iForumRx.org

Are Statins ALL THAT for Primary Prevention in Older Adults? A Second Look at ALLHAT-LLT

Statins reduce atherosclerotic cardiovascular disease (ASCVD) risk. However, the utility of statin therapy in older adults — particularly in those age 75 years and older — remains controversial. The need for additional evidence to guide clinical practice is underscored by the fact that one-in-three older Americans report taking a statin.  Given the paucity of prospective data, a post-hoc analysis of the ALLHAT-LLT (Antihypertensive and Lipid Lowering treatment to prevent Heart Attack Trial - Lipid Lowering Trial) was recently published.  Does this new analysis really help inform the decision?

Guest Author:  Leo Buckley, Pharm.D.

Music by Good Talk

All for One and FOURIER for All!

Although statins have a proven benefit and are widely used, ASCVD continues to be the leading cause of death in the US.  In 2015, two proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, alirocumab (Praluent®) and evolocumab (Repatha®), were approved to treat elevated cholesterol when added to maximally-tolerated statin therapy in patients with familial hypercholesterolemia or history of ASCVD.  However, the lack of long-term CV outcomes data, high cost, and uncertainty regarding place in therapy have limited their wide-spread use. The recently published FOURIER Study provides compelling new evidence.

Guest Author:  Kelly Starman, Pharm.D., BCPS

Theme music by Good Talk.

Peeling Back the Layers on Coated Aspirin

More than 15 million Americans have coronary heart disease and most should be taking aspirin daily.  Given aspirin’s ubiquity in cardiovascular medicine and patients’ pill boxes, it is shocking that there are still so many unanswered questions about aspirin use. Which dose and dosage forms should be prescribed?  How common is aspirin resistance?  What is the relationship between platelet inhibition and clinical outcomes?

Guest Author:  Daniela Valencia, Pharm.D.

Theme Music by Good Talk

Antithrombotic Therapy Following Stent Placement in Patients with A-Fib: Should DOACs Be Preferred?

Many patients with atrial fibrillation (AF) received triple antithrombotic therapy after undergoing a percutaneous coronary intervention (PCI) and receiving cardiac stent. Triple therapy consists of warfarin plus dual antiplatelet therapy (DAPT) with a P2Y₁₂ inhibitor and low-dose aspirin. But is triple therapy the best approach? This practice, while widely employed, is not entirely evidence-based. Moreover, the effectiveness and safety of the direct oral anticoagulants (DOACs) in this patient population is unknown.

Theme Music by Good Talk

Sweetening the Deal: Effects of SGLT-2 Inhibitors on Kidney Disease Progression

Approximately one in three patients with diabetes in the United States have chronic kidney disease (CKD).  The Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes (EMPA-REG OUTCOME) trial, published in 2015, demonstrated a reduction in cardiovascular and all-cause mortality in patients treated with empagliflozin. More recent data from the EMPA-REG OUTCOME trial suggests that empagliflozin may also confer significant renal protection. 

HIP-HIP-HOPE-3! Expanded role for statin therapy for primary prevention

The HOPE-3 trial sought to determine if blood pressure (BP) and cholesterol-lowering therapies are effective and safe as primary prevention strategies in intermediate risk patients. The American College of Cardiology and American Heart Association (ACC/AHA) guidelines support a risk-based approach to statin use but in intermediate risk patients the tradeoffs between benefit and risk were deemed “less clear.”  Do the results of HOPE-3 trial provide enough evidence to support routinely treating intermediate risk patients?

Liraglutide: the new LEADER for second line therapy in diabetes management?

According to the current (2016) ADA guidelines, no agent is “the preferred” second line therapy after metformin monotherapy — instead the benefits, risks, cost, and convenience of each option should be considered and treatment should be individualized.  The liraglutide and cardiovascular outcomes in type 2 diabetes (LEADER) trial, which assessed the long-term cardiovascular effects of liraglutide, a GLP-1 receptor agonist, comes at an interesting time shortly after the publication of the empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes (EMPA-REG OUTCOME) trial.  Both studies found a cardiovascular benefit. How, then, will the results of these trials affect the algorithm for type 2 diabetes management and more importantly, clinical practice?

PATHWAY-2: Does the road lead to spironolactone for resistant hypertension?

Resistant hypertension (RH) is frequently encountered in primary care practice and often presents a significant clinical challenge because limited evidence-based guidance exists. RH is a major cause of cardiovascular disease and death, and has been associated with a 50% increased risk of myocardial infarction, stroke, congestive heart failure, and chronic kidney disease when compared to patients without RH. The American Heart Association defines RH as uncontrolled BP despite maximal treatment with a three-drug regimen, ideally including a diuretic. The exact prevalence of RH is unknown, but large randomized controlled trials suggest it affects one in five patients with elevated BP.  Previous research findings suggest chlorthalidone, spironolactone, and eplerenone are all effective add-on therapies when BP remains uncontrolled with typical first line agents.  The Pathway-2 study provides the first direct comparative evaluation of three different four-drug antihypertensive regimens.

Does Coenzyme Q10 Have the ENERGY to Change Heart Failure Therapy?

Could a nutritional supplement be the “magic bullet” in heart failure therapy?  Coenzyme Q10 (CoQ10), or ubiquinone, is an electron carrier in mitochondria and plays a key role in ATP synthesis. It is also thought to have antioxidant effects and may stabilize LDL molecules. All of which would, theoretically, help the failing heart.

Lixisenatide and Cardiovascular Outcomes: The Burden of Proof

After cardiovascular (CV) safety concerns emerged with rosiglitazone use, the Food and Drug Administration (FDA) now requires outcome studies to be performed for all new diabetes medications.   The first CV safety study (ELIXA) for a drug in the glucagon-like peptide 1-receptor agonist (GLP-1 RA) class – lixisenatide - was published in December 2015.  Lixisenatide is a once-daily injectable GLP-1 RA approved for use in Europe and awaits FDA approval in the United States.