Comparing effectiveness of high-dose Atorvastatin and Rosuvastatin among patients undergone Percutaneous Coronary
Debabrata Roy1, Tanmay Mahapatra2, Kaushik Manna1
1Department of Cardiology, Narayana Hrudayalaya Rabindranath Tagore International Institute of Cardiac Sciences, Kolkata, West Bengal, India.
Insights
High-dose atorvastatin (80mg) and rosuvastatin (40mg) are effective post-PCI statins. Atorvastatin showed better tolerability and inflammation control (hs-CRP) at a lower cost, suggesting greater cost-effectiveness.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Research
Background:
- High-dose statins, atorvastatin (80mg) and rosuvastatin (40mg), are commonly used post-Percutaneous Coronary Intervention (PCI) to achieve ≥50% reduction in low-density-lipoprotein cholesterol (LDL-C).
- Limited evidence exists from developing nations on the comparative effectiveness, safety, and tolerability of high-dose rosuvastatin versus atorvastatin, especially considering rosuvastatin's higher cost.
Purpose of the Study:
- To conduct a comparative assessment of high-dose atorvastatin (80mg) and rosuvastatin (40mg) in post-PCI patients.
- To evaluate differences in clinical outcomes, safety profiles, tolerability, and endothelial inflammation control between the two statin regimens.
Main Methods:
- A record-based non-concurrent cohort study involving 942 post-PCI patients (aged 18-75 years) on high-dose statins for at least three months, with a follow-up of one year.
- Patients were divided into two groups: atorvastatin-80mg (n=321) and rosuvastatin-40mg (n=621).
- Comparison focused on outcomes (mortality, myocardial infarction, hospitalizations, revascularization, LDL-C, and hs-CRP control), safety (liver enzymes, muscle-related adverse events), and tolerability (gastrointestinal issues), adjusted for various covariates using SAS-9.4.
Main Results:
- No mortality was observed during the one-year follow-up. Rates of acute myocardial infarction and target vessel revascularization were similar between groups.
- The atorvastatin group exhibited significantly lower rates of gastroesophageal reflux disease/gastritis (2.18% vs. 4.83%), uncontrolled hs-CRP (22.74% vs. 31.08%), and overall non-tolerability (4.67% vs. 8.21%) compared to the rosuvastatin group.
- Logistic regression indicated that rosuvastatin-40mg was associated with poorer hs-CRP control (A3OR=1.45), higher adverse effects (A3OR=2.07), poorer safety profile (A3OR=1.23), increased GERD/gastritis (A3OR=1.50), and lower overall tolerability (A3OR=1.50) relative to atorvastatin-80mg.
Conclusions:
- High-dose statins (atorvastatin-80mg and rosuvastatin-40mg) are effective, safe, and well-tolerated in post-PCI patients, with similar clinical efficacy.
- Atorvastatin-80mg demonstrated superior control of high-sensitivity C-reactive protein (hs-CRP) and better tolerability compared to rosuvastatin-40mg.
- Given its lower cost and better tolerability/inflammation control, atorvastatin-80mg/day appears to be a more cost-effective option, warranting further head-to-head trials on cost-effectiveness and efficacy.
Introduction:
Atorvastatin-80mg/day and Rosuvastatin-40mg/day are the commonest high-dose statin (3-hydroxy-3-methylglutaryl coenzyme-A reductase inhibitors) regimes for post-PCI (Percutaneous Coronary Interventions) patients to lower (by ≥50%) blood low-density-lipoprotein cholesterol (LDL-C). Dearth of conclusive evidence from developing world, regarding overall safety, tolerability and comparative effectiveness (outcome/safety/tolerability/endothelial inflammation control) of Rosuvastatin over Atorvastatin in high-dose, given its higher cost, called for an overall and comparative assessment among post-PCI patients in a tertiary cardiac-care hospital of Kolkata, India.
Methods:
A record-based non-concurrent cohort study was conducted involving 942 post-PCI patients, aged 18-75 years, on high-dose statin for three months and followed up for ≥one year. Those on Atorvastatin-80mg (n = 321) and Rosuvastatin-40mg (n = 621) were compared regarding outcome (death/non-fatal myocardial infarction: MI/repeated hospitalization/target-vessel revascularisation/control of LDL and high-sensitivity C-reactive protein: hsCRP), safety (transaminitis/myopathy/myalgia/myositis/rhabdomyolysis), tolerability (gastroesophageal reflux disease: GERD/gastritis) and inflammation control adjusting for socio-demographics, tobacco-use, medications and comorbidities using SAS-9.4.
Results:
Groups varied minimally regarding distribution of age/gender/tobacco-use/medication/comorbidity/baseline (pre-PCI) LDL and hs-CRP level. During one-year post-PCI follow up, none died. One acute MI and two target vessel revascularizations occurred per group. Repeated hospitalization for angina/stroke was 2.18% in Atorvastatin group vs. 2.90% in Rosuvastatin group. At three-months follow up, GERD/Gastritis (2.18% vs 4.83%), uncontrolled hs-CRP (22.74% vs 31.08%) and overall non-tolerability (4.67% vs. 8.21%) were lower for Atorvastatin group. Multiple logistic regression did show that compared to Atorvastatin-80mg, Rosuvastatin-40mg regime had poorer control of hs-CRP (A3OR = 1.45,p = 0.0202), higher (A3OR = 2.07) adverse effects, poorer safety profile (A3OR = 1.23), higher GERD/Gastritis (A3OR = 1.50) and poorer overall tolerability (A3OR = 1.50).
Conclusion:
Post-PCI high dose statins were effective, safe and well-tolerated. High dose Rosuvastatin as compared to high dose Atorvastatin were similar in their clinical efficacy. Patients treated with Atrovastatin had significantly lower number of patients with hs-CRP (high-sensitivity C-reactive protein)/C-reactive protein (CRP) level beyond comparable safe limit and relatively better tolerated as opposed to Rosuvastatin-40mg.Thus given the lower price, Atorvastatin 80mg/day appeared to be more cost-effective. A head-to-head cost-effectiveness as well as efficacy trial may be the need of the hour.
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