Category Archives: Heart Disease

Finerenon: New Hope for Prevention of Kidney Disease and Cardiac Death in Type 2 Diabetes

Your friendly neighborhood drug supplier

Verbatim from the FDA press release:

FDA has approved Kerendia (finerenone) tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in adults with chronic kidney disease associated with type 2 diabetes.

Diabetes is the leading cause of chronic kidney disease and kidney failure in the United States. Chronic kidney disease occurs when the kidneys are damaged and cannot filter blood normally. Because of defective filtering, patients can have complications related to fluid, electrolytes (minerals required for many bodily processes), and waste build-up in the body. Chronic kidney disease sometimes can progress to kidney failure. Patients also are at high risk of heart disease.

The ultimate role of finerenone in our armamentarium against disease and suffering will probably depend on cost and the number needed to treat.

The efficacy of Kerendia to improve kidney and heart outcomes was evaluated in a randomized, multicenter, double-blind, placebo-controlled study in adults with chronic kidney disease associated with type 2 diabetes. In this study, 5,674 patients were randomly assigned to receive either Kerendia or a placebo.

The study compared the two groups for the number of patients whose disease progressed to a composite (or combined) endpoint that included at least a 40% reduction in kidney function, progression to kidney failure, or kidney death. Results showed that 504 of the 2,833 patients who received Kerendia had at least one of the events in the composite endpoint compared to 600 of the 2,841 patients who received a placebo.

The study also compared the two groups for the number of patients who experienced cardiovascular death, a non-fatal heart attack, non-fatal stroke, or hospitalization for heart failure. Results showed that 367 of the 2,833 patients receiving Kerendia had at least one of the events in the composite endpoint compared to 420 of the 2,841 patients who received a placebo, with the treatment showing a reduction in the risk of cardiovascular death, non-fatal heart attack, and hospitalization for heart failure.

Side effects of Kerendia include hyperkalemia (high levels of potassium), hypotension (low blood pressure), and hyponatremia (low levels of sodium). Patients with adrenal insufficiency (when the body does not produce enough of certain hormones) and those receiving simultaneous treatment with strong CYP3A4 inhibitors should not take Kerendia.

Kerendia received priority review and fast track designations for this application.

FDA granted the approval of Kerendia to Bayer Healthcare.


Click for prescribing information.


Parker here.

Just offhand, finerenone doesn’t look like a great drug. Helpful, maybe. Chronic kidney disease can end up at ESRD (end stage renal disease), which requires thrice weekly hemodialysis if the patient wants to stay alive. (Yes, peritoneal dialysis is an alternative.) Preventing ESRD is an incredible benefit for an individual.

Finerenone seems to be a well-tolerated daily pill. The main adverse effect is elevated blood potassium level, which can cause palpitations, and death infrequently. Less commonly, the drug can cause low blood pressure.

Steve Parker, M.D.

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Does Salt Restriction Lower Blood Pressure in Type 2 Diabetes?

Yes, according to an article in Nutrition, Metabolism & Cardiovascular Disease. The systolic pressure lowering is 5-6 points, but only 1-2 points on average for diastolic pressure. This degree of BP lowering is not dramatic, but might prevent an escalation of antihypertensive drug dosing or initiation of an additional drug.

Blood pressure control is also extremely important for protection of heart, kidneys, and brain.

Steve Parker, M.D.

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Should You Reduce Your Aspirin Dose from 325 to 81 mg/day?

Photo by Anna Shvets on Pexels.com

For patients with established cardiovascular disease, a recent study found that aspirin 81 mg/day was just as effective as 325 mg/day in preventing combined risk of death and hospitalization for heart attack or stroke. Rates of major bleeding were the same regardless of dose.

Click for details at NEJM.

Don’t make changes in your medication regimen without consulting your personal physician.

Steve Parker, M.D.

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High Blood Pressure: What’s the Number to Shoot For?

Not a bad monitor

First, recall that blood pressure is reported as two numbers: systolic and diastolic. E.g., 135/92. The first number is the systolic number. A systolic pressure goal of under 120 mmHg may be better than the traditional goal of under 140, at least if you’re “at increased risk for cardiovascular disease.” The study at hand excluded folks with diabetes or prior stroke.

We randomly assigned 9,361 participants who were at increased risk for cardiovascular disease but did not have diabetes or previous stroke to adhere to an intensive treatment target (systolic blood pressure, <120 mm Hg) or a standard treatment target (systolic blood pressure, <140 mm Hg). The primary outcome was a composite of myocardial infarction, other acute coronary syndromes, stroke, acute decompensated heart failure, or death from cardiovascular causes. Additional primary outcome events occurring through the end of the intervention period (August 20, 2015) were adjudicated after data lock for the primary analysis. We also analyzed post-trial observational follow-up data through July 29, 2016.

RESULTS

At a median of 3.33 years of follow-up, the rate of the primary outcome and all-cause mortality during the trial were significantly lower in the intensive-treatment group than in the standard-treatment group (rate of the primary outcome, 1.77% per year vs. 2.40% per year; hazard ratio, 0.73; 95% confidence interval [CI], 0.63 to 0.86; all-cause mortality, 1.06% per year vs. 1.41% per year; hazard ratio, 0.75; 95% CI, 0.61 to 0.92). Serious adverse events of hypotension, electrolyte abnormalities, acute kidney injury or failure, and syncope were significantly more frequent in the intensive-treatment group. When trial and post-trial follow-up data were combined (3.88 years in total), similar patterns were found for treatment benefit and adverse events; however, rates of heart failure no longer differed between the groups.

Steve Parker, M.D.

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Which Diets Help Lower Blood Pressure?

Probably all on the Portfolio Diet

Increasingly, I’m suspicious of results from meta-analyses. Anyway, here’s the abstract of one from American Journal of Clinical Nutrition in 2020. In case you’re not familiar with the LDL-lowering, vegetarian, “portfolio diet,” click for an infographic.

Background: Many systematic reviews and meta-analyses have assessed the efficacy of dietary patterns on blood pressure (BP) lowering but their findings are largely conflicting.

Objective: This umbrella review aims to provide an update on the available evidence for the efficacy of different dietary patterns on BP lowering.

Methods: PubMed and Scopus databases were searched to identify relevant studies through to June 2020. Systematic reviews with meta-analyses of randomized controlled trials (RCTs) were eligible if they measured the effect of dietary patterns on systolic (SBP) and/or diastolic blood pressure (DBP) levels. The methodological quality of included systematic reviews was assessed by A Measurement Tool to Assess Systematic Review version 2. The efficacy of each dietary pattern was summarized qualitatively. The confidence of the effect estimates for each dietary pattern was graded using the NutriGrade scoring system.

Results: Fifty systematic reviews and meta-analyses of RCTs were eligible for review. Twelve dietary patterns namely the Dietary Approaches to Stop Hypertension (DASH), Mediterranean, Nordic, vegetarian, low-salt, low-carbohydrate, low-fat, high-protein, low glycemic index, portfolio, pulse, and Paleolithic diets were included in this umbrella review. Among these dietary patterns, the DASH diet was associated with the greatest overall reduction in BP with unstandardized mean differences ranging from -3.20 to -7.62 mmHg for SBP and from -2.50 to -4.22 mmHg for DBP. Adherence to Nordic, portfolio, and low-salt diets also significantly decreased SBP and DBP levels. In contrast, evidence for the efficacy of BP lowering using the Mediterranean, vegetarian, Paleolithic, low-carbohydrate, low glycemic index, high-protein, and low-fat diets was inconsistent.

Conclusion: Adherence to the DASH, Nordic, and portfolio diets effectively reduced BP. Low-salt diets significantly decreased BP levels in normotensive Afro-Caribbean people and in hypertensive patients of all ethnic origins.

Source: Efficacy of different dietary patterns on lowering of blood pressure level: an umbrella review – PubMed

Steve Parker, M.D.

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High Glycemic Index Eating Linked to Higher Risk of Cardiovascular Disease and Death

Haven’t we known this for years? Click for definition and discussion of glycemic index and glycemic load.

“One little piece won’t hurt . . .”

From New England Journal of Medicine:

Most data regarding the association between the glycemic index and cardiovascular disease come from high-income Western populations, with little information from non-Western countries with low or middle incomes. To fill this gap, data are needed from a large, geographically diverse population.

METHODS

This analysis includes 137,851 participants between the ages of 35 and 70 years living on five continents, with a median follow-up of 9.5 years. We used country-specific food-frequency questionnaires to determine dietary intake and estimated the glycemic index and glycemic load on the basis of the consumption of seven categories of carbohydrate foods. We calculated hazard ratios using multivariable Cox frailty models. The primary outcome was a composite of a major cardiovascular event (cardiovascular death, nonfatal myocardial infarction, stroke, and heart failure) or death from any cause.

RESULTS

In the study population, 8780 deaths and 8252 major cardiovascular events occurred during the follow-up period. After performing extensive adjustments comparing the lowest and highest glycemic-index quintiles, we found that a diet with a high glycemic index was associated with an increased risk of a major cardiovascular event or death, both among participants with preexisting cardiovascular disease (hazard ratio, 1.51; 95% confidence interval [CI], 1.25 to 1.82) and among those without such disease (hazard ratio, 1.21; 95% CI, 1.11 to 1.34). Among the components of the primary outcome, a high glycemic index was also associated with an increased risk of death from cardiovascular causes. The results with respect to glycemic load were similar to the findings regarding the glycemic index among the participants with cardiovascular disease at baseline, but the association was not significant among those without preexisting cardiovascular disease.

CONCLUSIONS

In this study, a diet with a high glycemic index was associated with an increased risk of cardiovascular disease and death.

Source: Glycemic Index, Glycemic Load, and Cardiovascular Disease and Mortality | NEJM

The low-carb Mediterranean diet is low glycemic index.

Steve Parker, M.D.

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Gastric Bypass Surgery Improves Heart and Kidney Outcomes in Type 2 Diabetes

Steve Parker MD, bariatric surgery, gastric bypass

Band Gastric Bypass Surgery

From a recent Diabetes Care article:

Our data suggest robust benefits for renal outcomes, heart failure, and CV mortality after GBP in individuals with obesity and T2DM. These results suggest that marked weight loss yields important benefits, particularly on the cardiorenal axis (including slowing progression to end-stage renal disease), whatever the baseline renal function status.

Source: Renal and Cardiovascular Outcomes After Weight Loss From Gastric Bypass Surgery in Type 2 Diabetes: Cardiorenal Risk Reductions Exceed Atherosclerotic Benefits | Diabetes Care

Because of the risk of surgery, I’d make sure first that diet modification was seriously tried and failed.

Steve Parker, M.D.

low-carb mediterranean diet

Click the pic to purchase at Amazon.com. E-book versions also available at Smashwords.com.

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Olive Oil Linked to Reduced Cardiovascular Disease Risk

Steve Parker MD, low-carb diet, diabetic diet

Olives, olive oil, and vinegar: classic Mediterranean foods

A new analysis of the Nurses Health Study confirms the headline above. Olive oil, of course, is a primary component of the healthy Mediterranean diet. From the American College of Cardiology:

Higher olive oil intake was associated with a lower risk of CHD [coronary heart disease] and total CVD [cardiovascular disease] in two large prospective cohorts of US men and women. The substitution of margarine, butter, mayonnaise, and dairy fat with olive oil could lead to lower risk of CHD.

***

This study of well-educated health professionals is the first in the United States to show the relative value of higher intake of olive oil for preventing CHD and CVD. It was conducted in the era that margarine was primarily trans fatty acids and would not apply to the present soft and liquid margarines. The benefit attributed to olive oil is not simply the substitution for saturated fatty acid. The modest benefit of olive oil in the United States occurred at relatively low olive oil intake (average 12 g/day). In contrast, the Mediterranean diet generally has over 25 g/day. In European studies, a healthy cohort had a 7% reduction in CHD risk for each 10 g/d increase in olive oil; extra virgin olive oil reduced cerebrovascular events by 31% in a high-risk group, and regular olive oil was associated with a 44% lower risk of CHD after about 7.8 years in Italian women survivors of an MI. Amongst the benefits of olive oil include positive effects on inflammation, endothelial function, hypertension, insulin sensitivity, and diabetes.

Source: Olive Oil Consumption and Cardiovascular Risk – American College of Cardiology

Steve Parker, M.D.

low-carb mediterranean diet

Click the pic to purchase at Amazon.com. E-book versions also available at Smashwords.com.

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Low-Carb Diets Improve Cardiovascular Risk Factors

This Avocado Chicken soup is very low-carb. Use the search box to find the recipe.

A meta-analysis by Chinese investigators found that low-carb diets improve cardiovascular risk factors. Specifically: body weight (lowered), triglycerides (lowered), HDL-cholesterol (raised), blood pressure (lowered systolic and diastolic, but less than 2 points each).

Additionally, they found increases in total cholesterol  and HDL-cholesterol. Some consider those to be going in the wrong direction, increasing cardiovascular risk. The study authors, however, considered these increases “slight,” implying lack of real-world significance.

I’ll not fisk the entire research paper. Have a go at it yourself by clicking the link to full-text below.

The researchers included 12 randomized controlled trials in their analysis. They defined low-carb diets as having less than 40% of calories derived from carbohydrates. If you’re eating 2200 calories a day, 39% of calories from carb would be 215 g of carbs/day. That’s a lot of carb, and wouldn’t be much lower than average. I scanned the report pretty quickly and didn’t run across an overall average for carb grams or calories in the low-carb diets. The “control diets” had 45–55% of calories from carbohydrate.

Here’s the abstract:

Background

Low-carbohydrate diets are associated with cardiovascular risk factors; however, the results of different studies are inconsistent.

Purpose

The aim of this meta-analysis was to assess the relationship between low-carbohydrate diets and cardiovascular risk factors.

Method

Four electronic databases (PubMed, Embase, Medline, and the Cochrane Library) were searched from their inception to November 2018. We collected data from 12 randomized trials on low-carbohydrate diets including total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglycerides, and blood pressure levels, as well as weight as the endpoints. The average difference (MD) was used as the index to measure the effect of a low-carbohydrate diet on cardiovascular risk factors with a fixed-effects model or random-effects model. The analysis was further stratified by factors that might affect the results of the intervention.

Results

From 1292 studies identified in the initial search results, 12 randomized studies were included in the final analysis, which showed that a low-carbohydrate diet was associated with a decrease in triglyceride levels of -0.15mmol/l (95% confidence interval -0.23 to -0.07). Low-carbohydrate diet interventions lasting less than 6 months were associated with a decrease of -0.23mmol/l (95% confidence interval -0.32 to -0.15), while those lasting 12–23 months were associated with a decrease of -0.17mmol/l (95% confidence interval -0.32 to -0.01). The change in the body weight in the observation groups was -1.58kg (95% confidence interval -1.58 to -0.75); with for less than 6 months of intervention, this change was -1.14 kg (95% confidence interval -1.65 to -0.63),and with for 6–11 months of intervention, this change was -1.73kg (95% confidence interval -2.7 to -0.76). The change in the systolic blood pressure of the observation group was -1.41mmHg (95% confidence interval—2.26 to -0.56); the change in diastolic blood pressure was -1.71mmHg (95% confidence interval—2.36 to -1.06); the change in plasma HDL-C levels was 0.1mmHg (95% confidence interval 0.08 to 0.12); and the change in serum total cholesterol was 0.13mmol/l (95% confidence interval 0.08 to 0.19). The plasma LDL-C level increased by 0.11mmol/l (95% confidence interval 0.02 to 0.19), and the fasting blood glucose level changed 0.03mmol/l (95% confidence interval -0.05 to 0.12),which was not significant.

Conclusions

This meta-analysis confirms that low-carbohydrate diets have a beneficial effect on cardiovascular risk factors but that the long-term effects on cardiovascular risk factors require further research.

Source: The effects of low-carbohydrate diets on cardiovascular risk factors: A meta-analysis

Steve Parker, M.D.

PS: You know what else reduces cardiovascular disease risk? The Mediterranean diet. The Diabetic Mediterranean Diet provides between 20 and 100 grams of digestible carb daily, depending on your individual carbohydrate tolerance level.

Click the pic to purchase at Amazon.com. E-book versions also available at Smashwords. com

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Diabetes Drug Dapagliflozin Prevents Worsening Heart Failure and Cardiovascular Deaths

Pulmonary artery arrow is wrong

The amazing thing about this research is that dapagliflozin 10 mg/day seemed to benefit patient who didn’t even have diabetes. Unfortunately, the abstract doesn’t mention how many non-diabetic patients were in the study. As always, you should take news like this with a grain of salt.

Conclusion from the abstract:

Among patients with heart failure and a reduced [left ventricular] ejection fraction [under 40%], the risk of worsening heart failure or death from cardiovascular causes was lower among those who received dapagliflozin than among those who received placebo, regardless of the presence or absence of diabetes.

Source: Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction | NEJM

Steve Parker, M.D.

PS: Your doctor isn’t going to prescribe dapagliflozin for you if you don’t have diabetes. Guess what else helps prevent heart failure and premature cardiac death. The Mediterranean diet.

Click the pic to purchase at Amazon.com. E-book versions also available at Smashwords. com

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