A study to compare rosuvastatin which is administered daily in one group and on alternate days in the other group comparing the improvement of blood lipid profile and to compare the side effects
- Conditions
- Hyperlipidemia, unspecified,
- Registration Number
- CTRI/2024/05/067550
- Lead Sponsor
- George T Varghese
- Brief Summary
Dyslipidemiahas been closely linked to the pathophysiology of ASCVD (Atheroscleroticcardiovascular disease).Worldwide an estimated 17.7 millionpeople died from ASCVD in 2018, representing 31% of all global deaths. In India,there has been an alarming increase in the prevalence of CVD over the past twodecades and accounts for 24% of all deaths among adults aged 25–69 years.India is expected to contribute more than half the cases of ASCVDglobally in the next 15 years.Elevated plasma LDL cholesterol(LDL-C) levels being a major modifiable risk factor for atherosclerosispresents an important point of intervention in the primary prevention of ASCVD.
TheNational Cholesterol Education Programme (NCEP) adult treatment panel (ATP) IIIguidelines and American College of Cardiology/American Heart Association(ACC/AHA) recommends statins as the first choice hypolipidemic drug which arethe most effective and best tolerated agents for treating dyslipidemia.When compared with other statins, rosuvastatin has low potential for drug-drug interactions,is hepato-specific, hydrophilic and exhibits pleiotropic effects such as plaquestabilization, anti-platelet aggregation, anti-atherogenic and anti-oxidant properties. Additionally, rosuvastatinalong with its long lasting active metabolites confer a much longerhydroxy-methyl-glutaryl (HMG) CoA reductase inhibition of twenty five to thirtyhours which makes it effective even on the next day.
In spite ofmany beneficial effects of statins, patients of lower socio-economic status maydiscontinue long term daily statin therapy due to its prohibitive cost.Additionally, some patients discontinue statin therapy secondary to adverseeffects such as myalgias, muscle cramps and weakness. Dosing a statin likerosuvastatin on alternate day as opposed to a daily regimen may providesignificant lipoprotein changes while reducing common adverse effects at a moreaffordable cost to the patient.In view of the limited body ofcomparative studies between the two regimens, this study is undertaken tocompare the efficacy and safety of daily versus alternate day rosuvastatintherapy in reduction of lipid parameters in treatment naïve patients ofdyslipidemia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 96
- Patients willing to give written informed consent.
- Patients aged more than 18 and less than or equal to 65 years.
- Treatment naive patients of dyslipidemia in low to moderate risk group as diagnosed by NCEP ATP III guidelines.
- Patients unwilling to give written informed consent.
- Patients with a documented history of acute coronary syndrome, cerebrovascular accident, on-going angina.
- Pregnant and lactating mothers.
- Patients on co-existing medication which aggravate statin myopathy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2. Changes in other lipid markers like total cholesterol, triglycerides, HDL-C 6 weeks 1. Percentage reduction in LDL-C 6 weeks
- Secondary Outcome Measures
Name Time Method Number and severity of adverse events reported by the patient at any time during the study. 6 weeks
Trial Locations
- Locations (1)
Bangalore Medical College & Research Institute Super Speciality Hospital
🇮🇳Bangalore, KARNATAKA, India
Bangalore Medical College & Research Institute Super Speciality Hospital🇮🇳Bangalore, KARNATAKA, IndiaDr George T VarghesePrincipal investigator8073225710drgeorgetv94@gmail.com