CVD Risk Algorithm / RotaTeq & Intussusception / Snuff & Lung Cancer / & More

Marzo 5, 2007

Physician's First Watch for February 14, 2007

David G. Fairchild, MD, MPH, Editor-in-Chief

Algorithm More Accurately Predicts Cardiovascular Risk in Women

FDA Notes Cases of Intussusception After New Rotavirus Vaccine

Lung Cancer Risk Still Elevated When Smokers Switch to Chewing Tobacco or Snuff

Study Casts Doubt on Relation Between Excess Iron and Cardiovascular Disease

Another Study Supports Switch to an Aromatase Inhibitor for Breast Cancer Treatment

Algorithm More Accurately Predicts Cardiovascular Risk in Women

Researchers have developed an improved algorithm for predicting 10-year cardiovascular risk in women, according to a report in today's JAMA.

The Reynolds Risk Score algorithm was created using data from nearly 25,000 healthy women, aged 45 or older, who were monitored for cardiovascular events over a median of about 10 years. Researchers derived the algorithm using data from two-thirds of the cohort, then validated it in the remainder. The algorithm incorporates two variables not used by the current ATP-III algorithm: family history of premature coronary heart disease and C-reactive protein.

An editorial calls the study an "important contribution" and observes: "Overall, approximately 20% of women will have different lipid treatment goals based on the Reynolds model than recommended by the ATP-III guidelines."

JAMA article (Free abstract; full text requires subscription)

JAMA editorial (Subscription required)

Reynolds Risk Score calculator (Free)

Related Journal Watch link(s):
Journal Watch Cardiology summary (Free)

FDA Notes Cases of Intussusception After New Rotavirus Vaccine

The FDA issued a public health notice yesterday regarding 28 cases of intussusception that have occurred over the past year following receipt of live, oral, pentavalent rotavirus vaccine (RotaTeq).

Whether any of these cases is related to the vaccine is unknown. Premarketing studies did not identify an increased risk; however, an earlier rotavirus vaccine was withdrawn because of concerns about higher rates of intussusception. The manufacturer and the CDC are conducting further studies to assess the risk.

The FDA said that it issued the notice "to remind people that intussusception is a potential complication of RotaTeq" and to encourage reporting of any further cases of intussusception that may have occurred to the Vaccine Adverse Event Reporting System.

FDA public health notification (Free)

Vaccine Adverse Event Reporting System (Free)

Updated RotaTeq patient information (Free PDF)

Updated RotaTeq label (Free PDF)

Lung Cancer Risk Still Elevated When Smokers Switch to Chewing Tobacco or Snuff

Smokers who switch to snuff and chewing tobacco have a higher risk for dying from lung cancer and possibly other causes than those who quit cigarettes entirely, according to a large prospective study published in Tobacco Control.

The research was based on a 20-year follow-up of about 112,000 male smokers who quit entirely and about 4000 who switched. After controlling for the number of cigarettes formerly smoked and other factors, investigators found that those who switched were significantly more likely to die from lung cancer (hazard ratio, 1.46). They were also more likely to die from all causes (HR, 1.08), coronary heart disease (HR, 1.13), and stroke (HR, 1.24), although the statistical significance was borderline.

The authors said it is biologically plausible that snuff and chewing tobacco cause lung cancer because of their high nitrosamine content.

Tobacco Control article (Free abstract; full text requires subscription)

Study Casts Doubt on Relation Between Excess Iron and Cardiovascular Disease

Reducing iron stores in patients with peripheral arterial disease does not reduce either all-cause mortality or a combined measure for death plus nonfatal MI and stroke, according to a randomized trial published in today's JAMA.

Researchers randomized nearly 1300 men and postmenopausal women with symptomatic but stable peripheral arterial disease to either iron-reduction treatment (phlebotomy at 6-month intervals) or to a control group. Phlebotomy group members had sufficient blood removed to keep their ferritin levels between 25 and 60 ng/mL.

After a mean of 4.5 years of follow-up, investigators found no difference between the groups with regard to the study's primary (death from any cause) or secondary (death plus nonfatal myocardial infarction and stroke) endpoints.

An editorial calls the study underpowered to provide definitive proof, but says "the overall results are consistent with largely negative epidemiologic evidence accumulated so far."

JAMA article (Free abstract; full text requires subscription)

JAMA editorial (Subscription required)

Related Journal Watch link(s):
Journal Watch General Medicine summary (Free)

Another Study Supports Switch to an Aromatase Inhibitor for Breast Cancer Treatment

A randomized study published early online yesterday in Lancet concludes that switching to an aromatase inhibitor after 2 to 3 years of initial treatment with tamoxifen increases survival of women with estrogen-receptor-positive breast cancer. The results are similar to those of a pooled analysis of two other trials published on Monday in Cancer.

Lancet article (Free abstract with one-time registration; full text requires subscription)

Lancet comment (Free)

Related Journal Watch link(s):
Physician's First Watch coverage of Cancer article (Free)

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