Postmarketing Surveillance Study on Atorlip-F (Atorvastatin/Fenofibrate combination)

18 Mar, 14

PROMISE Trial

Aim

To evaluate the efficacy and safety of ATORLIP F (atorvastatin 10 mg plus micronized fenofibrate 160 mg tablets) under real world conditions in Indian patients with combined hyperlipidemia.

Participating Centers

20 centres across India.

Study Design

Open label, non-comparative, practice based study
Patients enrolled at the discretion of the treating physician.

Patients

Combined hyperlipidemia

Dosage of Atorlip F

One tablet daily

Study Duration

6 months

Parameters Evaluated

Efficacy: Effect on lipids and 10-year risk of myocardial infarction (estimated) by PROCAM risk calculator at 3 months.
Safety: Assessed at 3 months and 6 months including effect on liver enzymes.

Results

ATORLIP F resulted in significant reductions in LDL cholesterol by 28.9% (p<0.001).

HDL cholesterol was significantly increased by 11.3% with ATORLIP F (p<0.001). In patients with low HDL(<40 mg/dl)at baseline, ATORLIP F increased HDL by 19.9% (p<0.001).

Non-HDL cholesterol was significantly reduced by 30.9% (p<0.001)

Triglyceride (TG) was significantly reduced by 36.6% (p<0.001)

ATORLIP F significantly reduced TG/HDL ratio, the surrogate marker of small dense LDL by 43.4%. In addition ATORLIP F was associated with attainment of TG/HDL goal <3.8 in 135 patients (46.1%).

ATORLIP F also yielded significant reductions in total cholesterol and other lipid ratios

ATORLIP F significantly reduced the probability of having a myocardial infarction in the next 10 years by 54.3%.

Safety:

Total 8 patients experienced adverse events viz., fatigue, nausea, body ache and gastritis, all of which were of mild nature and transient.
No patient discontinued therapy due to adverse events
None of the patients reported myopathy or rhabdomyolysis with ATORLIP F.
There were no clinically significant increase in SGOT and SGPT at 3 months and 6 months after therapy with ATORLIP F. Further none of the patients had an increase greater than 3 times upper limit of the normal for both this enzymes.
Tolerability of ATORLIP F was rated excellent or good by the study investigators in 93.5% patients.

Conclusion

Thus, Atorlip-F represents an effective and safe therapeutic strategy for the management of combined hyperlipidemia in Indians under real world conditions.
Improvements in lipids with Atorlip-F may significantly reduce MI risk.

The Ind Pract 2009;62:75-82