Evaluation of the Efficacy and Safety of Rosuvastatin 5 mg Versus Pravastatin 40 mg and Atorvastatin 10 mg in Type IIa and IIb Hypercholesterolaemic Patients: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Evaluation of the Efficacy and Safety of Rosuvastatin 5 mg Versus Pravastatin 40 mg and Atorvastatin 10 mg in Type IIa and IIb Hypercholesterolaemic Patients (NCT00631189), a randomized phase 4 study. The primary outcome is Change in Low Density Lipoprotein Cholesterol (LDL-C) Level After 8 Weeks.

2. Clinical Question

The study also identifies secondary questions about reaching LDL-C goals under AFSSAPS 2005 guidelines and changes in other lipid measures and biomarkers. These include total cholesterol, HDL-C, triglycerides, the apolipoprotein B/apolipoprotein A1 ratio, C-reactive protein, and phospholipase A2. Those outcomes broaden the questions examined, but the primary question remains the mean percentage change in LDL-C after 8 weeks.

3. Trial Design

This was a Phase 4, randomized, quadruple-masked, parallel-group study sponsored by AstraZeneca. It enrolled patients with Type IIa and IIb hypercholesterolaemia to evaluate rosuvastatin 5 mg against pravastatin 40 mg and atorvastatin 10 mg. The registry gives an enrollment of 668. The listed start was 2007-10, primary completion was 2008-10, and the study status is completed.

The intended comparison concerned LDL-C change after 8 weeks of treatment. The posted primary outcome is a continuous measure: percentage variation from baseline, summarized as a mean with standard deviation. The outcome summaries give values for atorvastatin, pravastatin, and rosuvastatin groups. The registry also describes arms as rosuvastatin and pravastatin, and rosuvastatin and atorvastatin. Further details about the dosing schedule, allocation ratio, masking procedures, and how these arm descriptions relate to the posted group summaries are not reported in the registry record.

The registry states that the recruitment target was not reached at the date initially planned. In view of recruitment difficulties, AstraZeneca decided not to extend the recruitment period and to perform only a descriptive analysis. This is important to the interpretation: the posted group summaries should not be read as the results of a reported confirmatory test of differences between treatments.

The primary-outcome description reports 92 participants who completed the study in the pravastatin group, but says the outcome measures are described for 91 because one datum was missing. The posted outcome summaries list 97 participants for atorvastatin, 91 for pravastatin, and 103 for rosuvastatin. Reasons for non-completion or other differences between enrollment and the outcome-summary counts are not reported in the registry record.

The record lists 11 posted secondary outcomes, including LDL-C goal attainment and changes in additional lipid measures and biomarkers. Details of the analysis methods for those outcomes, beyond the stated descriptive approach, are not reported in the registry record.

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.

Before assignment: This French multicentre, randomized double-blind study was conducted on three parallel arms. The 14-week study comprised 3 visits: a screening visit (week 0, V1), a randomization and treatment allocation visit (week 6, V2) and an evaluation visit (week 14, V3). Patients were randomized at V2 and were treated for a period of 8 weeks.

Initial Phase

Reasons for not completing this period:

Treatment Phase

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: 92 patients completed the study in the Pravastatin group, nevertheless, primary and secondary outcome measures are described on 91 patients in the Pravastatin arm due to one missing data in this group

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.

6. Primary Endpoint

The registry lists the primary outcome as Change in Low Density Lipoprotein Cholesterol (LDL-C) Level After 8 Weeks, measured over Change from baseline and after 8 weeks of treatment.

The primary endpoint is the change in low-density lipoprotein cholesterol (LDL-C) level from baseline after 8 weeks, expressed as a percentage of LDL-C decrease. The registry describes the measure as a comparison of percentages of LDL-C variation and summarizes it using a mean and standard deviation. The posted group values are -39.4 for atorvastatin, -30.3 for pravastatin, and -37.6 for rosuvastatin. The corresponding reported standard deviations are 13.77, 15.43, and 17.96, respectively.

LDL-C is the prespecified measurement of interest because the study's stated purpose was to compare the efficacy of the three statin regimens for hypercholesterolaemia, and the registry identifies percentage LDL-C variation after 8 weeks as the primary efficacy assessment. Expressing change as a percentage relates the observed change to the starting measurement, rather than reporting only a change in concentration. The exact baseline values and the concentration units used for the underlying LDL-C measurements are not reported in the registry record.

The mean describes the central value of the posted group observations; the standard deviation describes their spread. Neither alone gives the uncertainty around a difference between treatments. The registry does not post a between-group estimate, confidence interval, or inferential test for the primary endpoint. The values therefore describe group outcomes, rather than demonstrating the size or precision of a treatment contrast.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is continuous: each participant has an LDL-C percentage variation, and the registry reports a mean and standard deviation for each treatment group. In general, a mean is the arithmetic average of observations and gives a measure of their central location. A standard deviation describes how dispersed observations are around that mean. The registry reports these descriptive statistics for the atorvastatin, pravastatin, and rosuvastatin groups, with endpoint counts of 97, 91, and 103, respectively.

The mean percentage variations are -39.4 for atorvastatin, -30.3 for pravastatin, and -37.6 for rosuvastatin. The standard deviations are 13.77, 15.43, and 17.96, respectively. The negative values are the posted direction and scale of the change measure; they should be retained as reported rather than converted into a different metric. The arm summaries describe outcomes within groups. A comparison of treatment effects would ordinarily require an estimate of a between-group contrast and its uncertainty, neither of which is reported in the registry record.

In general, a confidence interval gives a range of values compatible with the data under a stated statistical procedure and conveys uncertainty in an estimate. It is not interchangeable with a standard deviation. The registry record does not report confidence intervals for the group means or treatment contrasts. It also does not report primary-outcome p-values or a formal test comparing the treatment groups. Consequently, the posted summary statistics support descriptive reading but not a conclusion about statistical significance.

The registry explicitly characterizes the analysis as descriptive. The recruitment target was not reached at the date initially planned, and the sponsor decided not to extend recruitment in light of recruitment difficulties. The record does not report the target enrollment, the sample-size justification, the originally planned inferential analysis, or whether a prespecified analysis plan was amended. Those details should not be inferred from the final outcome counts or the descriptive results.

Planning illustrations based on observed effects are a different kind of calculation from the trial’s observed analysis. In general, such illustrations ask how many participants per arm might be needed to detect a specified fraction of an observed effect under stated assumptions. The assumptions stated for the planning illustrations are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. These are planning assumptions, not evidence that the trial used that design or achieved a particular probability of detecting an effect. The record does not report the trial’s own sample-size justification. Planning estimates are not observed power, and no numerical planning result is included in the registry record for this analysis.

In general, power is a property of a specified study design and assumed effect, variability, significance level, and sample size. It is not a measure of whether an observed result is true. Calculating or interpreting power after observing the data does not replace confidence intervals or a clear account of the trial’s planned analysis. Because the registry describes the outcome analysis as descriptive and gives no formal comparison result, the group means should not be presented as a test of the trial’s ability to detect a difference.

The record notes that the pravastatin group had 92 completers, while the primary and secondary outcome measures are described on 91 participants because one datum was missing. In general, missing outcome data can affect a group summary if participants with missing observations differ from those with observed measurements. The impact depends on why data are missing and how the analysis handles them. Here, the registry identifies one missing datum in the pravastatin group but does not report its cause, any imputation, or a broader missing-data strategy. It does not report comparable missing-data details for the other groups.

Masking and randomization are features of the recorded design, not substitutes for reporting the analysis. The study is identified as randomized, quadruple-masked, and parallel-group. In general, random allocation is intended to reduce systematic differences between groups, while masking is intended to limit the influence of knowledge of treatment assignment on study conduct or assessment. The registry does not report the allocation procedure, concealment details, identities of the masked parties, or implementation details. Those features therefore cannot be assessed beyond the design labels in the record.

Over-dispersion is a general concern when data vary more than a statistical model assumes. When variability is underestimated, uncertainty estimates can be too narrow and inferential tests can be misleading. The endpoint is continuous and summarized with standard deviations, but the registry does not report a fitted model or an assumption about over-dispersion. There is no basis in the registry record to claim that over-dispersion was assessed or that any particular adjustment was used.

The record lists 11 secondary outcomes, while the primary endpoint is the stated focus of the efficacy analysis. When multiple outcomes or comparisons are tested, the chance of at least one apparently notable result can increase. In general, multiplicity procedures can address that issue by adjusting the analysis or by defining a hierarchy of questions. The registry does not report a multiplicity adjustment, testing hierarchy, or inferential analyses for the secondary outcomes. Since the stated analysis was descriptive, no formal multiplicity strategy is reported.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Atorvastatin", "Pravastatin", "Rosuvastatin")
n   <- c(97, 91, 103)
m   <- c(-39.4, -30.3, -37.6)
sp  <- c(13.77, 15.43, 17.96)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Atorvastatin  97  -39.400  13.770  -42.175  -36.625
CARM  Pravastatin  91  -30.300  15.430  -33.513  -27.087
CARM  Rosuvastatin  103  -37.600  17.960  -41.110  -34.090

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 11 posted secondary outcomes, including LDL-C goal attainment under AFSSAPS 2005 guidelines and changes in total cholesterol, HDL-C, triglycerides, the apolipoprotein B/apolipoprotein A1 ratio, C-reactive protein, and phospholipase A2. The primary endpoint concerns LDL-C percentage variation after 8 weeks. The registry record does not report a hierarchy among the outcomes, a multiplicity adjustment, or a plan for controlling the chance of false-positive findings across multiple tests. It also describes the analyses as descriptive, rather than reporting formal tests across these outcomes.

The record states that 92 patients completed the study in the pravastatin group, but that the primary and secondary outcome measures are described for 91 patients because one datum was missing. The reason for the missing datum and the method used to address it are not reported in the registry record. The endpoint summaries list 97 participants for atorvastatin, 91 for pravastatin, and 103 for rosuvastatin. Other analysis-population definitions, including whether participants were analyzed as randomized and how other missing measurements were handled, are not reported in the registry record.

In general, missing data can affect estimates if the availability of an outcome is related to the outcome itself or to participant characteristics. The registry’s note identifies the difference between pravastatin completers and the participants included in its outcome summaries, but does not provide enough detail to assess that possibility. No imputation method, sensitivity analysis, or missing-data assumption is reported.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: benign prostatic nodular hyperplasia (1.1%), left lumbar cruralgia (1.0%), viiolent abdominal pain (1.0%), worsening of gonalgia (1.0%), morton syndrome (1.0%).

The serious adverse event summaries report 4 affected participants among 97 at risk in the atorvastatin group, 1 among 92 at risk in the pravastatin group, and 0 among 103 at risk in the rosuvastatin group. The initial-phase group is listed as 2 affected among 317 at risk. These are counts of participants with serious adverse events and their corresponding group denominators, as reported in the registry. They are not a comparison adjusted for differences in follow-up, baseline characteristics, or exposure.

The record also reports other adverse events separately: 5 among 97 at risk for atorvastatin, 7 among 92 for pravastatin, 5 among 103 for rosuvastatin, and 6 among 317 in the initial-phase group. These counts should not be conflated with the serious adverse event counts. The serious-event terms listed in the record include benign prostatic nodular hyperplasia, left lumbar cruralgia, violent abdominal pain, worsening of gonalgia, Morton syndrome, and coxarthrosis aggravation, with the percentages recorded for those terms.

Deaths are not reported in the registry record. The posted counts are descriptive safety summaries; the registry does not report a statistical comparison of adverse event risks. They do not by themselves establish whether differences between groups are meaningful or attributable to treatment.

13. What the Result Does, and Does Not, Mean

The results show the group-level mean percentage LDL-C variations recorded after 8 weeks: -39.4 for atorvastatin, -30.3 for pravastatin, and -37.6 for rosuvastatin. The accompanying standard deviations describe within-group variability. These figures answer a descriptive question about the observed outcome summaries, but they are not estimates of treatment differences and do not indicate the uncertainty around a contrast.

The record says the sponsor performed only a descriptive analysis because recruitment difficulties prevented the recruitment target from being reached, and recruitment was not extended. No formal inferential results for the primary endpoint are reported in the registry record. Thus, the summaries do not establish superiority, equivalence, or non-inferiority of one treatment relative to another. The absence of a reported test is also not evidence that the treatments are identical.

The endpoint is a measured change in LDL-C over the stated treatment period. It is not, by itself, a result about clinical events, longer-term outcomes, or all possible benefits and harms. The registry lists secondary questions about LDL-C goals and other lipid measures and biomarkers, but their numerical results are not reported in the registry record for this analysis. Those questions cannot be answered from the primary-outcome summaries.

For safety, the registry lists serious adverse event counts and the numbers at risk in each group. The counts are descriptive, and the record does not report a formal statistical comparison. Deaths are not reported in the registry record. The safety figures therefore should not be interpreted as establishing a difference in risk or as a complete account of all possible safety outcomes.

Overall, the posted information supports a careful description of the endpoint means, their observed spread, the recorded participant counts, and the serious adverse event counts. It does not provide a confirmatory estimate of comparative treatment effects, the precision of those effects, or enough detail to evaluate all aspects of missing data and analysis populations.

14. Why This Trial Matters Statistically

This trial illustrates why design labels and outcome summaries need to be read together with the analysis description. The record identifies a randomized, quadruple-masked, parallel-group study, but also says that recruitment difficulties led the sponsor to stop without reaching the recruitment target and to conduct only a descriptive analysis. The distinction matters: randomization describes how assignment was intended to occur, while the reported analysis determines what can be inferred from the posted results.

The endpoint summaries give means and standard deviations, but no formal between-group estimates or uncertainty intervals are reported. This is a useful statistical distinction for clinical researchers: numerical differences between group means are not, by themselves, inferential evidence about comparative effects. The group summaries also need to be read with their endpoint counts, including the registry’s note that one missing datum left 91 pravastatin participants in the outcome descriptions despite 92 completers.

The record also makes visible the difference between planning calculations and the design actually used. Planning illustrations are based on observed effects and assumptions such as a two-sided significance level of 0.05, equal allocation, and a normal approximation. Those assumptions do not establish that the trial was designed or conducted according to that calculation. The trial’s own sample-size justification is not reported in the registry record.

Finally, the trial raises common reporting questions around secondary outcomes, missing measurements, and safety summaries. The registry lists multiple secondary outcomes but does not report a multiplicity strategy or detailed analysis methods. It provides adverse event counts, but not inferential comparisons. These limits show why transparent reporting of estimands, analysis populations, missing-data handling, and uncertainty is important when interpreting clinical trial results.

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 most consequential limitation recorded is that the recruitment target was not reached and the recruitment period was not extended. The registry says recruitment difficulties prompted a descriptive analysis. The intended enrollment target and its justification are not reported in the registry record, so the degree to which the final enrollment affected planned precision cannot be assessed from this information.

The primary endpoint is accompanied by group means, standard deviations, and endpoint counts, but no reported between-group estimates, confidence intervals, or p-values. The registry therefore does not provide a formal inferential comparison of the treatments. Details of any original statistical analysis plan, changes to it, or interim analyses are not reported in the registry record.

The record notes one missing datum in the pravastatin group and gives a lower count for the outcome summaries than for study completers. The cause of the missing datum and its handling are not reported. Other details on missing outcomes and analysis populations are also not reported in the registry record. This limits assessment of whether the outcome summaries represent comparable participant sets.

The registry lists multiple secondary outcomes but does not report their numerical results or a multiplicity strategy in the registry record for this analysis. The listed randomized, masking, and parallel-group design labels do not provide details of allocation procedures or masking implementation. Further, the safety summaries are counts without reported comparative analyses; deaths are not reported in the registry record. These limitations restrict what can be concluded about both comparative efficacy and safety.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Evaluation of the Efficacy and Safety of Rosuvastatin 5 mg Versus Pravastatin 40 mg and Atorvastatin 10 mg in Type IIa and IIb Hypercholesterolaemic Patients — NCT00631189.
• Registry record last updated 2013-11-26; status last verified 2011-06.
• Results first posted 2010-09-17.
• 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.

19. Record Summary

NCT00631189 is a completed Phase 4 randomized, quadruple-masked, parallel-group study sponsored by AstraZeneca. It evaluated rosuvastatin 5 mg, pravastatin 40 mg, and atorvastatin 10 mg in patients with Type IIa and IIb hypercholesterolaemia. The recorded enrollment was 668; the study started in 2007-10 and had primary completion in 2008-10.

The primary outcome was mean percentage LDL-C variation from baseline after 8 weeks, reported with standard deviations. The posted group means were -39.4 for atorvastatin, -30.3 for pravastatin, and -37.6 for rosuvastatin. The registry states that recruitment difficulties prevented the recruitment target from being reached and that the sponsor conducted only a descriptive analysis. It reports 11 secondary outcomes. The primary-outcome description notes 92 pravastatin completers but outcome measures for 91 because one datum was missing.