Health Condition 1: null- Patients suffering with Isolated Low HDL cholesterol
Conditions
Interventions
Intervention1: Atorvastatin: Atorvastatin 10 and 20 mg/day(for 6 weeks each)
Control Intervention1: Micronised Fenofibrate: Micronised Fenofibrate 160 and 320 mg/day(for 6 weeks each)
Control Interven
Sponsors
Uttar Pradesh Council of Science TechnologyUPCST
Eligibility
Inclusion criteria
Inclusion criteria: Isolated Low HDL-c cases which were CHD risk equivalent, i.e. with a predicted 10-year risk for developing CHD>=20% (employing Framingham CHD risk calculator), without no overt history/symptoms of CHD. (Note: ILHDL-C was defined in our study as subjects having TC and TG<=200 mg/dl, LDL-c <130 mg/dl and HDL-c<=35 mg/dl in men and <=45 mg/dl in women.)
Exclusion criteria
Exclusion criteria: Presence of proven CHD (by history and consistent ECG findings, positive non-invasive test or angiographically proven CHD), Secondary causes of dyslipidemia (e.g. diabetes mellitus, hypothyroidism, nephrotic syndrome, cirrhosis, alcoholism, drugs like cyclosporine etc.), Abnormal liver functional test (more than 3 times elevation of OT/PT), Abnormal renal functional test (serum creatinine > 2 mg/dl), Abnormal CPK (more than 3 times the normal), Pregnancy, Known sensitivity to statins, fibrates and Niacin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase in mean HDL-c levels at 6 and 12 weeks post therapy compared with that at baseline.Timepoint: At 6 and 12 weeks post therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Decrease in mean estimated Framingham 10-year CHD risk percentage at 6 and 12 weeks post therapy compared with that at baselineTimepoint: At 6 and 12 weeks post therapy | — |
Countries
India
Contacts
Public ContactDr Sudeep Kumar
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Outcome results
None listed