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Protecting patients during influenza season especially important this year
Also, in the STIP trial, statins will be studied for boosting the immune system among patients in the ICU with influenza.
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With the flu season here and the H1N1 influenza (swine flu) virus circulating since it emerged in south and central areas of Mexico in late April, it is hard to ignore the potential complications among our patients who have or are at high risk for CVD — and the possible CVD complications to the patient who has influenza.
For example, Madjid et al showed that influenza epidemics are linked with autopsy-confirmed cases of MI and ischemic heart disease deaths, supporting recommendations that patients be vaccinated against seasonal influenza to not only protect against the respiratory disease but the possible CVD complications. Smeeth et al reported that acute infections such as influenza lead to a transient increase in a patient’s risk for CVD events. Oseltamivir (Tamiflu, Roche) and zanamivir (Relenza, GlaxoSmithKline) are recommended for those with CVD who have recent onset of flu-like symptoms. For these patients at high risk for CV complications, treatment should be started as soon as possible. It is reasonable to consider post-exposure prophylaxis for those at higher risk for CV or pulmonary complications. For high-risk patients with definite exposure to cases prophylaxis may be considered, when to stop treatment is debatable, as there is concern that this could lead to resistance. So this leads to a recommendation for watchful waiting. The CDC places an emphasis on early recognition of illness and treatment as an alternative to prophylaxis after an exposure.
It is exciting to see new research testing statins for yet another crossover, from cardiology into infectious diseases.
Statins for the flu?
Interest in statins and response to infectious is becoming popular as several observational studies suggest they may provide protection from community-acquired pneumonia and influenza pneumonia/death (Frost et al 2007 and The Irish Critical Care Trials Group 2008). A possible dose response has also been suggested (Shah et al). Results, however, are not unanimous, as short-term mortality was not reduced in studies by Yang et al, Thomsen et al 2006, Kor et al 2009, Fernandez et al 2006. However, it is likely that statin use is a marker of higher disease severity and comorbidities that were insufficiently considered in the multivariable adjustments for mortality.
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Recently, Gordon Bernard, MD, et al started the STIP (Statin Trial for Influenza Patients) clinical trial (ClinicalTrials.gov Identifier: NCT00970606). Bernard and colleagues are examining the utility of rosuvastatin (Crestor, AstraZeneca) vs. placebo in hospital mortality to 28 days, or time to resolution of respiratory failure. Secondary outcomes will include days free of ventilator, days free of ICU and survival to 28 days.
The researchers are enrolling patients 13 years and older with suspected or confirmed flu. The fact that they are including patients at such a young age is fantastic (and rosuvastatin was just approved for use in children with hypercholesterolemia). Bernard, professor of medicine and associate vice chancellor for research at Vanderbilt, believes that results should be available by May. With this approach, the type of flu – H1N1 or seasonal flu – does not matter because the statin is being used to affect the host response, not as a specific influenza treatment.
Another novel intervention is a statin/caffeine combination. Caffeine modulates both innate and adaptive immunity by affecting cytokine production (Horrigan et al, 2006), has potential as an antiviral agent (Prahoveanu and Esanu, 1985), and appears more effective administered preventatively rather than as treatment. A lovastatin/caffeine combination was recently studied in H5N1-, H3N2- and H1N1-infected BALB/c mice (Liu Z, et al. Eur J Pharmaceutical Sci. 2009; 38:215–23), and it inhibited viral replication and ameliorated lung damage. Interestingly, this combination was at least as effective as oseltamivir and ribavirin and appeared more effective when given preventatively rather than as treatment. Stay tuned!
Despite this possible new utility, statins are not ready for the drinking water just yet.
Message for patients
With all that said, tell your patients to get vaccinated for regular flu as soon as possible, and then they should get the H1N1. Get that as quickly as possible when it is offered. When this vaccine becomes available for general population ,encourage the close contacts of your CV patients to get vaccinated.
Doctors, wash hands between patients and cough into your elbow. Remember to keep your fingers out of your eyes! These may seem like unnecessary elementary instructions, but it can be easily forgotten in a busy day; they should not be. There are several well-done videos on YouTube, and I recommend showing one of them in your office waiting rooms.
In October, and again this month, we included stories updating you on H1N1 news that runs in our sister publications, Infectious Diseases in Children and Infectious Disease News. We hope you find the information useful. Staying abreast of the situation makes us better prepared to deal with the months ahead.
Carl J. Pepine, MD, is Professor of Medicine, Division of Cardiovascular Medicine at the University of Florida, Gainesville. He is also the Chief Medical Editor of Cardiology Today.
For more information:
- Imad MT. Arch Intern Med. 2009;169:1658-1667.