Use of selective serotonin reuptake inhibitors for treatment...

Details Use of selective serotonin reuptake inhibitors for treatment... Use of selective serotonin reuptake inhibitors for treatment...

2000-03-01

2001-11-13

Jarvis, William R. A. (Department: 1614)

Drug, bio-affecting and body treating compositions

Designated organic active ingredient containing

Having -c-, wherein x is chalcogen, bonded directly to...

C514S469000, C514S640000, C514S649000, C514S657000

Reexamination Certificate

active

06316469

ABSTRACT:

TECHNICAL FIELD
The present invention relates in general to treatment of a medical condition. More particularly, the present invention relates to a new use of a selective serotonin reuptake inhibitor (which medicament is already known for use in treatment of depression) in the treatment of chest pain of non-cardiac origin. In an alternative embodiment, another new use of a selective serotonin reuptake inhibitor is in the treatment of symptoms of gastro-esophageal reflux disease.
Table of Abbreviations
angio
angiogram
BDI
Beck Depression Inventory
BP
bodily pain
DSM-IV
Diagnostic and Statistical Manual for
Mental Disorders, 4
th
Edition,
published by the American
Psychiatric Association
D
drug
GERD
gastro-esophageal reflux disease
GH
general health
kg
kilogram
LCI
lower confidence interval
L95 CI
95% lower confidence interval
MH
mental health
mg
milligram
MAOI
monoamine oxidase inhibitor
neg
negative
N
number of persons in test sample
OLS
ordinary least squares
PF
physical functioning
P
placebo
RH
reported health
RE
role--emotional
RP
role--physical
SSRI
selective serotonin reuptake inhibitor
SF
Social Functioning
SF36
Social Functioning Health Survey
Manual
STD ERR
standard error
PROB
Student's t-test
UCI
upper confidence interval
U95 CI
95% upper confidence interval
VAIS-PR
visual analogue inventory scale--
pain response
wk
week
BACKGROUND
Between 10-30% of patients with symptoms similar to angina and sufficient to justify cardiac catheterization are often found to have normal coronary angiograms. Since coronary artery disease (the typical organic cause of chest pain) is not the cause of the chest pain, management of chest pain patients with no apparent cardiac etiology is a major clinical problem.
Most of these patients continue to experience chest pain, often resulting in visits to the emergency room and occasionally even repeat cardiac catheterization. See, for instance, Papanicolaou et al., “Prognostic Implications of Angiographically Normal and Insignificantly Narrowed Coronary Arteries”,
Am. J. Cardiol.,
58(13): 1181-1187 (Dec. 1, 1986); Proudfit et al., “Selective Cine Coronary Arteriography. Correlation with Clinical Findings in 1,000 Patients”,
Circulation,
33(6): 901-910 (June, 1966); Dart et al., “Angina' and Normal Coronary Arteriograms: A Follow-up Study”,
Eur. Heart J.,
1(2): 97-100 (1980); Dart et al., “Chest Pain with Normal Coronary Arteries”,
Lancet,
1(8163): 311 (Feb. 9, 1980); Kemp et al., “The Anginal Syndrome Associated with Normal Coronary Arteriograms. Report of a Six Year Experience”,
Am. J. Med.,
54(6): 735-742 (June, 1973); Kemp et al., “Seven Year Survival of Patients with Normal or Near Normal Coronary Arteriograms: A CASS Registry Study”,
J. Am. Coll. Cardiol.
7(3): 479-483 (March, 1986.); and Cannon, R. O. 3
rd
, “The Conundrum of Cardiovascular Syndrome X”,
Cardiol. in Rev.,
6(4): 213-220 (1998).
Thus, the condition of non-cardiac chest pain has considerable effects on quality of life and utilization of health care resources, resulting from a poor symptomatic, functional, and psychological outcome. Although most patients with non-cardiac chest pain are discharged after being reassured, they rarely feel reassured and often desire additional clinical evaluations. The basis of unexplained chest pain and the management of patients who have unexplained chest pain, despite a normal coronary angiogram and/or a normal stress test, is controversial. They continue to believe that they have significant disease which has been missed. See, for instance, Lantinga et al., “One-year Psychosocial Follow-up of Patients with Chest Pain and Angiographically Normal Coronary Arteries”,
American Journal of Cardiology,
62 (4): 209-213, (Aug. 1, 1988); Potts et al., “Psychosocial Outcome and Use of Medical Resources in Patients with Chest Pain and Normal or Near-normal Coronary Arteries: A Long-term Follow-up Study”,
Q. Journal of Medicine,
86 (9): 583-593 (1993); Mayou et al., “Management of Non-cardiac Pain: from Research to Clinical Practice”,
Heart,
81(4): 387-392 (1999); Cannon, R. O. 3
rd
, “Can Measures of Coronary Dynamics Explain Chest Pain without Coronary Artery Disease?”,
Mayo Clinic Proceedings,
73 (12): 1226-1228 (December, 1998); Cannon, R. O. 3
rd
; “Does Coronary Endothelial Dysfunction Cause Myocardial lschemia in the Absence of Obstructive Coronary Artery Disease?”,
Circulation,
96(10): 3251-3254 (Nov. 18, 1997); Richter et al., “Chest Pain with Normal Coronary Arteries. Another Perspective”,
Digestive Diseases and Sciences,
35(12): 1441-1444 (December, 1990); Cannon, R. O. 3
rd
; “How to Manage Chest Pain in Patients with Normal Coronary Angiograms”,
Cardiologia,
42 (1): 21-29, (January, 1997); and Cannon, R. O. 3
rd
; “Chest Pain and the Sensitive Heart”,
Eur. J. of Gastroenterol.
&
Hegatol.,
7(12): 1166-1171 (1995).
Estimates are that a person with chest pain that is non-cardiac (because the coronary angiogram was normal) spends about $3,500 a year to manage this pain. See, for instance, Richter et al., “Esophageal Chest Pain: Current Controversies in Pathogenesis, Diagnosis, and Therapy”,
Annals of Internal Med.,
110(1): 66-78 (Jan. 1, 1989). Furthermore, although coronary artery disease is ruled out to be the cause of the chest pain (since the coronary angiogram was normal), other medical causes exist, which can be the cause of the chest pain.
For instance, other medical causes of non-cardiac chest pain may be organic. Examples of organic causes include Prinzmetal angina, microvascular angina and potentially esophageal, rheumatological and pulmonary diseases. See, for instance, Chambers, “Chest Pain: Heart, Body or Mind?”,
Journal of Psychosomatic Research,
43(2): 161-167 (1997); and Jolobe et al., “Comparative Study of Chest Pain Characteristics in Patients with Normal and Abnormal Coronary Angiograms”,
Heart,
80(2): 210 (1998). However, frequently no organic cause can be found.
Also, other medical causes of non-cardiac chest pain may be psychiatric. More particularly, psychiatric evaluation of these patients with non-cardiac chest pain has suggested that a significant proportion of them may meet the criteria for panic disorder. Depressive symptoms may also occur in these patients. Many other patients also have some symptoms of anxiety, though these patients do not meet clinical diagnostic criteria for panic disorder and/or other psychiatric disorders. See, for instance, Katon et al., “Chest Pain: Relationship of Psychiatric Illness to Coronary Arteriographic Results”,
The American Journal of Medicine,
84(1): 1-9 (January 1988); and Cannon, R. O. 3
rd
, et al, “Imipramine in Patients with Chest Pain Despite Normal Coronary Angiograms”,
The New England Journal of Medicine,
330 (20): 1411-1417 (May 19, 1994).
An early randomized, double-blind, placebo-controlled study that used a psychotropic drug to evaluate the treatment of chest pain, despite normal coronary angiograms, was reported by Cannon et al. in “Imipramine in Patients . . . ” supra. In this study, 60 patients, some with and some without psychiatric disorders, underwent treatment in a double-blind protocol receiving clonidine 0.1 mg (twice a day), imipramine (50 mg nightly), or placebo (twice a day). (Clondine is an antihypertensive, and imipramine is a tricyclic antidepressant and a member of the dibenzazepine group.) Patients were treated initially with a single blind placebo, given twice a day, and pain ratings were evaluated using a simple scale based on a daily pain diary. The patients were then randomized to either drug or placebo. The reduction in the frequency of chest pain in the imipramine group was approximately 50% compared to the placebo group. This benefit was seen irrespective of either current or past psychiatric disease. The effect was noted within 3 weeks. Also noted was a reduction in right ventricle sensitivity to pain.
The benefit of imipramine in the treatment of non-cardiac chest pain has been recently confirmed. See, for instance, Cox et al., “Low Dose lmipramine Improves Chest Pain but not Q

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