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Optimal Medical Therapy, what is it anyway?
In a number of articles and blogs I have talked about Optimal Medical Therapy (OMT), but what is OMT? Isn’t every treatment by your doctors “optimal”?
The term comes from an article published in 2007 as the COURAGE Trial about which I have written and blogged a number of times.
In it, “optimal treatment” with medications and behavior modification (smoking cessation, diet & exercise) was compared with Stenting in the same type of patient. What caused a minor uproar in the medical community, quickly suppressed by those benefiting most, was the fact that patients with coronary artery disease, but with “stable” symptoms actually did better than those who underwent Stenting (the same did not hold true for Bypass surgery).
“… (Patients) who received PCI plus optimal medical therapy had no better rates of acute MI, stroke, death, or hospitalizations from CAD than patients who received optimal medical therapy alone. In fact, the rates of acute MI, stroke, death, and hospitalizations were slightly higher in the PCI group… and … For patients with stable CAD, PCI does not offer clinical benefits over medical therapy alone. Because nearly 850,000 PCI procedures are performed every year at a cost of approximately$20,000 to $50,000 each, eliminating these elective procedures will not only save patients substantial hassle and risk but will also have beneficial effects on the costs of health care in the United States.”
A much published criticism following COURAGE was that patients would never be able to follow the OMT regimen in real life.
Recently, a follow-up study showed that OMT is in fact quite feasible in that it provides an effective model for secondary prevention among patients with chronic coronary disease.
So what is OMT?
Risk Factor Goals in the COURAGE Trial (Table 1):
|Total dietary fat/saturated fat||<30%/<7% of calories|
|Dietary cholesterol||<200 mg/day|
|Physical activity||30–45 min, moderate intensity 5 times/week|
|Body weight by BMI||Initial BMI||Weight Loss Goal|
|25–27.5 kg/m2||BMI <25 kg/m2|
|>27.5 kg/m2||10% relative weight loss|
|Blood pressure||<130/85 mm Hg (<130/80 mm Hg if diabetes or renal disease present)|
|LDL cholesterol (primary goal)||60–85 mg/dl; the goal became <70 mg/dl in July 2004|
|HDL cholesterol (secondary goal)||>40 mg/dl|
|Triglyceride (secondary goal)||<150 mg/dl|
BMI = body mass index; COURAGE = Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation; HbA1c = hemoglobin A1c; HDL = high-density lipoprotein; LDL = low-density lipoprotein.
Medical therapy goals:
Table 2. Pharmacologic Therapy in the COURAGE Trial
|Antiplatelet agents||Aspirin (clopidogrel if aspirin not tolerated)||Aspirin for all subjects; clopidogrel for at least 1 month after PCI with bare-metal stent|
|ACE inhibitors||Lisinopril||Hypertension, heart failure, LVEF <40%; encouraged for all patients|
|Angiotensin receptor blocker||Losartan||Consider in individuals with hypertension or clinical evidence of heart failure or LVEF <40% who are intolerant of ACE inhibitors|
|Long-acting nitrate||Isosorbide mononitrate||Angina|
|Niacin||extended-release niacin||LDL >85 mg/dl, HDL <40 mg/dl, TG >150 mg/dl on statin|
|Cholesterol absorption inhibitor||Ezetimibe||LDL >85 mg/dl on statin|
|Fibrate||Fenofibrate||TG >150 mg/dl on statin|
|Omega-3 fatty acids||Various formulations||TG >150 mg/dl on statin|
ACE = angiotensin converting enzyme; LVEF = left ventricular ejection fraction; MI = myocardial infarction; TG = triglycerides; other abbreviations as in Table 1.
In the study a nurse case manager was assigned to the patients and counseled them at regular intervals for the duration of the study (5 years).
This follow-up study of COURAGE showed not only that significant improvement in the health status of a patient is possible, but that patients with chronic stable angina and significant coronary artery disease can be treated for long periods of time without the need of any intervention.
There is no question OMT requires more than just the goodwill from doctors and their patients, but also the involvement of nurses, councilors, dieticians and exercise therapists. There is also no doubt there will be considerable costs involved to achieve an impact on health care. However, these costs will be only a fraction of the expenses of interventions. The longer a patient can be treated without a procedure, the longer all its consequences (complications, repeat interventions and all associated costs) can be avoided.
 No Added Benefits of PCI over Optimal Medical Therapy Alone in Patients with Coronary Artery Disease, Ashish K. Jha, MD, MPH , JCOM May 2007 Vol. 14, No. 5
 Intensive Multifactorial Intervention for Stable Coronary Artery Disease, Maron, et al. JACC Vol. 55, No. 13, March 30, 2010:1348–58
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