Clinical Briefs

By Louis Kuritzky, MD, Clinical Assistant Professor, University of Florida, Gainesville, and Associate Editor of Internal Medicine Alert.

Daily vs As-Needed Steroids for Asthma

Management of asthma in America remains problematic, with as many as 5,000 deaths annually in recent years. Current guidelines suggest that for anyone with any degree of persistent asthma, maintenance anti-inflammatory medication is appropriate. The first-line recommended anti-inflammatory medication is inhaled corticosteroids (ICS), which are generally prescribed for daily use. Despite clinician advice to use ICS daily, prescription patterns indicate that this advice is often not heeded.

Reflecting upon the observed pattern of ICS administration, Boushey and colleagues randomized 225 adult asthmatics to receive 1) daily ICS, or 2) daily zafirlukast, or 3) brief steroid bursts with worsening asthma symptoms (10 days ICS or 5 days oral steroids), but no daily asthma maintenance medications. Subjects were followed for one year.

The primary end point of the study, change in morning peak expiratory flow rate, did not differ amongst the 3 groups. As anticipated, ICS did provide more favorable effects upon pulmonary inflammatory cellular changes (eg, degree of sputum eosinophilia). The number of asthma exacerbations did not differ between the groups. Although the daily administration of ICS did result in a greater number of symptom-free days than other regimens (26 days per year), this must be counterbalanced with the lack of impact of ICS upon exacerbations. Boushey et al caution that their results should be considered preliminary; larger studies would be required before such an approach could be endorsed.

Boushey HA, et al. N Engl J Med. 2005;352:1519-1528.

Intensive Lipid Lowering with Atorvastatin

The vasculopath—anyone with established vascular disease such as previous MI, stroke, PAD, or type 2 diabetes—is known to be at increased risk for subsequent vascular events and mortality. A large body of encouraging data of late have indicated that use of statins to lower lipids has favorable effects in diverse populations, including primary and secondary prevention, and even impressive results in acute coronary syndromes (ACS). Statin data from the ACS studies may not accurately reflect risk reductions that might be attained in stable patient populations. Additionally, although the PROVE IT trial suggested that lower lipid levels achieved were responsible for more favorable outcomes in a pravastatin vs atorvastatin trial, there still remained the possibility that there was some inherent difference between statins. So, 2 critical questions remained: Is lower better? Do persons with stable coronary disease benefit similarly to other populations?

Patients with stable demonstrated coronary heart disease and modest levels of LDL (< 130 mg/dL mean) were enrolled and randomized to 10 mg or 80 mg of atorvastatin daily for a median of 4.9 years (n = 10,00).

The relative risk reduction in the primary end point (first major cardiovascular event) was 22% (absolute risk reduction 2.2%). These favorable effects were achieved with a mean LDL of 77 mg/dL on 80 mg/dL atorvastatin, vs an LDL of 101 mg/dL on 10 mg/d. Lower is better.

LaRosa JC, et al. N Engl J Med. 2005;352:1425-1435.

The Polymeal: Natural Strategy to Reduce CVD

You may recall spirited discussion prompted by commentary in the British Medical Journal (Wald NJ. BMJ. 2003;326:1419-1423) that in theory, a sound public health measure would simply be to administer to everyone at age 55, regardless of health status, a multicomponent pill containing a statin, HCTZ, and ACE inhibitor, Beta Blocker, and Folic acid, all at half-standard dose. Administered population-wide, such a ‘polypill’ could conceivably provide radical reductions in cardiovascular disease end points.

Franco and colleagues believe there is perhaps a better, less expensive, less adverse effect-laden method that is substantially more palatable: The Polymeal.

Based upon their literature review of favorable data on individual components of diet, the following ingredients of the Polymeal would have a beneficial effect: wine (150 mL/d), fish (114 g 4×/week), dark chocolate (100 g/d), fruits and vegetables (400 g/d), garlic (2.7 g/d), and almonds (68 g/d).

Based upon the Framingham life table data, Franco et al calculate the Polymeal reducing cardiovascular disease by 76%. Omitting any component might reduce the benefits; for instance, simply by omitting the wine,one might lose 11% of that benefit! They also calculate a 4.8 years (women), 6.6 years (men) increase in life expectancy from the Polymeal. Cost, of course, will be highly variable depending upon one’s tastes in wine and chocolate, but could certainly conform to the most modest of economic settings. Bon appétit!

Franco O, et al. BMJ. doi:10.1136/bmj.329.7480.1447.