Crestor failed to beat rival Lipitor, produced by Pfizer, in a head to head trial known as Saturn, with the results in the primary trial failing to reach "statistical significance".
The primary trial outcome was total energy of intended food purchase.
The primary trial endpoint was the rate of change of common carotid artery intima-media thickness (IMT).
The primary trial endpoint was the percentage change in perfused fibroid volume, as assessed by contrast-enhanced MRI at 3 months by an independent core laboratory.
The null hypothesis for the primary trial endpoint at 3 months was H0: probability of success <50%% versus the alternative Ha: probability of success ≥50%%.
A core MRI facility was used to reduce variability and bias in MRI imaging quality, interpretation, and measurements relative to the primary trial endpoint.
The primary trial endpoint success criterion was achievement of >30 % reduction in mean target fibroid perfused volume in at least 50%% of patients at 3 months.
The primary trial outcome was the physical component of the SF-36 quality of life measure at 6 months after recruitment.
All longitudinal prospective or retrospective design, relating to the primary trial outcomes (birth weight, prenatal tobacco use, emergency attendances and inpatient admissions, and second pregnancy within two years of first birth), measuring child health/well-being/criminality/education were considered.
Taken together, the findings of the systematic review show that if improvements could be made in terms of the primary trial outcomes, real benefits could be observed over the longer-term.
The cost of delivering the Telephone Counselling intervention and the Usual Care alternative were measured during the primary trial.
