Elevated Lp(a): Guidance for Identifying and Managing Patients.

Lipoprotein(a) (Lp(a)) is a unique low-density lipoprotein-like lipoprotein that is considered an independent and causal risk factor for atherosclerotic cardiovascular disease (ASCVD) and calcific aortic valve stenosis. The Lp(a) molecule also contains apolipoprotein A and apolipoprotein B, which collectively promote atherosclerosis, thrombosis, and inflammation. Lp(a) is highly genetic and minimally responsive to nonpharmacological measures. Lp(a) serum levels ≥125 nmol/L are associated with increased ASCVD risk, but this threshold has not been accepted universally. Elevated Lp(a) is the most common genetic dyslipidemia affecting approximately 20% of the general population. Certain currently available lipid-lowering drugs, including the proprotein convertase subtilisin/kexin type 9 therapies, produce moderate reductions in Lp(a); however, none are indicated for the treatment of elevated Lp(a). There are currently four investigational RNA-based therapeutic agents that reduce Lp(a) by 70% to 100%. Two of these agents are being evaluated for ASCVD risk reduction in adequately powered outcomes trials, with results expected in 2 to 3 years. Until such therapies become available and demonstrate favorable clinical outcomes, strategies for elevated Lp(a) primarily involve early and intensive ASCVD risk factor management.

Vitamin D supplements: The pharmacists' perspective.

OBJECTIVE: The purpose of this narrative review was to provide guidance for pharmacists concerning vitamin D supplementation. METHODS: Relevant studies were identified in a search of MEDLINE/PubMed, EBSCOhost, and Google Scholar from January 1966 to September 2020 using the search terms vitamin D, vitamin D2, vitamin D3, calcitriol, and vitamin D deficiency. Abstracts were reviewed for relevance and, if relevant, full-text articles were retrieved and reviewed. References were checked, and citation searches using identified studies were conducted. The literature search included English-language studies involving administration of vitamin D monotherapy compared with placebo. RESULTS: Serum 25-hydroxyvitamin D levels of less than 12 ng/mL indicate a vitamin D deficiency. The Institute of Medicine recommends a daily intake of 600 IU of vitamin D in individuals aged up to 70 years and 800 IU in those aged above 70 years. Vitamin D is labeled for rickets, osetomalacia, hypophosphatemia (familial or secondary), renal osteodystrophy, and corticosteroid-induced osteoporosis. When used for these indications, vitamin D should be prescribed with appropriate monitoring by a qualified health care practitioner. There is evidence for vitamin D supplementation in individuals aged 75 years or older and in those with problems associated with mobility, gait, or balance. There is insufficient evidence to support vitamin D supplementation in the prevention of cardiovascular disease, cancer, asthma, chronic obstructive pulmonary disease exacerbations, new-onset type 2 diabetes, infectious lung diseases, cognitive dysfunction, Alzheimer disease, and depression, or in prenatal use. CONCLUSION: Pharmacists can provide evidence-based recommendations concerning the indications, dosing, monitoring, and adverse effects of vitamin D supplements.

Evidence for the Efficacy of an Opioid-Sparing Effect of Intravenous Acetaminophen in the Surgery Patient: A Systematic Review.

BACKGROUND: Intravenous (IV) acetaminophen is used in multimodal analgesia to reduce the amount and duration of opioid use in the postoperative setting. METHODS: A systematic review of published randomized controlled trials was conducted to define the opioid-sparing effect of IV acetaminophen in different types of surgeries. Eligible studies included prospective, randomized, double-blind trials of IV acetaminophen compared with either a placebo- or active-treatment group in adult (age ≥18 years) patients undergoing surgery. Trials had to be published in English in a peer-reviewed journal. RESULTS: A total of 44 treatment cohorts included in 37 studies were included in the systematic analysis. Compared with active- or placebo-control treatments, IV acetaminophen produced a statistically significant opioid-sparing effect in 14 of 44 cohorts (32%). An opioid-sparing effect was more common in placebo-controlled comparisons. Of the 28 placebo treatment comparisons, IV acetaminophen produced an opioid-sparing effect in 13 (46%). IV acetaminophen produced an opioid-sparing effect in only 6% (one out of 16) of the active-control groups. Among the 16 active-control groups, opioid consumption was significantly greater with IV acetaminophen than the active comparator in seven cohorts and not significantly different than the active comparator in eight cohorts. CONCLUSIONS: The results of this systematic analysis demonstrate that IV acetaminophen is not effective in reducing opioid consumption compared with other adjuvant analgesic agents in the postoperative patient. In patients where other adjuvant analgesic agents are contraindicated, IV acetaminophen may be an option.

Alpha-1 Antitrypsin Replacement in Patients With COPD.

Chronic obstructive pulmonary disease can be attributed to genetic conditions and predispositions, among other factors. Alpha-1 antitrypsin deficiency (AATD) is a significant risk factor for COPD development and progression, and aggressive screening for all patients with COPD or adult-onset asthma is encouraged.

The clinical relevance of omega-3 fatty acids in the management of hypertriglyceridemia.

Hypertriglyceridemia (triglycerides > 150 mg/dL) affects ~25 % of the United States (US) population and is associated with increased cardiovascular risk. Severe hypertriglyceridemia (≥ 500 mg/dL) is also a risk factor for pancreatitis. Three omega-3 fatty acid (OM3FA) prescription formulations are approved in the US for the treatment of adults with severe hypertriglyceridemia: (1) OM3FA ethyl esters (OM3EE), a mixture of OM3FA ethyl esters, primarily eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (Lovaza®, Omtryg™, and generics); (2) icosapent ethyl (IPE), EPA ethyl esters (Vascepa®); and (3) omega-3 carboxylic acids (OM3CA), a mixture of OM3FAs in free fatty acid form, primarily EPA, DHA, and docosapentaenoic acid (Epanova®). At approved doses, all formulations substantially reduce triglyceride and very-low-density lipoprotein levels. DHA-containing formulations may also increase low-density lipoprotein cholesterol. However, this is not accompanied by increased non-high-density lipoprotein cholesterol, which is thought to provide a better indication of cardiovascular risk in this patient population. Proposed mechanisms of action of OM3FAs include inhibition of diacylglycerol acyltransferase, increased plasma lipoprotein lipase activity, decreased hepatic lipogenesis, and increased hepatic ß-oxidation. OM3CA bioavailability (area under the plasma concentration-time curve from zero to the last measurable concentration) is up to 4-fold greater than that of OM3FA ethyl esters, and unlike ethyl esters, the absorption of OM3CA is not dependent on pancreatic lipase hydrolysis. All three formulations are well tolerated (the most common adverse events are gastrointestinal) and demonstrate a lack of drug-drug interactions with other lipid-lowering drugs, such as statins and fibrates. OM3FAs appear to be an effective treatment option for patients with severe hypertriglyceridemia.

Prescription Omega-3 Fatty Acid Products and Dietary Supplements Are Not Interchangeable.

PURPOSE: To provide an overview of prescription and dietary supplement omega-3 fatty acid (OM3-FA) products and considerations for clinical use. DESIGN: Narrative review. METHODOLOGY: The PubMed database was searched for cardiovascular-related investigations focused on eicosapentaenoic acid (EPA) and/or docosahexaenoic acid (DHA) (limit: English-only articles). Additional regulatory information on prescription and dietary supplements was obtained from United States Food and Drug Administration online sources. RESULTS: Prescription QM3-FA products are supported by robust clinical development and safety monitoring programs, whereas dietary supplements are not required to demonstrate safety or efficacy prior to marketing. There are no over-the-counter OM3-FA products available in the United States. Investigations of OM3-FA dietary supplements show that quantities of EPA and DHA are highly variable within and between brands. Dietary supplements also may contain potentially harmful components, including oxidized OM3-FA, other lipids, cholesterol, and toxins. Prescription OM3-FA products may contain DHA and EPA or EPA alone. All prescription OM3-FA products have demonstrated statistically significant triglyceride reduction as monotherapy or in combination with statins in patients with hypertriglyceridemia. Differential effects between products containing EPA and DHA compared with a high-purity EPA product (icosapent ethyl) have clinical implications: Increases in low-density lipoprotein cholesterol associated with DHA have the potential to confound strategies for managing patients with dyslipidemia. Cardiovascular outcomes studies of prescription CM3-FA products are ongoing. CONCLUSIONS: OM3-FA dietary supplements should not be substituted for prescription products, and prescription OM3-FA products that contain DHA are not equivalent to or interchangeable with high-purity EPA (icosapent ethyl) and should not be substituted for it.

The prevention of contrast-induced nephropathy.

OBJECTIVE: Contrast-induced nephropathy (CIN) is a complication which may develop after exposure to iodinated contrast media. The resulting acute kidney injury (AKI) is associated with an increase in both short- and long-term morbidity and mortality, increased hospital length of stay, and greater health care costs. The pathophysiological mechanism associated with the development of CIN remains unknown. This narrative review summarizes the pathophysiology, risk factors, and current evidence for the prevention of CIN. DATA SOURCES: A MEDLINE literature search (2004-May 2014) was performed using search terms contrast-induced nephropathy and prevention. Additional references were identified from literature citations, review articles, and meta-analyses. STUDY SELECTION AND DATA EXTRACTION: Abstracts of English-language human clinical trials that examined therapies for the prevention of CIN were evaluated. Studies that did not investigate a preventative intervention for CIN were excluded. Emphasis was placed on recent publications. DATA SYNTHESIS: A multitude of therapies focused on the prevention of CIN have been investigated. Unfortunately, many of these studies have produced negative and/or inconsistent results. There is a paucity of adequately designed clinical studies evaluating strategies for the prevention of CIN. However, the best data supports use of preprocedural hydration with isotonic solution as the standard of care for prophylaxis. CONCLUSION: Given the poor prognosis associated with CIN, there is need for improved methods to prevent it. At present, the best tools to protect patients from unnecessary risk for CIN are careful assessment of renal function, judicious use of procedures that utilize contrast media, and adequate hydration with isotonic solution.

Lipid lowering therapy: implications of recent clinical trials.

Recent lipid lowering therapy trials have provided important insights on certain agents while also continuing to expand our understanding of atherosclerotic cardiovascular disease (ASCVD) risk. Findings from current trials include the impact of statin therapy on ASCVD among populations with HIV, the benefit of lowering low-density lipoprotein cholesterol with bempedoic acid among patients considered statin intolerant, the safety and efficacy of inclisiran over a 4-year period, another failed attempt for fibrates to reduce ASCVD risk, which omega-3 fatty to utilize for lowering cardiovascular events, 'n-of-1' trials evaluating statin intolerance, and how low-dose rosuvastatin compared with commonly utilized supplements for lowering lipid parameters. Such data help inform so clinicians can optimize lipid lowering therapy and improve ASCVD outcomes.

Overview of omega-3 Fatty Acid therapies.

The triglyceride (TG)-lowering benefits of the very-long-chain omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are well documented. Available as prescription formulations and dietary supplements, EPA and DHA are recommended by the American Heart Association for patients with coronary heart disease and hypertriglyceridemia. Dietary supplements are not subject to the same government regulatory standards for safety, efficacy, and purity as prescription drugs are; moreover, supplements may contain variable concentrations of EPA and DHA and possibly other contaminants. Reducing low-density lipoprotein-cholesterol (LDL-C) levels remains the primary treatment goal in the management of dyslipidemia. Dietary supplements and prescription formulations that contain both EPA and DHA may lower TG levels, but they may also increase LDL-C levels. Two prescription formulations of long-chain omega-3 fatty acids are available in the U.S. Although prescription omega-3 acid ethyl esters (OM-3-A EEs, Lovaza) contain high-purity EPA and DHA, prescription icosapent ethyl (IPE, Vascepa) is a high-purity EPA agent. In clinical trials of statin-treated and non-statin-treated patients with hypertriglyceridemia, both OM-3-A EE and IPE lowered TG levels and other atherogenic markers; however, IPE did not increase LDL-C levels. Results of recent outcomes trials of long-chain omega-3 fatty acids, fibrates, and niacin have been disappointing, failing to show additional reductions in adverse cardiovascular events when combined with statins. Therefore, the REDUCE-IT study is being conducted to evaluate the effect of the combination of IPE and statins on cardiovascular outcomes in high-risk patients. The results of this trial are eagerly anticipated.

Atherosclerotic Cardiovascular Disease in Women: Providing Protection With Lipid-altering Agents.

PURPOSE: Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of death in women, yet it remains underdiagnosed, undertreated, and understudied in women compared with men. Although estrogen has provided observational evidence of cardioprotection, randomized controlled trials using hormone replacement therapy have generally produced unfavorable results. METHODS: For this narrative review, a literature search was performed using the key words cardiovascular disease, women, and dyslipidemia in PubMed and Google Scholar with no date limitations. References within each article were also reviewed for additional relevant articles. FINDINGS: Sex-specific risk factors and underrecognized conditions more predominant in women elevate ASCVD risk, creating further clinical challenges, such as the need for accurate risk stratification, compared with in men. Dyslipidemia frequently manifests or worsens during the menopausal transition. Therefore, identification during midlife and implementing lipid-lowering strategies to reduce ASCVD risk is imperative. Women have historically been poorly represented in cardiovascular (CV) outcome trials. However, more recent studies and meta-analyses have indicated that lipid-lowering therapies are equally effective in women and produce similar reductions in CV events and total mortality. Major cholesterol guidelines address many of the challenges that clinicians face when assessing ASCVD risk in women. Key points specific to women include obtaining a detailed history of pregnancy-related conditions, identification of common autoimmune disorders associated with systemic inflammation, and use of 10-year ASCVD risk calculators and imaging modalities (coronary artery calcium) to optimize ASCVD assessment. In terms of treatment, similar to men, women with existing ASCVD or high-risk primary prevention patients should be treated aggressively to achieve ≥50% LDL-C reductions and/or LDL-C goals as low as <55 mg/dL. Appropriate lipid-lowering therapies include high-intensity statins with or without ezetimibe and proprotein convertase subtilisin kexin/type 9 inhibitors. Women with lower ASCVD risk may be considered for low- to moderate-intensity statin therapy (approximately 30%-50% LDL-C reduction). All women, regardless of ASCVD risk category, should implement therapeutic lifestyle changes, which improve many common age-related cardiometabolic conditions. IMPLICATIONS: Although ASCVD and current risk factor trends in women are concerning, numerous evidence-based approaches are available to protect women with ASCVD risk from life-changing CV events.

A systematic review of nicardipine vs labetalol for the management of hypertensive crises.

Hypertensive emergencies are acute elevations in blood pressure (BP) that occur in the presence of progressive end-organ damage. Hypertensive urgencies, defined as elevated BP without acute end-organ damage, can often be treated with oral agents, whereas hypertensive emergencies are best treated with intravenous titratable agents. However, a lack of head-to-head studies has made it difficult to establish which intravenous drug is most effective in treating hypertensive crises. This systematic review presents a synthesis of published studies that compare the antihypertensive agents nicardipine and labetalol in patients experiencing acute hypertensive crises. A MEDLINE search was conducted using the term "labetalol AND nicardipine AND hypertension." Conference abstracts were searched manually. Ultimately, 10 studies were included, encompassing patients with hypertensive crises across an array of indications and practice environments (stroke, the emergency department, critical care, surgery, pediatrics, and pregnancy). The results of this systematic review show comparable efficacy and safety for nicardipine and labetalol, although nicardipine appears to provide more predictable and consistent BP control than labetalol.

Management of patients with fibrosing interstitial lung diseases.

PURPOSE: This article summarizes the appropriate use and pharmacology of treatments for fibrosing interstitial lung diseases, with a specific focus on the antifibrotic agents nintedanib and pirfenidone. SUMMARY: The interstitial lung diseases are a heterogenous group of parenchymal lung disorders with a common feature-infiltration of the interstitial space with derangement of the normal capillary-alveolar anatomy. Diseases characterized by fibrosis of the interstitial space are referred to as the fibrosing interstitial lung diseases and often show progression over time: idiopathic pulmonary fibrosis is the most common fibrotic interstitial lung disease. Historically, therapies for fibrosing lung diseases have been limited in number, questionable in efficacy, and associated with potential harms. Food and Drug Administration (FDA) approval of the antifibrotic agents nintedanib and pirfenidone for idiopathic pulmonary fibrosis in 2014 heralded an era of reorganization of therapy for the fibrotic interstitial lung diseases. Subsequent investigations have led to FDA approval of nintedanib for systemic sclerosis-associated interstitial lung disease and interstitial lung diseases with a progressive phenotype. Although supportive care and pulmonary rehabilitation should be provided to all patients, the role(s) of immunomodulators and/or immune suppressing agents vary by the underlying disease state. Several agents previously used to treat fibrotic lung diseases (N-acetylcysteine, anticoagulation, and pulmonary vasodilators) lack efficacy or cause harm. CONCLUSION: With the introduction of effective pharmacotherapy for fibrosing interstitial lung disease, pharmacists have an increasingly important role in the interdisciplinary team managing these patients.

Statin-associated muscle symptoms-A review: Individualizing the approach to optimize care.

The 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors, also known as "statins" are considered first-line pharmacologic therapy for reducing low-density lipoprotein cholesterol (LDL-C). They have been demonstrated efficacy in a variety of patients populations to reduce atherosclerotic cardiovascular disease (ASCVD) risk. Like any pharmacologic therapy, however, they are not without possible adverse effects that can lead to discontinuation, thus leading to a loss of benefit. The most common side effect related to statin therapy impacting compliance is musculoskeletal related, commonly referred to as statin-associated muscle systems (SAMS). While the overall incidence is relatively low, the consequences of nonadherence to statin therapy can have a negative impact on patient care. Therefore, it is important for healthcare providers to understand risk factors, how to diagnose, and how to manage this unfortunate adverse effect in order to optimize care.

Challenges in Implementing Evidence Based Cross-Disciplinary Therapies: Are Cardiovascular Specialists Ready to Claim SGLT-2 Inhibitors and GLP-1 Analogs?

Cardiovascular disease is a leading cause of morbidity, mortality and financial burden to the United States health system. A change in focus towards preventive medicine along with advances in pharmacologic and invasive therapies, has led to improved cardiac death rates. These benefits however, come with increased prevalence of heart failure and soaring readmission rates. Reducing burden of hospitalizations has therefore, been a focus of clinicians and researchers over the years. An improvement in clinical outcomes has been demonstrated in multiple trials investigating HF therapies, however, execution of guideline recommendations has been trailing. Over the past decade, 2 classes of hypoglycemic agents, the glucagon-like peptide-1 (GLP-1) receptor agonists and the sodium-glucose cotransporter 2 (SGLT-2) inhibitors have been recognized for their cardiovascular morbidity and mortality benefits. Studies have shown that there has been a steady increase in prescription rates of these medications, however, overall usage remains quite low. Various patient, physician and system-based factors have been identified that cause barriers to translation of trial data to real-world clinical outcomes. A strategy focused on physician and patient education, quality improvement, multi-disciplinary team approach, and patient centered care is essential to meet treatment goals.

Comparative antiplatelet effects of chlorthalidone and hydrochlorothiazide.

Chlorthalidone (CTD) may be superior to hydrochlorothiazide (HCTZ) in the reduction of adverse cardiovascular events in hypertensive patients. The mechanism of the potential benefit of CTD could be related to antiplatelet effects. The objective of this study was to determine if CTD or HCTZ have antiplatelet effects. This study was a prospective, double-blind, randomized, three-way crossover comparison evaluating the antiplatelet effects of CTD, HCTZ, and aspirin (ASA) in healthy volunteers. The effects of these treatments on platelet activation and aggregation were assessed using a well-established method with five standard platelet agonists. Thirty-four patients completed the three-way crossover comparing pre- and post-treatment changes in platelet activation and aggregation studies. There were statistically significant antiplatelet effects with ASA but not with CTD or HCTZ. Hypokalemia occurred in 0 (0%), 10 (30%), and 6 (18%) of the ASA, CTD, and HCTZ patients, respectively. The results of our study suggest that the benefits of CTD and HCTZ in reducing adverse cardiovascular events in patients with hypertension is not a result of an antiplatelet effect. In our study, hypokalemia with CTD was more prevalent than that reported in a large outcome trial in patients with hypertension. The clinical relevance of this finding is uncertain.

Economic evaluation of a disease management program for chronic obstructive pulmonary disease.

BACKGROUND: The data on cost savings with disease management (DM) in chronic obstructive pulmonary disease (COPD) is limited. A multicomponent DM program in COPD has recently shown in a large randomized controlled trial to reduce hospitalizations and emergency department visits compared to usual care (UC). The objectives of this study were to determine the cost of implementing the DM program and its impact on healthcare resource utilization costs compared to UC in high-risk COPD patients. MATERIALS AND METHODS: This study was a post-hoc economic analysis of a multicenter randomized, adjudicator-blinded, controlled, 1-year trial comparing DM and UC at 5 Midwest region Department of Veterans Affairs (VA) medical centers. Health-care costs (hospitalizations, ED visits, respiratory medications, and the cost of the DM intervention) were compared in the COPD DM intervention and UC groups. RESULTS: The composite outcome for all hospitalizations or ED visits were 27% lower in the DM group (123.8 mean events per 100 patient-years) compared to the UC group (170.5 mean events per 100 patient-years) (rate ratio 0.73; 0.56-0.90; p < 0.003). The cost of the DM intervention was $241,620 or $650 per patient. The total mean ± SD per patient cost that included the cost of DM in the DM group was 4491 ± 4678 compared to $5084 ± 5060 representing a $593 per patient cost savings for the DM program. CONCLUSIONS: The DM intervention program in this study was unique for producing an average cost savings of $593 per patient after paying for the cost of DM intervention.

New and emerging lipid-lowering therapy.

Statins remain the drugs of choice in patients at risk of or with atherosclerotic cardiovascular disease (ASCVD). Statins have limitations that drive the development of investigational agents to manage dyslipidemias and/or reduce ASCVD risk. There are a few small-molecule drugs that have the potential to mitigate ASCVD risk either alone or in combination with statins. Most lipid-modifying drugs in clinical development are biologic agents that target specific enzymes or genetic-based protein synthesis. Limitations of the biologic agents include complex mechanisms of action and manufacturing processes with indications in select patients with genetic dyslipidemia or who have failed traditional therapies. The ultimate clinical utility of the new and investigational agents will become established over the next several years.

Lay abstract The most common medications that reduce fat (cholesterol) in the blood are called 'statins.' Statins reduce the chance of having a heart attack, stroke or cardiac death. Statins do not completely eliminate these risks and some patients cannot tolerate them. New medications are being tested to find out if they reduce the risk of heart problems. Many of the new drugs are called 'biologics.' Biologics work through complex mechanisms to reduce the amount of fat produced or by limiting the toxicity of the fat. Many of the new medications are difficult to manufacture and must be given as injections. They are expensive but possibly effective for patients unable to take statins or patients with rare cholesterol disorders.

Recombinant peptides in thrombolysis.

Recombinant thrombolytic peptides are mainly represented by recombinant forms of tissue plasminogen activator (t-PA), a proteolytic enzyme that catalyzes the conversion of plasminogen into active plasmin, which then functions to dissolve clots. The three clinically relevant recombinant thrombolytic peptides are alteplase (t-PA), reteplase (r-PA), and tenecteplase (TNK). r-PA and TNK have been structurally modified from native t-PA to increase their half-life and fibrin specificity. Thrombolytics play an important role in several diseases, including ST-segment elevation myocardial infarction (STEMI), deep vein thrombosis (DVT) and pulmonary embolism (PE), ischemic stroke, and peripheral arterial disease. Thrombolytic therapy has evolved into an alternative treatment for STEMI, reserved predominantly for patients who do not have access to timely percutaneous coronary intervention. In patients with DVT/PE or arterial related critical limb ischemia, the use of thrombolytic therapy is limited to specific patient populations. Thrombolytic therapy is the treatment of choice for ischemic stroke in patients who present

Comparison of amlodipine/valsartan fixed-dose combination therapy and conventional therapy.

PURPOSE: Single-pill-combination (SPC) antihypertensive drug products have been shown to improve compliance but are associated with higher acquisition costs. This study compared the clinical and economic outcomes associated with the use of an SPC of amlodipine/valsartan (trade name Exforge) with the outcomes from conventional combination therapy in patients failing to respond to initial monotherapy with either a dihydropyridine calcium channel blocker (DHP-CCB) or an angiotensin receptor blocker (ARB). DESIGN: We conducted a retrospective cohort study of hypertensive patients failing to respond to monotherapy with either a DHP-CCB or an ARB who were switched to an SPC of amlodipine/valsartan (SPC group) or to treatment that could not include any SPC (control group). The groups were matched for age, gender, race, baseline blood pressure (BP), and comorbidities. The primary outcomes of the study included the proportion of patients achieving BP targets, the absolute change in BP from baseline, the proportion of patients discontinuing drug therapy because of side effects, the proportion of patients non-compliant with drug therapy, and health care resource utilization and costs. PRINCIPAL FINDINGS: Fifty-eight SPC patients achieved BP targets compared with 47 control patients (P = 0.119). The absolute reduction in BP was significantly greater in the SPC group (-22.8 +/- 6.9/-19.3 +/- 5.2 mmHg) than in the control group (-20.6 +/- 6.4/-17.8 +/- 5.6 mmHg) (P < 0.03). Significantly fewer patients discontinued anti-hypertensive therapy because of side effects and noncompliance in the SPC group compared with the control group (both P = 0.042). SPC patients accrued fewer clinic visits, laboratory tests, and electrocardiograms but had higher drug acquisition costs. Median medical therapy costs were significantly lower in the SPC group at the end of the 6-month follow-up, primarily because of lower costs for clinic visits. CONCLUSION: The use of the SPC of amlodipine/valsartan was associated with greater absolute BP reductions and fewer antihypertensive drug discontinuations because of side effects and noncompliance compared with the use of the individual drugs. Although the acquisition cost of the SPC was greater than that of the individual drugs, SPC combination therapy resulted in fewer clinic visits, laboratory tests, and electrocardiograms. As a result, the total cost of SPC therapy was significantly less than that associated with the use of the individual drug components.

Knowledge, Perceptions, and Patterns of Fish Oil Use in Cardiac Patients.

BACKGROUND: Fish oils are the most widely used nonvitamin, nonmineral dietary supplements in the United States. They are not over-the-counter medications and are neither approved nor indicated for treating disease. Patient knowledge and patterns of fish oil use are not well defined. OBJECTIVE: To determine cardiac patients' knowledge and patterns of fish oil use. METHODS: One thousand consecutive patients admitted to an in-patient cardiology service (2015-2017) taking fish oil dietary supplements or prescription omega-3 fatty acids were asked to complete an anonymous questionnaire concerning product knowledge and use. RESULTS: A total of 711 (71%) patients completed the questionnaire. Primary reasons for use included general health (34%), heart health (28%), arthritis (9%), and lipid disorders (8%). Few patients (14%) were advised to take fish oil products by a health-care provider. Only 2.5% were taking prescription omega-3 fatty acids. Only 26% knew the active ingredient in their fish oil product. Supplements were purchased through a nonpharmacy retail seller by 81% of respondents. CONCLUSIONS: Most cardiac patients consuming fish oil dietary supplements do so without medical supervision and without knowledge of the active ingredients. As most patients obtain supplements outside of a pharmacy, opportunities to monitor and educate patients remain a major challenge.