52 In contrast, the randomized comparative PATRONUS (comPArator sTudy of CERA and darbepOetin alfa in patieNts Undergoing dialySis) trial 53 conducted with 490 HD patients demonstrated a dose increase of 6.8% after switching from once-weekly DA to once-monthly CERA.
A Phase 2, Multicenter, Double-Blind, Placebo-Controlled Comparator Study of 2 Doses of LY2140023 Versus Placebo in Patients With DSM-IV-TR Schizophrenia ClinicalTrials.gov identifier: NCT01086748.
The RECORD study was an open-label, 5.5-year randomized active comparator study of rosiglitazone against metformin or sulfonylurea (50% of each) (12).
However, a number of issues pertain to comparator studies of possible estimators; in particular data structure and the full assessment, or otherwise, of model specification.
Because treat-to-target trials essentially equalize glycaemic efficacy of the agents under study, the evaluation of differences in other measures of utility may differ from those used in traditional efficacy trials, such as placebo-controlled or active comparator studies of oral antidiabetic agents (OADs).
The dearth of head-to-head comparator studies of glucose-lowering medications, either alone or in combinations, and of trials that have lasted >6 12 months to examine the durable effects of interventions on glycemic control (10, 11, 20, 21) has hampered the development of all these algorithms.
The same database also reported a meta-analysis of the suicide-related events reported from comparator studies of atomoxetine and methylphenidate and reported no difference in rates between these agents (Maentzel-Haentzel incidence difference -0.12 (95% confidence interval -0.62 to 0.38; p = 0.649).
These trials were placebo-controlled or active-comparator studies of saxagliptin (2.5, 5, or 10 mg/d in most studies; 20, 40, or 100 mg/d in 1 phase 2b study) as monotherapy or add-on therapy to metformin, a sulfonylurea, a thiazolidinedione, or insulin ± metformin for up to 206 weeks (including long-term extension studies) in patients with T2DM (Table 1).
Another primary endpoint of this comparator study was the effect of the two combinations on lipid profile, which is discussed below (Derosa et al. 2007a).
Based on that indirect comparisons are generally accepted within the German early benefit assessment, the challenge for the future will be to bring together: the determination of the appropriate comparator by G-BA and the selection of the appropriate comparator, study choice and selection of patient subgroups by the manufacturer to give indirect comparisons a higher relevance in Germany.
We believe the next stage in this line of research could be an active comparator study examining the effects of pharmacists, perhaps with prescriptive autonomy, relative to other case managers.
