BIOTECH AND PHARMANEWS

Low-Salt Weight-reduction design Functional for HF Signs, But No longer Basically for Scientific Events

WASHINGTON — A dietary intervention diminished sodium intake, but didn’t lower scientific events, for of us with coronary heart failure (HF), per the SODIUM-HF trial.

Between patients randomized to a low-sodium diet or usual like 12 months, there become as soon as no statistically foremost distinction within the mixed fracture result of cardiovascular-connected admissions to sanatorium, cardiovascular-connected emergency division visits, and all-reason loss of life within the trial (15% vs 17%, HR 0.89, 95% CI 0.63-1.26), reported Justin Ezekowitz, MBBCh, of the College of Alberta in Edmonton, Canada.

Nonetheless, sodium restriction become as soon as connected to lifelike enhancements in quality of lifestyles (QoL) and Current York Heart Affiliation (NYHA) functional class, per the leisurely-breaking trial presented on the American School of Cardiology (ACC) meeting. Results were concurrently published within the Lancet.

Ezekowitz entreated clinicians to proceed recommending a low-sodium diet as a therapy to red meat up QoL as fragment of an total effectively being approach for HF patients.

Particularly, his group had estimated that approximately 1,000 patients would be wanted for the trial. The 806-person trial had been stopped early attributable to an expansion of causes including futility, feasibility, and COVID-19.

ACC past president Mary Norine Walsh, MD, of St. Vincent Heart Center in Indianapolis, basic that the average sodium intake within the U.S. is 3,400 mg per day.

She careworn the importance of affected person-centered outcomes, and the contrivance in which other folks can surely feel better anecdotally from sodium restriction. SODIUM-HF reassures patients that if they hump up with their salt intake sooner or later, they might well well perchance also neutral no longer end up within the sanatorium, she stated right by means of an ACC press conference.

The dietary intervention within the look focused <1,500 mg sodium per day -- approximately two-thirds of the 2,300 mg aim listed within the Dietary Guidelines for Americans — and supplied members with meal plans and pattern menus tailored to their vitality requirements, vitality distribution, and regional tastes. Behavioral counseling supported the intervention.

Of us randomized to the sodium intervention saw median day by day sodium intake fall from 2,286 mg to 1,658 mg after 12 months. Peers within the regulate group had sodium intake diminished from 2,119 mg to correct 2,073 mg.

ACC instantaneous past president Athena Poppas, MD, of Warren Alpert Clinical School of Brown College in Windfall, Rhode Island, wondered how meaningfully sodium reduction become as soon as diminished by the intervention within the look.

Sodium restriction has long been embraced by clinicians despite mixed results in scientific experiences. “We’ve been chasing the holy grail of sodium reduction in HF for a truly, very long time,” Poppas stated following Ezekowitz’s presentation.

HF “is connected to neurohormonal activation and abnormalities in autonomic regulate that lead to sodium and water retention; thus, dietary restriction of sodium has been historically counseled as a mechanism to prevent fluid overload and subsequent scientific outcomes; nonetheless, extra recent files has wondered the validity of those solutions,” Ezekowitz’s group basic.

As an instance, geriatric HF patients didn’t possess QoL red meat up greatly within the GOURMET-HF look of dwelling-delivered sodium-restricted meals.

Conducted in six countries, the SODIUM-HF trial randomized other folks to the intervention or usual care, which included normal advice to restrict dietary sodium supplied right by means of routine scientific be conscious.

Investigators recruited 806 other folks with chronic HF (NYHA class II-III) on maximally-tolerated, guideline-directed clinical therapy. Participants had a median age of 67, and two-thirds were males. No files on plod and ethnicity were available, though 22% of the members in both groups were in Mexico, Chile, and Columbia.

Dietary sodium intake become as soon as assessed using 3-day meals diaries on the least at baseline, 6 months, and 12 months. These diaries suggested correct adherence to the assigned diets, per Ezekowitz.

He moreover reported that sodium restriction become as soon as no longer connected to any security events.

Among the trial limitations were the dearth of blinding among members and the lacking files on urinary biomarkers.

“Despite the truth that 24 h [hour] urinary excretion is the gold normal dietary evaluation contrivance for sodium intake, meals records are a sound dietary evaluation methodology in coronary heart failure and the dispute of 24 h urine collections would possess restricted trial feasibility and generated doubtlessly deceptive files for patients with coronary heart failure on diuretics,” the investigators stated.

  • Nicole Lou is a reporter for MedPage As of late, where she covers cardiology news and diverse inclinations in medication. Apply

Disclosures

The look become as soon as funded by Canadian Institutes of Health Analysis; College Clinic Foundation, Edmonton, Alberta, Canada; and Health Analysis Council of Current Zealand.

Ezekowitz disclosed research grants from American Regent, Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb/Pfizer, eko.ai, Us2.ai, Merck, Novartis, Otsuka, Sanofi, and Servier; and consulting expenses from American Regent, Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb/Pfizer, Merck, Novartis, Otsuka, Sanofi, and Servier.

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