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HFpEF

Aternative News:

• Potential use of ubiquinol and d-ribose in patients with heart failure with preserved ejection fraction - Annals of Medicine and Surgery, Volume 55, July 2020, Pages 77-80 - "HFpEF is a common and often debilitating disease process that may be difficult to diagnose and has limited targeted therapeutic options. Mitochondrial dysfunction appears to play a significant role in the pathophysiologic processes of this clinical syndrome. Improved methods of diagnosis for HFpEF are needed, as are specific effective therapies. Active ongoing research into the roles of ubiquinol and d-ribose in HFpEF may provide clinicians with additional management opportunities" - [Nutra USA] - See D-ribose at Amazon.com and ubiquinol products at Amazon.com.

Other News:

• l -Arginine Can Enhance the Beneficial Effect of Losartan in Patients with Chronic Aortic Regurgitation and Isolated Systolic Hypertension - Int J Angiol 2021 Jun;30(2) - "chronic aortic regurgitation (CAR) and isolated systolic hypertension (ISH) ... Both groups had a significant reduction in systolic blood pressure (SBP) and diastolic blood pressure (DBP), left ventricular end-diastolic volume index (LVEDVI), LV end-systolic volume index (LVESVI), LV mass index (LVMI), and LV mean wall stress after 6- and 12-month treatment ( p <0.01 in all comparisons). Both groups had a significant increase in LV ejection fraction and exercise duration after 6- and 12-month treatment ( p < 0.01 in all comparisons). Using multivariate linear regression analysis, only losartan + l -arginine therapy achieved a significantly lower LVESVI (38.89 ± 0.23 mL/m 2 ), LVEDVI (102.3 ± 0.3 mL/m 2 ), LVMI (107.6 ± 0.3 g/m 2 ), SBP (123.5 ± 1.0 mm Hg), and greater exercise duration (7.38 ± 0.02 minutes) than those of the losartan-only treated groups ( p <0.01 in all comparisons). These findings suggest that early co-administrative strategy provides a beneficial approach to favorably influence the natural history of CAR" - See l-arginine products at Amazon.com.
• Cost-effectiveness of Dapagliflozin for Treatment of Patients With Heart Failure With Reduced Ejection Fraction - Medscape, 6/4/21
• Sotagliflozin's HFpEF Benefit Confirmed by New Analyses - Medscape, 5/24/21 - "The meta-analysis (Abstract 410-08) included 4,500 patients with type 2 diabetes and diagnosed heart failure at entry; its primary endpoint, which was the same in both trials, was the combined incidence of cardiovascular death and the total number of either hospitalization for heart failure or urgent outpatient visits for heart failure ... Compared with placebo, treatment with sotagliflozin for a median of about 15 months dropped this composite endpoint by a relative 33% among the 1,931 who began the study with a left ventricular ejection fraction (LVEF) of at least 50% (HFpEF), by a relative 22% in the 1,758 patients who entered with an LVEF of less than 40% (patients with heart failure with reduced ejection fraction), and by a relative 43% among the 811 patients who began with an LVEF of 40%-49% (patients with heart failure with mid-range ejection fraction). The relative risk reductions were significant for all three subgroups, Deepak L. Bhatt, MD, reported at the meeting"
• Usefulness of Sodium-Glucose Cotransporter 2 Inhibitors for Primary Prevention of Heart Failure in Patients With Type 2 Diabetes Mellitus - Am J Cardiol 2021 May 15 - "The sodium-glucose cotransporter 2 inhibitors (SGLT2i) empagliflozin, canagliflozin, and dapagliflozin reduce the risk of heart failure (HF) events in patients with diabetes mellitus (DM) at high risk for HF. Differences in HF outcomes between SGLT2i were demonstrated in a recent-published meta-analysis ... Our findings suggest that between the available SGLT2i, the cost of primary prevention of HF in patients with DM at high risk for HF is lowest with empagliflozin" - See dapagliflozin at ReliableRXPharmacy.  They don't carry empagliflozin, which in my view is better.  I read somewhere that India would no longer sell generic versions after a certain patent date until that drug goes generic.  I think that's the problem with buying generic empagliflozin from India.
• Effect of empagliflozin on cardiorenal outcomes and mortality according to body-mass index: A subgroup analysis of the EMPA-REG OUTCOME trial with a focus on Asia - Diabetes Obes Metab 2021 May 5 - "Overall, hazard ratios for empagliflozin versus placebo for all-cause mortality, HHF or CV death, and incident or worsening nephropathy were 0.68 (95% CI 0.57, 0.82), 0.66 (0.55, 0.79), and 0.61 (0.53, 0.70), respectively, and were consistent across BMI categories (P-values for interaction between treatment and BMI: 0.6772, 0.3087, and 0.6265, respectively). Results were similar in Asians using these BMI categories and < 24, 24 to <28, ≥28 kg/m2 categories. Thus, empagliflozin reduced cardiorenal and mortality risk regardless of BMI at baseline, including in Asians with lower BMI"
• Tips for Navigating Prior Authorization and Out-of-Pocket Costs for HFrEF Medications - Medscape, 5/11/21 - "Moreover, in the past decade, a series of large randomized trials have shown the efficacy of newer classes of medications in improving health outcomes of patients with HFrEF. These newer medications include the I f inhibitor ivabradine (SHiFT study); the angiotensin receptor-neprilysin inhibitor (ARNI) sacubitril-valsartan (PARADIGM-HF and PIONEER-HF trials); the sodium-glucose transporter 2 (SGLT2) inhibitors dapagliflozin (DAPA-HF study) and empagliflozin (EMPEROR-Reduced trial); and the soluble guanylate cyclase activator vericiguat (VICTORIA trial) ... Although these new treatment options for HFrEF are proven to be safe and well tolerated across a wide range of patients, there are obstacles to their widespread use — namely, the high cost of these drugs, prior authorization requirements, and out-of-pocket fees. Not only must patients often first obtain approval from their insurance companies for these prescriptions, but they are also required to pay greater out-of-pocket costs for them than generic drugs. Perhaps not surprisingly, the use of generic ACE inhibitors and beta-blockers for HFrEF remains high, whereas uptake of ivabradine and sacubitril-valsartan continues to be slow and SGLT2 inhibitors are only just beginning to be prescribed." - See dapagliflozin at ReliableRXPharmacy.  They don't carry empagliflozin, which in my view is better.  I read somewhere that India would no longer sell generic versions after a certain patent date until that drug goes generic.  I think that's the problem with buying generic empagliflozin from India.
• Women, Black, and Asian Patients Least Likely to Get SGLT2 Inhibitors - Medscape, 4/23/21 - "If left unaddressed, these inequities in utilization will continue to widen well-documented disparities in cardiovascular and kidney outcomes in the [United States] ... Study after study, including large randomized trials, have demonstrated a cardio-protective and kidney-protective effect of this class of medications"
• Effects of Sacubitril/Valsartan on clinical symptoms, echocardiographic parameters, and outcomes in HFrEF and HFmrEF patients with coronary heart disease and chronic kidney disease - Curr Med Res Opin 2021 Mar 25 - "To compare the effects of Angiotensin Receptor-Neprilysin inhibitor (ARNI) on the clinical symptoms, echocardiographic parameters, and outcomes (cardiovascular death and hospitalization) in heart failure with reduced ejection fraction (HFrEF) and heart failure with mid-range ejection fraction (HFmrEF) patients with coronary heart disease and chronic kidney disease ... A statistically significant increase of 68.8% was observed in left ventricular ejection fraction (LVEF) in HFrEF patients compared to that in HFmrEF patients, with an increase of 27.2% at 8 months of follow-up. Sacubitril/valsartan significantly reduced left ventricular end-systolic volumes (LVESV) in HFrEF patients unlike in HFmrEF patients. The decrease in LVESV was 28.8% in HFrEF patients and 17.1% in HFmrEF patients. A significant reduction in the prevalence of severe secondary mitral regurgitation (EROA >0.4cm2) was observed in HFrEF compared to that in HFmrEF patients with the use of sacubitril/valsartan. A reduction of 15.6% was observed in HFrEF patients, whereas a reduction of 7.1% was observed in HFmrEF patients. Improvement in functional classification (NYHA) was observed during follow-up. The prevalence of (NYHA III) reduced from 50% to 15.7% in HFrEF patients, whereas a reduction from 21.1% to 8.8% was observed in HFmrEF patients. There was a significant reduction in NT-proBNP in HFrEF patients compared to that in HFmrEF patients. A reduction of 52% was observed in HFrEF patients, whereas a reduction of 28.7% was observed in HFmrEF pateints. Sacubitril/valsartan reduced primary endpoint events in both groups. The prevalence of HF-related hospitalization was higher in HFrEF than in HFmrEF patients: 12.1% vs 7.5%, respectively. The prevalence of CV death in HFrEF vs HFmrEF patients was 3.7% vs 0.5%, respectively. Cardiovascular (CV) was higher in patients with atrial fibrillation in both groups"
• Cardiac and Kidney Benefits of Empagliflozin in Heart Failure Across the Spectrum of Kidney Function - Medscape, 3/29/21 - "Empagliflozin reduced the primary outcome and total HF hospitalizations in patients with and without CKD: hazard ratio (HR)=0.78 (95% CI, 0.65–0.93) and HR=0.72 (95% CI, 0.58–0.90), respectively (interaction P=0.63). Empagliflozin slowed the slope of eGFR decline by 1.11 (0.23–1.98) ml/min/1.73 m2/yr in patients with CKD and by 2.41 (1.49–3.32) ml/min/1.73 m2/yr in patients without CKD. The risk of the composite kidney outcome was reduced similarly in patients with and without CKD: HR=0.53 (95% CI, 0.31–0.91) and HR=0.46 (95% CI, 0.22–0.99), respectively. The effect of empagliflozin on the primary composite outcome and key secondary outcomes was consistent across a broad range of baseline kidney function, measured by clinically relevant eGFR subgroups or by albuminuria, including patients with eGFR as low as 20 ml/min/1.73 m2. Empagliflozin was well tolerated in CKD patients ... In EMPEROR-Reduced, empagliflozin had a beneficial effect on the key efficacy outcomes and slowed the rate of kidney function decline in patients with and without CKD, and regardless of the severity of kidney impairment at baseline."
• SGLT-2 inhibitors for prevention of cardiorenal outcomes in type 2 diabetes: an updated meta-analysis - Diabetes Obes Metab 2021 Mar 12 - "A total of 8 cardiorenal outcomes trials of SGLT-2i (empagliflozin, canagliflozin, dapagliflozin, ertugliflozin, sotagliflozin) were identified, with 66 601 patients ... Overall, SGLT-2i were associated with a 12% reduced risk of major adverse cardiovascular events (MACE, HR = 0.88; 95% CI, 0.83-0.93; Q statistic, P = 0.19), with no significant heterogeneity (p for interaction = 0.465) between subgroups of patients with or without cardiovascular disease (CVD). The risk of the composite renal outcome was significantly reduced by treatment with SGLT-2i (HR = 0.61, 95% CI, 0.54-0.70), with no significant heterogeneity of associations with outcome (I2 = 37%, P = 0.11), and no difference in the risk between patients with or without CVD (p for interaction = 0.665). SGLT-2i have moderate benefits on MACE and major benefits on the progression of diabetic kidney disease"
• Dapagliflozin Reduces Systolic Blood Pressure and Modulates Vasoactive Factors - Diabetes Obes Metab 2021 Mar 17 - "24 and 23 patients receiving dapagliflozin and placebo, respectively, completed the 12 weeks' study. Systolic BP fell significantly, compared to placebo, both after a single dose (by 7 ± 3 mmHg) and 12-week (by 7 ± 2 mmHg) treatment with dapagliflozin. Dapagliflozin suppressed angiotensin II and angiotensinogen (by 10.5 ± 2.1 pg/mL and 1.45 ± 0.42 μg/mL, respectively) and increased ANP and cGMP (by 34 ± 11 pg/mL and 29 ± 11 pmol/mL, respectively) compared to placebo group. cGMP levels also increased acutely following a single dose of dapagliflozin. Dapagliflozin also suppressed PDE5 expression by 26 ± 11% in MNC. There was no change in the other vasoactive mediators investigated."
• Could Taking Viagra Come With an Extra Perk? - Medscape, 3/24/21 - "The researchers identified around 240,000 Swedish men who had a prior myocardial infarction or revascularization. Of that group, around 20,000 were receiving medication for ED — mostly PDE5 inhibitors but enough on alprostadil to do the analysis. ... Topline results: Men taking PDE5 inhibitors for ED were way less likely to have MIs, coronary revascularization, or heart failure than those taking alprostadil. In fact, over the course of up to 15 years of follow-up, 14% of men died of any cause in the PDE5 group compared with 26% in the alprostadil group" - Related study:
  • Erectile dysfunction drug 'effective' as heart failure treatment - Science Daily, 5/1/19 - "The study of Tadalafil -- which is in the same class as Viagra -- proves that the drug is biologically effective as a treatment for heart failure in sheep ... When the animals had heart failure -- induced by pace makers -- which was sufficiently advanced to need treatment, the team administered the drug. Within a short period the progressive worsening of the heart failure was stopped and, importantly the drug reversed the effects of heart failure ... And the biological cause of breathlessness in heart failure- the inability of the heart to respond to adrenaline was almost completely reversed" - See tadalafil at reliablerxpharmacy.com.
• Spironolactone in Patients With Heart Failure, Preserved Ejection Fraction, and Worsening Renal Function - J Am Coll Cardiol 2021 Mar 9 - "Treatment of heart failure with preserved ejection fraction (HFpEF) with spironolactone is associated with lower risk of heart failure hospitalization (HFH) but increased risk of worsening renal function (WRF) ... Among HFpEF patients enrolled in TOPCAT-Americas, spironolactone increased risk of WRF compared with placebo. Rates of CV death were lower with spironolactone in both patients with and without WRF"
• Hydrogel injection may change the way the heart muscle heals after a heart attack - Science Daily, 3/1/21 - "The international research team, which included researchers from Ireland, Spain, Sweden, France and Italy, were able to show that if their hydrogel was injected into the heart muscle shortly after a heart attack, it resulted in less fibrosis (scarring of the cardiac tissue) and an increase in the generation of new blood vessels in the area. They were also able to observe the rise in the preservation and survival of cardiomyocytes, a type of cell that allows the heart to beat, in the affected area"
• Nebivolol is more effective than atenolol for blood pressure variability attenuation and target organ damage prevention in L-NAME hypertensive rats - Hypertens Res 2021 Feb 22 - "β-Adrenergic blockers are no longer recommended as first-line therapy due to the reduced cardioprotection of traditional β-blockers compared with other antihypertensive drugs. It is unknown whether third-generation β-blockers share the limitations of traditional β-blocker ... Nebivolol had a greater ability than atenolol to decrease central SBP and mid-term and short-term blood pressure variability (BPV) in L-NAME rats. Echocardiographic analysis showed that nebivolol was more effective than atenolol on E/A wave ratio normalization. Compared with atenolol treatment, nebivolol had a greater protective effect on different TOD markers, inducing a decrease in collagen deposition and a reduction in the proinflammatory cytokines IL-6 and TNF-α in the left ventricle and aorta. Our findings suggest that the adverse hemodynamic profile and the reduced cardiovascular protection reported with traditional β-blockers must not be carried forward to third-generation β-blocker" - Note: For years cardiologists have put out that third-generation Nebivolol wouldn't work for heart failure and you had to use the first generation ones with unbearable side effects. That said, with Entresto and Jaridience or Farxiga, why do you even need a beta-blocker?
• Diabetes Drug Can Treat and Reverse Heart Failure and Reduce Hospitalizations - mountsinai.org - "Roughly 80 percent of the patients treated with empagliflozin showed significant improvement, and their hearts returned to near normal, the researchers found. This group had a 16.6 percent improvement in left ventricular ejection fraction at the six-month mark and their hearts pumped blood in a stronger way. Their hearts became smaller, less dilated because of less congestion and less fluid accumulation in the body, meaning that their heart failure became less severe, and the walls of the heart were less thick, meaning that the left ventricle could pump blood more easily"
• FDA Expands Sacubitril/Valsartan Indication to Embrace Some HFpEF - Medscape, 2/17/21 - "The US Food and Drug Administration (FDA) has approved a groundbreaking expanded indication for sacubitril/valsartan (Entresto), making it the first drug in the United States indicated for chronic heart failure (HF) not specifically characterized by ejection fraction ... PARAGON-HF had assigned more than 4800 patients whose LVEF was 45% or higher and were in NYHA class 2-4 to receive sacubitril/valsartan or valsartan only. Those taking the combo drug showed a 13% drop in risk for HF hospitalization or cardiovascular deaths over an average of 3 years, which narrowly missed significance (P = .059) ... But a subgroup analysis garnered attention for its hint of benefit for patients with "mid-range" LVEF, in this case, below the median of 57%. The finding was supported by a later PARAGON-HF and PARADIGM-HF meta-analysis that pointed to a significant benefit for patients with HFpEF at its lowest LVEF levels, especially in women"
• The role of SGLT-2 inhibitors in managing type 2 diabetes - Cleve Clin J Med 2020 Dec 31 - "Sodium-glucose cotransporter-2 (SGLT-2) inhibitors are an exceptionally versatile class of medication, and their glycemic and nonglycemic benefits could help millions of patients with type 2 diabetes. Of note, they have been shown to improve cardiac and renal outcomes, much-needed benefits in patients with type 2 diabetes, who are at a higher risk for developing cardiac and renal dysfunction than those who do not have diabetes. The indications for SGLT-2 inhibitors may continue to expand as ongoing clinical trials provide more insight into these drugs"
• FDA Approval Adds Vericiguat (Verquvo) to HF Treatment Options - Medscape, 1/20/21 - "Vericiguat, which promotes vasodilation through stimulation of a nitric-oxide signaling enzyme pathway, was approved based primarily on the VICTORIA trial, which saw a 10% drop in adjusted risk for the primary end point, cardiovascular death, or first HF hospitalization (P = .019) in those who took the drug, compared with a placebo"
• Five Reasons Sacubitril/Valsartan Should NOT Be Approved for HFpEF - Medscape, 1/15/21
• FDA Panel Supports Expanded HF Role for Sacubitril/Valsartan - Medscape, 12/15/20 - "The U.S. Food and Drug Administration asked its Cardiovascular and Renal Drugs Advisory Committee to broadly consider whether new analyses of data from the PARAGON-HF trial, combined with other information, could support use of sacubitril/valsartan (Entresto, Novartis) in heart failure with preserved ejection fraction (HFpEF) ... The advisory committee voted 12-1 on this question"
• Sacubitril/Valsartan: Neprilysin Inhibition 5 Years After PARADIGM-HF - Medscape, 12/4/20 - "Sacubitril/valsartan is an efficacious, safe, and cost-effective therapy that improves quality of life and longevity in patients with chronic HFrEF and reduces hospital admission. An in-hospital initiation strategy offers a potentially new avenue to improve the clinical uptake of sacubitril/valsartan ... The recently completed PARAGON-HF trial showed that sacubitril/valsartan modestly reduced the risks of total heart failure hospitalizations and cardiovascular death than valsartan in patients with HFpEF, although this finding narrowly missed statistical significance,[18] Clinical benefits were observed in secondary endpoints including quality of life and kidney endpoints; women and patients at the lower end of the LVEF spectrum appeared to preferentially benefit. The safety profile of sacubitril/valsartan was largely consistent with prior trial experiences. Regulatory review of sacubitril/valsartan for the treatment of HFpEF is currently under way. Ongoing trials are evaluating the clinical utility of sacubitril/valsartan among patients with HFpEF (PARALLAX) and acute myocardial infarction ... In the last 5 years, sacubitril/valsartan has been established as a cornerstone component of comprehensive disease-modifying medical therapy in the management of chronic HFrEF. The next 5 years should see its wider implementation in practice and potential expansion of its therapeutic indications"
• Randomized Trial of Empagliflozin in Non-Diabetic Patients with Heart Failure and Reduced Ejection Fraction - J Am Coll Cardiol 2020 Nov 9 - "Empagliflozin administration to non-diabetic HFrEF patients significantly improves LV volumes, LV mass, LV systolic function, functional capacity, and quality of life when compared with placebo. Our observations strongly support a role for SGLT2 inhibitors in the treatment of HFrEF patients independently of their glycemic status"
• EMPEROR-Reduced: Empagliflozin's HFrEF Benefit Holds Steady on Top of Sacubitril/Valsartan - Medscape, 10/7/20 - "When there are two very effective treatments, it's common for people to ask: Which should I use?' The goal of my presentation was to emphasize that the answer is both. We shouldn't choose between neprilysin inhibition [sacubitril inhibits the enzyme neprilysin] and SGLT2 [sodium-glucose transporter 2] inhibition; we should use both"
• HFpEF: Gender Difference in Sacubitril/Valsartan Response Remains Mystery - Medscape, 4/20/20 - "In women, however, who comprised more than half of the study population, the benefit of sacubitril/valsartan was larger: a 27% relative risk reduction compared to valsartan alone. That's a statistically significant difference in a prespecified subgroup analysis, but according to the rules of clinical trials and statistics it must be considered hypothesis-generating and nondefinitive, since the overall trial was negative. Men randomized to sacubitril/valsartan had a modest 3% increased risk of the primary endpoint compared to men on valsartan."
• PARAGON-HF: Optimal Systolic Pressure in HFpEF is 120-129 mmHg - Medscape, 3/18/20 - "A target systolic blood pressure (SBP) of 120-129 mm Hg in patients with heart failure with preserved ejection fraction (HFpEF) proved to be the sweet spot with the lowest rates of major adverse cardiovascular and renal events in a new analysis from the landmark PARAGON-HF trial"