to find the difference in anti inflammatory effect of atorvaststin and rosuvastatin in patients with cardiac diseases
- Conditions
- acute coronary syndrome
- Registration Number
- CTRI/2013/02/003385
- Lead Sponsor
- subharti medical college meerut
- Brief Summary
Inflammation plays a critical role in the onset and development of atherosclerosis but more importantly inflammation is pivotal in evolution of a silent atherosclerotic plaque to an unstable “vulnerable plaque†leading to acute coronary syndromes. Inflammation leads to plaque destabilization and sets in motion a self perpetuating cycle of platelet activation and thrombus formation.
With a focus on role of inflammation in plaque formation, progression, rupture and thrombosis, various novel inflammatory markers have been identified. One such marker is C- reactive protein (CRP), an acute phase reactant is most consistently associated in predicting subjects with greater risk of both first and recurrent cardiovascular events. Several large scale prospective, epidemiological studies have shown that plasma levels of C-reactive protein correlate strongly with increased vascular event rates in healthy individuals, in patients with coronary artery disease and in patients with coronary syndromes. This observation implies that bringing down the levels of CRP can help in primary as well as secondary prevention of cardiovascular events.
Statins are the most commonly prescribed agents for treatment of hypercholesterolemia and reduce coronary events in population at risk and in patients with stable coronary artery disease. Recently it has been suggested that a wide spectrum of statin mediated actions which are independent of cholesterol lowering, collectively termed as “pleiotropic effects†may contribute to potential benefits of statin therapy in acute coronary syndrome (ACS). Among the major pleiotropic effects like antioxidant action, plaque stabilization, improvement of endothelial dysfunction and anti-inflammatory effects, the anti-inflammatory effects of statins have generated the maximum interest. This has been demonstrated in a number of studies showing rapid decrease in CRP levels in the patients of ACS. This CRP lowering property of statins has also translated into clinical benefits as suggested by reduction in rate of recurrent angina, repeat MI and mortality. All major statins have shown almost similar and significant efficacy in reducing CRP levels both on short term and long term treatment basis.
Not many studies have been conducted on Rosuvastatin, a commonly prescribed stain, to study its anti-inflammatory effect in patients of ACS in Indian population. Hence this study was planned to compare the anti inflammatory effect of Atorvastatin and Rosuvastatin in the patients of acute coronary syndrome.
One hundred adult patients of either sex with a diagnosis of ACS, admitted in Chatrapati Shivaji Subharti Hospital, Subharti Medical College (SMC), Meerut (UP) were enrolled in the study after they signed the informed consent. After enrolment a thorough clinical, systemic examination and laboratory investigations were done. After selecting the patients by above criteria, participants were randomized into either of the two groups. In group A, 50 patients received Atorvastatin 40mg/d in addition to standard anti anginal therapy (Asprin, Clopidogrel, β Blocker, Nitrates, ACE Inhibitors). In group B, 50 patients received Rosuvastatin 20 mg/d in addition to standard anti anginal therapy. The patients were in turn followed up in one month’s time with further investigations were done. The primary parameter for comparison of anti inflammatory property was alteration in CRP in both the groups. The secondary outcome parameters were evaluated based on occurrence of recurrent angina, recurrent MI, stroke, mortality and treatment of emergent side effects.
In our study, CRP levels decreased significantly (35%) in group A which was treated with 40mg of atorvastatin for 4 weeks and the level of CRP also decreased significantly (44%) in group B which was treated with 20 mg of rosuvastatin for 4 weeks. P value was <0.001 in both the groups. The fall in CRP was more significant in group B as compared to group A (p value <0.05).
It was also seen in our study that level of CRP decreased significantly in both groups (p<0.001) in patients with history of smoking, diabetes mellitus, hypertension and family history of CAD as compared to the baseline levels. The decrease in CRP was similar in all the subgroups in both atorvastatin and rosuvastatin group.
Our study showed no significant difference between the secondary outcome measures of recurrent angina, recurrent MI, stroke and mortality between the two groups. There were no cases of recurrent MI, stroke or mortality in either group. There were three cases of recurrent angina in group A and four cases in group B but the difference was not significant. The absence of any significant difference between clinical events in two groups in our study can be explained by short duration of study and that both the groups had been given statins whereas most of the previous studies have compared various statins against placebos.
In our study, 40mg atorvastatin and 20 mg of rosuvastatin had a favourable effect on lipid profile also after 4 weeks of treatment. Total cholesterol decreased by 26% (from 191mg/dl to 140mg/dl) in group A and 28% (from 209mg/dl to 150 mg/dl) in group B. LDL cholesterol decreased by 37% (from 102mg/dl to 64mg/dl) in group A and 39% (from 109mg/dl to 67 mg/dl) in group B. There were no cases of any serious adverse drug reaction including hepatic dysfunction or myositis. Most common adverse effects were related to gastrointestinal system like constipation, upper GI discomfort and pain abdomen. All these adverse effects were mild in severity and none needed any change or termination of treatment.
In conclusion, findings of our study showed that both atorvastatin (40mg) and rosuvastatin (20mg) are effective in decreasing CRP and LDL cholesterol levels even in a short duration of 4 weeks. This dose of rosuvastatin was found to be more effective in decreasing CRP levels. Both the drugs were effective, safe and offer an attractive approach for early treatment of ACS patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
WHO criteria for the diagnosis of Acute Coronary Syndrome (STEMI, Non STEMI, Unstable angina).
- Patients who are already taking statins and/or other hypolipidemic drugs.
- Severe Cardiac Dysfunction (EF < 30 %).
- Severe anaemia.
- Chronic Liver Disease.
- Chronic Renal Failure.
- Pregnancy or Lactation.
- If coronary revascularisation was planned or anticipated at the time of screening.
- Any history of hypersensitivity or allergy to statins.
- Any contra indication to the use of statins.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Level of CRP after 1 month of treatment one month 2.Lipid profile one month
- Secondary Outcome Measures
Name Time Method Recurrent MI 2. Recurrent Angina
Trial Locations
- Locations (1)
Department of medicine, CCU
🇮🇳Meerut, UTTAR PRADESH, India
Department of medicine, CCU🇮🇳Meerut, UTTAR PRADESH, Indiadr sushant khuranaPrincipal investigator09810902463sushantkhurana02@gmail.com