms of antibiotic resistance.(NewScientist by Linda Geddes)

January 16, 2009: Senator: Schools Failing to Regulate Medical Conflicts of Interest

• Iowa Sen. Charles Grassley (R) says schools don’t go far enough to disclose researchers’ ties to industry. The senator recently informed the University of Wisconsin that one of its lead spinal surgeons/researchers under-reported payments received by spinal device maker Medtronic – by a factor of 100. While only required by the school to report receiving “more than $20,000,” Dr. Thomas Zdeblick actually received at least $2.6 million a year in royalty and consulting payments. In all, Dr. Zdeblick received $19 million from 2003 to 2007. Sen. Grassley blames the school’s disclosure requirements.(Wall Street Journal by David Armstrong and Thomas M. Burton)

January 16, 2009: Coffee Can Reduce Alzheimer’s, Cause Hallucinations

• Those daily coffee runs may help reduce the risk of Alzheimer’s. Middle-aged people who drink between three and five cups a day lowered their risk of developing dementia and Alzheimer’s by nearly two-thirds. Scientists aren’t sure why, exactly, but believe it may have something to do with the antioxidants found in coffee. Or it could be its ability to protect the nervous system.(Agence France-Presse)

• But that comes on the heels of another study that showed college students who drink more than seven cups of coffee a day sometimes hear voices that aren’t really there. The study’s researchers say they couldn’t prove a direct link between java and auditory hallucinations but more study is warranted.(Scientific American)

January 6, 2009: Cytochrome P450 2C19 polymorphism linked to poor outcomes for young MI patients treated with clopidogrel

• Patients who had CYP2C19*2 genetic variant in the CYP2C19 gene and were treated with clopidogrel after a myocardial infarction (MI) demonstrated worse cardiovascular outcomes than patients with a normal copy of the cytochrome P450 2C19 encoding gene, according to a study published in the Lancet. The study population was composed of 259 patients, all under the age of 45, who received clopidogrel treatments for at least one month (median exposure time was 1.07 years (IQR 0.28-3.0)). Patients who were carriers of the CYP2C19*2 genetic variant had 15 primary endpoint events, which was a composite of death, MI, and urgent revascularisation during treatment with clopidogrel, while non-carriers had only 11 primary endpoint events (HR 3.69 (95% CI 1.69-8.05), p=0.0005). Further, the study demonstrated that the CYP2C19*2 genetic variant "was the only independent predictor of cardiovascular events (HR 4.04 (1.81-9.02), p=0.0006)." The investigators noted that additional genetic variants, such as CYP2C19*17, may play a role in the reduced responsiveness to clopidogrel and that it remains unclear if a higher maintenance dose could overcome this reduced clopidogrel responsiveness.(Lancet by Jean-Philippe Collet, et al.)

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