·         This is a phase IV, randomized, open label and multicentre study, designed to evaluate the safety and tolerability of study drug Atorsave D.

·       Approximately 144 patients will be enrolled to get complete data of 120 patients from multiple sites in India. This will be a prescription-based study.

·       This study will include patients with hyperlipidemia or statin induced myalgia in accordance with the respective local prescribing information and routine clinical practice.

·       Patients eligible for participation in this study will, as part of their routine medical care, receive Atorsave D tablets.

·       Recommended data collection time points are intended to be aligned with most local labels and patterns of care that most patients will receive in routine clinical practice. Since this is a post marketing study, there are no special protocol–mandated procedures associated with the study. However whenever applicable, evaluations documented in the eCRF are expected to be aligned with the local prescribing information recommendations and individual clinician practice. Information on safety areas of specific interest will be specifically collected. The potential patients will be enrolled as per the inclusion and exclusion criteria only after obtaining written informed consent from each patient.

·         Patients will be dosed with Atorsave D for 8 weeks.

·         Patients will be instructed not to take supplemental vitamins. The patients treated with Atorsave D will be followed for assessment of safety parameters throughout the study.

·         Overall assessment for safety & tolerability in the patients will be assessed by investigator during the 8 week study.

·         Safety assessment will include monitoring of AEs, SAEs, physical examination results, vital signs and clinical laboratory results

·         Physical examination including vital signs will be done at baseline as well as at every follow-up visit (4 weeks & 8 weeks)or before discontinuation from the study..

·         Standard 12 lead ECG will be done at baseline as well as at end of treatment (8 weeks) or before patient’s discontinuation from the study.

·         Blood & urine samples will be collected for laboratory investigations at baseline as well as at the end of treatment (8 weeks) or before patient’s discontinuation from the study.

·         Visual analogue scale (VAS) scores for myalgia will be recorded [(myalgia score (range, 0 to 100 mm)] before the administration of first dose of Atorsave D, after 4 weeks and at the end of the treatment ( 8 weeks).

·         For QoL assessment, SF-12 questionnaire will be administered before the administration of first dose of Atorsave D, after 4 weeks & and at the end of the treatment (8 weeks).

• Tolerability will be assessed during the study. Any discontinuation of the drug will be recorded. The tab/pills consumed/unconsumed will be calculated.