Feature Article
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Development of Guidelines for the Use of Orexigenic Drugs in Long-Term Care Development of Guidelines for the Use of Orexigenic Drugs in Long-Term Care
John E. Morley, MB, BCh
David R. Thomas, MD
Division of Geriatric Medicine
Saint Louis University Health Sciences Center
GRECC, St. Louis VA Medical Center
St. Louis, Missouri
Chair: Moderator:
John E. Morley, MB, BCh William J. Evans, PhD
Dammert Professor of Gerontology Professor of Geriatrics, Physiology & Nutrition
Director, Division of Geriatric Medicine Director, Nutrition, Metabolism and Exercise Program
Saint Louis University Health Sciences Center Donald W. Reynolds Center for Aging, and GRECC
Director, GRECC University of Arkansas for Medical Sciences
St. Louis Medical Center Little Rock, Arkansas
St. Louis, Missouri
Council Members
Marianne Smith Edge, MS, RD, CD, FADA
Owner, MSE & Associates
President, American Dietetic Association
Owensboro, Kentucky
Laurie Forrester, PharmD
Vice President, Clinical Services
PharMerica
Dallas, Texas
Malcolm Fraser, MD, CMD
President, Synergy Health Solutions
St. Petersburg, Florida
Ann Gallagher, RD, LD, CD
President, F.A. Gallagher and Associates
Past President, The American Dietetic
Association
Fort Wayne, Indiana
Rob Godwin, RPh, FASCP
PharMerica / CliniCare Concepts
National Director of Clinical Program
Development
Co-Chair, P&T Liaison Committee
Smyrna, Georgia
Martin J. Gorbien, MD, CMD, FACP
Associate Professor of Internal Medicine
Director, Section of Geriatric Medicine
Director, The Johnston R. Bowman
Health Center
Rush-Presbyterian-St. Luke’s Medical Center
Chicago, Illinois
Morris Green, MD, PhD
Long-Term Care Coordinator
Geriatric Fellowship Program
University of Medicine & Dentistry of New Jersey
Hackensack, New Jersey
Clare Hendrick, RN, BSN, CRNP
VP of Education and Clinical Development
HealthEssentials, Inc.
San Clemente, California
Barbara L. Hoffmann, MD, CMD
President, Landis Consulting Corporation &
MedYork
York, Pennsylvania
Donna A. Israel, PhD, RD, LD, LPC, FADA
President, Preferred Nutrition Therapists, Inc.
Richardson, Texas
Karen Lou Kennedy, RN, CS, FNP
President, Kennedy Consultants
Fort Wayne, Indiana
Steven Levenson, MD, CMD
Baltimore, Maryland
Armon B. Neel, Jr., PharmD, CGP,
FASCP
President,
MedicationXpert, LLC (Griffin, Georgia)
Corporate Director of Pharmacy
Operations
Avante Group (Hollywood, Florida)
Dan Osterweil, MD, CMD
Professor of Clinical Medicine and Geriatrics
UCLA School of Medicine
Los Angeles, California
Carolyn D. Philpot, MSN (R), CS, GNP
Division of Geriatrics
aint Louis University Health Sciences Center
St. Louis, Missouri
Mary Ellen Posthauer, RD, CD
President, MEP Healthcare Dietary Services, Inc.
Evansville, Indiana
Gretchen E. Robinson, MS, RD, LD, FADA
Corporate Dietitian, Health Care Facilities, Inc.
Lima, Ohio
Miriam B. Rodin, MD, PhD, CMD
Assistant Professor of Medicine
The University of Chicago
Chicago, Illinois
Laurence Z. Rubenstein, MD, MPH, FACP
Professor of Geriatric Medicine
UCLA School of Medicine
Director, Sepulveda VA GRECC
Los Angeles, California
Debra Smith, RPh, FASCP
President
Mediclaim Inc.
Charlotte, North Carolina
Dennis H. Sullivan, MD
Director, GRECC
Central Arkansas Veterans Healthcare System
Executive Vice Chairman, Donald W.
Reynolds Department of Geriatrics
University of Arkansas for Medical Sciences
Little Rock, Arkansas
David R. Thomas, MD, CMD, FACP, AGSF Professor of Medicine
Division of Geriatric Medicine
Saint Louis University Health Sciences Center
St. Louis, Missouri
Margaret-Mary G. Wilson, MBBS, MRCP
Assistant Professor of Geriatric/ Internal Medicine
Division of Geriatric Medicine
Saint Louis University Health Sciences Center
St. Louis, Missouri
Shing-shing Yeh, PhD, MD
Associate Professor in Medicine
University Hospital, SUNY at Stony Brook
Geriatric Division, Department of Medicine
VA Medical Center at Northport
Northport, New York
Council Facilitator: Wendy C. Ashmen
Programs in Medicine
Newtown Square, Pennsylvania
Online CME Credit Available
In order to enhance the value of the material presented in this special publication, online CME credit is being extended through Cyberounds®, an interactive grand rounds moderated by distinguished academics, exclusively for physicians, medical students and other selected health professionals.
To participate in this online CME activity, you will need to follow these simple steps:
• Go to the Cyberounds® website at http://www.cyberounds.com
• Click on Conferences
Note: If you are not already a member of Cyberounds®, you will need to take a minute to register. Cyberounds® is free. Once you’ve registered, you can attend any conference on the Cyberounds® website. Member data cannot be accessed via the Web and will never be released without your permission.
• Click on Geriatrics
• Click on current conference
Note: After September 2003, this activity will be available until August 2006 by simply clicking on previous conference and then locating the article in reverse chronological order: 06/03 Development of Guidelines for the Use of Orexigenic Drugs in Long-Term Care.
Release date: September 2003
Termination date: August 2006
Peer-reviewed by Laurie Jacobs, MD, Professor of Medicine, and Head of the Unified Division of Geriatrics, Albert Einstein College of Medicine, Bronx, NY.
Sponsored by the Albert Einstein College of Medicine.
Albert Einstein College of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
This activity is made possible by an unrestricted educational grant from Solvay Pharmaceuticals, Inc.
This special publication was produced by MultiMedia HealthCare/Freedom, LLC.
The opinions expressed herein are those of the authors and do not necessarily represent the views of the sponsor or its publisher. Please review complete prescribing information of specific drugs or combinations of drugs, including indications, contraindications, warnings, and adverse effects before administering pharmacologic therapy to patients.
This publication may not be reproduced in whole or in part without the express written permission of MultiMedia HealthCare/Freedom, LLC.
The Geriatric Anorexia Nutrition (GAIN) Registry clearly demonstrated that persons living in long-term care who are losing weight have a higher mortality compared to those who stop losing weight.1 Those who gained weight had a lower mortality than those in whom weight stabilized.
Numerous other studies have shown that weight loss and protein energy malnutrition in older persons is associated with an increase in mortality.2-4 Weight loss is also associated with a variety of other adverse effects (Table I).5 In addition, protein energy malnutrition aggravates the deterioration in the immune system that is normally associated with aging and causes a decline in CD4+ T lymphocytes (Table II).6 For these reasons, weight loss has been considered a sentinal event in the life of the nursing home resident.
Estimates of the prevalence of protein energy malnutrition in cross-sectional studies of nursing home residents range from 23-85%.7 In a prospective study of admissions to a long-term care facility, 54% of the residents were malnourished at the time of admission.8 Serum albumin levels below 3.5 g/dL occur in 6-43% of nursing home residents. While low serum albumin levels are often associated with protein deficiency, they are also caused by cytokine excess, which inhibits albumin production in the liver and causes albumin leakage into the extravascular space. The effects of cytokines on albumin make it a poor marker of nutritional status. Pyridoxine deficiency occurs in 65% of residents, thiamine deficiency in 19%, and ascorbic acid deficiency in 2% of residents.9
Because of the importance of weight loss for residents in nursing homes, the Council for Nutritional Clinical Strategies in Long-Term Care has developed a series of guidelines for nutritional assessment and management in long-term care (Tables III and IV).10 At a recent meeting of the Council, it was felt that it would be useful to develop guidelines for the use of orexigenic agents in long-term care. In this article, we present a review of the efficacy and safety of orexigenic agents and the recommendations of the Council for Nutritional Clinical Strategies in Long-Term Care on the use of orexigenic agents in long-term care residents.
Protein and Energy Supplementation in Malnourished Older Persons
While there is a paucity of high-quality studies on liquid protein and energy supplementation in malnourished older persons, the Cochrane Database of Systematic Reviews found 31 trials with 2464 randomized participants that could be analyzed.11 Based on their analysis, they found that supplements were associated with weight gain, decreased mortality (RR 0.67, 0.52–0.87), and decreased length of hospitalization by 3.4 days. No decrease in the risk of non-nutritional morbidity was found, and there were inadequate numbers to judge the effects on function (eg, grip strength, walking distance, and Barthel index). Most studies were considered too short to have a realistic probability of detecting changes in function, quality of life, or morbidity.
Based on the finding that glucose when infused into the duodenum increased hunger in older persons compared to younger persons,12 Wilson et al13 studied the effect of a liquid caloric supplement administered concomitantly with the meal, or 60 minutes before the meal. They found that when a caloric liquid supplement was administered 60 minutes before a meal, it increased total caloric intake (supplement plus meal), but had no effect when given with the meal. It is, therefore, recommended that caloric supplements be given between meals and not with meals.
A number of recent caloric supplementation trials further support the positive conclusions of the Cochrane Database. Beattie et al14 examined 101 malnourished surgical patients and found that caloric supplements postoperatively retarded weight loss and improved grip strength, quality of life, and morbidity compared to the control group. Lauque et al15 examined the effect of a 400-kcal oral supplement daily in persons at nutritional risk living in nursing homes. They found an increase in daily protein and energy intake, body weight (1.4 ± 0.5 kg), and nutritional status in the supplemented group. In a 60-month randomized, placebo-controlled trial of 82 patients who had experienced a hip fracture (mean age, 80.7 years), protein repletion resulted in increased serum levels of insulin-like growth factor-1 (IGF-1), attenuation of proximal femur bone loss, and decreased length of stay in the rehabilitation setting.16
These studies confirm the utility of protein-calorie supplementation to improve outcomes, but to a limited extent, suggesting the need for a more aggressive therapeutic effect. Caloric supplements should be given between meals. The utility of “med-pass” supplements (the giving of medications with a nutritional supplement) requires a controlled trial.
Depression
Depression is a common cause of severe weight loss in older persons, particularly those living in long-term care.17-19 All persons losing weight should be screened for depression, using validated tools such as the Geriatric Depression Scale (if not demented) or with the Cornell Scale for Depression in Demented Persons. At present, the drug of choice for treating depression in persons with weight loss is mirtazapine, since it has most often been associated with weight gain. However, weight gain may accompany improvement in depression despite the particular drug used.20-24 There is some evidence that mirtazapine has specific orexigenic as well as antidepressant properties. However, any antidepressant that reverses depression will cause weight gain. If antidepressants are ineffective and the weight loss continues to be of significant concern, electroconvulsive therapy should be considered.
Anabolic Agents
Two types of anabolic agents have been utilized to increase weight in malnourished older persons (ie, the anabolic steroids and growth hormone). Insulin growth factor-1 levels, which are regulated by growth hormone, decline to low levels in older persons, and fall even further with the onset of malnourishment.25 Thus, growth hormone was a reasonable agent to test in reversing protein energy undernutrition in older persons. Early studies demonstrated that in these individuals growth hormone caused nitrogen retention and produced weight gain.26 Chu et al27 found that growth hormone could improve nutritional status in malnourished older persons. However, a large study on malnourished patients in intensive care units found that growth hormone increased length of hospitalization, ventilator dependence, and death.28 Thus, at present, growth hormone cannot be recommended for use in older malnourished persons.
Ghrelin is a peptide hormone produced by the fundus of the stomach. Ghrelin increases food intake and releases growth hormone.29 It produces these effects by activating nitric oxide synthase in the hypothalamus. Ghrelin appears to be an excellent potential mediator for the development of drugs to treat anorexia and weight loss.
Testosterone levels decline in men and women with aging.30,31 Testosterone is an anabolic steroid. It increases strength, decreases fat mass, increases bone mineral density, and improves visuospatial cognition.31,32 Low testosterone levels have been shown to be highly related to the development of sarcopenia33-35 and to poor function (frailty).36 Bakhshi et al37 showed that testosterone administration improved function in men during rehabilitation following hospitalization. While there are no studies conducted in long-term care on testosterone replacement, it would appear that this may be a reasonable option for malnourished men with low testosterone levels.
Other anabolic steroids have been used in malnourished ill patients. Nandrolone has been shown to enhance nutritional status in persons with renal failure.38 Oxandrolone has been shown to decrease weight loss, nitrogen loss, time to healing, and length of hospitalization in elderly burn patients.39 In an open-label trial, oxandrolone 10 mg twice daily produced weight gain in patients with chronic obstructive pulmonary disease.40 No trials on the effects of oxandrolone on residents in longer-term care are available.
Megestrol Acetate
Megestrol acetate is a progestational agent that increases food intake. A number of studies on cancer patients have shown that megestrol acetate increases appetite and weight, and improves quality of life.41-43 Similar findings have been reported in patients with AIDS.44,45
There is limited experience of the use of megestrol in geriatric patients. Castle et al46 reported that two out of four patients receiving megestrol acetate had weight gain. In a retrospective study of 27 long-term care patients, 74% had an increase in body weight, with weight gain being greater in women than in men.47 Karcic et al48 reported increased food intake, body mass index, albumin prealbumin, hemoglobin, and lymphocyte count in a small number of nursing home residents who received megestrol.
Yeh et al,49 in a placebo-controlled randomized 3-month trial of megestrol, found that there was a significant increase in weight in the 3 months following megestrol administration. It is now well recognized that cytokines decrease food intake, inhibit albumin synthesis, cause muscle wasting, decrease nitrogen retention, and cause extravasation of albumin from intravascular spaces (Figure 1).50,51 Yeh et al52 reported that megestrol produced a decrease in interleukin-6, tumor necrosis factor receptor-p75, and soluble interleukin-2 receptor levels. Lambert et al53 also found that megestrol reduced interleukin-6 levels. These findings suggest that megestrol may be a useful drug in persons with cytokine excess. Cytokine excess may be gauged by measuring a C-reactive protein.
A major potential problem with megestrol is that it produces an increase mainly in fat mass rather than fat-free mass.54 While an exercise program increased thigh muscle, cross-sectional area megestrol failed to do this. Megestrol acetate markedly decreased testosterone levels over a short time period. In addition to hypogonadism, megestrol acetate has been reported to produce hyperglycemia, adrenal suppression,55 and possibly deep vein thrombosis (Table V).56 For the latter reason, megestrol acetate should not be used in immobile persons. The effective dose of megestrol acetate was 800 mg daily.
Dronabinol
Cannabis was first recognized as an appetite stimulant in Aryuvedic medicine, and then in Arabic medicine by Al Badri in 1251. In 1838, O’Shaugnessy pointed out that cannabis made patients voraciously hungry, and in The Lancet in 1890, Reynolds wrote that cannabis “…when pure and administered carefully is one of the most valuable medicines we possess.” In the 1970s, during studies on the psychological effects of cannabis, it was noted to increase the intake of marshmallows and chocolate milk. In 1973, Morley et al57 reported that cannabis increased the desire for food, made substances taste better and smell richer, decreased pain, and increased happiness. These are the ideal properties of a drug for palliative care.
Based on these findings, the active ingredient of cannabis, tetrahydrocannabinol, was isolated and a therapeutic agent, dronabinol, became available. Dronabinol has been shown to increase appetite in persons with cancer58-60 or AIDS.61-63
Volicer et al64 studied 11 patients with Alzheimer’s disease and disturbed behavior. They ranged in age from 65-82 years. Dronabinol, on average, produced a 3-pound weight gain compared to placebo. In addition, dronabinol improved scores on the Cohen-Mansfield Agitation Index.
Jatoi et al58 found that dronabinol and megestrol improved appetite and produced weight gain. There was no advantage of utilizing the drugs in combination. Neither drug had any major side effects.
Another major effect of dronabinol is its antiemetic effect.65 It is a particularly potent agent in preventing anticipatory nausea and vomiting in chemotherapy patients. In addition to dronabinol’s appetite stimulation effects and reduction of aggressive behavior in patients with Alzheimer’s disease, it is also an antispasmodic and an analgesic.66 As an analgesic, it is an excellent adjuvant therapy with opioids for use in central post-stroke pain and neuropathic pain.
Because dronabinol produces appetite stimulation, has antinausea properties, decreases pain, and enhances general well being, it is considered the ideal drug for the management of end-of-life palliative care (Figure 2).
Because persons naïve to dronabinol may have mild delirium when first exposed to the drug, it should first be given at a dose of 2.5 mg prior to bedtime. After 1 week, the 2.5-mg dose should be given before supper. After 2 weeks, if there has been no response, the nursing home resident should be given 2.5 mg before lunch and supper (Table VI).
Council for Nutritional Clinical Strategies in Long-Term Care Recommendations for Use of Orexigenics
As weight loss is a sentinel event, the Council recommends:
• Previous recommendations of the Council for nonpharmacologic interventions should be instituted in persons at nutritional risk.
• Persons who are depressed should receive treatment with an antidepressant that has orexigenic properties (eg, mirtazapine). In depressed persons with severe weight loss, electroconvulsive therapy should be considered.
• Orexigenics should be used when no obvious treatable cause of weight loss is present, or when the above recommendations fail to reverse weight loss.
• Use of anabolic steroids, preferably testosterone, should be used only to treat sarcopenia, not anorexia.
• Megestrol acetate should be used in ambulatory persons with cytokine excess.
• Because megestrol acetate reduces testosterone levels, it should be used in men only together with testosterone.
• Megestrol acetate should be given for a maximum of 3 months.
• Persons receiving megestrol acetate should be monitored for adrenocortical insufficiency.
• Dronabinol should be used early when weight loss occurs without an apparent cause, or when no reversible cause is present.
• Dronabinol appears to be an ideal drug for end-of-life and palliative care.
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54. Lambert CP, Sullivan DH, Freeling SA, et al. Effects of testosterone replacement and/or resistance exercise on the composition of megestrol acetate stimulated weight gain in elderly men: A randomized controlled trial. J Clin Endocrinol Metab 2002;87:2100-2106.
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63. Struwe M, Kaempfer SH, Geiger CJ, et al. Effect of dronabinol on nutritional status in HIV infection. Ann Pharmacother 1993;27:827-831.
64. Volicer L, Stelly M, Morris J, et al. Effects of dronabinol on anorexia and disturbed behavior in patients with Alzheimer’s disease. Int J Geriatr Psychiatry 1997;12:913-919.
65. Gonzalez-Rosales F, Walsh D. Intractable nausea and vomiting due to gastrointestinal mucosal metastases relieved by tetrahydrocannabinol (dronabinol). J Pain Symptom Manage 1997;14:311-314.
66. Clermont-Gnamien S, Atlani S, Attal N, et al. The therapeutic use of Delta 9-tetrahydrocannabinol (dronabinol) in refractory neuropathic pain. Presse Medicale 2002;31:1840-1845.
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2. How many skilled nursing facilities do you serve?
o 1-2 o 3-5 o > 5
3. What is the total skilled care bed size for
these facilities?
o < 100 o 100 – 150 o 151 – 200 o > 200
4. On average, how frequently do you see each
of your skilled care patients?
o Once a week
o At least once a month
o Once every 2-3 months
5. In a typical month, what percentage of your skilled care patients experiences some nutrition problems (eg, appetite loss and weight loss)? __________%
6. What are the three most common diseases or conditions associated with appetite loss and reduced food intake in your skilled care patients?
o Cancer o HIV or AIDS
o Renal disease o Pulmonary disease
o Heart disease o Stroke (CVA)
o Alzheimer’s disease o GI disease
o Psychological illness
(eg, depression, anxiety)
o Other; please specify: ________
7. Based upon your clinical judgment, what do you believe to be the underlying cause of the appetite loss for most skilled care patients?
o Medication o Depression
o Acute infection/illness o Disease-related
o Surgical procedure o Other; please specify: _______
8. How frequently are nutritional assessments typically performed on your skilled care patients?
o At least once a week o Once every 2 weeks
o Once a month o Once every 3 to 6 months
o If less frequent, please specify: ____________________________
9. Who conducts the nutritional assessment?
o Physician o Physician Assistant
o Nurse Practitioner o Skilled care nurse
o Dietitian o Other; please specify: _____________________
10. How do you typically first become aware that your skilled care patients have a nutritional problem?
o You diagnose the problem
o You are notified by a skilled care nurse
o Your are notified by someone else in
the skilled nursing facility
o You are notified by a dietitian
o Other; please specify: ___________________________
11. At what point are your skilled care patients first treated for appetite and/or weight loss?
o At first signs of appetite loss, but
before weight loss has occurred
o Weight loss of less than 5% of normal
body weight
o Weight loss of 5% or more of normal
body weight
o Other; please specify: ___________________________
12. What is the typical first-line treatment that you prescribe for your skilled care patients who experience appetite and weight loss?
o Nutritional supplements o Tube feeding
o Drug therapy o Total parenteral nutrition (TPN)
o Other; please specify: ________
13. Of all your skilled care patients who experience appetite and/or weight loss, what percent are treated at any point with drug therapy? __________%
14. Of the following drugs, please check those with which you are familiar:
o Cyproheptadine (Periactin)
o Oxandrolone (Oxandrin)
o Dronabinol (Marinol) o Oxymetholone (Anadrol)
o Growth hormone o Testosterone
o Megestrol acetate (Megace)
o Mirtazapine (Remeron)
o Other; please specify: _____________
15. Which of the following drugs do you currently use with your patients who have experienced appetite and/or weight loss, and please indicate percentage of total with the total equaling 100%.
o Cyproheptadine (Periactin) ______%
o Oxandrolone (Oxandrin) ______%
o Dronabinol (Marinol) ______%
o Oxymetholone (Anadrol) ______%
o Growth hormone ______%
o Testosterone ______%
o Megestrol acetate (Megace) ______%
o Mirtazapine (Remeron) ______%
o Other; please specify: _____ ______%
16. Which of the following drugs do you plan to use with your patients who experience appetite and/or weight loss:
o Cyproheptadine (Periactin)
o Oxandrolone (Oxandrin)
o Dronabinol (Marinol)
o Oxymetholone (Anadrol)
o Growth hormone
o Testosterone
o Megestrol acetate (Megace)
o Mirtazapine (Remeron)
o Other; please specify: ______________
17. Please rank in order of importance the impact of the following factors in your drug selection using a scale of 1 to 7, where “1” means most important and “7” means least important:
____ Product efficacy
____ Product cost
____ Ease of use and patient compliance
____ Prior experience with product
____ Patient/family request
____ Product is on formulary or part of formal protocol
____ Other; please specify: ____________
18. Please rate the degree of influence that each of the following parties has on your supportive care prescribing decisions using a scale of 1 to 5, where “1” means not at all influential and “5” means extremely influential (circle rating).
Not at all Extremely
Influential Influential
Skilled nursing home formulary 1 2 3 4 5
Skilled care director of nursing 1 2 3 4 5
Skilled care nurses 1 2 3 4 5
Dietitians 1 2 3 4 5
Consultant pharmacist 1 2 3 4
19. Would you be interested in participating in research involving the use of orexigenic agents in your long-term care facility(ies)?
o Yes o No
20. What type of educational programs focusing on nutrition would you like to see? ____________________________________________________________________________ion:
Full Name Degree(s)
Title/Position
Practice Name
Full Address
City State Zip
Phone Fax E-mail
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