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Update in General Internal Medicine

Darrell W. Harrington, MD; and Mark T. Munekata, MD, MPH*
[+] Article and Author Information

From Harbor–University of California, Los Angeles, Medical Center, Torrance, California.


*Adapted for publication in Annals of Internal Medicine by Jennifer Fisher Wilson and Michael Berkwits, MD, MSCE.

Potential Financial Conflicts of Interest: None disclosed.

Requests for Single Reprints: Darrell W. Harrington, MD, Division of General Internal, Medical Director Office, Box 2, Harbor–UCLA Medical Center, 1000 West Carson Street, Torrance, CA 90502; e-mail, dharrington@ladhs.org.

Current Author Addresses: Dr. Harrington: Division of General Internal, Medical Director Office, Box 2, Harbor–UCLA Medical Center, 1000 West Carson Street, Torrance, CA 90502.

Dr. Munekata: Harbor–UCLA Medical Center, David Geffen School of Medicine at University of California, Los Angeles, 1000 West Carson Street, Box 459, Torrance, CA 90502.


Ann Intern Med. 2007;147(2):104-116. doi:10.7326/0003-4819-147-2-200707170-00009
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The current Update in General Internal Medicine reviews the past year's most important articles relevant to the practicing internist. The general internist is confronted with a wide variety of clinical scenarios and must maintain a broad database and skill set that often overlap with those of subspecialists. We discuss influential articles from 2006 that have important implications for common therapeutic and diagnostic challenges in internal medicine. The Table(19) shows changes to clinical practice that should emerge from these articles.

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Updating in General Internal Medicine – please, don´t SPARCL
Posted on August 1, 2007
Manfred Gogol
Geriatric Department, Krankenhaus Lindenbrunn, Lindenbrunn 1, 31863 Coppenbruegge, Germany
Conflict of Interest: None Declared

To the Editor: Harrington and Munekata (1) discussed in their update the SPARCL-study (2) and judged that physicians can consider to describe 80 mg atorvastatin for secondary prevention in stroke patients. I think we shouldn´t do so because the study is flawed by some basic aspects. The purpose of the study was to include patients with previous stroke or transient ischemic attack (TIA) without known coronary heart disease (CHD). The accuracy of determing the absent of CHD is low while only using an electrocardiogram (ECG). As we teach our students that the diagnostic accuracy of routine ECG´s detecting CHD is roundabout 50 % a great number of the study population will have CHD. The results of chest X-rays, echocardiography or ultrasound finding from extracerebral vessels are missing too. The number of patients with heart failure caused by CHD or others is not reported or not measured. There are no information about the time course of diseases qualified as risk factors nor the quality (efficacy) of treatment previous and during the study (e.g. pack years for current or former smokers, HbA1c in diabetes). The SPARCL authors described the counselling for diet regime following the National Cholesterol Education Program Step 1 without measuring that (2,3). Also is to question which possible influence other changes in life style, e.g. exercise, will have. And why were 139 patients (5.9 %) in the atorvastatin group and 154 (6,5 %) in the placebo group treated with vitamin K antagonists? Furthermore I want to state, from a clinician point of view, that TIA is a soft inclusion and outcome variable, but this diagnosis qualified roundabout 30 % for study entry. Summing-up the study design have had lots of flaws and the results can´t referred to general population. So judging this treatment regime as "to consider" even to a limited population don't´t find my agreement.

1. Harrington DW, Munekata MT. Update in General Internal Medicine. Ann Intern Med 2007;147:104-16.

2. Amarenco P, Bogousslavsky J, Callahan A 3rd et al, The Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) Investigators. High-dose atorvastatin after stroke or transient ischemic attack. N Engl J Med 2006;355:549-59.

3. The SPARCL Investigators. Design and baseline characteristics of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) study. Cerebrovasc Dis 2003;18:389-95.

Conflict of Interest:

None declared

benefits of salmeterol
Posted on August 2, 2007
Daniel M. Hartung
Oregon State University College of Pharmacy
Conflict of Interest: None Declared

To The Editor,

I read the Update In General Internal Medicine with interest and was particularly intrigued with the commentary on the Salmeterol Multicenter Asthma Research Trial (SMART).1 In the synopsis, the authors outline the salient characteristics of this important clinical trial mentioning both the nonsignificant increase in the primary outcome, a combined measure of respiratory-related deaths or life-threatening experiences, as well as statistically significant increases in risk of asthma and respiratory- related death associated with salmeterol. The reviewers' conclusion states "Salemterol provided no significant benefit over placebo, and subgroup analyses suggested it might cause harm in African-American persons." We believe that the authors' interpretation diminishes the primary intent of this important safety study by neglecting to reiterate that salmeterol was also associated with significant increases in asthma and respiratory-related mortality. The failure to reach statistical significance for the primary outcome was likely impacted by the early termination of this study by the sponsor. The commentary further downplayed the findings by suggesting the study was flawed due to enrollment misclassification, recruitment of a sicker population, and sub- optimal asthma care at baseline. However, as long as the randomization procedure was successful, these issues would primarily affect the external validity of the findings. There is no evidence indicating the randomization was unsuccessful and the characteristics described were likely evenly distributed between treatment groups. While non-adherence and treatment completion were relatively low, they were numerically and statistically similar in both treatment and placebo and consistent with real world use.2, 3

This interpretation of the long-acting beta agonist controversy stands in stark contrast to the discussion section of an earlier meta- analysis drawing heavily from SMART where the authors suggested the data warrant an assessment of whether the drugs should be withdrawn from the market.4 Finally, the authors did not disclose any potential financial conflict of interests. However, a letter to the editor published in JAMA in January of this year indicates Dr. Harrington serves on the speakers' bureau and advisory board of GlaxoSmithKline, makers of two long-acting beta agonist containing products, Serevent and Advair.5 Full disclosure of potential financial conflicts of interest is especially critically for unstructured review papers because of the subtle ways bias can be introduced.

Daniel M Hartung, PharmD, MPH

Craig D Williams, PharmD

1. Harrington DW, Munekata MT. Update in General Internal Medicine. Ann Intern Med 2007;147(2):104-16.

2. Butz AM, Tsoukleris M, Donithan M, et al. Patterns of Inhaled Antiinflammatory Medication Use in Young Underserved Children With Asthma. Pediatrics 2006;118(6):2504-13.

3. Nelson HS, Weiss ST, Bleecker ER, Yancey SW, Dorinsky PM, the SMART Study Group. The Salmeterol Multicenter Asthma Research Trial: A Comparison of Usual Pharmacotherapy for Asthma or Usual Pharmacotherapy Plus Salmeterol 10.1378/chest.129.1.15. Chest 2006;129(1):15-26.

4. Salpeter SR, Buckley NS, Ormiston TM, Salpeter EE. Meta-Analysis: Effect of Long-Acting {beta}-Agonists on Severe Asthma Exacerbations and Asthma-Related Deaths. Ann Intern Med 2006;144(12):904-12.

5. Harrington DW, Jindeel A. Fixed-Dose Unfractionated Heparin vs Low- Molecular-Weight Heparin for Venous Thromboembolism. JAMA 2007;297(3):262- a-.

Conflict of Interest:

Craig Williams has received honoraria from Merck & Co

Correction: Update in GIM 2007
Posted on October 16, 2007
Jim L. Meisel
Massachusetts General Hospital, Boston, MA
Conflict of Interest: None Declared

I believe an error appears in the Table accompanying the 2007 Update in General Internal Medicine.* The Annals table erroneously includes the word "hemorrhagic" in reference to the SPARCL study:** the reader should "consider prescribing atorvastatin...for secondary prevention of stroke in patients with TIA or ischemic or hemorrhagic stroke."

In the study, atorvastatin reduced the overall incidence of strokes and of cardiovascular events, but saw an increase in the incidence of hemorrhagic stroke. Indeed, Annals commentators note, "Given the possible increased risk for hemorrhagic stroke, providers must weigh the risks and benefits in patients with an identifiably higher risk for hemorrhagic stroke."

*Darrell W. Harrington and Mark T. Munekata Update in General Internal Medicine Ann Intern Med, Jul 2007; 147: 104 - 116.

** Amarenco P, Bogousslavsky J, Callahan A 3rd, et al. Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) Investigators High-dose atorvastatin after stroke or transient ischemic attack. N Engl J Med. 2006;355:549-59

Conflict of Interest:

None declared

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