Brian F. McBride

Levosimendan: Implications for Clinicians

Levosimendan is a novel calcium sensitizing agent in development for the treatment of acute and chronic heart failure. The agent increases myocardial force without increasing myocyte calcium concentrations, thus reducing the possibility for myocardial necrosis. In addition, the agent also causes vasodilation of coronary and peripheral vessels to improve coronary blood flow and reduce afterload. The short half‐life is a benefit for intravenous administration but could be problematic for the drugs use in chronic heart failure. The risk of the development of arrhythmias from levosimendan appears small secondary to an increase in the QTc interval of 15 msec but needs to be evaluated in light of the ability of levosimendan to open adenosine triphosphate (ATP)– sensitive potassium channels. In addition, the agent has not been studied in patients with additional risks for torsades de pointes. Levosimendan has been shown to have beneficial survival effects in several populations; its use improves patient outcomes relative to the standard of care and has the potential to reduce hospital costs associated with heart failure.

Acute Decompensated Heart Failure: A Contemporary Approach to Pharmacotherapeutic Management

Hospital admissions for acute decompensated heart failure (ADHF) have increased precipitously during the past few decades and are projected to continue to increase in the future. To optimize patient outcomes and reduce the costs associated with this disorder, evidenced‐based pharmacotherapy is essential. Continuous infusions of loop diuretic therapy rather than bolus dosing may enhance efficacy and reduce the extent of diuretic resistance. Nesiritide is a pharmacologically novel preload and afterload reducer but based on clinical trial evidence should be reserved for those unable to take or with resistance to intravenous nitrate therapy. Catecholamine‐ and phosphodiesterase‐based inotropic therapies are efficacious, but the increased risk of arrhythmogenesis and the potential for negative survival effects limit their use. The experimental agent levosimendan is a positive inotropic agent but does not increase myocyte calcium concentrations as do catecholamines or phosphodiesterase inhibitors. Clinical trial evidence demonstrates a positive survival benefit for levosimendan versus dobutamine.

The Impact of Catecholamines on Defibrillation Threshold in Patients with Implanted Cardioverter Defibrillators

Objectives: To determine the effect of physiologic catecholamine concentrations on the defibrillation threshold (DFT) in patients with implanted cardioverter defibrillators.

Anemia Management in Heart Failure: A Thick Review of Thin Data

Heart failure is defined as the inability of the heart to pump blood at an amount sufficient to meet the metabolic needs of the body. In heart failure, the inability to meet the bodys metabolic needs is based on hemodynamic derangement and suboptimal oxygen‐carrying capacity of the blood itself. Current pharmacologic therapy attempts to improve survival and reduce symptomatology by optimizing hemodynamics to increase oxygen delivery, but does not address oxygen‐carrying capacity. Unfortunately, there is a high prevalence of anemia in patients with heart failure, which compromises oxygen‐carrying capacity, is an independent predictor of mortality, and may be caused in part by pharmacologic agents that confer morbidity and mortality benefits in this population. Recombinant human erythropoietin supplementation improves the functional capacity of the failing myocardium, reverses and antagonizes the detrimental remodeling induced by autoimmune activity, and may reduce mortality and morbidity among patients receiving maximal pharmacologic therapy for heart failure. However, limited clinical data prohibit widespread recommendations for its use in patients with heart failure.

Inappropriate Implantable Cardioverter Defibrillator Discharge Following Consumption of a Dietary Weight Loss Supplement

This report describes the clinical course of a 40‐year‐old female who experienced repetitive ICD firing after consuming Metabolife 356, a multicomponent dietary weight loss supplement. Following the initiation of Metabolife 356, the patient experienced four shocks over a 3 day period with two 30 J shocks being delivered sequentially. Interrogation of the device revealed atrial tachycardia with 1:1 AV conduction at a rate of 240 beats/min. Metabolife 356 was discontinued and the dosage of sotalol was increased to 120 mg twice daily without recurrence of ICD discharge.

Electrocardiographic Effects of an Ephedra‐Free, Multicomponent Weight‐Loss Supplement in Healthy Volunteers

Study Objective. Metabolife 356, an ephedra‐containing weight‐loss product, substantially increases the corrected QT (QTc) interval. Metabolife Ephedra Free, a similar supplement, contains caffeine and extracts of green tea, garcinia cambogia, and yerba mate. Its electrocardiographic (ECG) effects are not known. Therefore, we sought to determine the effect of this supplement on the QTc interval.

The impact of catecholamines in patients with or without beta-blockers on the ventricular fibrillation cycle length and ventricular fibrillation cycle length variability

Objectives: To evaluate the impact of epinephrine, norepinephrine, or placebo on the ventricular fibrillation cycle length (VFCL) and the variability of VFCL (cvVFCL) measurements in implantable cardioverter defibrillator (ICD) patients with or without beta‐blockers.

Criterion for Board Certification Needs Revision

TO THE EDITOR: New graduates should not be allowed to sit for the Board Certification in Pharmacotherapy (BCPS) without residency training. In my professional practice, I am noting 2 disturbing trends regarding BCPS. First, professionals are using certification inappropriately as a replacement for postgraduate residency or fellowship education. Second, employers are starting to require board certification as a condition of employment. Based on recent survey data, approximately 70% of my colleagues in pharmacy academia who did not renew their BCPS perceive that there is no perceived benefit to BCPS apart from personal satisfaction. Without critical revisions to the eligibility criteria, the BCPS, could lose additional credibility in the pharmacy community, and thus risks being perceived as a waste of time and money by a greater proportion of pharmacists. Prerequisites for BCPS certification do not appear to have been revised since the first certification test was administered 2 decades ago. As it stands now, the Board of Pharmacy Specialties recognizes that 3 years of clinical experience is analogous to a year of formal residency or fellowship education. Pharmacy students with whom I have worked claim they can work for 3 years and take a standardized test to make their experience equivalent to a residency (or fellowship). In my opinion, this devalues the importance of formalized postgraduate education. Going forward, a minimum of 2 years of residency and/or fellowship training should be required of all new graduates (graduating in 2018 and beyond) as a prerequisite to the BCPS examination. This is the standard practice for any physician who sits for Board Certification in Internal Medicine. In my trained subspecialty, Clinical Pharmacology, a National Institutes of Health–funded fellowship in Clinical Pharmacology is a prerequisite to Board Certification in Clinical Pharmacology. I do not believe the BCPS should be any different in its approach to certification. Moreover, and in contrast to Board Certification processes in Internal Medicine, Cardiology, and Clinical Pharmacology, the BCPS has never been shown to improve patient care. Although the Board of Pharmaceutical Specialties lists such outcome studies in their longitudinal plan, no protocols have been publicly proposed for comment. Accordingly, there are also no data showing that Board Certification reduces readmission rates, a key barometer of Medicare reimbursement to hospitals. There are data, however, that residency programs, including those with formal education on medication safety do reduce medication errors. Considering this paucity of similar data for the BCPS, it is bewildering that some employing organizations require BCPS as a condition of employment. The amount of money employers spend on the BCPS and requisite maintenance for employees is simply a money grab for the 2 organizations that provide BCPS eligible continuing education. In my opinion, these funds could better be used in an area that does improve patient outcomes: more residencytrained pharmacists! In our profession, we would not likely treat a patient with a drug that increases cost and is not proven to improve outcomes. So, why is our profession, in some instances, requiring the BCPS as a condition of employment when it is not yet proven to improve outcomes? In my opinion, pushing the BCPS without evidence of effectiveness or lack thereof is ridiculous. To rectify these issues, the Board of Pharmaceutical Specialties should