In the Journals

High-dose atorvastatin reduced PAD incidence in post-MI patients

In patients with previous MI, therapy with high-dose atorvastatin significantly decreased the incidence of peripheral arterial disease compared with moderate-dose simvastatin, according to data from the IDEAL study.

Further, patients with a history of PAD at baseline had greater risk for future CV events, but this risk was lowered with high-dose atorvastatin.

“These findings provide support for the recommendation in the recently updated American College of Cardiology/American Heart Association guideline that high-risk patients, including patients with PAD, should be initially treated with high-intensity statin therapy,” researchers wrote.

The prospective, randomized, open-label, blinded–outcome-assessment trial compared atorvastatin 80 mg/day (n=4,439) with simvastatin 20 mg/day to 40 mg/day (n=4,449; Zocor, Merck) in patients aged 80 years and older with previous MI. Follow-up occurred at 12 and 24 weeks and then every 6 months. At 24 weeks, simvastatin dose could be increased to 40 mg/day if plasma total cholesterol was greater than 190 mg/dL. Atorvastatin dose could be decreased to 40 mg/day if adverse events were observed.

The prespecified outcome was incident PAD. Among patients without PAD at baseline, this outcome was defined as a new clinical diagnosis necessitating diagnostic procedures or interventions. In patients with a history at baseline, this outcome was defined as recurrence of PAD requiring hospitalization. An exploratory post-hoc analysis examined the effect of baseline PAD on clinical outcomes and the benefits of high-dose vs. usual-dose statin treatment. The primary outcome for this analysis was the rate of major coronary events (coronary death, hospitalization for nonfatal MI or cardiac arrest with resuscitation).

During a median follow-up of 4.8 years, incident PAD was reported in 2.2% of the high-dose atorvastatin group vs. 3.2% of the moderate-dose simvastatin group (HR = 0.7; 95% CI, 0.53-0.91).

Patients with PAD at baseline had an almost twofold greater risk for major coronary events; however, this trend did not persist after researchers adjusted for adverse CV risk profile.

Among patients with PAD, major coronary events were less common in the high-dose atorvastatin group (14.4% vs. 20.1%; HR = 0.68; 95% CI, 0.41-1.11).

Treatment with high-dose atorvastatin yielded significant decreases in overall CV (P = .046) and coronary events (P = .007) as well as need for coronary revascularization (P = .007).

According to the researchers, this is the first study to show the benefit of high-dose vs. moderate-dose statin therapy for the prevention of incident PAD in post-MI patients.

Disclosure: The IDEAL study was sponsored by Pfizer. Several researchers report financial relationships with Aegerion, Amgen, AstraZeneca, Genzyme, MSD, Orion Company, Pfizer and Roche.

In patients with previous MI, therapy with high-dose atorvastatin significantly decreased the incidence of peripheral arterial disease compared with moderate-dose simvastatin, according to data from the IDEAL study.

Further, patients with a history of PAD at baseline had greater risk for future CV events, but this risk was lowered with high-dose atorvastatin.

“These findings provide support for the recommendation in the recently updated American College of Cardiology/American Heart Association guideline that high-risk patients, including patients with PAD, should be initially treated with high-intensity statin therapy,” researchers wrote.

The prospective, randomized, open-label, blinded–outcome-assessment trial compared atorvastatin 80 mg/day (n=4,439) with simvastatin 20 mg/day to 40 mg/day (n=4,449; Zocor, Merck) in patients aged 80 years and older with previous MI. Follow-up occurred at 12 and 24 weeks and then every 6 months. At 24 weeks, simvastatin dose could be increased to 40 mg/day if plasma total cholesterol was greater than 190 mg/dL. Atorvastatin dose could be decreased to 40 mg/day if adverse events were observed.

The prespecified outcome was incident PAD. Among patients without PAD at baseline, this outcome was defined as a new clinical diagnosis necessitating diagnostic procedures or interventions. In patients with a history at baseline, this outcome was defined as recurrence of PAD requiring hospitalization. An exploratory post-hoc analysis examined the effect of baseline PAD on clinical outcomes and the benefits of high-dose vs. usual-dose statin treatment. The primary outcome for this analysis was the rate of major coronary events (coronary death, hospitalization for nonfatal MI or cardiac arrest with resuscitation).

During a median follow-up of 4.8 years, incident PAD was reported in 2.2% of the high-dose atorvastatin group vs. 3.2% of the moderate-dose simvastatin group (HR = 0.7; 95% CI, 0.53-0.91).

Patients with PAD at baseline had an almost twofold greater risk for major coronary events; however, this trend did not persist after researchers adjusted for adverse CV risk profile.

Among patients with PAD, major coronary events were less common in the high-dose atorvastatin group (14.4% vs. 20.1%; HR = 0.68; 95% CI, 0.41-1.11).

Treatment with high-dose atorvastatin yielded significant decreases in overall CV (P = .046) and coronary events (P = .007) as well as need for coronary revascularization (P = .007).

According to the researchers, this is the first study to show the benefit of high-dose vs. moderate-dose statin therapy for the prevention of incident PAD in post-MI patients.

Disclosure: The IDEAL study was sponsored by Pfizer. Several researchers report financial relationships with Aegerion, Amgen, AstraZeneca, Genzyme, MSD, Orion Company, Pfizer and Roche.