Patiromer for the management of hyperkalemia in heart failure with reduced ejection fraction: the DIAMOND trial.

AIMS: To investigate the impact of patiromer on the serum potassium level and its ability to enable specified target doses of renin-angiotensin-aldosterone system inhibitor (RAASi) use in patients with heart failure and reduced ejection fraction (HFrEF). METHODS AND RESULTS: A total of 1642 patients with HFrEF and current or a history of RAASi-related hyperkalemia were screened and 1195 were enrolled in the run-in phase with patiromer and optimization of the RAASi therapy [≥50% recommended dose of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker/angiotensin receptor-neprilysin inhibitor, and 50 mg of mineralocorticoid receptor antagonist (MRA) spironolactone or eplerenone]. Specified target doses of the RAASi therapy were achieved in 878 (84.6%) patients; 439 were randomized to patiromer and 439 to placebo. All patients, physicians, and outcome assessors were blinded to treatment assignment. The primary endpoint was between-group difference in the adjusted mean change in serum potassium. Five hierarchical secondary endpoints were assessed. At the end of treatment, the median (interquartile range) duration of follow-up was 27 (13-43) weeks, the adjusted mean change in potassium was +0.03 mmol/l in the patiromer group and +0.13 mmol/l in the placebo group [difference in the adjusted mean change between patiromer and placebo: -0.10 mmol/l (95% confidence interval, CI -0.13, 0.07); P < 0.001]. Risk of hyperkalemia >5.5 mmol/l [hazard ratio (HR) 0.63; 95% CI 0.45, 0.87; P = 0.006), reduction of MRA dose (HR 0.62; 95% CI 0.45, 0.87; P = 0.006), and total adjusted hyperkalemia events/100 person-years (77.7 vs. 118.2; HR 0.66; 95% CI 0.53, 0.81; P < 0.001) were lower with patiromer. Hyperkalemia-related morbidity-adjusted events (win ratio 1.53, P < 0.001) and total RAASi use score (win ratio 1.25, P = 0.048) favored the patiromer arm. Adverse events were similar between groups. CONCLUSION: Concurrent use of patiromer and high-dose MRAs reduces the risk of recurrent hyperkalemia (ClinicalTrials.gov: NCT03888066).

Effects of an herbal medication containing bee products on menopausal symptoms and cardiovascular risk markers: results of a pilot open-uncontrolled trial.

OBJECTIVES: Fifty-five postmenopausal women with menopausal complaints were treated with the food supplement Melbrosia for 3 months. Menopausal symptom evaluation scales and psychological questionnaires were administered, and cardiovascular disease markers in blood were analyzed at the beginning and the end of the trial. SETTING: The perimenopausal care unit of Second Obstetrics and Gynecology Hospital, Sofia, Bulgaria. DESIGN: The study was an open, multicenter, uncontrolled, prospective observation study. The subjective symptoms questionnaires administered before Melbrosia treatment and after 3 months of treatment were Kupperman Score, Zerssen Symptom List, Zung Depression Score, and Frankfurt Self-concept Scale (self-assessment test, problem-solving test, self-esteem test, and irritability test). The blood levels of high-density lipoproteins (HDL), low-density lipoproteins (LDL), triglycerides (TG), total cholesterol (TC), vascular cell adhesion molecule-1 (VCAM-1), and C-reactive protein (CRP) levels were measured in a subgroup of patients. RESULTS: Treatment of postmenopausal women with Melbrosia led to a statistically significant reduction in the Kupperman score, Zerssen's Symptoms List, and Zung Depression Score. The Frankfurt Self-concept Scale revealed significant improvement in problem-solving, no change in self-assessment and self-esteem, and worsening of irritability. Treatment with Melbrosia significantly reduced TC and LDL and significantly elevated HDL and TG. There were nonsignificant changes of serum VCAM-1 and CRP levels in patients treated with Melbrosia. CONCLUSIONS: The presented data suggest that Melbrosia may offer a potential alternative to hormone therapy for the treatment of menopausal symptoms. However, because of this study's uncontrolled, open- label methodology, no cause-and-effect inferences can be drawn until a larger, longer-term, blinded, placebo-controlled, randomized clinical trial is performed.