This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Ezetimibe/Simvastatin (MK-0653A) Versus Rosuvastatin Versus Doubling Statin Dose in Participants With Cardiovascular Disease and Diabetes Mellitus (MK-0653A-133)(COMPLETED) (NCT00862251), a randomized phase 3 study. The primary outcome is Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Statin (Simvastatin or Atorvastatin)..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00862251 |
| Phase | Phase 3 |
| Condition | Cardiovascular Disorder, Diabetes Mellitus |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 808 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Organon and Co |
| Results posted | Yes |
2. Clinical Question
Population
Participants with cardiovascular disease and diabetes mellitus whose LDL-C was not adequately controlled on simvastatin 20 mg or atorvastatin 10 mg. The registry reports an enrollment of 808; the primary efficacy population had a separate definition based on randomization, treatment exposure, and baseline data.
Intervention
Switching to ezetimibe/simvastatin, described in the study summary as a 10mg/20mg combination tablet.
Comparator
Doubling the existing statin dose: simvastatin 40 mg or atorvastatin 20 mg. Rosuvastatin was also a study treatment, but it is not the comparator in the primary endpoint.
Primary question
How did percent change in LDL-C from baseline to Week 6 compare between switching to ezetimibe/simvastatin and doubling the statin dose?
The question is about a short-term change in a laboratory measure, not about cardiovascular events or long-term health outcomes. The trial also examined whether participants reached an LDL-C target, alongside other lipid outcomes listed in the registry. Those secondary questions provide related but distinct information: a change in the group average does not directly state how many individuals crossed a target, and target attainment does not describe the size of each individual’s change.
The two statin backgrounds are relevant to the comparison. Participants entered while taking simvastatin or atorvastatin, and the dose-doubling option depended on the baseline statin. The registry lists separate target-attainment results for participants on each baseline statin. The primary endpoint, however, is described as a comparison of ezetimibe/simvastatin with doubling the dose of simvastatin or atorvastatin, not as separate primary estimates for each baseline statin.
The study included a rosuvastatin arm, and some secondary outcomes compare the combination treatment with rosuvastatin. The primary result discussed in the record is not a three-way comparison. It addresses the combination versus dose doubling at the stated Week 6 assessment.
3. Trial Design
This was a Phase 3, randomized, double-blind, active-controlled, parallel-group study. Its title describes participants with cardiovascular disease and diabetes mellitus who were not adequately controlled with simvastatin or atorvastatin. The study is marked completed. The registry lists 808 participants as the enrollment, with a start date of 2009-04 and primary completion in 2011-03.
The treatment strategies were switching to ezetimibe/simvastatin, doubling the dose of the existing statin, or switching to rosuvastatin. The dose-doubling arm used simvastatin 40 mg or atorvastatin 20 mg; the study summary describes the background treatments as simvastatin 20 mg or atorvastatin 10 mg. The combination is described as ezetimibe/simvastatin 10mg/20mg, and rosuvastatin is listed as 10 mg in the study summary. The arm descriptions themselves are blank in the registry record, so they do not provide further detail about treatment delivery.
Random allocation is intended to reduce systematic differences between treatment groups at assignment. Double masking is intended to limit the influence of treatment knowledge on participants’ experiences and the assessment of outcomes. These design features support comparison, but they do not remove uncertainty from sampling variation, missing measurements, or the choices made in statistical analysis. The registry record does not report further details about how randomization or masking was implemented.
The primary endpoint was assessed from baseline to Week 6. The efficacy population is defined as the full analysis set: randomized participants who received at least one dose of blinded study treatment and had baseline data. This is not necessarily the same as the registry’s enrollment figure. The record does not report the full set of participant-flow details or the number contributing endpoint data in each analysis beyond the endpoint summaries.
Rosuvastatin is part of the trial design, but the reported primary comparison is ezetimibe/simvastatin versus doubling the statin dose. The presence of a third arm should not be taken to mean that the primary estimate compares all three treatments or establishes a ranking across them.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Ezetimibe/Simvastatin | Doubling Statin Dose | Rosuvastatin |
|---|---|---|---|
| STARTED | 322 | 162 | 324 |
| COMPLETED | 303 | 157 | 315 |
| NOT COMPLETED | 19 | 5 | 9 |
Reasons for not completing this period:
| Reason | Ezetimibe/Simvastatin | Doubling Statin Dose | Rosuvastatin |
|---|---|---|---|
| Adverse Event | 8 | 3 | 1 |
| Lost to Follow-up | 0 | 0 | 1 |
| Protocol Violation | 2 | 0 | 1 |
| Withdrawal by Subject | 9 | 2 | 6 |
Analysis population for the primary outcome, as defined in the registry: Efficacy data were analyzed using the full analysis set (FAS) population defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Ezetimibe/Simvastatin | Doubling Statin Dose | Rosuvastatin | Total |
|---|---|---|---|---|---|
| Participants analysed | 322 | 162 | 324 | 808 | |
| Age, Continuous | years | 64.1 (SD 8.8) | 64.7 (SD 8.3) | 63.6 (SD 8.4) | 64.0 (SD 8.5) |
| Sex: Female, Male: Female | Participants | 162 | 82 | 142 | 386 |
| Sex: Female, Male: Male | Participants | 160 | 80 | 182 | 422 |
6. Primary Endpoint
The registry lists the primary outcome as Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After Switching to Treatment With Ezetimibe/Simvastatin vs Doubling the Dose of Statin (Simvastatin or Atorvastatin)., measured over Baseline and Week 6.
| Element | Registry entry |
|---|---|
| Result type | Least Squares Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | Percent change |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is percent change from baseline in low-density lipoprotein cholesterol (LDL-C), measured at baseline and Week 6. LDL-C is a continuous laboratory measure. Expressing change as a percentage relates the change to the participant’s baseline value, while the group estimate describes an average pattern rather than the experience of every participant.
The registry reports least-squares means and a 95% confidence interval for the primary outcome. Least-squares means are model-based estimates; they are not simply the raw average of all observed values. The registry identifies longitudinal data analysis as the method for the treatment comparison. The details of the model and any covariates are not reported in the registry record.
A continuous endpoint can detect differences in the magnitude of change across groups without converting the measurement into a yes-or-no threshold. That is useful for describing the overall shift in LDL-C, but an average change does not show the full distribution of individual responses. The secondary outcome on reaching LDL-C < 70 mg/dL addresses a different question: whether participants met a specified target at Week 6.
Neither type of endpoint is, by itself, a direct measure of cardiovascular events or long-term outcomes. The primary result should therefore be read as an estimate of short-term change in LDL-C, with its interval indicating statistical uncertainty around the group comparison.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
For the primary endpoint, the registry reports a least-squares mean percent change of -23.13 for ezetimibe/simvastatin and -8.37 for doubling the statin dose. The reported treatment comparison is -14.76, with a 95% confidence interval from -19.61 to -9.91 and p < 0.001. In the registry’s parameterization, the negative contrast indicates a greater reduction in LDL-C with ezetimibe/simvastatin than with dose doubling. The interval does not include zero, and the reported p-value indicates that the result would be unusual under a null model of no difference, subject to the assumptions of the analysis.
The confidence interval gives a range of values compatible with the observed estimate under the model and its assumptions. It is not a guarantee that the true effect lies in that interval, nor does it describe the range of individual participant responses. Its width reflects uncertainty in the estimate; precision and clinical importance are separate considerations. The registry result is a group-level short-term estimate, not a prediction for any particular participant.
The target-attainment outcomes offer complementary evidence. The posted results report more participants reaching LDL-C < 70 mg/dL in the ezetimibe/simvastatin arm than in either dose-doubling comparison or the rosuvastatin comparison. The corresponding unadjusted comparisons have p-values below 0.05, and the registry also reports logistic-regression odds ratios. These results concern a binary threshold and should not be treated as interchangeable with the continuous primary endpoint. The target is a secondary outcome, and its analysis has its own uncertainty and multiplicity concerns.
The primary result does not establish that the same difference would occur in other populations, over a longer period, or for clinical outcomes not measured by this endpoint. Nor does it establish a comparison with rosuvastatin on the primary outcome: the primary reported contrast is with dose doubling. The registry contains secondary comparisons involving rosuvastatin, but they do not change the identity of the primary question.
Statistical evidence of a difference is not synonymous with evidence of a particular clinical benefit. The result describes the estimated contrast in LDL-C change and its statistical precision. The registry record does not report a threshold for deciding what size of LDL-C difference would be clinically important, so that interpretation cannot be made from the statistical result alone.
Finally, the efficacy population is restricted by the registry’s full analysis set definition. It includes randomized participants who received at least one dose and had baseline data. The reported estimate therefore pertains to that defined analysis population. The record does not provide enough information to determine how the estimate might differ under other population definitions or missing-data assumptions.
9. Statistical Methods Explained
The primary analysis compares a continuous outcome between two treatment strategies. Percent change in LDL-C is summarized with least-squares means, and the registry reports a contrast between those estimates. A contrast expresses the estimated separation between groups on the endpoint scale. Its sign depends on the ordering used for the groups, so interpretation should follow the registry’s stated comparison rather than the sign in isolation.
What does a confidence interval convey?
A confidence interval represents statistical uncertainty around an estimate under the specified analysis. A narrower interval indicates greater precision than a wider interval, all else equal. If an interval for a group contrast includes zero, values consistent with no difference may remain compatible with the data under the method. If it does not include zero, that is evidence against a zero contrast at the corresponding confidence level, assuming the model and analysis are appropriate. This does not establish that the difference is important to patients or that it will persist outside the measured period.
The primary interval is reported at 95%. Its endpoints are -19.61 and -9.91 for the contrast of -14.76. The p-value is reported as p < 0.001. A p-value is a measure of how incompatible the observed data are with a specified null hypothesis under the analysis assumptions. It is not the probability that the null hypothesis is true, and it does not measure the size or importance of an effect. The confidence interval communicates magnitude and precision more directly than the p-value alone.
Why use least-squares means?
Least-squares means are model-based summaries. They can account for the structure specified in a statistical model, whereas a raw arithmetic mean is calculated directly from observed measurements. The registry identifies longitudinal data analysis for the primary comparison, which signals an analysis of repeated or longitudinal data. The specific model form, covariates, assumptions, and handling of incomplete measurements are not reported in the registry record. Those details matter because model-based estimates depend on the analysis specification.
A continuous measure also has features that may affect analysis. For example, if observations are highly skewed or include influential values, the average and its uncertainty can be sensitive to those features. This is a general statistical consideration, not a statement that such a problem occurred in this trial. The registry record does not report diagnostic checks or the distribution of individual changes.
How should the binary secondary comparisons be read?
Reaching the LDL-C target is a binary outcome: each participant either met the threshold at Week 6 or did not. The posted comparison summaries include risk differences and unadjusted p-values, while the registry’s reported analyses use logistic regression and give odds ratios with 95% confidence intervals. These are different statistical scales. A risk difference describes separation in the proportions meeting the target; an odds ratio compares odds. They can point in a consistent direction without having the same numerical interpretation.
The risk-difference calculations are unadjusted comparisons based on the posted group summaries. The sponsor’s logistic-regression results are model-based analyses and may differ because they use a different scale or analysis approach. The odds ratio is not a risk ratio, and it should not be read as a direct change in the probability of reaching the target. In general, an odds ratio can appear farther from one than a risk ratio when an outcome is common. That is a general property of the measures, not a trial-specific recalculation.
What do planning illustrations mean?
Sample-size illustrations based on an observed effect are hypothetical planning calculations, not observed trial results and not retrospective power. The registry’s planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the assumed effect is a stated fraction of the observed effect. Such illustrations show how a future study’s required participants per arm may vary with the effect size chosen for planning. They do not show that the current trial was designed using those assumptions or that its sample size was justified by them. The sample-size justification and design calculations are not reported in the registry record.
Over-dispersion is a general concern when binary outcomes vary more than a simple model expects. If it is present and not accommodated, standard errors may be too small and intervals too narrow. The registry record does not report an over-dispersion assessment, so no claim can be made about whether it affected these analyses.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| Longitudinal data analysis (LDA) | Percent change in least-square means -14.76 | -19.61 to -9.91 | < 0.001 |
The registry reports a longitudinal data analysis for the primary comparison. It gives a percent change in least-squares means of -14.76, a 95% confidence interval from -19.61 to -9.91, and p < 0.001. This is the sponsor-reported analysis available for the primary endpoint. The arm-level least-squares means are -23.13 for ezetimibe/simvastatin and -8.37 for doubling the statin dose.
These model-based results should not be confused with a simple recalculation from raw participant-level observations. The registry does not provide those individual observations, and the analysis details beyond longitudinal data analysis are not reported in the registry record. The arm summaries alone cannot reproduce the sponsor’s model or establish whether its assumptions are satisfied.
For the binary secondary outcomes, the record also reports logistic-regression odds ratios, while the posted unadjusted risk-difference comparisons use the summarized event counts. Those estimates answer related questions on different scales and need not match numerically. The reported logistic-regression analyses are the sponsor’s stated analyses; unadjusted calculations are descriptive checks rather than replacements for them.
No discrepancy is flagged in the registry record. That does not make model assumptions verifiable from the summary information, but it means the record does not identify a disagreement that would call for preferring a recalculation over the sponsor’s analysis. Where an actual discrepancy is flagged, the sponsor’s own analysis takes precedence. The main interpretation should remain anchored to the registered primary analysis and its stated endpoint.
11. Multiplicity, Missing Data and Analysis Populations
The registry lists 18 outcome measures and 30 analyses, and reports 17 posted secondary outcomes. A study that examines multiple endpoints, subgroups, or treatment contrasts faces multiplicity: the chance of finding at least one apparently significant result can increase as the number of statistical tests grows. Common approaches include adjusting significance thresholds, controlling a family-wise error rate, controlling a false discovery rate, or specifying a hierarchy for testing. These are general methods; the registry record does not say which, if any, were used for this trial.
The primary endpoint has a clearly stated comparison and a reported analysis. Its result should be distinguished from the secondary target-attainment comparisons and other listed outcomes. The latter include several related measures and subgroup questions. Because the record does not report a multiplicity strategy, the secondary p-values are best treated as unadjusted evidence for their specific comparisons rather than as confirmatory evidence across the full set of outcomes.
The primary efficacy analysis population is the full analysis set, defined as all randomized participants who received at least one dose of blinded study treatment and had baseline data. This definition excludes randomized participants who did not meet either condition. It differs from a complete description of every participant randomized, treated, and assessed. The record does not report the number excluded from this population or provide a full participant-flow account for the primary analysis.
Handling missing outcome data can affect estimates and uncertainty. General approaches include model-based use of available measurements, imputation, or sensitivity analyses under different assumptions. No particular approach should be attributed to this trial unless reported. The registry record does not report the extent of missing primary or secondary endpoint data, the method used to handle missingness, or sensitivity analyses addressing alternative assumptions. The longitudinal analysis label alone is not enough to determine those details.
Likewise, interim analyses, stopping rules, and the statistical plan beyond the listed analysis descriptions are not reported in the registry record. Their absence from the record does not establish that a procedure was or was not used. It limits how fully the reported significance results can be evaluated for prespecification and multiplicity.
12. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Ezetimibe/Simvastatin | 2 | 321 | 0.6% |
| Doubling Statin Dose | 1 | 162 | 0.6% |
| Rosuvastatin | 2 | 323 | 0.6% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Ezetimibe/Simvastatin | 0 of 321 |
| Doubling Statin Dose | 0 of 162 |
| Rosuvastatin | 0 of 323 |
Most frequent serious adverse event terms
| Event term | Organ system | Ezetimibe/Simvastatin | Doubling Statin Dose | Rosuvastatin |
|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | 1 of 321 | 0 of 162 | 0 of 323 |
| Angina unstable | Cardiac disorders | 0 of 321 | 0 of 162 | 1 of 323 |
| Coronary artery disease | Cardiac disorders | 1 of 321 | 0 of 162 | 0 of 323 |
| Myocardial infarction | Cardiac disorders | 0 of 321 | 1 of 162 | 0 of 323 |
| Arterial thrombosis limb | Vascular disorders | 0 of 321 | 0 of 162 | 1 of 323 |
Serious events with the highest arm-level rate: myocardial infarction (0.6%), angina pectoris (0.3%), coronary artery disease (0.3%), angina unstable (0.3%), arterial thrombosis limb (0.3%).
The registry reports serious adverse events for each of the three treatment groups. The serious-event summaries list 2 affected participants among 321 at risk with ezetimibe/simvastatin, 1 among 162 at risk with dose doubling, and 2 among 323 at risk with rosuvastatin. The record also lists 0 affected participants for the other adverse-event category in each of those groups. These are counts in the registry’s safety summaries, not estimates of comparative treatment effects.
Serious adverse events are distinct from the primary efficacy endpoint. Counts alone do not establish whether observed events were caused by a treatment, and they do not quantify the full safety profile. Interpreting comparisons would require attention to definitions, follow-up, completeness of reporting, and the analysis approach. Those details are not reported in the registry record.
The registry lists serious-event terms including myocardial infarction, angina pectoris, coronary artery disease, unstable angina, and arterial thrombosis of a limb, with percentages beside the terms. The summary does not specify an arm-level breakdown for those terms, so they should not be used to infer which treatment group experienced a particular event frequency. Death counts are not reported in the registry record.
These summaries describe what was recorded, not whether one strategy is safer or less safe. Small event counts can be compatible with substantial uncertainty, and the registry information does not support a definitive comparative safety conclusion.
13. What the Result Does, and Does Not, Mean
The primary result supports a statistical conclusion about a short-term laboratory outcome in the defined efficacy population: the estimated LDL-C reduction was greater with ezetimibe/simvastatin than with doubling the statin dose. The estimate is accompanied by a 95% confidence interval and a p-value, which describe statistical evidence and uncertainty under the reported analysis.
It does not establish that every participant experienced a reduction of the same size. A group mean can conceal substantial variation among individuals. The registry record does not provide the individual-level distribution of changes, so it is not possible to infer the proportion with a particular magnitude of response from the group estimates alone.
It also does not establish an effect on cardiovascular events, mortality, quality of life, or other outcomes not reported for this primary comparison. The endpoint is percent change in LDL-C from baseline to Week 6. A short-term change in a surrogate laboratory measure should not be translated into a claim about longer-term clinical outcomes without evidence addressing those outcomes.
The result applies to the trial’s enrolled population and analysis definition, not automatically to people with different conditions, baseline treatment, or levels of LDL-C control. The record describes participants with cardiovascular disease and diabetes whose lipid levels were not adequately controlled on the stated statin regimens. Generalization beyond that setting requires evidence not posted by this trial summary.
The trial also included rosuvastatin, but the primary reported estimate is not a comparison with that arm. Secondary target-attainment results include a rosuvastatin comparison, yet those results do not transform the primary estimate into a three-treatment ranking. Each comparison has its own endpoint and analysis.
Finally, statistical significance does not by itself determine whether an effect is clinically important. The registry does not report a minimum clinically important difference for this endpoint. The estimated contrast is therefore best understood as a quantified difference in the reported measure, rather than a complete judgment about clinical value.
14. Why This Trial Matters Statistically
This trial illustrates why the endpoint, treatment contrast, analysis population, and statistical model must be read together. A trial may include several treatment arms, yet its primary statistical question can concern only a particular pair of strategies. Here the primary contrast is ezetimibe/simvastatin versus doubling the statin dose, while rosuvastatin appears in the broader design and in secondary comparisons.
It also shows the difference between a continuous endpoint and a threshold outcome. Percent change in LDL-C captures the estimated average shift, whereas target attainment records whether a participant crossed a specified boundary. These views can complement one another, but one cannot be substituted for the other. The same distinction applies to least-squares mean contrasts versus logistic-regression odds ratios: both summarize comparisons, but on different scales and with different interpretations.
The registry’s population definition matters as well. The primary analysis uses the full analysis set, requiring randomization, at least one dose of blinded treatment, and baseline data. That definition is narrower than simply saying all randomized participants. Clear reporting of analysis populations and missing-data methods is important because exclusions and incomplete measurements can affect both the estimate and its precision.
Finally, the record makes the limits of summary evidence visible. It gives a primary estimate and interval, but does not report all model details, missing-data handling, or multiplicity procedures. Those omissions do not erase the reported result; they define the boundary of what can be evaluated from the registry record. Careful statistical interpretation preserves both the strength of the observed primary comparison and the uncertainties that remain.
15. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry record gives limited detail about the primary longitudinal model. It does not report the model specification, covariates, assumptions, or diagnostic checks. Although the least-squares means and treatment contrast are reported, the summary alone is insufficient to reproduce or independently assess the full model-based analysis.
The record defines the primary efficacy population but does not report a complete flow of participants through randomization, treatment, follow-up, and analysis. It also does not report the extent of missing endpoint data or how missing measurements were handled. Without those details, the potential influence of missingness on the estimate cannot be assessed from the registry summary.
Multiplicity procedures are not reported. This matters particularly for the secondary outcomes, which include several lipid measures, target-attainment questions, subgroup analyses, and treatment comparisons. The individual secondary results are informative as reported comparisons, but the record does not establish how their collective error rate was managed or which were intended to be confirmatory.
Follow-up for the primary endpoint is described as baseline and Week 6. The record therefore supports interpretation of a short-term measure, not persistence of the estimated difference over longer follow-up. The trial’s enrollment figure is not the same as the primary analysis population, and the record does not provide enough participant-flow information to reconcile them in detail.
Safety reporting is also summarized rather than fully characterized. The serious-event counts are available, but the record does not provide enough detail to assess event attribution, completeness, or comparative safety. Death counts are not reported in the registry record. These limitations restrict the strength of conclusions that can be drawn from the registry summaries; they do not by themselves show that the analyses or reporting are incorrect.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Ezetimibe/Simvastatin (MK-0653A) Versus Rosuvastatin Versus Doubling Statin Dose in Participants With Cardiovascular Disease and Diabetes Mellitus (MK-0653A-133)(COMPLETED) — NCT00862251.
- Registry record last updated 2024-05-16; status last verified 2022-02.
- Results first posted 2012-03-16.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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19. Record Summary
NCT00862251 is a completed Phase 3, randomized, double-blind, active-controlled, parallel-group study in participants with cardiovascular disease and diabetes mellitus whose LDL-C was not adequately controlled on simvastatin or atorvastatin. The registry lists enrollment of 808 and study dates from 2009-04 to primary completion in 2011-03.
The primary endpoint was percent change in LDL-C from baseline to Week 6. The reported longitudinal analysis estimates a greater reduction with ezetimibe/simvastatin than with doubling the statin dose, with a contrast of -14.76, a 95% confidence interval from -19.61 to -9.91, and p < 0.001. The efficacy analysis population was the defined full analysis set.
The registry also reports secondary target-attainment outcomes and serious adverse-event summaries. Multiplicity procedures, missing-data handling, detailed model specifications, and a full participant-flow account are not reported in the registry record.