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Published on: March 11, 2021
To study the effect of high dose Atorvastatin 40mg versus 80mg in patients with dyslipidemia
Deepak Agrawal1, S C Manchanda2, J P S Sawhney3
1Department of Cardiology, Sir Ganga Ram hospital, 13/4, Upper ground floor, West Patel Nagar, New Delhi, 110008, India.
Insights
This study found that both 40mg and 80mg doses of atorvastatin are equally effective for treating atherosclerotic dyslipidemia in Indian patients. However, the higher 80mg dose was associated with a greater incidence of myalgia.
Area of Science:
- Cardiology
- Pharmacology
- Metabolic Diseases
Background:
- Atherosclerotic dyslipidemia is a significant risk factor for cardiovascular disease.
- Statins, like atorvastatin, are cornerstone therapies for managing dyslipidemia.
- Optimal dosing strategies for atorvastatin in diverse populations require ongoing investigation.
Purpose of the Study:
- To compare the efficacy and safety of atorvastatin 40mg versus 80mg in Indian patients with atherosclerotic dyslipidemia.
- To evaluate the impact of different atorvastatin doses on LDL-C, HDL-C, and triglycerides.
- To assess the incidence of side effects, including myopathy, hepatotoxicity, and new-onset diabetes mellitus, for each atorvastatin dose.
Main Methods:
- A prospective, randomized, open-label, comparative study involving 240 Indian patients diagnosed with dyslipidemia.
- Patients were divided into two groups: Group A received atorvastatin 40mg daily, and Group B received atorvastatin 80mg daily.
- A 6-month follow-up period was utilized to assess lipid profiles and adverse events.
Main Results:
- Both atorvastatin 40mg and 80mg demonstrated significant reductions in LDL cholesterol at 3 and 6 months.
- No statistically significant difference was observed in LDL-C reduction between the 40mg and 80mg groups at either time point (p=.118 & p=.149).
- A higher incidence of myalgia was reported in the 80mg group (7 patients) compared to the 40mg group (2 patients), with a significant difference (p=.045). No significant CPK elevation was noted.
Conclusions:
- Atorvastatin 40mg and 80mg are equally effective in improving lipid profiles for atherosclerotic dyslipidemia in the studied Indian population.
- The higher dose of atorvastatin (80mg) is associated with an increased risk of myalgia.
- These findings suggest a need for individualized dosing strategies to balance efficacy and tolerability.
Objective:
Primary objective was to compare the effects of atorvastatin 40mg vs 80mg on LDL-C in Indian patients with atherosclerotic dyslipidemia. Secondary objectives were to compare the effects of atorvastatin 40mg vs 80mg on HDL-C and triglycerides and also comparing of side effects (myopathy, hepatotoxicity and new onset diabetes mellitus) of both doses.
Method:
This Study is A Prospective, randomized, open-label, comparative study. This study was conducted on 240 patients of dyslipidemia (as per ACC/AHA 2013 lipid guidelines) attending the OPD/wards/CCU of department of cardiology, Sir Ganga Ram Hospital. They were randomly divided into 2 groups of 120 each. Group A consisted patients who received Atorvastatin 40mg daily and Group B Atorvastatin 80mg daily. The follow up period was 6 months.
Results:
At 3 and 6 month follow up, Atorvastatin 40mg leads to mean LDL cholesterol reduction of 47.18±20.81 & 50.03±18.06 respectively. While Atorvastatin 80mg results in LDL reduction as 50.11±15.85 & 52.30±13.72. The comparison between two doses revealed a non-significant difference (p=.118 & p=.149 respectively). At 6 months of follow up, few patients reported myalgia (2 in group A and 7 in Group B). The difference between groups was significant (p=.045). Although none of our patient had significant elevation of CPK.
Conclusion:
This study concluded that both doses of atorvastatin (40 & 80mg) are equally efficacious in improving dyslipidemia but higher dose leads to more incidence of myalgia.
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