Monthly Archives: May 2014

No Link Seen Between Vaccines and Lupus

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Recent vaccination was not associated with an increased risk for the development of systemic lupus erythematosus (SLE), a case-control study found.

A total of 21% of individuals who developed lupus had received any vaccine within the previous 2 years, as did 25.4% of controls, for an adjusted odds ratio (OR) of 0.9 (95% CI 0.5-1.5), according to Lamiae Grimaldi-Bensouda, PharmD, PhD, of LA-SER and Conservatoire National des Arts et Metiers in Paris, and colleagues.

Similarly, 16.2% of cases and 20.8% of controls had been vaccinated within the previous 12 months, for an adjusted odds ratio of 0.9 (95% CI 0.5-1.6), the researchers reported in the June Arthritis & Rheumatology.

“Because vaccinations are designed to stimulate an antigen-specific immune response, they have been proposed as potential triggers for autoimmunity and the onset or exacerbation of SLE,” they wrote.

To examine this possibility, Grimaldi-Bensouda and colleagues analyzed data from the Pharmacoepidemiologic General Research eXtension (PGRx) system in France and Quebec, which conducts surveillance for vaccine-associated adverse events. The system also maintains a registry of SLE cases.

Between April 2008 and June 2012, there were 105 incident cases of SLE reported from the 36 centers participating in PGRx. A group of 712 controls also were recruited, matched for age, sex, smoking, alcohol use, and family history of autoimmunity.

Participants were interviewed by telephone and provided information about 85 health conditions and medications, as well as 27 vaccines.

The minimum detectable odds ratio for vaccination during the 2 years before SLE onset was set at 1.96.

The most common vaccinations among the cases in the 2 years before disease onset were for influenza and for diphtheria/tetanus/pertussis/poliomyelitis (DTPP).

The influenza vaccine had been given to 7.6% of cases and 9.1% of controls, for an odds ratio of 1.1 (95% CI 0.5-2.6), while the DTPP immunization had been given to 9.5% and 11%, respectively (OR 0.9, 95% CI 0.4-1.9).

The researchers also analyzed the risks according to age, and found an odds ratio of 1.1 (95% CI 0.5-2.3) for patients under 30 versus those older at the time of disease onset.

In an additional analysis, they excluded patients who had been exposed to medications that have been linked with SLE, such as chlorpromazine and isoniazid, and once again found no association (OR 0.8, 95% CI 0.5-1.3).

“Our study shows that exposure to vaccines is not associated with an increased risk of developing SLE. Although our study has some limitations, we are reassured by the finding that the ORs for the relationship between vaccination and SLE onset are less than 1,” Grimaldi-Bensouda and colleagues concluded.

These limitations included the small numbers, potential unmeasured confounders, and the lack of information about ethnicity in the database.

In addition, the study only addressed SLE onset, not disease flares, although other studies have found no association of vaccination with disease exacerbations.

The study was supported by LA-SER. Grimaldi-Bensouda is a director of LA-SER and has received research support from INSERM.

One co-author disclosed relevant relationships with LA-SER, which is a research organization that owns the PGRx database. LA-SER receives funding from various sources, including AstraZeneca, Bioron, Genevrier, GlaxoSmithKline, Pfizer, Novartis, and Sanofi.





Daily aspirin to prevent first heart attack does not get FDA backing

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The US Food and Drug Administration concludes that daily aspirin use can help ward off a heart attack or stroke in some people, but it is not for everyone.

The federal agency says while there is evidence that low-dose aspirin can prevent heart attacks, strokes and cardiovascular problems reoccurring (so-called secondary prevention), the case has yet to be made for using it to prevent a first event (primary prevention).

Aspirin works by interfering with the blood’s clotting action, so reducing the chance of clots developing and obstructing flow of oxygen and blood. Clots that obstruct a coronary artery are a cause of heart attacks, while blockages in the blood supply to the brain are a cause of stroke.

The Food and Drug Administration (FDA) draw these conclusions after “carefully examining scientific data from major studies,” according to a new Consumer Update.

Dr. Robert Temple, FDA’s deputy director for clinical science, says:

“Since the 1990s, clinical data have shown that in people who have experienced a heart attack, stroke or who have a disease of the blood vessels in the heart, a daily low dose of aspirin can help prevent a reoccurrence.”

For primary prevention, ‘benefits not established, while risks are still present’

But for people who have not had a heart attack, stroke or cardiovascular problems, “the benefit has not been established but risks – such as dangerous bleeding into the brain or stomach – are still present,” warn the FDA.

And neither does the data support the use of aspirin to prevent heart attack or stroke in people who have never had them but have a family history of them or are showing evidence of arterial disease, it adds.

However, large trials looking at use of aspirin in primary prevention of heart attack and stroke are ongoing, and the FDA will continue to monitor them and update consumers should the evidence change.

“The bottom line is,” say the FDA, “that in people who have had a heart attack, stroke or cardiovascular problems, daily aspirin therapy is worth considering.”

If you are considering using daily aspirin, says Dr. Temple, you should only do so after talking to your doctor, who can help you weigh the benefits and the risks.

How much aspirin you take is important, he adds. Your doctor should ensure the dose you take and how often you take it is right for you, and recommend the dose and frequency that will bring you the greatest benefit with the fewest side effects.

Aspirin doses range from low-strength, as in an 80 mg tablet, to regular strength, as in a 325 mg tablet.

Also, because aspirin reduces risk of blood clotting, care is needed when using it with other blood thinners like warfarin, dabigatran (Pradaxa), rivaroxaban (Xarelto) and apixaban (Eliquis), warn the FDA.

And, if your doctor recommends daily aspirin to lower your risk of heart attack and clot-related stroke, you should read the labels carefully to make sure you use the correct product. Some combine aspirin with other painkillers and ingredients and should not be taken for long-term use.

Medical News Today recently reported on research that found use of low-dose aspirin is linked to improvedcolon cancer survival, while an earlier study showed regular aspirin is linked to age-related macular degeneration risk.

Written byCatharine Paddock PhD




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