Cholecalciferol (vitamin D3) reduces mortality in adults; other forms of vitamin D do not

ACPJC article.
Bjelakovic G, Gluud LL, Nikolova D, et al. Vitamin D supplementation for prevention of mortality in adults.
Cochrane Database Syst Rev. 2011;(7):CD007470.

In meta-analysis, cholecalciferol (vitamin D3) reduced all cause mortality by 6% (NNT 161).

Systematic pain management reduced agitation in nursing home residents with dementia

ACPJC article.
Husebo BS, Ballard C, Sandvik R, Nilsen OB, Aarsland D. Efficacy of treating pain to reduce behavioural disturbances in residents of nursing homes with dementia: cluster randomised clinical trial.
BMJ. 2011;343:d4065.

A 5-item score predicted risk for warfarin-associated major hemorrhage in patients with atrial fibrillation

ACPJC. 15 November 2011.
5-item ATRIA score (score range 0 to 10):
1. Anemia (3 points)
2. hyperTension (1 point)
3. severe Renal disease: GFR <30 ml/min or dialysis-dependent (3 points)
4. history of Incidental bleed, ie past hemorrhage (1 point)
5. Age ≥ 75 years (2 points)

ATRIA risk categories (annual risk):
1. low risk for hemorrhage, score ≤ 3 (0.8%)
2. intermediate risk, score = 4 (2.6%)
3. high risk, score ≥ 5 (5.8%)

Abstract

OBJECTIVES:

The purpose of this study was to develop a risk stratification score to predict warfarin-associated hemorrhage.

BACKGROUND:

Optimal decision making regarding warfarin use for atrial fibrillation requires estimation of hemorrhage risk.

METHODS:

We followed up 9,186 patients with atrial fibrillation contributing 32,888 person-years of follow-up on warfarin, obtaining data from clinical databases and validating hemorrhage events using medical record review. We used Cox regression models to develop a hemorrhage risk stratification score, selecting candidate variables using bootstrapping approaches. The final model was internally validated by split-sample testing and compared with 6 published hemorrhage risk schemes.

RESULTS:

We observed 461 first major hemorrhages during follow-up (1.4% annually). Five independent variables were included in the final model and weighted by regression coefficients: anemia (3 points), severe renal disease (e.g., glomerular filtration rate <30 ml/min or dialysis-dependent, 3 points), age ≥75 years (2 points), prior bleeding (1 point), and hypertension (1 point). Major hemorrhage rates ranged from 0.4% (0 points) to 17.3% per year (10 points). Collapsed into a 3-category risk score, major hemorrhage rates were 0.8% for low risk (0 to 3 points), 2.6% for intermediate risk (4 points), and 5.8% for high risk (5 to 10 points). The c-index for the continuous risk score was 0.74 and 0.69 for the 3-category score, higher than in the other risk schemes. There was net reclassification improvement versus all 6 comparators (from 27% to 56%).

CONCLUSIONS:

A simple 5-variable risk score was effective in quantifying the risk of warfarin-associated hemorrhage in a large community-based cohort of patients with atrial fibrillation.

Behavior Change and Application of Tools in Clinical Practice/Health IT

ACPM's Webcast of the Month

Session Description: If your cell phone asked you what you were going to eat every time you stopped at McDonalds, or told you where the closest set of stairs were every time you stood in front of an elevator, would you be healthier? And what if, upon entering Facebook, you were immersed in an accountability environment that facilitated meet-ups, networking and community building that connected to your health goals? Would you be healthier?

This session gives health care providers information on the latest health behavior change technologies available to both providers and their patients, and discuss how these can be applied in clinical practice. It also reviews some of the science behind why these technologies have been developed, and discuss where we expect them to evolve next.

Atrial Fibrillation and Anticoagulation Articles

Dronedarone in High-Risk Permanent Atrial Fibrillation (PALLAS Trial)

http://www.nejm.org/doi/full/10.1056/NEJMoa1109867

Dronedarone increased rates of heart failure, stroke, and death from cardiovascular causes in patients with permanent atrial fibrillation who were at risk for major vascular events. Our data show that this drug should not be used in such patients.

Dronedarone in Atrial Fibrillation — Jekyll and Hyde? (Editorial)

http://www.nejm.org/doi/full/10.1056/NEJMe1111997

Has a nice comparison of the ATHENA, PALLAS, and ANDROMEDA studies.

Take home messages:

1)      Patients with permanent atrial fibrillation have no reason to receive antiarrhythmic drugs, and on the basis of the PALLAS findings, they should certainly not receive dronedarone;

2)      Dronedarone will also need to be avoided in high-risk patients with nonpermanent atrial fibrillation, particularly those with heart failure;

3)      Dose adjustment of digoxin is clearly essential in patients taking dronedarone;

4)      Reserve dronedarone for selected low-risk patients with persistent or paroxysmal atrial fibrillation, possibly those in whom other antiarrhythmic drugs have failed.

(UPDATE) FDA puts new warnings on Dronedarone
December 19, 2011 (Silver Spring, Maryland) — The FDA is requiring new safety warnings to be included on the labeling for the antiarrythmic drug dronedarone (Multaq, Sanofi-Aventis) in light of clinical data showing the drug increases the risk of serious cardiovascular events, including death, in patients with permanent atrial fibrillation (AF).
The agency is adding the following revisions and recommendations to the drug's label: Healthcare professionals should prescribe the drug only to patients who can be converted into normal sinus rhythm, and the drug should be discontinued in patients in AF. Healthcare professionals should monitor the heart rhythm of patients taking dronedarone by ECG at least once every three months.
Dronedarone is indicated to reduce hospitalization for AF in patients in sinus rhythm with a history of paroxysmal or persistent AF. Patients on dronedarone should also be on appropriate antithrombotic therapy, the FDA insists.

Risks for Stroke, Bleeding, and Death in Patients With Atrial Fibrillation Receiving Dabigatran or Warfarin in Relation to the CHADS₂ Score: A Subgroup Analysis of the RE-LY Trial

http://www.annals.org/content/155/10/660.full

Higher CHADS₂ scores were associated with increased risks for stroke or systemic embolism, bleeding, and death in patients with atrial fibrillation receiving oral anticoagulants.

Learning the Respective Roles of Warfarin and Dabigatran to Prevent Stroke in Patients With Nonvalvular Atrial Fibrillation (Editorial)

http://www.annals.org/content/155/10/714.full

1)    Dabigatran is more effective and safer for many patients with nonvalvular atrial fibrillation, especially younger patients, patients with CHADS₂ scores of 0 or 1, and those in whom the INR is not maintained within the therapeutic range at least 60% of the time;

2)    If less frequent INR monitoring can also safely keep patients within the therapeutic range of warfarin at least 70% of the time, warfarin may remain the preferred anticoagulant therapy, especially in patients aged 75 years or older or with CHADS₂ scores of 3 or higher.

FDA Approves Rivaroxaban for Stroke Prevention in AF Patients

http://www.medscape.com/viewarticle/752961?src=ptalk