This was a Phase III, an open-label, randomized, comparative, multicentric study in which efficacy and safety of the FDC of Atorvastatin + Vitamin D3 was determined in 335 patients at 11 different centers across different geographies in India. Patients were randomized to receive either FDC of Atorvastatin (10mg/20mg) + Vitamin D3 / OD or Atorvastatin/(10mg/20mg) / OD alone. Vitamin D3 (60,000 IU) sachet was given to patients who were on fixed dose combination of Atorvastatin + Vitamin D3 group once in a week for 8 weeks. Male or female subjects aged between 18-70 years with hyperlipidemia, fulfilling all the inclusion criteria and none of the exclusion criteria were enrolled in the study. Patients were evaluated for percent average change in serum LDL and total cholesterol level from baseline to end of the treatment as primary efficacy variables. Percent average change in serum HDL, TG and Vitamin D3 level were measured as secondary efficacy variables. Blood samples were collected for laboratory testing of hemoglobin, total and differential WBC count, total bilirubin, SGOT and SGPT, serum creatinine, urine analysis at screening visit and at end of the study. ECG was performed at screening visit and at end of study.

The duration of study participation of each patient was up to 25 weeks (i.e., 01 week of screening period and 24 weeks of treatment period).

Based on the study results it is concluded that FDC [Atorvastatin 10/20 mg and Vitamin D3 (1000 IU)] is safe and effective in patients with hyperlipidemia. It is especially useful in patients with baseline Vitamin D3 level < 30 nmol/L. In this population supplementation of Vitamin D3 with Atorvastatin has been shown to cause (1) clinically relevant faster reduction in LDL and total cholesterol in comparison to Atorvastatin alone and (2) exert similar action to the one observed with double dose of Atorvastatin. This effect is relevant in Indian population wherein a larger population is deficient in Vitamin D3.