Physician's First Watch: Archives

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Smoking Cessation Drugs to Get Boxed Warning

The smoking cessation drugs bupropion (Wellbutrin, Zyban) and varenicline (Chantix) must now carry boxed warnings on their labels to alert patients of the risk for serious neuropsychiatric symptoms, according to the FDA.

Physicians should help patients understand the benefits of quitting smoking versus the risks posed by these drugs, the agency says. The FDA advises patients with these symptoms to stop taking the drugs immediately: changes in behavior, hostility, agitation, depression, and suicidal thoughts or behavior.

(Unfortunately, irritability, anxiety, depression, and difficulty sleeping are also common symptoms of nicotine withdrawal.)

The FDA warns that patients with a preexisting psychiatric illness may experience worsening of symptoms while taking bupropion or varenicline.

LINK(S):

FDA alert (Free)

FDA's Drug Safety Newsletter, including details of bupropion and varenicline review (Free PDF)

Previous Physician's First Watch coverage of varenicline and neuropsychiatric symptoms (Free)

Published in Physician's First Watch July 2, 2009

Diabetic Retinopathy, But Not Nephropathy, Benefits from Renin-Angiotensin Blockade

In type 1 diabetes, blockade of the renin-angiotensin system to prevent nephropathy "is not supported," a New England Journal of Medicine study finds.

Study investigators randomized some 300 patients with type 1 diabetes to daily therapy with either the angiotensin-receptor blocker losartan, the ACE inhibitor enalapril, or placebo, and followed them for 5 years. At baseline, all patients were normotensive, normoalbuminuric, and did not have retinopathy.

At follow-up, histopathologic changes (increased mesangial volume relative to baseline renal biopsy) were similar among the three groups. Losartan was associated with a faster progression of albuminuria. Renin-angiotensin blockade did, however, have a salutary effect on retinopathy, with reductions in progression by about two thirds relative to placebo.

Editorialists say the results change accepted concepts about diabetic nephropathy, and that further work will be needed before renin-angiotensin blockade to prevent retinopathy can be used in clinical practice.

LINK(S):

NEJM article (Free abstract; full text requires subscription)

NEJM editorial (Subscription required)

Published in Physician's First Watch July 2, 2009

FDA Panel Votes to Ban Vicodin, Percocet

Patients may be asking about news articles regarding an FDA advisory panel's recommendation to ban the painkillers Percocet and Vicodin, citing the danger posed to the liver by products combining narcotics with acetaminophen.

The FDA does not have to heed the advice of its expert panels, but it frequently does, according to the New York Times. If the FDA follows the panel's recommendation, seven other prescription drugs combining acetaminophen and narcotics could also be banned.

In addition, the panel voted to reduce the maximum daily dose of acetaminophen to less than 4000 mg and the maximum dose in over-the-counter formulations to 325 mg (down from 500 mg).

LINK(S):

New York Times story (Free)

Previous Physician's First Watch coverage of FDA advisory panel meeting on acetaminophen (Free)

Published in Physician's First Watch July 1, 2009

Value of CRP and Other Cardiovascular-Risk Biomarkers Questioned

C-reactive protein's role in heart disease and its value (and that of other biomarkers) in risk assessment are called into doubt by two JAMA studies.

In the first study, researchers used genome-wide association studies to find genetic loci associated with CRP. Variants associated with lower CRP levels were not associated with lower risk, "arguing against a causal role for CRP in atherosclerosis."

Researchers in the second study examined the value of "novel" biomarkers (e.g., CRP and cystatin C) used in conjunction with conventional risk factors (smoking, diabetes, hypertension, hyperlipidemia) to predict cardiovascular risk. In a cohort of some 5000 participants initially free of cardiovascular disease and followed almost 13 years, the novel biomarkers improved prediction scores "only minimally," resulting in the reassignment of only 1% of participants to a higher risk group.

LINK(S):

JAMA article on CRP & coronary heart disease risk (Free)

JAMA article on novel biomarkers & cardiovascular events (Free abstract; full text requires subscription)

JAMA editorial (Subscription required)

Published in Physician's First Watch July 1, 2009

Meta-analysis Finds Statin Benefit in Primary Prevention

Statin use is associated with lower risks of all-cause mortality and major coronary and cerebrovascular events, according to a BMJ meta-analysis published online.

Researchers examined data from 10 controlled trials comprising some 70,000 older subjects (mean age, 63) without established cardiovascular disease, but with risk factors for it. After a mean follow-up of 4 years, statin recipients showed a 0.6% absolute risk reduction in all-cause mortality, a 1.3% absolute risk reduction in major coronary events, and a 0.4% absolute risk reduction in major cerebrovascular events.

The authors say that the reductions seen are "comparable to that observed in secondary prevention." They emphasize, however, that "significant numbers of participants would need to be treated to prevent one event."

LINK(S):

BMJ article (Free)

Previous Physician's First Watch coverage of JUPITER trial (Free)

Published in Physician's First Watch July 1, 2009

Interferon No Help in Idiopathic Pulmonary Fibrosis

Patients with idiopathic pulmonary fibrosis do not benefit from treatment with interferon gamma-1b, according to a Lancet study released online.

Researchers randomized some 800 patients with mild-to-moderate disease in an international, double-blind trial sponsored, designed, and conducted in part by the manufacturer. Patients received thrice-weekly doses of either interferon or placebo.

After a median treatment of some 15 months, the trial was stopped when it became apparent that there was no survival benefit with interferon treatment.

The authors write that their results "conclusively refute the findings that interferon gamma-1b improves survival" in idiopathic pulmonary fibrosis. An editorialist says the results "should be regarded as definite."

LINK(S):

Lancet article (Free abstract; full text requires subscription)

Lancet comment (Subscription required)

Published in Physician's First Watch June 30, 2009

Insulin Glargine Associated with Cancer Risk; ADA Calls Findings "Conflicting and Confusing"

Patients will likely ask about a study in Diabetologia that associates use of insulin glargine (Lantus) with a higher risk for cancer. The journal's editor and the American Diabetes Association both urge caution in interpreting the results.

German researchers first identified the association and submitted their results to Diabetologia. Before agreeing to acceptance, that journal's editors commissioned three additional studies using Swedish and U.K. databases. Two of those studies confirmed an association of insulin glargine with cancer risk, but editorialists judge the evidence "entirely insufficient to bring in a verdict."

On the basis of laboratory studies, the editorial writers conclude: "There is no reason to believe that insulin therapy causes cancer, but there is, nonetheless, reason to suspect that high concentrations of insulin may promote [earlier onset of] its development."

The American Diabetes Association called the data "conflicting and confusing" and urged patients not to change their regimens until more information is available.

LINK(S):

Diabetologia articles and press release (Free)

Diabetologia editorial (Free PDF)

ADA statement (Free)

Diabetologia webcast (Free)

Wall Street Journal story (Subscription required)

Published in Physician's First Watch June 29, 2009

Novel H1N1 Now Spreading in Southern Hemisphere

Novel H1N1 disease "is not going away," according to CDC. Australia, Chile, and Argentina are now reporting "significant numbers of cases" at the start of their flu season, CDC officials said at a briefing on Friday.

The agency estimates that over 1 million people in the U.S. have been infected, and it reports that the New England and New York/New Jersey regions continue to experience higher-than-usual levels of health care visits for influenza-like illness. A dozen states report widespread influenza activity: Arizona, California, Connecticut, Delaware, Hawaii, Maine, New Jersey, New York, Pennsylvania, Rhode Island, Utah, and Virginia.

U.S. cases remain most prevalent among the young — especially in those under 25.

LINK(S):

CDC briefing transcript (Free)

NEJM/Journal Watch H1N1 Influenza Center (Free)

Published in Physician's First Watch June 29, 2009

Offer High School Students HIV Testing, CDC Reiterates

Only about 13% of high school students have ever been tested for HIV, despite the fact that this age group harbors a disproportionate number of undiagnosed cases, according to MMWR.

According to a 2007 survey of high school students across the U.S., testing prevalence increased with increasing grade and was generally higher among the groups at greatest risk for HIV.

MMWR's editors conclude: "Health-care providers [among others] play critical roles in providing support and guidance to adolescents in making decisions about the timing and frequency of HIV testing. Because adolescents might be sexually active but unwilling to discuss this information, health-care providers should provide HIV testing routinely to all patients aged 13 years or older in accordance with CDC recommendations."

LINK(S):

MMWR article (Free)

CDC recommendations on testing for HIV (Free)

Published in Physician's First Watch June 26, 2009

CDC Reinstates Haemophilus Vaccine Booster Dose

The CDC has reinstated its recommendation to administer the Haemophilus influenzae type b (Hib) booster vaccine to children aged 12 to 15 months, MMWR reports.

In 2007, the agency asked healthcare providers to defer this booster because of a recall-related vaccine shortage. This shortage is now resolved.

Children who skipped the booster dose should receive it at their next visit.