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Summary Statement of the American
College of Cardiology and the American Heart Association on the Use of Sildenafil
(Viagra™) in Patients at Clinical Risk From Cardiovascular Effects
August 10, 1998
The American College of Cardiology (ACC), in conjunction with the American Heart
Association (AHA), is currently developing an expert consensus document titled "The
Use of Sildenafil (Viagra™) in Patients at Clinical Risk From Cardiovascular
Effects." Pending ACC Board of Trustees and AHA approval, the document is expected to
be released in December 1998. Until the document is available, the ACC and the AHA are
making interim recommendations to assist physicians managing cardiac patients on
Viagra™. This statement reflects the current state of knowledge, realizing that
modifications may be necessary in the near future as more information is evaluated.
Recommendation for Prescribing Viagra™ in Patients
at Clinical Risk From Cardiovascular Effects
Viagra™ is absolutely contraindicated in patients who are taking any chronic
nitrate drug therapy or who utilize short-acting nitrate-containing medications, due to
the risk of developing potentially life-threatening hypotension. Therefore, nitrates and
Viagra™ should not be taken concurrently. In addition, the combination of
Viagra™ and inhaled nitrates, such as amyl nitrates or "poppers" (an
illicit recreational drug) could prove to be fatal and should be avoided.
The cardiovascular effects of Viagra™ may be potentially hazardous for patients
with certain medical profiles, and clinicians need to exercise caution when advising the
following patients who are considering taking Viagra™.
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Patients with active coronary ischemia who are not on nitrates,
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Patients with congestive heart failure and borderline low blood
pressure and borderline low volume status,
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Patients on a complicated multi-drug, anti-hypertensive program,
and
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Patients on drugs (e.g., erythromycin, cimetidine) or who have
conditions (e.g., liver or renal disease) that can prolong the half-life of Viagra™.
Management of Acute Cardiac Ischemic Syndromes With
Patients on Viagra™
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In the event that a patient on Viagra™ experiences an acute
cardiac ischemic event, the physician should first try to establish the time of the last
dose of Viagra™. Definitive evidence is currently lacking, but it is possible that a
precipitous reduction in blood pressure may occur over the initial 24 hours following a
dose of Viagra™. Administration of nitrates in this time interval should be avoided.
In the event that nitrates are given following Viagra™ administration, it is
essential to have the capability to support the patient with fluid resuscitation and
alpha-adrenergic agonists, if needed. In patients in whom the half-life of Viagra™
may be prolonged, such as in renal and hepatic dysfunction, a more extended period of time
between the Viagra™ administration and the nitrate administration may be required. In
patients with recurring mild angina after Viagra™ use, other non-nitrate,
anti-anginal agents, such as beta blockers, should be considered.
-
Patients on Viagra™ with an acute myocardial infarction
should be treated in the usual manner as described in the ACC/AHA clinical practice
guidelines, including, where appropriate, primary angioplasty or thrombolytics. The only
difference is that nitrates are contraindicated for these patients.
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In patients with unstable angina, therapy should include only
non-nitrate, anti-anginal medications but otherwise adhere to principles established in
the clinical practice guideline available from the Agency for Health Care Policy and
Research. To date, there is no evidence of significant interactions with heparin,
beta-adrenergic blockers, calcium-channel blockers, narcotics, and aspirin. These agents
can be used as appropriate.
Treatment of the Hypotensive Patient With Inadvertent
Viagra™ Nitrate Combination Effect
In patients who inadvertently received the combination of
nitrates and Viagra™ and who are manifesting a severe hypotensive response, nitrate
and nitroprusside therapy should be immediately stopped. Depending on clinical
circumstances, any of the following therapies should be considered alone or in
combination:
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Placing the patient in Trendelenburg position;
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Aggressive fluid resuscitation;
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Judicious use of an intravenous alpha-adrenergic agonist, such as
phenylephrine (Neosynephrine™);
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An alpha- and beta-adrenergic agonist (norepinephrine) for blood
pressure support with the realization that this could exacerbate or lead to an acute
ischemic syndrome;
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Intra-aortic balloon counterpulsation.
Copyright © 1998 American College of Cardiology
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