U.S. patent application number 09/943322 was filed with the patent office on 2002-02-28 for comprehensive pharmacologic therapy for treatment of obesity.
Invention is credited to Hinz, Martin C..
Application Number | 20020025972 09/943322 |
Document ID | / |
Family ID | 23634093 |
Filed Date | 2002-02-28 |
United States Patent
Application |
20020025972 |
Kind Code |
A1 |
Hinz, Martin C. |
February 28, 2002 |
Comprehensive pharmacologic therapy for treatment of obesity
Abstract
The comprehensive pharmacologic therapy for treatment of obesity
is a procedure which involves the administration of a desired
therapeutic range of Diethylpropion and/or Phentermine in
combination with a SSRI medication and nutritional supplementation
for brief and long durations which may be 12 months or more. The
preferred procedure involves the administration of drugs in
combination which are identified as: Citalopram (Celexa) and
Phentermine; Citalopram (Celexa) and Diethylpropion; Citalopram
(Celexa), Phentermine, and Diethylpropion. In addition nutritional
supplementation such as a multivitamin, 5-Hydroxytryptophan,
vitamin B6, vitamin C, Tyrosine, Calcium, and Lysine may be used to
enhance the performance of the weight loss treatment program.
Inventors: |
Hinz, Martin C.; (Duluth,
MN) |
Correspondence
Address: |
VIDAS, ARRETT & STEINKRAUS, P.A.
6109 BLUE CIRCLE DRIVE
SUITE 2000
MINNETONKA
MN
55343-9185
US
|
Family ID: |
23634093 |
Appl. No.: |
09/943322 |
Filed: |
August 30, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09943322 |
Aug 30, 2001 |
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09412701 |
Oct 4, 1999 |
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Current U.S.
Class: |
514/330 ;
514/356; 514/418; 514/474 |
Current CPC
Class: |
A61K 31/343 20130101;
A61K 31/405 20130101; A61K 31/4415 20130101; Y10S 514/909 20130101;
A61K 31/198 20130101; Y10S 514/91 20130101; Y10S 514/905 20130101;
A61K 31/343 20130101; A61K 31/34 20130101; A61K 31/375 20130101;
A61K 31/405 20130101; A61K 31/195 20130101; A61K 31/4415 20130101;
A61K 2300/00 20130101; A61K 2300/00 20130101; A61K 2300/00
20130101; A61K 2300/00 20130101; A61K 31/135 20130101; A61K 31/44
20130101; A61K 2300/00 20130101; A61K 31/135 20130101; A61K 2300/00
20130101; A61K 2300/00 20130101; A61K 31/34 20130101; A61K 31/375
20130101; A61P 3/04 20180101; A61K 31/375 20130101; A61K 33/06
20130101; A61K 31/405 20130101; A61K 33/06 20130101; A61K 31/198
20130101; A61K 33/06 20130101; A61K 31/34 20130101 |
Class at
Publication: |
514/330 ;
514/418; 514/474; 514/356 |
International
Class: |
A61K 031/445; A61K
031/375; A61K 031/404 |
Claims
What is claimed is:
1. A method to facilitate weight loss for a patient comprising: A.
administration of Citalopram; and B. administration of Phentermine
wherein said Citalopram and said Phentermine are administered in an
effective therapeutic range to effectuate weight loss.
2. A method according to claim 1 said effective therapeutic range
comprising: A. administration of 10 mg of Citalopram each day for a
period of six days followed by the administration of a dosage of
between 10 mg and 80 mg of said Citalopram each day thereafter; and
B. the administration of 15 mg of said Phentermine each day for
said period of six days followed by the administration of a dosage
of between 15 mg and 60 mg of said Phentermine for each day
thereafter.
3. A method according to claim 1 further comprising the
administration of an effective amount of Diethylpropion each
day.
4. A method according to claim 1 further comprising the
administration of 5-Hydroxytryptophan each day.
5. A method according to claim 4 further comprising the
administration of vitamin B6 each day.
6. The method according to claim 5 further comprising the
administration of vitamin C each day.
7. The method according to claim 6 further comprising the
administration of Tyrosine, a multivitamin, calcium, and Lysine
each day.
8. The method according to claim 7 further comprising the
administration of: A. 50 mg to 900 mg of 5-Hydroxytryptophan each
day; B. 2 mg to 150 mg of vitamin B6 each day; C. 50 mg to 2000 mg
of vitamin C each day; D. 50 mg to 4000 mg of Tyrosine each day; E.
50 mg to 2000 mg calcium each day; and F. 50 mg to 2000 mg of
Lysine each day.
9. A method to facilitate weight loss for a patient comprising: A.
administration of Citalopram; and B. administration of
Diethylpropion wherein said Citalopram and said Diethylpropion are
administered in an effective therapeutic range to effectuate weight
loss.
10. The method according to claim 9 said effective therapeutic
range comprising: A. the administration of 10 mg of said Citalopram
each day for a period of six days followed by the administration of
a dosage between 10 mg and 80 mg of said Citalopram each day
thereafter; and B. the administration of 25 mg of said
Diethylpropion each day for said period of six days followed by the
administration of a dosage of between 25 mg and 75 mg of said
Diethylpropion each day thereafter.
11. The method according to claim 9 further comprising the
administration of an effective amount of Phentermine each day.
12. The method according to claim 9 further comprising the
administration of 5-Hydroxytryptophan each day.
13. The method according to claim 9 further comprising the
administration of vitamin B6 each day.
14. The method according to claim 13 further comprising the
administration of vitamin C each day.
15. The method according to claim 14 further comprising the
administration of Tyrosine, a multivitamin, calcium and Lysine each
day.
16. The method according to claim 15 further comprising the
administration of: A. 50 mg to 900 mg of 5-Hydroxytryptophan each
day; B. 2 mg to 150 mg of vitamin B6 each day; C. 50 mg to 2000 mg
of vitamin C each day; D. 50 mg to 4000 mg of Tyrosine each day; E.
50 mg to 2000 mg of calcium each day; and F. 50 mg to 2000 mg of
Lysine each day.
17. A method to facilitate weight loss for a patient comprising: A.
administration of Citalopram; B. administration of Diethylpropion;
and C. administration of Phentermine wherein said Citalopram, said
Diethylpropion, and said Phentermine are administered in an
effective therapeutic range to effectuate weight loss.
18. The method according to claim 17, said effective therapeutic
range comprising: A. the administration of 10 mg of said Citalopram
each day for a period of six days followed by the administration of
a dosage of between 10 mg and 80 mg of said Citalopram each day
thereafter; B. the administration of 15 mg of said Phentermine each
day for said period of six days followed by the administration of a
dosage of between 15 mg and 60 mg of said Phentermine each day
thereafter; and C. the administration of 25 mg of said
Diethylpropion each day for said period of six days followed by the
administration of a dosage of between 25 mg and 75 mg of said
Diethylpropion each day thereafter.
19. The method according to claim 18 further comprising the
administration of 5-Hydroxytryptophan each day.
20. The method according to claim 19 further comprising the
administration of vitamin B6 each day.
21. The method according to claim 20 further comprising the
administration of vitamin C each day.
22. The method according to claim 21 further comprising the
administration of Tyrosine, a multivitamin, calcium, and Lysine
each day.
23. The method according to claim 22 further comprising the
administration of: A. 50 mg to 900 mg of 5-Hydroxytryptophan each
day; B. 2-150 mg of vitamin B6 each day; C. 50 mg to 2000 mg of
vitamin C each day; D. 50 mg to 4000 mg of Tyrosine each day; E. 50
mg to 2000 mg of calcium each day; and F. 50 mg to 2000 mg of
Lysine each day.
24. A method to facilitate weight loss for a patient comprising: A.
administration of a selective Serotonin reuptake inhibitor (SSRI);
B. administration of Phentermine; and C. administration of
5-Hydroxytryptophan, vitamin B6, and vitamin C, wherein said SSRI,
said Phentermine, said 5-Hydroxytryptophan, said vitamin B6, and
said vitamin C are administered in an effective therapeutic range
to effectuate weight loss.
25. The method according to claim 24 said effective therapeutic
range comprising: A. the administration of 10 mg of said SSRI each
day for a period of six days followed by the administration of a
dosage between 10 mg and 80 mg of said SSRI each day thereafter; B.
administration of 15 mg of said Phentermine each day for said
period of six days followed by the administration of a dosage of
between 15 mg and 60 mg of said Phentermine each day thereafter;
and C. the administration of 50 mg to 900 mg of said
5-Hydroxytryptophan each day, 2 mg to 150 mg of vitamin B6 each
day, and 50 mg to 2000 mg of vitamin C each day.
26. The method of claim 25 further comprising the administration of
Tyrosine, a multivitamin, calcium, and Lysine.
27. The according to claim 16 further comprising the administration
of: A. 50 mg to 4000 mg of Tyrosine each day; B. 50 mg to 2000 mg
of calcium each day; and C. 50 mg to 2000 mg of Lysine each
day.
28. The method according to claim 1 wherein said administration of
said Citalopram and the administration of said Phentermine is
increased when said patient experiences low weight loss, said low
weight loss comprising: said patient weight at a previous visit
plus said patient current weight first divided by 2 and then
multiplied by 10, less said current patient weight, less said
patient weight at said previous visit, multiplied by 3500, divided
by the number of days between said previous visit and said current
weight for the provision of a first sum; calculating a second sum
by multiplying a patient goal weight by ten and then divided by
0.8929; and comparing said first sum to said second sum where low
weight loss occurs when said first sum is larger than said second
sum.
Description
BACKGROUND OF THE INVENTION
[0001] Research has identified that long term use of medications
for treatment of obesity in patients has resulted in many problems.
The two most significant problems encountered by patients using
medications to assist in weight loss, assuming the absence of
irreversible side effects from the medications, are that:
[0002] The medications stop working during therapy where at least
40% to 50% of patients quit losing weight (plateau) on an average
of 3.3 months into therapy; and 5% to 8% of patients who receive
drug therapy for weight problems experience the complication where
the medications fail to assist in appetite suppression where the
patient therefore does not lose significant weight.
[0003] In the past long term treatment, defined as treatment longer
than 3 months to many years, with drugs has been a problem due to
long term safety issues including, medication intolerability by the
patient, medication side effects and most important ineffectiveness
of the drugs or the cessation of benefit of the drugs which in turn
causes the patient to fall out of appetite suppression and
terminate weight loss.
[0004] A weight loss procedure using SSRI medication is disclosed
in U.S. Pat. No. 5,795,895. The potential for patients to obtain
goal weight loss under the process of U.S. Pat. No. 5,795,895 is
low, and the failure of the drugs to provide a desired level of
performance is at the heart of the problem.
[0005] In the past obesity or weight management procedures, as
noted in U.S. Pat. No. 5,795,895, implement a single dosing
schedule of SSRI medication for a patient. A single dosing schedule
of SSRI medication is not optimal for a desired level of weight
loss performance. Individuals frequently fail to lose a desired
amount of weight when alternative doses of medication are
unavailable.
[0006] Second, patients receiving treatment for weight loss through
the use of medication frequently experience complications such as a
cessation of performance of the medication due to a "nutritional
deficiency". Frequently it is difficult to predict which patients
are likely to experience unacceptable performance of weight loss
medication due to "nutritional deficiencies" associated with
calorie deficit's.
[0007] It is also problematic to predict the outcome of medication
treatment upon individuals receiving Norepinephrine medications
such as Phentermine and/or Diethylpropion. These medications have
unique chemical properties making the outcome of treatment of
patients uncertain. In addition not all medications function to
assist in weight loss. In the past SSRI (selective Serotonin
Reuptake Inhibitor) medications which have been used in weight loss
include Fluoxetine Hydrochloride (Prozac), Sertraline (Zoloft),
Fluvoxamine Maleate (Luvox), and Trazodone Hydrochloride
(Desyrel).
[0008] The treatment programs for obesity as known also teach away
from the use of alternative dosing procedures in the treatment of
weight loss. Specifically U.S. Pat. No. 5,795,895 teaches that an
SSRI medication never needs to be raised to improve the anorexiant
effect of weight loss and that the SSRI medication level
administered to a patient may be raised to assist in the treatment
of coexisting conditions such as depression.
[0009] It is therefore desirable to have a weight loss treatment
program for a patient which provides for an effective therapeutic
range of available medication to enhance desired weight loss. It is
also desirable to provide a weight loss program which minimizes the
percent of individuals who do not initially respond to the
medication treatment regime or who cease to continue to receive the
beneficial effects of the weight loss program following the
initiation of the medication treatment due to nutritional
deficiencies. These and other problems are solved by the disclosed
Comprehensive Pharmacologic Therapy For Treatment Of Obesity.
SUMMARY OF THE INVENTION
[0010] The invention embodies the use of Phentermine and/or
Diethylpropion with an SSRI medication, Citalopram. The SSRI
medication is used in an "effective therapeutic range" to provide
optimal results. The treatment enables individuals to have a much
higher expectation of weight loss to achieve a desired weight than
the previous known treatments. The method of weight loss enables
individuals to lose weight optimally and safely. With treatment, as
individuals lose weight other diseases or illnesses caused by or
associated with weight problems get markedly better or resolve
completely such as type II diabetes, hypertension,
hypercholesterolemia, orthopedic problems, depression, anxiety,
panic attacks, migraine headaches, PMS, chronic pain states,
fibromyalgia, insomnia, sleep apnea, impulsivity, obsessive
compulsive disorder, and myoclonus. Duration of treatment may be
long term, or for life if needed, to reduce weight and maintain
weight loss as desired by an individual.
[0011] A principal object of the present invention is the provision
of a comprehensive pharmacologic therapy for treatment of obesity
of relatively simple and inexpensive design which fulfills the
intended purpose of appetite suppression to enable weight loss
without fear of injury to persons.
[0012] Another principal object of the present invention is the
provision of a comprehensive pharmacologic therapy for treatment of
obesity which is easy for patients to initiate and continue to
effectuate weight loss.
[0013] Still another principal object of the present invention is
the provision of a comprehensive pharmacologic therapy for
treatment of obesity which is effective for all patients attempting
to lose weight.
[0014] Still another principal object of the present invention is
the provision of a comprehensive pharmacologic therapy for
treatment of obesity which continues to function to enable patient
weight loss following the initiation of therapy by an
individual.
[0015] Still another principal object of the present invention is
the provision of a comprehensive pharmacologic therapy for
treatment of obesity which promotes appetite suppression while
simultaneously maintaining nutritional balance for an
individual.
[0016] Still another principal object of the present invention is
the provision of a comprehensive pharmacologic therapy for
treatment of obesity which minimizes risk of undesirable side
effects for a patient.
[0017] Still another principal object of the present invention is
the provision of a comprehensive pharmacologic therapy for
treatment of obesity which may be used long term defined as a
period of time exceeding three months.
[0018] Still another principal object of the present invention is
the provision of a comprehensive pharmacologic therapy for
treatment of obesity which minimizes risk of medication
intolerability for a patient.
[0019] Still another principal object of the present invention is
the provision of a comprehensive pharmacologic therapy for
treatment of obesity which minimizes medication side effects and/or
complications for a patient.
[0020] Still another principal object of the present invention is
the provision of a comprehensive pharmacologic therapy for
treatment of obesity which assists in empowering a patient to
achieve a desired goal weight through monitored, healthy, and
controlled weight loss.
[0021] Still another principal object of the present invention is
the provision of a comprehensive pharmacologic therapy for
treatment of obesity which is flexible to a patient's needs through
the provision of an effective therapeutic range of weight loss
medication.
[0022] Still another principal object of the present invention is
the provision of a comprehensive pharmacologic therapy for
treatment of obesity which minimizes risk of nutritional deficiency
for a patient.
[0023] Still another principal object of the present invention is
the provision of a comprehensive pharmacologic therapy for
treatment of obesity which simultaneously treats other diseases or
obesity related illnesses such as type II diabetes, hypertension,
hypercholesterolemia, orthopedic problems, depression, anxiety,
panic attacks, migraine headaches, PMS, chronic pain states,
fibromyalgia, insomnia, sleep apnea, impulsivity, obsessive
compulsive disorder, and/or myoclonus.
[0024] A feature of the present invention is the provision of a
comprehensive pharmacologic therapy for treatment of obesity which
includes the regulated prescription of an SSRI medication namely,
Citalopram in an effective therapeutic range for a patient to
effectuate weight loss.
[0025] Another feature of the present invention is the provision of
a comprehensive pharmacologic therapy for treatment of obesity
which includes the regulated prescription of Phentermine in an
effective therapeutic range for a patient to effectuate weight
loss.
[0026] Still another feature of the present invention is the
provision of a comprehensive pharmacologic therapy for treatment of
obesity which includes the regulated prescription of Diethylpropion
in an effective therapeutic range for a patient to effectuate
weight loss.
[0027] Still another feature of the present invention is the
provision of a comprehensive pharmacologic therapy for treatment of
obesity which includes the consumption of 5-Hydroxytryptophan by a
patient in an effective therapeutic range to assist in avoiding
nutritional deficiencies and effectuating weight loss.
[0028] Still another feature of the present invention is the
provision of a comprehensive pharmacologic therapy for treatment of
weight loss which includes the consumption of vitamin B6 by a
patient in an effective therapeutic range to assist in avoiding
nutritional deficiency and effectuating weight loss.
[0029] Still another feature of the present invention is the
provision of a comprehensive pharmacologic therapy for treatment of
obesity which includes the consumption of vitamin C by a patient in
an effective therapeutic range to assist in avoiding nutritional
deficiency and effectuating weight loss.
[0030] Still another feature of the present invention is the
provision of a comprehensive pharmacologic therapy for treatment of
obesity which includes the consumption of Tyrosine by a patient in
an effective therapeutic range to assist in avoiding nutritional
deficiency and effectuating weight loss.
[0031] Still another feature of the present invention is the
provision of a comprehensive pharmacologic therapy for treatment of
obesity which includes the consumption of a multi-vitamin by a
patient to assist in avoiding nutritional deficiency and
effectuating weight loss.
[0032] Still another feature of the present invention is the
provision of a comprehensive pharmacologic therapy for treatment of
obesity which includes the consumption of calcium by a patient in
an effective therapeutic range to assist in avoiding nutritional
deficiency and effectuating weight loss.
[0033] Still another feature of the present invention is the
provision of a comprehensive pharmacologic therapy for treatment of
obesity which includes the consumption of Lysine in an effective
therapeutic range to assist in avoiding nutritional deficiency and
effectuating weight loss.
[0034] Still another feature of the present invention is the
provision of a comprehensive pharmacologic therapy for treatment of
obesity which involves consumption of citalopram by a patient for
an initial six (6) day period of time at an initial dosage level
where the dosage level may be subsequently modified after the
initial six (6) day period of time to maximize likelihood of
success of weight loss by a patient.
[0035] Still another feature of the present invention is the
provision of a comprehensive pharmacologic therapy for treatment of
obesity which involves the monitoring of a patients weight loss
progress through calculation of "low weight loss" as defined by a
patient weight at a previous visit added to a patient current
weight then divided by two (2) followed by multiplication by 10 and
then less the current patient weight, less the patient weight at
the previous visit, then multiplied by 3,500 and then divided by
the number of days between the previous visit and the date of the
current weight for the provision of a first sum; calculating a
second sum by multiplying a patient goal weight times ten then
divided by 0.8928; and comparing the first sum to the second sum
where low weight loss occurs when said first sum is larger than
said second sum.
DETAILED DESCRIPTION OF INVENTION
[0036] The comprehensive pharmacological therapy for treatment of
obesity involves the combination of medications within "effective
dosing ranges" and "optimal dosing ranges". The weight loss therapy
in general involves the use of effective dosing ranges of
Citalopram and Phentermine; Citalopram and Diethylpropion;
Citalopram, Phentermine, and Diethylpropion to effectuate weight
loss in a patient.
[0037] The use of Citalopram, Phentermine, and Diethylpropion in
effective dosing ranges as well as optimum dosing ranges in
conjunction with proper replacement of vitamins to counter
nutritional deficiency successfully resolves two problems unique to
weight loss management programs which use medications. The use of
Citalopram, Phentermine, and Diethylpropion in conjunction with
nutritional supplements in effective dosing ranges generally
achieves acceptable weight loss performance for all patients
thereby eliminating the failure of the weight loss program to be
effective for five percent to eight percent of the patients who
have initiated medication therapy. In addition, the use of
Citalopram, Phentermine, and Diethylpropion in conjunction with
nutritional supplements in effective dosing ranges also continues
to function to assist patients to lose weight beyond a three month
period of time thereby solving the problem where 40 percent to 50
percent of the patients undergoing medication therapy encounter a
complication where the medication therapy stops working at a
plateau which occurs approximately three months on average into the
medical treatment.
[0038] Through the proper use of effective dosing ranges and
nutritional supplementation, generally all patients successfully
lose weight from the beginning of therapy and continue to lose
weight during medication therapy until a desired goal weight is
obtained. In addition, there appears to be no irreversible side
effects known during use of the medication combinations of
Citalopram, Phentermine and Diethylpropion in conjunction with
vitamin supplementation. Proper treatment of weight problems with
the disclosed method is highly effective in resolving additional
problems caused by or associated with obesity such as diabetes,
hypertension, hypercholesterolemia, orthopedic problems,
depression, anxiety, panic attacks, migraine headaches and other
associated obesity related problems.
[0039] The weight loss therapy utilizing medications within an
effective therapeutic range and/or optimal dosing range provide
superior weight loss results in contrast to weight loss treatment
programs implementing a single dose SSRI (Selective Serotonin
Reuptake Inhibitor) approach. In the past, the single dose SSRI
medication approach to weight loss ceased to provide desired
performance for a patient resulting in unacceptable weight loss.
The failure of the single dose SSRI therapy to adequately provide a
desired level of performance frequently results from the patient
having a nutritional deficiency.
[0040] The failure of the single dose SSRI therapy to provide for
an acceptable level of weight loss frequently occurs because
Serotonin and Norepinephrine are two neurotransmitters implicated
in weight problems and eating disorders. The chemical pathway for
manufacturing Serotonin within a body is
Tryptophan-Hydroxytryptophan-Serotonin. Vitamin B6 and vitamin C
directly and indirectly work as co-factors in this chemical
equation.
[0041] The chemical pathway for the manufacture of Norepinephrine
within the body is Tyrosine-Dopamine-Norepinephrine. Patients who
are nutritionally deficient in tryptophan or Tyrosine prior to
and/or after initiation of medication therapy may develop Serotonin
and/or Norepinephrine deficiencies respectively. Specifically, SSRI
medications work with Serotonin and Norepinephrine, such as
Phentermine and Diethylpropion, which do not provide adequate
performance where a deficiency in Serotonin or Norepinephrine is
present. In order to avoid a Serotonin and/or Norepinephrine
deficiency a patient under the comprehensive pharmacological
therapy for treatment of obesity receives a generic multiple
vitamin, 5-Hydroxytryptophan in a range of 50 mg to 900 mg per day,
vitamin B6 in a range of 2 mg to 150 mgs per day, vitamin C in a
range of 50 mg to 2000 mg per day, and Tyrosine in a range of 50 mg
to 4000 mgs per day, as well as calcium in a range of 50 mg to 2000
mgs per day to prevent bone demineralization and Lysine in a range
of 50 mg to 2000 mgs per day which is used to prevent hair loss and
other protein metabolism problems while a patient is in a medically
induced starvation state of weight management. In addition, the 5
percent to 8 percent of the patients who did not receive any
benefit from the initiation of medication therapy under the single
dose SSRI treatment regime experience adequate weight loss under
the comprehensive pharmacologic therapy for treatment of obesity
when a potential nutritional deficiency was treated simultaneously
to the introduction of the effective therapeutic range of SSRI
medication, Phentermine or Diethylpropion, in conjunction with the
vitamin supplementation. In general, all patients experience weight
loss under the comprehensive pharmacological therapy when effective
therapeutic ranges of SSRI medication, Phentermine and/or
Diethylpropion, and/or vitamin supplementation is used.
[0042] Within the comprehensive pharmacologic therapy for treatment
of obesity the use of Phentermine and/or Diethylpropion in generic
form, should be taken concurrently with Citalopram (Celexa), to
treat exogenous obesity. Medication combinations that may be used
are "Phentermine and Citalopram", "Diethylpropion and Citalopram",
and "Phentermine, Diethylpropion and Citalopram". As is known in
the art Celxa.RTM. is available from Forest Laboratories, Inc., of
New York, N.Y., and/or Forest Pharmaceuticals, Inc., of St. Louis,
Mo. Citalopram is a racemic mixture of both the enatomers S- and
R-Citalopram. The S-Citalopram enatomer is biologically active
while the R-enatomer is inactive. As is known in the art, the
S-Citalopram enatomer is the SSRI chemical utilized in treating
patients. The chemical name for Citalopram is
citalopramhydrobromide;(RS)-1-[3-[dimethylamino]propyl]-.rho.-fluoropheny-
l)-5-phthalancarbonitrile, hydrobromide, having the chemical
formula C.sub.20h.sub.22b.sub.rFN.sub.20.
[0043] During the first week the patient is instructed to take 15
mg of generic Phentermine by mouth each morning along with 10 mg of
Citalopram for the first 6 days followed by 20 mg of Citalopram
thereafter to decrease the gastrointestinal side effects of the
Citalopram. Diethylpropion may be used with or without Phentermine
in combination with Citalopram in a daily dosing of 75 mg, short or
long acting, if increased appetite suppression is desired. A few
patients experience tolerability issues with Diethylpropion and a
starting dose of 25 mg per day increased incrementally as tolerated
to 75 mg per day may be used. The Phentermine should be given in
the morning to minimize sleep disturbance, experienced on start-up.
The SSRI medications may be given any time during the day with
preferential time being at noon. In addition to Citalopram other
SSRI medications may include Fluoxetine Hydrochloride (Prosac),
Sertralin (Coloft), Fluvoxamine Maleate (Luvox), and Trazodone
Hydrochloride (Desyrel).
[0044] On start-up, to minimize the possibility of medication
ineffectiveness the patient should consume 50 to 200 mg of
5-Hydroxytryptophan a day, Vitamin B6 in the dosing range of 2 to
150 mg per day, Vitamin C in the dosing range of 50 to 2000 mg per
day and optionally Tyrosine in the dosing range of 50 to 4000 mg
per day as well as Calcium in the dosing range of 50-2000 mg per
day and Lysine in the dosing range of 50 to 2000 mg per day.
[0045] After the first week of treatment the patients should be
evaluated for continued appetite suppression. Appetite suppression
may be identified through patient questioning to ascertain
"significant hunger", snacking, nibbling, failure to adhere to
diet, or using willpower which induces stress to follow the diet.
If appetite suppression does not appear to have been obtained, then
the medications and/or nutritional supplements may be further
adjusted as needed.
[0046] At a second visit at the end of the first week of treatment,
the patient should have the Phentermine increased from 15 mg taken
in the morning to 15 mg taken in the morning and 15 mg taken at
noon unless tolerability issues exist, and the Citalopram dosage
should now be at a 20 mg daily taken at noon or 10 mg taken at noon
and 10 mg taken in the late afternoon (approximately one hour
before the last meal of the day).
[0047] Citalopram may be increased in 20 mg increments in the
"effective therapeutic range" of 20 mg to 80 mg per day.
Phentermine is started at 15 mg per day the first week followed by
a total daily dosing of 30 mg per day recommended as divided into
doses of 15 mg in the morning and 15 mg at noon if no problems with
tolerance are noted for the patient. On subsequent visits,
Phentermine may be increased to a total daily dosing of 60 mg per
day preferably as divided into doses of 30 mg in the morning and 30
at noon. The Phentermine has an "effective therapeutic range" of 15
mg to 60 mg per day. The daily "optimal dosing range" for most
patients consuming Citalopram is 20 mg to 40 mg per day. The daily
"optimal dosage range" for most patients with Phentermine is 30 mg
to 60 mg per day.
[0048] Citalopram may be provided in a dosing range of 10 mg per
day for the first six days of therapy, to minimize start-up side
effects, followed by 20 mg per day thereafter. At subsequent
visits, if a patient is experiencing low weight loss or significant
hunger, Citalopram may be increased in 20 mg increments in the
"effective therapeutic range" of 20 mg to 80 mg per day. The
Phentermine may have an "effective therapeutic range" of 15 mg to
60 mg per day. Diethylpropion dosage in the amount of 75 mg per day
is given. The problems with tolerance develop Diethylpropion dosage
may be started at 25 mg per day and increased in 25 mg per week
increments to a total daily dosing of 75 mg if "low weight loss" or
"significant hunger" is present. The "effective therapeutic range"
of Diethylpropion is 25 mg to 75 mg per day. The daily "optimal
dosing range" for most patients with Citalopram is 20 mg to 40 mg
per day. The "optimal therapeutic range" for most patients for
Phentermine is 30 mg to 60 mg per day. The "optimal therapeutic
range" for most patients with Diethylpropion is 75 mg per day.
[0049] At initiation of therapy the nutritional supplement dosing
schedule may be to provide 50 mg to 200 mg of 5-Hydroxytryptophan,
50 mg to 100 mg of vitamin B6, 50 mg to 1000 mg of vitamin C, 500
mg to 1000 mg of Tyrosine, 500 mg to 1000 mg of Lysine, and 500 mg
to 1000 mg of calcium. If after the first two visits the patient is
experiencing "low weight loss" or "significant hunger" the
5-Hydroxytryptophan may be increased in 100 mg to 300 mg per week
increments to a maximum dose of 900 mg per day. If the patient is
still refractory to treatment at that point, the Tyrosine may be
increased in 500 mg to 1000 mg increments to a maximum dose of 4000
mg per day. Once a patient no longer has "significant hunger" or
"low weight loss" the 5-Hydroxytryptophan and Tyrosine may be
incrementally decreased back to starting doses or to the lowest
dose needed to insure that the patient does not again resume
"significant hunger" or "low weight loss".
[0050] Patients should further schedule follow up appointments no
more than every 2 weeks. At any patient visit should the patient be
experiencing "low weight loss" or "significant hunger", the patient
should schedule a follow up visit in 1 week.
[0051] "Low weight loss" is defined as:
[0052] 1. Formula 1=[(((weight at previous visit+current
weight)/2).times.10)-((weight loss since last
visit.times.3,500)/number of days since last visit)]
[0053] 2. Formula 2=[((goal weight*10).times.0.8929)]
[0054] 3. When the answer to Formula 1 is greater than the answer
to Formula 2 the patient has "low weight loss".
[0055] After the second visit if the patient still is experiencing
"significant hunger", then the Citalopram should be increased to 40
mg. At subsequent visits if "significant hunger" is still present
Citalopram may be increased incrementally to 80 mg per day total
dosing. The Phentermine may also be increased incrementally to 60
mg per day total dosing (generally given as 30 mg in the morning
and 30 mg at noon). The Diethylpropion may be increased
incrementally to 75 mg per day total dosing if regular release is
utilized.
[0056] During subsequent visits while the medications are being
increased, the nutritional supplements should also be adjusted. The
patient should be consuming the basic doses of Vitamin B6, Vitamin
C, as well as Tyrosine, Calcium, a multi-vitamin and Lysine. The
5-Hydroxytryptophan should be increased incrementally in 50 to 300
mg doses from 50, 100, 200, or 300 mg starting doses in 100 mg to
300 mg increments to a maximum dosing of 900 mg per day following
each visit as the patient continues to express hunger. Once the
patients are in adequate appetite suppression for 7-10 days, the
5-Hydroxytryptophan may be decreased to the first initial dose
below which the patient experienced appetite suppression that being
300 or 100 mg per day. The 300 mg dose should be maintained at that
level for 2-3 weeks prior to trying to decrease the dosage further
to 100 mg per day of 5-Hydroxytryptophan. If at any time the
patient does begin to experience hunger after lowering
5-Hydroxytryptophan doses, then the daily dose should be increased
back to the dosage that induced full appetite suppression. It
should be noted that for patients who have previously consumed
5-Hydroxytryptophan for appetite suppression successfully, and who
have terminated the consumption of 5-Hydroxytryptophan and
experienced hunger, then the patient will likely be required to
restart the consumption of 5-Hydroxytryptophan from the initial
dose and duplicate the amount of time necessary to return to full
appetite suppression. For example, a patient who initially received
20 days of additional 5-Hydroxytryptophan to obtain appetite
suppression and where the patient was no longer taking the
additional 5-Hydroxytryptophan following a loss of appetite
suppression which resulted in the return of hunger then, the
patient will likely be required to receive 20 additional days of
5-Hydroxytryptophan to once again return to full appetite
suppression. All patients consuming 5-Hydroxytryptophan should be
encouraged to increase the dosage of 5-Hydroxytryptophan if hunger
is experienced upon the lowering of the dosage.
[0057] Once a patient has obtained adequate appetite suppression
through increased dosage of Citalopram within the "effective
therapeutic range" of 10 mg to 80 mg per day, and with regulation
of nutritional supplements, an attempt should be made within 1 to 3
months after appetite suppression is induced to lower the patient's
Norepinephrine and SSRI medication dosage. Many patients at the
point in time are able to be maintained on lower dosages of SSRI
medication through nutritional supplementation which enhance the
underlying Serotonin and Norepinephrine levels.
[0058] As the patients are treated with weight management, calorie
prescriptions may be needed to ensure that the patient is fully
cognizant of their food intake while in appetite suppression.
Calorie prescriptions are not only important from the aspect that
the patients will lose optimal weight by eating at their calorie
prescription, but it is also important to make sure the patients
are consuming enough food and not entering into a starvation state
with subsequent ketosis which is cardiotoxic. A calorie
prescription developed may be:
[0059] 1. CALRX=((goal weight (which in most cases we use the high
end weight on the Metropolitan Tables).times.10)-500).
[0060] Patients should use ketostix at least once daily to ensure
that they are not going into a true starvation state and
experiencing ketosis. Exposure to a deep state of ketosis for a
long period of time may be fatal from cardiac dysrhythmia.
[0061] An initial medical work-up for patients may include a
thyroid panel. Approximately 12.5% of patients having obesity
problems also have never been properly diagnosed for a hypothyroid
abnormality. It may also be beneficial to perform a chem-screen
panel to ensure that electrolyte balance and organ function is
intact prior to inducing patients into a medical starvation state
of weight loss. A cell blood count, a urine analysis, as well as an
EKG may also assist to insure that there are no underlying heart
problems which may be exacerbated by very low calorie diet.
[0062] With regards to exercise, patients are instructed that,
"exercise is not to lose weight, it is to tone the body". Patients
are already losing optimal weight through the calorie prescription.
If patients desire to receive a high intensity work-out the
patients will be required to eat more food to ensure that they do
not go into ketosis from lowering their effective caloric intake by
burning extra calories.
[0063] With regards to treatment of type II Diabetes, most
diabetics may terminate insulin consumption safely with initiation
of therapy. Patients should be switched over to maximum dose double
oral hypoglycemic therapy and evaluate their blood sugars four
times a day. Further the patients may be placed on a sliding scale
with regular insulin where the patient may respond to each
individual blood sugar reading with appropriate levels of Regular
insulin should their blood sugars be elevated. Most type II
diabetics will need no further shots of insulin after initiation of
therapy. There is a need for moderately good control of Diabetes
prior to initiation of therapy. As type II diabetics continue to
lose weight most reach a point where all diabetes medications may
be withdrawn. Patients with blood sugars that are relatively high
should have them brought under control prior to initiation of
therapy.
[0064] If weight loss is low during therapy and the patient claims
that they are in good appetite suppression and not experiencing
"significant hunger", the patient's calorie counting should be
vigorously evaluated and proper teaching undertaken with the
patient as well as considerations made for increasing the patients
medication and/or nutritional supplement dosing as previously
discussed.
[0065] After a patient reaches goal weight or ideal body weight,
the patient needs to be individually assessed for long term
maintenance to prevent weight regain. If the patient has a history
of having medically dieted in the past and gaining significant
weight back, these patients may simply be maintained on lower doses
of medications. If the patient does not have a history of medically
dieting in the past, then the medications may be removed for four
to eight weeks in order to evaluate the continuing need for
medications to maintain weight loss. The medications for patients
placed directly on maintenance and continued on medications, should
be reduced progressively back at 2 week increments to the lowest
possible level to maintain weight. While on maintenance a patient
should continue on nutritional supplementation as described
previously. Any of the previously discussed combinations of
medications are acceptable in maintenance as long as the patient
tolerates the combination and is effective maintaining weight
loss.
[0066] As far as standards for implementing care in patients the
"Body Mass Index" (BMI) is used. The BMI is defined as the body
weight in kilograms divided by the square of the height in meters.
If the patients have BMI of 30 or above they are a candidate for
weight therapy and if the BMI is 25 or above with significant
co-morbidity such as Diabetes, Hypertension, Hypercholesterolemia,
they patient can be treated at a BMI of 25 or greater.
[0067] There are numerous medical counter indications to weight
therapy including severe tremor, uncompensated for Schizophrenia,
Active tachycardia, Severe narrowing of Glaucoma, Symptomatic gall
stones, obstructive enlarged prostate, history of allergy
intolerance to Phentermine or SSRI medication, or Diethylpropion,
Diabetes out of control, severe hypertension, angina pectoris,
recurrent myocardial infarction, congestive heart failure,
epilepsy, hyperthyroidism. In addition patients taking the
medications Beta blockers, Theophylline, Ritalin, oral Beta-agonist
should not take weight loss medications in addition to these other
medications. Caffeine in the diet should also be reduced.
[0068] The adjustment of SSRI medications within a dosing range is
much more effective than utilization of a single dose of medicine
to treat all patients. By increasing medications in the dosing
range and using nutritional supplements an effective appetite
suppression may be induced with all patients, including patients
who are new to therapy and those patients who have prior experience
with the medications.
[0069] The above Examples and disclosure are intended to be
illustrative and not exhaustive. These examples and description
will suggest many variations and alternatives to one of ordinary
skill in this art. All these alternatives and variations are
intended to be included within the scope of the attached claims.
Those familiar with the art may recognize other equivalents to the
specific embodiments described herein which equivalents are also
intended to be encompassed by the claims attached hereto.
* * * * *