An Open label, Prospective, Multi-Center, Observational Study to Evaluate the Lipid Lowering Efficacy and Safety of Rosuvastatin in Indian Dyslipidemics in Routine Clinical Practice.
Loading...
Date
2014-09
Journal Title
Journal ISSN
Volume Title
Publisher
Abstract
Altered cholesterol levels in the blood or
dyslipidemia is a major modifiable risk factor for CVD and is
closely associated with the pathophysiology of CVD. Asians,
particularly Indians, have a unique pattern of dyslipidemia;
with lower HDL cholesterol, increased triglyceride levels and
higher proportion of small dense LDL cholesterol, with
characteristic centripetal obesity. ‘Statins’ belong to the group
of 3-hydroxy-3-methylglutaryl Coenzyme A reductase
inhibitors that have been shown to reduce levels of total and
LDL cholesterol. Study Objective: To evaluate the lipid
lowering efficacy and safety of Rosuvastatin in Indian
dyslipidemics in routine clinical practice by measuring the
percent change in Total Cholesterol, LDL, TG and HDL over
a period of 16 weeks. Methodology : This was a multicentric,
open-labeled, post-marketing surveillance study. A
committee of key opinion leaders was formed. A total of 1200 doctors were approached of whom 800 provided us
with subject data. Each participating doctor was given case
report forms and requested to recruit patients according to
the inclusion and exclusion criteria. Lipid profile of each
recruited patient was done before initiating therapy and at
the end of 4 months. Rosuvastatin was given at a dose of
either 5mg/ 10mg OD for 4 months. Results : A total of 11,
656 subjects were recruited into this study out of which 10,
410 complete case report forms were considered (n=10410).
The study included 65% males and 35% females. Majority
of the subjects were in the age group of 46-55years (35.2%)
and 56-65 years (29.4%). In this study, the total cholesterol
(TC), LDL-C, Triglycerides (TG) has significantly decreased
by 46.13%, 53.74% and 41.93% respectively. Also the HDLC
levels increased by 26.84%, thereby, indicating a significant
change in the levels of all the dyslipidemic indicators. With
the reported number of adverse events (n=4) related to
Rosuvastatin, it is evident that the drug is safe and tolerable.
There were no significant changes observed in the liver and
renal function tests with Rosuvastatin reiterating their safety.
Conclusion : Rosuvastatin has shown greater efficacy in
lowering LDL cholesterol and non-HDL-cholesterol
concentrations. It has been shown to enable more patients
to reach their LDL cholesterol goals and to do so with an
acceptable safety profile.
Description
Keywords
rosuvastatin, indian dyslipidemics, efficacy, safety, cholesterol
Citation
Trivedi Himansu, Karthik Kalidoss, Mehta Harshad S, Kumar N, Parmar Mahendra, Jain Rohit, Gupta Yogesh, Khetarpal Vinod, Sheth Jignesh. An Open label, Prospective, Multi-Center, Observational Study to Evaluate the Lipid Lowering Efficacy and Safety of Rosuvastatin in Indian Dyslipidemics in Routine Clinical Practice. Indian Medical Gazette. 2014 Sep ; 148 (9): 313-320-