PrimeCuts: This Week in the Journals

December 8, 2008

porterhouse.jpgCommentary by Denise Pate MD, PGY-1

Faculty Peer Reviewed 

These days, when patients are concerned about being able to afford keeping a roof over their head and food on their table, the cost of prescription drugs is an additional financial burden. High costs can adversely impact patients’ compliance with healthcare. One way of mounting this hurdle is the utilization of less-expensive generic drugs versus their more-expensive brand-name counterparts. This week in JAMA, a review and meta-analysis examined whether there are differences in the effectiveness of generic and brand-name drugs used in the treatment of cardiovascular disease. 

Brand-name drugs are typically sold at higher prices during their period of patent protection after acquiring FDA approval. Once the brand-name exclusivity period ends, other manufacturers can formulate bioequivalent generic versions. Generic pills are identical in terms of their active ingredients, but may differ in terms of binders, fillers and physical appearance. The JAMA paper analyzed 47 studies comparing the efficacy of generic and brand-name medications, including 38 randomized control trials. These trails examined medication effects on vital signs (HR, BP, urine output), clinical laboratory value (INR, lipid values), patient morbidity, mortality and health system utilization.
The majority of trials compared Beta Blockers, diuretics, and calcium channel blockers, and importantly included drugs with a narrow therapeutic index (NTI) including anticoagulants and class I and III antiarhythmics. The study found no significant difference in clinical outcomes between generic and brand-name drugs. While the short-term evaluations may not address long-term outcomes, such as rates of myocardial infarction or death, we can rest assured that patients will reap the same benefits from generic drugs as they would from their brand-name equivalents, while keeping their pockets a little fuller.

Now that we know that generics are just as good for our patients we can continue to tackle the issue of treating hypertension. This week, in the NEJM, the ACCOMPLISH (Avoiding Cardiovascular Events through Combination Therapy in Patients Living with Systolic Hypertension) trial was published, with results questioning the JNC 7 recommendation of using a thiazide diuretic as initial therapy for hypertension. Although the name of the trial may be somewhat ridiculous, the thinking behind it is not as physicians continue to fail in our battle against hypertension.
ACCOMPLISH compares cardiovascular events in patients treated with benazepril (ACE inhibitor) combined with either amlodipine (Ca channel blocker) or hydrochlorothiazide (thiazide diuretic). A motivating force behind this study was evidence that combining an ACE inhibitor and a Ca channel blocker might slow progression of atherosclerosis in animal models and might reduce left ventricular hypertrophy and arterial stiffness in humans, protecting target organs as well as reducing blood pressure. While the study does not promote abandonment of hydrochlorothiazide, it showed an absolute risk reduction of 2.2% in cardiovascular events when benazepril and amlodipine are used in combination versus benazepril with hydrochlorothiazide.

While we are working endlessly for our patients’ cardiovascular health, ‘What about our happiness?’ On December 2nd the Institute of Medicine (IOM) published a report examining the effect of trainee fatigue on patient safety. The report also focused on increasing trainee supervision by senior physicians and improving the “sign out” process, whereby patients are handed off between shifts. The IOM’s Committee on Optimizing Graduate Medical Trainee Hours and Work Schedules to Improve Patient Safety stated that implementation of their proposed guidelines would cost somewhere in the range of $1.7 billion, mere chump change to a government that is willing to put forward hundreds of billions of dollars for a Wall Street bailout.

The IOM stated that “a robust evidence base links fatigue with decreased performance in both research laboratory and clinical settings.” They suggested that fatigue be combated by allowing for an extended period of uninterrupted sleep during extended duty and by permitting for adequate sleep recovery time while off-duty. The specific proposal states that residents on duty for greater than 16 hours be required to have 5 hours of uninterrupted sleep between the hours of 10 PM and 8 AM. In addition, no resident should be able to admit a patient after having been on duty for 16 hours and that the maximum consecutive night-shifts would be 4 and followed by a 48 hour period of being off-duty. The committee found a great degree of variability among industrialized countries with regard to work hour limits for medical trainees. In Australia and Canada (except for one province) no limits exist, while in much of Europe, trainee work hour limits ranged from 37 to 72 hours. The committee found that the health care system would require an additional 229 nurses aides, 45 laboratory technicians, 320 licensed nurses, 5984 midlevel providers (nurse practitioners or physician’s assistants), and 5001 attending physicians; if hospitals were to increase the number of residents instead, an estimated 8247 additional residency positions would have to be created.

Decreasing fatigue can definitely improve our happiness, but so can having a happy neighbor. In this week’s feel-good story, the British Medical Journal published a study examining 4739 individuals followed from 1983 to 2003. The goal of the study was to evaluate happiness within social networks. They found that happiness can spread up to three degrees of separation and is influenced by closeness in proximity to the other happy individual. Your happy next-door neighbor can increase your happiness by 34% versus your neighbor further down the street (or down the hall) who may have no significant effect on your happiness. The study utilized a questionnaire entitled “The Center for Epidemiological Studies depression scale” and focused specifically on four items assessing happiness. Overall they analyzed approximately 50,000 social ties. The New York Times included a piece about this article, and the author of the study, Professor Fowler, was quoted as saying “…we are not giving you the advice to start smiling at everyone you meet in New York. That would be dangerous.” Dr.Fowler may know something about happiness, but he obviously knows nothing about New Yorkers.

This week in PrimeCuts, take home points are that you should feel happy prescribing generic drugs because they are just as good as brand-name drugs, feel happy giving calcium channel blockers in combination with ACE-inhibitors because of possible benefits in treating hypertension, feel happy that measures to decrease trainee fatigue are being considered, and most of all feel happy because it may benefit those around you.

References:
1.Kesselheim et al. Clinical Equivalence of Generic and Brand-Name Drugs Used in Cardiovascular Disease A Sytematic Review and Meta-analysis. JAMA 2008; 300(21):2514-2526
2.Jamerson et al. Benazepril plus Amiodarone or Hydrochlorothiazide for Hypertension in High-Risk Patients. NEJM 2008; 359:2417-2428
3.Iglehart JK. Revisiting Duty-Hour Limits-IOM Recommendations for Patient Safety and Resident Education. NEJM 2008;359:2633-2635
4. Fowler JH, Christakis NA. Dynamic Spread of Happiness in a Large Social Network:Longitudinal Analysis over 20 years in the Framingham Heart Study. BMJ 2008;337:2338-2346
5.Belluck P. Strangers May Cheer You Up, Study Says. NY Times 2008 December 4th www.nytimes.com/2008/12/05/health/05happy-web.html

Reviewed by Michael Poles MD, Associate Editor, Clinical Correlations

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