The selective aldosterone blocker eplerenone is safe and efficacious for the long-term treatment of mild-to-moderate hypertension
Bibliographic record
Abstract
Eplerenone (EPL), the first selective aldosterone blocker (SAB), binds preferentially to aldosterone receptors, with little affinity for progesterone or androgen receptors. EPL is to be used for the treatment of hypertension and heart failure. This 6- to 16-month, open-label, single-group, titration-to-effect study assessed the safety, tolerability, and efficacy of EPL in patients with mild-to-moderate hypertension. Patients (n=586) with DBP ≥90 mmHg and <110 mmHg, or SBP ≥140 mmHg and <180 mmHg, received EPL 50 mg QD. If BP was uncontrolled at Weeks 2 or 4 (DBP ≥90 mmHg or SBP ≥140 mmHg), EPL was up-titrated to 100 mg QD and, if necessary, 200 mg QD. If BP remained uncontrolled at any time from Week 6 to the end of Month 3, a second antihypertensive medication of the investigator's choice was added. Safety, tolerability, and BP were assessed at protocol-specified times. The proportions of patients reporting treatment-emergent AEs for which a relationship to the study medication was considered “uncertain” or “probable” were 21.5% and 8.4%, respectively. Impotence, gynecomastia, and menstrual abnormalities were noted in 3.0%, 0.7%, and 2.5% of patients, respectively, but the majority of these events were considered to be of uncertain or no relationship to study medication. Elevated K+ levels were noted in 2.4% of patients, primarily those receiving EPL 200 mg. The mean change from baseline SBP/DBP was −15.9/−10.6 in patients whose final dose level was EPL 50 mg (N=68); −18.1/−12.2 for EPL 100 mg (N=89); −19.1/−12.5 for EPL 200 mg (N=104); and −24.9/−14.6 for EPL 200 mg plus add-on therapy (N=172). A total of 433 patients (74.3%) were classified as responders (DBP <90mmHg or ≥10 mmHg from baseline), and 261 patients (44.8%) responded to EPL monotherapy. The incidence of withdrawal due to treatment failure at or after Month 4 was 4.8%. In conclusion, long-term treatment of mild-to-moderate hypertension with the SAB eplerenone was safe and efficacious when used as a monotherapy or in combination with other antihypertensive medications.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".