Updates in Hemodynamic Monitoring: A Review for Pharmacists.

Vital signs are regularly monitored in hospitalized patients. In the intensive care unit (ICU), traditional non-invasive blood pressure monitoring and telemetry may not provide enough information to determine the etiology of hemodynamic instability or guide intervention. Arterial catheters remain the gold-standard for continuous blood pressure monitoring and are commonly used in ICU patients. Pulmonary artery catheters and central venous catheters are beneficial in select patient populations and provide more advanced and specific information about a patient's hemodynamics. However, neither are benign and can increase risk of complications such as infection, arrhythmias, pneumothorax and vascular or valvular damage. In the past 10 years, the development of reliable non-invasive (NICOM), or minimally-invasive (MICOM), cardiac output monitoring devices has accelerated. The MICOM devices require an arterial catheter to obtain hemodynamic values, whereas NICOM devices do not require any arterial or venous access. These devices have emerged to be particularly useful in evaluating and managing patients with suspected mixed shock. As these devices become more prevalent, it is imperative that clinical pharmacists become familiar with interpreting this data as it may have a substantial impact on medication selection and optimization. This review will discuss the basics of NICOM and MICOM devices, limitations with these methods of monitoring, and clinical application for pharmacists.

Arterial hypertension.

Arterial hypertension is the most important contributor to the global burden of disease; however, disease control remains poor. Although the diagnosis of hypertension is still based on office blood pressure, confirmation with out-of-office blood pressure measurements (ie, ambulatory or home monitoring) is strongly recommended. The definition of hypertension differs throughout various guidelines, but the indications for antihypertensive therapy are relatively similar. Lifestyle adaptation is absolutely key in non-pharmacological treatment. Pharmacologically, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, calcium channel blockers, and diuretics are the first-line agents, with advice for the use of single-pill combination therapy by most guidelines. As a fourth-line agent, spironolactone should be considered. The rapidly evolving field of device-based therapy, especially renal denervation, will further broaden therapeutic options. Despite being a largely controllable condition, the actual rates of awareness, treatment, and control of hypertension are disappointingly low. Further improvements throughout the process of patient screening, diagnosis, treatment, and follow-up need to be urgently addressed.

Evaluation of the Effectiveness and Safety of Alirocumab Use in Statin-Intolerant Veterans.

BACKGROUND: Since 1987, statin therapy has been the mainstay of treatment for hypercholesterolemia, and current practice guidelines recommend statins as first-line therapy given demonstrated reductions in elevated low-density lipoprotein cholesterol (LDL-C) and cardiovascular (CV) mortality reduction in robust clinical trials. The primary objective of this case series was to assess LDL-C reduction associated with alirocumab use in statin-intolerant veterans at a single US Department of Veterans Affairs medical center. The secondary objective was to assess the incidence of CV events. METHODS: A retrospective chart review was conducted to identify statin-intolerant veterans who were initiated on treatment with alirocumab for LDL-C and/or CV risk reduction between June 2017 and May 2019. Electronic health records of all eligible patients who received alirocumab were reviewed, and basic demographics (patient age, sex, and race/ethnicity) as well as medical characteristics at baseline were collected. Baseline LDL-C was compared with levels at 4 and 24 weeks. RESULTS: Although a majority of patients saw a significant and clinically meaningful reduction in LDL-C, the group of patients with an increase in LDL-C may have benefitted from targeted intervention to improve medication and dietary adherence. CONCLUSIONS: Alirocumab use in 24 statin-intolerant veterans resulted in a significant reduction in LDL-C at 4 and 24 weeks after initiation. Large long-term studies would better evaluate CV benefit associated with alirocumab therapy in a veteran population.

Bempedoic Acid: A New Drug for an Old Problem.

OBJECTIVE: To review the pharmacology, pharmacokinetics, safety, and efficacy of bempedoic acid for low-density lipoprotein cholesterol (LDL-C) reduction. DATA SOURCES: A PubMed search was conducted from January 2000 to June 15, 2020, using the keyword bempedoic acid for phase III clinical trials published in the English language. STUDY SELECTION AND DATA EXTRACTION: Articles related to the Food and Drug Administration (FDA) approval of bempedoic acid and other trials relating to the safety and efficacy of this drug were included. DATA SYNTHESIS: The findings from this review show that bempedoic acid is a safe and effective option for lowering LDL-C levels in patients requiring LDL-C lowering for primary or secondary prevention of cardiovascular events. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: Statin therapy remains the mainstay of treatment for both primary and secondary prevention. However, many patients cannot tolerate statin therapy because of statin-associated muscle symptoms. Bempedoic acid may be a reasonable adjunct for LDL-C reduction, though further evaluation of cardiovascular outcomes with bempedoic acid in this population is needed. CONCLUSIONS: The recent FDA approval of bempedoic acid offers an additional option for lowering LDL-C levels in patients with atherosclerotic cardiovascular disease or heterozygous familial hyperlipidemia. Additional data regarding effect on long-term cardiovascular outcomes with bempedoic acid are currently being studied.

Does Social Desirability Influence Preceptors' Completion of Student Experiential Evaluations?

Many variables influence a preceptor's experiential evaluation of a pharmacy learner. However, the impact of social desirability bias, or the measure of an individual's need for social approval, and its impact on the truthfulness of an evaluation is not well understood. Social desirability may present a barrier to students receiving accurate and truthful evaluations. Differences in the effect of social desirability may be seen between full-time faculty and non-faculty preceptors. Colleges of pharmacy should work to support preceptors by providing professional development, standardizing evaluation processes, and ensuring two-way communication. Additionally, a social desirability measure could be used for each preceptor and used by the experiential team to identify preceptors potentially in need of additional development. Future studies should evaluate the effect of social desirability on how preceptors complete evaluations, and propose methods to mitigate this form of bias in the evaluation process.

Role of Bempedoic Acid in Dyslipidemia Management.

Statins remain the preferred agent to reduce low-density lipoprotein cholesterol (LDL-C) and lower atherosclerotic cardiovascular disease (ASCVD) risk. Additional nonstatin agents are recommended to further lower LDL-C among patients at high-risk of ASCVD or those with heterozygous familial hypercholesterolemia, despite statin therapy. Patients unable to tolerate recommended doses of statin therapy due to adverse effects, including statin-associated muscle symptoms, may also require additional nonstatin agents to lower LDL-C and ASCVD risk. Bempedoic acid is a first-in-class, once-daily oral agent, recently approved as monotherapy and in combination with ezetimibe, as an adjunct to maximally tolerated statin therapy in patients with ASCVD or heterozygous familial hypercholesterolemia who require additional LDL-C lowering. Its novel mechanism is reported to avoid adverse muscle symptoms associated with statins. The effectiveness and safety of bempedoic acid and bempedoic acid/ezetimibe combination have been reported in multiple phase 2 and 3 trials. In this review, we report the lipid-lowering effects associated with bempedoic acid, and the safety profile from multiple clinical trials. Based on available data, bempedoic acid significantly lowers LDL-C and other atherogenic lipoprotein measures, and high-sensitivity C-reactive protein when added to background lipid-lowering therapy in patients with and without statin intolerance. Overall safety of bempedoic acid seems to be comparable to placebo, except for increased serum uric acid and tendon rupture. Ongoing clinical trials assessing the long-term safety and cardiovascular outcomes will provide additional insight into the role of bempedoic acid as an adjunct lipid-lowering medication.

Is There Still a Role for Aspirin in Primary Prevention in Women in 2020?

PURPOSE OF REVIEW: Aspirin's place in primary prevention for females has not been well delineated and has been under increased scrutiny in light of recent literature and guideline recommendations. The purpose of this review is to discuss current literature reviewing aspirin use for primary prevention in women and to discuss when use is appropriate. RECENT FINDINGS: The Women's Health Study found no differences in major adverse cardiovascular events (MACE) in women randomized to aspirin vs. placebo, though a significant reduction was observed in women ≥ 65 years. More recent literature evaluated outcomes for primary prevention use in patients at increased cardiovascular risk, patients with diabetes, and patients who are elderly. These trials found either no benefit in MACE outcomes or a slight benefit accompanied by an increased risk of bleeding. Furthermore, no difference in outcomes were found in subgroup analyses comparing females receiving aspirin vs. placebo or comparing events in males vs. females. With improvements in risk factor reduction, such as blood pressure control, statin use, diabetes management, and smoking cessation, the role of aspirin for primary prevention in women is still uncertain. Aspirin use for primary prevention in females has failed to show a clear benefit except in women ≥ 65 years old, with a potential increase in bleeding events. An effort to better study aspirin in female patients would allow for better identification of women who would or would not benefit from therapy.

A Review of Hypertension Management in Black Male Patients.

Hypertension affects approximately 85 million Americans, or almost 1 in 3 adults. Black men have disproportionately higher rates of hypertension and are more likely to experience complications of hypertension, including stroke, myocardial infarction, and death. In addition, hypertensive black men are less likely to achieve optimal blood pressure (BP) than women and persons of other races. In light of this, we performed a literature search for articles published from January 1, 1966, to December 31, 2018, using terms including hypertension, blood pressure, black male, and African American male. Studies were selected for inclusion according to their relevance regarding hypertensive management in black men. Subsequent findings indicated that targeted identification (ie, barbershops), medication management, and close follow-up resulted in greater control of BP. Also, a reduction of systolic blood pressure greater than 20 mm Hg occurred with the use of pharmacists following algorithms specifically for the management of hypertension in black men. Continued emphasis to identify strategies to improve control of BP and outcomes in this population is needed.

A comparison of anticoagulation, antiplatelet, and placebo treatment for patients with heart failure reduced ejection fraction in sinus rhythm: a systematic review and meta-analysis.

Previous meta-analyses have not recommended routine warfarin use in heart failure (HF) patients but included limited data on contemporary anticoagulants and practices. We conducted an updated meta-analysis in light of newer literature evaluating rivaroxaban in this patient population. The aim of this meta-analysis was to assess if anticoagulation is associated with a decrease in all-cause mortality, myocardial infarction (MI), stroke, and hospitalization for HF exacerbation without an increased risk of major bleeding. A systematic search was conducted for randomized controlled trials to evaluate the use of antithrombotic therapy in patients with HF in sinus rhythm. Outcomes evaluated included all-cause mortality (ACM), non-fatal stroke, MI, hospitalization for HF exacerbation, and major bleeding. Five trials met criteria with a total of 9390 patients included. Four of the five trials evaluated warfarin use and one trial evaluated rivaroxaban. When anticoagulation was compared to control (antiplatelet and placebo groups), a significant reduction in ischemic stroke was found (OR 0.57; 95% CI, 0.42 to 0.78; P = 0.0005, I2 = 6.9%) and no significant difference was found in the risk of ACM, MI, or HF hospitalization. A significant increase in major bleeding was observed in the anticoagulation group when compared to the control group (OR 2.00; 95% CI, 1.45 to 2.75; P = < 0.0001, I2 = 25.79%). Anticoagulation in HF patients in normal sinus rhythm does not appear to reduce mortality rate, prevent MI, or decrease HF hospitalizations. Use reduces risk of ischemic stroke but is counterbalanced with an increase in major bleeding.

Management of Anticoagulation with Impella® Percutaneous Ventricular Assist Devices and Review of New Literature.

Cardiogenic shock is a life-threatening condition that may occur secondary to a variety of cardiac conditions, and may require temporary support with percutaneous ventricular devices like the Impella®. Anticoagulation in patients with Impella® devices can often be complicated due to unpredictable purge flow rates, pre-existing coagulopathy, or heparin allergies. The purpose of this article is to discuss the various options for anticoagulation in the setting of Impella®. The article will also describe recent updates (2014-current) in literature surrounding anticoagulation therapy for Impella® devices. At total of 228 articles were initially obtained through the PubMed search, with inclusion of 6 articles. A total of 51 patients had data in the six studies that were included in the review. Heparin for anticoagulation in the purge solution, at two different dextrose concentrations (5% and 20%), was associated with similar therapeutic activated partial thromboplastin time rates, thrombotic and bleeding events. One case series described the use of argatroban in the purge solution for anticoagulation in two patients with suspected heparin-induced thrombocytopenia, without bleeding or thrombotic complications. Pump thrombosis was not reported in any of the six studies. Anticoagulation in the setting of mechanical circulatory support devices is a challenging aspect of critical care. Institutions should have set protocols that clearly define the options for anticoagulation. Future studies that look at longer durations of support and possible operation of the Impella® device with a heparin-free purge solution are needed.