Effect of omega-3-acid ethyl esters on the steady-state plasma pharmacokinetics of rosuvastatin in healthy adults
Bibliographic record
Abstract
BACKGROUND: Patients with persistent hypertriglyceridemia while on statin therapy may require adjunctive lipid-lowering therapy to meet treatment goals. OBJECTIVE: To assess the effect of concomitant administration of prescription omega-3-acid ethyl esters (P-OM3), triglyceride-lowering agents, on the steady-state pharmacokinetics of rosuvastatin. METHODS: A randomized, open-label, repeated-dose, two-way crossover drug interaction study of two treatments - 4 g P-OM3 plus 40 mg rosuvastatin or 40 mg rosuvastatin alone administered daily for 14 days each under fasting conditions--was conducted in 48 non-smoking healthy adults. MAIN OUTCOME MEASURES: The primary determinants of drug interaction were the ln-transformed area under the plasma concentration versus time curve [AUC(t(ss))] over the final (day 14) 24 h dosing interval and maximum measured steady-state plasma rosuvastatin concentration [C(max(ss))] on day 14. Safety was assessed by clinical and laboratory testing and recording of adverse events. RESULTS: AUC(t(ss)) and C(max(ss)) following daily administration of rosuvastatin with P-OM3 were similar to those following monotherapy with rosuvastatin. All adverse events recorded during the study were classified as mild and self-limited. CONCLUSIONS: Administration of P-OM3 with rosuvastatin did not affect the pharmacokinetics of rosuvastatin under steady-state conditions in healthy individuals.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| 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 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".