Efficacy and safety of adding a second antihypertensive agent to eplerenone in patients with essential hypertension
Bibliographic record
Abstract
Aldosterone is a mineralocorticoid that plays an important, independent role in the pathophysiology of hypertension. Hypertension treatment often requires combination therapy; standard therapies, including ACEIs and ARBs, do not provide sustained reductions in aldosterone. This 14-month open-label, titration-to-effect study examined the efficacy and long-term safety of eplerenone (EPL), a selective aldosterone blocker, in 582 patients with mild-to-moderate hypertension. The dose of EPL was titrated from 50 to 100 mg, and from 100 to 200 mg at Weeks 2 and 4 if BP was uncontrolled (BP ≥140/90 mmHg). During Weeks 6–12, if BP remained uncontrolled on EPL 200 mg, investigators could add a second antihypertensive of their choice. A post hoc analysis was conducted on a subset of patients on EPL 200 mg who required a second antihypertensive agent to achieve BP control. Additional BP reductions from the last visit while on EPL 200 mg alone to the final visit and mean K+ at the final visit on add-on therapy plus EPL 200 mg are presented below: One patient on EPL 200 mg plus verapamil 180 mg was withdrawn after a serious adverse event of hyperkalemia (K+ ≥6.0 mEq/L). Another treated with EPL 200 mg plus chlorthalidone 12.5 mg was withdrawn for protocol-specified elevated K+ (≥ 6.0 mEq/L). In conclusion, in patients whose BP is not controlled with first-line treatment with EPL, adding a second antihypertensive agent provided further improvement in BP and was safe. In addition, blocking the RAAS at two levels with EPL and either an ACEI or ARB did not result in clinically remarkable mean changes in potassium levels. (See Table). Mean Change in BP From Last Visit on EPL 200 mg and Mean K+ at Last Visit Central Laboratory normal range for serum K+: 3.5–5.4 mEq/L
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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 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| 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".