M142
AHMED ET AL.
Center for Medicare and Medicaid Services (CMS) Disclaimer
supervision by one of the coauthors (JFD) rather than from
Medicare administrative files. Several limitations of the
study also need to be recognized. Due to the retrospective
chart review design of the study, documentation bias re-
mains a concern. This is especially true for procedures such
as echocardiography or MUGA scan performed in the past.
However, we believe any such underdocumentation of past
procedures would have been nondifferential to the indica-
tions for digoxin use. Moreover, when we restricted our anal-
yses to patients hospitalized with incident heart failure, we
found similar results. We have used admission electrocar-
diography as the criterion for AF. Events during the hospital
course, such as cardioversion or the use of medications for
the restoration and maintenance of sinus rhythm, might
have affected physician decision not to prescribe digoxin at
the time of discharge. However, we expect any such effect
to be minimal. The use of sinus-rhythm–restoring drugs in
outpatient settings was reportedly very low in the early
1990s (16). We were also not able to obtain data on pa-
tients’ functional status. Older heart failure patients, who
are more likely to have limited functional capacity, are also
less likely to be symptomatic (30,52). However, in our
study, symptoms were not associated with digoxin use, and
adjustment for symptoms did not alter the results. Similarly,
other unknown patient, family, or physician preference
might also have affected digoxin use.
The analyses upon which this publication is based were performed under
Contract Number 500-96-P60, entitled “Utilization and Quality Control
Peer Review Organization for the State of Alabama,” sponsored by the
CMS (formerly Health Care Financing Administration), Department of
Health and Human Services. The content of this publication does not neces-
sarily reflect the views or policies of the Department of Health and Human
Service, nor does mention of trade names, commercial products, or organi-
zations imply endorsement by the U.S. Government.
The authors assume full responsibility for the accuracy and complete-
ness of the ideas presented. This article is a direct result of the Health Care
Quality Improvement Program initiated by the CMS, which has encouraged
identification of quality improvement projects derived from analysis of pat-
terns of care, and therefore required no special funding on the part of this
contractor. Ideas and contributions to the author concerning experience in
engaging with issues presented are welcomed.
References
1. Digoxin products for oral use; reaffirmation of new drug status and
conditions for marketing. Federal Register [serial online]. Available
65:70573–70575.
2. Glaxo Wellcome. Lanoxin tablets [PDR.net web site]. 2001. Available
3. Krumholz HM, Baker DW, Ashton CM, et al. Evaluating quality of
care for patients with heart failure. Circulation. 2000;101:E122–E140.
4. Gheorghiade M, Pitt B. Digitalis Investigation Group (DIG) trial: a
stimulus for further research. Am Heart J. 1997;134:3–12.
5. Spargias KS, Hall AS, Ball SG. Safety concerns about digoxin after
acute myocardial infarction. Lancet. 1999;354:391–392.
Although the Digitalis Investigation Group (DIG) study
did not demonstrate any increased mortality (death rates of
23% for patients in both the digoxin and the placebo group;
risk ratio 0.99, 95% CI 0.76–1.28) from the use of digoxin
in heart failure patients with preserved LV systolic function
(ejection fraction ꢆ45%) (53), routine use of digoxin in this
group of patients is not recommended (38,39). In one popu-
lation-based study, use of digoxin was associated with in-
creased morbidity and mortality (54).
In conclusion, we observed a high prevalence of digoxin
use among older heart failure patients who had no approved
indication for its use. We also found a relative underutiliza-
tion of the drug for patients who might have benefited most
from the drug. Although the results of this observational
study should be interpreted with caution, the study provides
epidemiologic data about the high prevalence of inappropri-
ate use and initiation of digoxin, a drug with the potential
for serious complication in older patients. Electrocardio-
graphy and echocardiography should be performed in all
older heart failure patients, and consideration should be
given to discontinue digoxin if the absence of LVSD or
chronic AF can be established. Similarly, digoxin therapy
should not be initiated in the absence of these indications.
6. Falk RH, Knowlton AA, Bernard SA, Gotlieb NE, Battinelli NJ.
Digoxin for converting recent-onset atrial fibrillation to sinus rhythm: a
randomized, double-blinded trial. Ann Intern Med. 1987;106:503–506.
7. Jordaens L, Trouerbach J, Calle P, et al. Conversion of atrial fibrilla-
tion to sinus rhythm and rate control by digoxin in comparison to
placebo. Eur Heart J. 1997;18:643–648.
8. Rawles JM, Metcalfe MJ, Jennings K. Time of occurrence, duration,
and ventricular rate of paroxysmal atrial fibrillation: the effect of
digoxin. Br Heart J. 1990;63:225–227.
9. Galun E, Flugelman MY, Glickson M, Eliakim M. Failure of long-
term digitalization to prevent rapid ventricular response in patients
with paroxysmal atrial fibrillation. Chest. 1991;99:1038–1040.
10. Koh KK, Kwon KS, Park HB, et al. Efficacy and safety of digoxin alone
and in combination with low-dose diltiazem or betaxolol to control ven-
tricular rate in chronic atrial fibrillation. Am J Cardiol. 1995;75:88–90.
11. Farshi R, Kistner D, Sarma JS, Longmate JA, Singh BN. Ventricular
rate control in chronic atrial fibrillation during daily activity and pro-
grammed exercise: a crossover open-label study of five drug regimens.
J Am Coll Cardiol. 1999;33:304–310.
12. Go AS, Hylek EM, Phillips KA, et al. Prevalence of diagnosed atrial
fibrillation in adults: national implications for rhythm management
and stroke prevention: the Anticoagulation and Risk Factors In Atrial
Fibrillation (ATRIA) study. JAMA. 2001;285:2370–2375.
13. Congestive Heart Failure in the United States: A New Epidemic. Data
Facts Sheets. Bethesda, MD: National Heart, Lung, and Blood Insti-
tute; 1996.
14. Feinberg WM, Blackshear JL, Laupacis A, Kronmal R, Hart RG.
Prevalence, age distribution, and gender of patients with atrial fibril-
lation: analysis and implications. Arch Intern Med. 1995;155:469–
473.
Acknowledgments
15. Aronow WS. Prevalence of appropriate and inappropriate indications
for use of digoxin in older patients at the time of admission to a nurs-
ing home. J Am Geriatr Soc. 1996;44:588–590.
Dr. Ali Ahmed is supported by a faculty training support grant from the
Southeast Center of Excellence in Geriatric Medicine. During data analysis,
he was also supported by a Hartford/American Federation for Aging Re-
search Academic Geriatric Fellowship Award.
16. Stafford RS, Robson DC, Misra B, Ruskin J, Singer DE. Rate control
and sinus rhythm maintenance in atrial fibrillation: national trends in
medication use, 1980–1996. Arch Intern Med. 1998;158:2144–2148.
17. Li-Saw-Hee FL, Lip GY. Digoxin revisited. QJM. 1998;91:259–264.
18. Hauptman PJ, Kelly RA. Digitalis. Circulation. 1999;99:1265–1270.
19. Clinical Quality Improvement Network Investigators. Contemporary
utilization of digoxin in patients with atrial fibrillation. Ann Pharma-
cother. 1999;33:289–293.
Address correspondence to Dr. Ali Ahmed, Division of Geriatric Medi-
cine, University of Alabama at Birmingham, 1530 3rd Ave South, CH-19,
Ste-219, Birmingham, AL 35294-2041. E-mail: aahmed@uab.edu
A paper based on the preliminary findings of the study was presented at
the Annual Scientific Meeting of the American Geriatric Society, May
2001, Chicago, IL.