Effects on LDL-C, HDL-C, triglycerides, and the primary composite endpoint for the statin plus add-on agent arms of AIM-HIGH, HPS2-THRIVE, dal-OUTCOMES, and ILLUMINATE10–13
| Δ LDL-C | Δ HDL-C | Δ triglycerides | Effect estimate (95% CI) for primary endpoint* | ||
|---|---|---|---|---|---|
| Study | Add-on agent studied | At final recording, compared to baseline within-group (statin+add-on agent) measurement | |||
| AIM-HIGH† | ER niacin | −11 mg/dL | +7 mg/dL | −45.5 mg/dL | NA |
| HPS2-THRIVE‡ | ER niacin–laropiprant | −10 mg/dL | +6 mg/dL | −33 mg/dL | NA |
| dal-OUTCOMES§ | dalcetrapib | +6.4 mg/dL | +16 mg/dL | +5.8 mg/dL | NA |
| ILLUMINATE¶ | torcetrapib | −21.5 mg/dL | +34.2 mg/dL | −10 to 15 mg/dL | NA |
| At final recording, compared to final recording of statin-only group | |||||
| AIM-HIGH† | ER niacin | −6 mg/dL | +4 mg/dL | −31 mg/dL | HR 1.02 (0.87 to 1.21) |
| HPS2-THRIVE‡ | ER niacin–laropiprant | NR | NR | NR | RR 0.96 (0.90 to 1.03) |
| dal-OUTCOMES§ | dalcetrapib | NAD | +12.5 mg/dL | −5.8 mg/dL | HR 1.04 (0.93 to 1.16) |
| ILLUMINATE¶ | torcetrapib | −22.4 mg/dL | +33.7 mg/dL | −11 mg/dL | HR 1.25 (1.09 to 1.44) |
*Only the primary composite endpoint effect estimates are provided; thus, the reader is encouraged to consult the text of this article, as well as the corresponding cited publications, to appreciate more completely all the findings (including adverse effects) documented by these trials.
†Data reported are based on median changes at 2 years and come from table 2 of AIM-HIGH.10 The respective data at 3 years (with fewer participants) were either not materially different from or were identical to the data at 2 years. The primary composite endpoint included death from coronary heart disease, nonfatal myocardial infarction, ischaemic stroke, hospitalisation for acute coronary syndrome, or symptom-driven coronary or cerebral revascularization.
‡Data reported are based on study-averaged changes (weighted for participant-years at risk within region) and come from table S2 of HPS2-THRIVE.11 Median follow-up was 3.9 years. The primary composite endpoint included major coronary events (nonfatal myocardial infarction or death from coronary causes), stroke of any type, or coronary or noncoronary revascularization.
§Data reported are based on table 1, figure 1, and figure S2 of dal-OUTCOMES and are reported for the 36-month point (median follow-up in the trial was 31 months, and although the figures provided preclude precise estimation at 31 months, visual inspection suggests the results at 31 months would not be materially different for any of the basic lipid parameters reported in the table).12 The primary composite endpoint included death from coronary heart disease, nonfatal myocardial infarction, ischaemic stroke, unstable angina, or cardiac arrest with resuscitation.
¶Data reported are based on table 2 and web figures 1a and 1b of ILLUMINATE and are mean change at 12 months, except for triglycerides, which is reported as median change.13 Median follow-up at termination was 550 days (approximately 18 months), but data up to this point are not available. Note: There are discrepancies for these parameters between table 2 and the web figures. In most instances, where discrepancies occur for these values, they are on the order of 0.1 mg/dL and conceivably due to issues encountered with rounding. For triglycerides, however, there is a 5 mg/dL difference between table 2 and web figure 1b, which is the reason for the range listed for triglycerides. The primary composite endpoint included death from coronary heart disease, nonfatal myocardial infarction (excluding procedure-related events), stroke, and hospitalisation for unstable angina.
CI, confidence interval; ER, extended-release; HDL-C, high-density lipoprotein cholesterol; HR, hazard ratio; LDL-C, low-density lipoprotein cholesterol; NA, not applicable; NAD, no appreciable difference; NR, not reported; RR, rate ratio.