CardioExchange Archive

To celebrate the holiday season, CardioExchange asked several of our contributors to choose the 3 most important cardiology-related events of the past year and to make 3 predictions for 2011.

Looking back at 2010:

1. The ACCORD lipid trial investigated the effects of adding fenofibrate to a statin (simvastatin) in 5518 patients with type 2 diabetes deemed “high risk” for CVD and followed them for 4.7 years. The study results showed no significant difference in CV events—major fatal and nonfatal CV event rates/year were 2.2 in fenofibrate group and 2.4 in control group (p=NS). In a subgroup analysis, a trend toward benefit of fenofibrate was shown in the group of diabetics that had a significant dyslipidemia (low HDL and high triglycerides). Additional subgroup analysis showed a trend toward harm in women (but not men) in the fenofibrate group. While clinicians and trialists have continued to explore additional treatments to reduce risks in Type 2 DM, fibrates provided no benefit and a potential harm in women. These results will likely cause a redoubling of efforts toward reducing LDL in DM patients with statins given the evidence based there and the lack of evidence supporting alternative lipid lowering approaches in this group.

2. The ACCORD blood pressure (BP) trial randomized 4,733 type 2 diabetics to “intensive” (goal systolic BP <120 mmHg) or “standard” (goal systolic BP <140 mmHg) BP control arms. In this large study, there was no benefit of intensive BP control over standard control regarding the primary endpoint of major fatal and nonfatal CV events. There was a reduction in strokes in the intensive control arm, however, the NNT to prevent one stroke was 89 patients over 5 years. Further, the intensive group experienced significantly more adverse effects related to anti-hypertensive treatment than did the standard group (3.3% vs. 1.3%). This was certainly a finding that will likely change clinical practice. Previous clinical trials and current guidelines have supported lower BP goals for those with diabetes and for those without diabetes. This study suggests that BP control in diabetics is extremely important to a level below 140 mmHg, however, a goal lower than 120mmHg may not carry significant benefit and may even cause harm in high-risk diabetics. While some may argue that the stroke benefit in ACCORD was significant and that certain subgroups of diabetics might benefit from tighter control, for now the key is ensuring that all diabetics are at least below 140 mm Hg as a standard of care.

3. Meta-analysis showing no “benefit” of statins in primary prevention: Ray et al published a meta-analysis of 11 trials and 65,229 patients demonstrating no significant benefit of statins in high-risk primary prevention population based on no impact on short-term mortality. Although Ray and colleagues’ meta-analysis has shown no benefit of statins on mortality in primary prevention, this is in contrast to multiple other studies that demonstrate a benefit with respect to mortality and CV events. Importantly, we must not ignore statistically significant reductions in the incidence of MI, HF, or the need for revascularization.

Predictions for 2010:

1.  More individuals will be on statins as they go generic, yet fewer high-risk individuals will be at lipid goals.

2.  Despite evolving science and some guidelines, the use of biomarkers and pharmacogenomic strategies to refine CV risk will take a back seat as statins go generic.

3.  New prevention guidelines and ATP 4 will further increase those individuals requiring more aggressive primary and secondary prevention.

To celebrate the holiday season, CardioExchange asked several of our contributors to choose the 3 most important cardiology-related events of the past year and  to make 3 predictions for 2011.  Here is the first installment in the series.

Looking back at 2010:

1. On September 23, the European Medicines Agency withdrew rosiglitazone from the market and the US FDA limited access to patients who have failed other diabetes therapies including pioglitazone. This decision ended a 3-year battle over the cardiovascular safety of a drug that was once the largest selling diabetes medication in the world.

2. The first alternative to warfarin was approved by the FDA in 2010. Dabigatran is a direct thrombin inhibitor that protected atrial fibrillation patients from stroke with similar efficacy to warfarin. It’s main advantage is the lack of need for monitoring anti-coagulant effect, potentially freeing patients from repeated INR testing. The major downside is the very high cost, approaching $8 day, which will limit use.

3. The ACCORD Lipid study was published, demonstrating no benefit for routine administration of fenofibrate in diabetic patients. This study re-emphasizes the hazards of approving medications based upon surrogate endpoints. Despite favorable affects on lipids, fenofibrate failed to reduce morbidity and mortality. Unfortunately a widely used drug marketed since the 1970’s, when finally studied, failed to show significant health outcome benefits.

Predictions for 2011:

1. The Office of Inspector General will launch a major national investigation of the overuse of stents in cardiovascular practice.

2.The American College of Cardiology will acknowledge that it has been too cozy with industry and announce that the organization will no longer accept funding from drug and device makers.

3. The new Congress will consider revisions to the HealthCare Reform legislation, but each effort will fail due to a filibuster in the Senate.