Table 1.
Examples of post-marketing comparative effectiveness studies
| Study | Primary study question | Clinical wisdom before study | Main conclusion of active comparator study |
|---|---|---|---|
| (a) Randomized controlled trials | |||
| ALLHAT84 | Effectiveness of ACE inhibitors, CCBs, and thiazides to control hypertension and reduce cardiovascular events |
Thiazides are inferior in first-line antihypertensive treatment |
Thiazides are as effective as ACE inhibitors and CCBs in lowering blood pressure and slightly more effective in preventing cardiovascular events |
| CATIE85 | Is there a difference in effectiveness of and adherence to atypical antipsychotic medications in elderly patients with dementia? |
Some atypical antipsychotics may have slight advantages over others |
Atypical APMs are equally ineffective and little tolerated in elderly patients with dementia |
| (b) Non-randomized epidemiologic studies | |||
| Pilote et al.86 | Are all ACE inhibitors equally effective in reducing mortality after MI in elderly patients (65+ years)? |
There is little difference among long-acting ACE inhibitors in reducing mortality after MI |
Ramipril was associated with lower mortality after MI than most other ACE inhibitors |
| Wang et al.87 | Have elderly patients (65+ years) using conventional antipsychotic medications a similar or even higher risk of death? |
FDA’s public health advisory warned only that atypical APMs, not conventionals, are associated with increased mortality |
Conventional APMs have at least the same risk of death if not higher |
| Schneeweisset al.34 | In elderly patients (65+ years), what are the comparative gastroprotective benefits and CV risks of selective COX-2 inhibitors versus ns-NSAIDs? |
In elderly patients, there is insufficient RCT data to allow differentiation of CV risk between non-naproxen NSAIDs88 and coxibs have fewer gastric side effects |
Considering typical use of NSAIDs in elderly patients, there is no meaningful reduction in upper GI bleeds by coxibs, but diclofenac may have as high a risk of MI as rofecoxib |
ACE, angiotensin-converting enzyme; APM, antipsychotic medications; CCB, calcium channel blocker; COX-2, cyclooxygenase-2; CV, cardiovascular; FDA, Food and Drug Administration; GI, gastrointestinal; MI, myocardial infarction; ns-NSAID, non selective non-steroidal antinflammatory drug; NSAID, non-steroidal anti-inflammatory drug; RCT, randomized controlled trial.