Results After randomization of 262 participants (mean age, [SD, ] years; 96 [37%] women; eGFR, mL/min/ m 2 ; urine protein excretion, g/d) and years’ median follow-up, recruitment was discontinued because of excess serious adverse events. Serious events occurred in 20 participants (%) in the methylprednisolone group vs 4 (%) in the placebo group ( P = .001; risk difference, % [95% CI, %-%]), mostly due to excess serious infections (11 [%] vs 0; risk difference, % [95% CI, %-%]; P < .001), including 2 deaths. The primary renal outcome occurred in 8 participants (%) in the methylprednisolone group vs 20 (%) in the placebo group (hazard ratio, [95% CI, -]; risk difference, % [95% CI, %-%]; P = .02).
Results Of 14 671 patients, 7332 were randomized to sitagliptin and 7339 to placebo. Hospitalization for HF occurred in % (n = 228) and % (n = 229) of the sitagliptin and placebo groups, respectively (unadjusted hazard ratio, ; 95% CI, -). There was also no difference in total hHF events between the sitagliptin (n = 345) and placebo (n = 347) groups (unadjusted hazard ratio, ; 95% CI, -). Post-hHF all-cause death was similar in the sitagliptin and placebo groups (% vs %, respectively), as was CV death (% vs %, respectively). No heterogeneity for the effect of sitagliptin on hHF was observed in subgroup analyses across 21 factors ( P > .10 for all interactions). Meta-analysis of the hHF results from the 3 reported DPP4i CV outcomes trials revealed moderate heterogeneity ( I 2 = , P = .16).
The ACC recognized that clinicians and patients may seek firmer and more specific guidance on the adequacy of statin therapy and whether or when to use non-statin therapies if response to statins is deemed inadequate. Therefore, the ACC convened this expert consensus decision pathway writing committee to address current gaps in care for LDL-C lowering to reduce ASCVD risk. This effort relies extensively on the evidence base established by the 2013 ACC/AHA cholesterol guideline and attempts to provide further recommendations for clinicians and patients regarding use of non-statin therapies. It should be noted that this process did not involve formal systematic reviews, grading of evidence, or synthesis of evidence. The goal was to provide practical guidance for clinicians and patients in situations not covered by the 2013 ACC/AHA guideline until such time as the next round of guidelines has the opportunity to formally review recent scientific evidence and cardiovascular outcomes trials are completed with new agents for ASCVD risk reduction. Specifically, this panel was convened by the ACC to answer the following questions regarding use of non-statin therapies: