Comparing effectiveness of high-dose Atorvastatin and Rosuvastatin among patients undergone Percutaneous Coronary Interventions: A non-concurrent cohort study in India
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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