A Multicenter Prospective Hospital-based Cohort Study on the Efficacy and Safety of Pitavastatin.

AIMS

We aim to investigate the efficacy and safety of pitavastatin 4 mg in a population of people living in the United Arab Emirates (UAE).

BACKGROUND

Pitavastatin is a member of the HMG-CoA reductase inhibitors family which was approved for use in adult subjects with primary hyperlipidemia or mixed dyslipidemia. To date, no published studies have assessed the efficacy and safety of pitavastatin in the United Arab Emirates.

OBJECTIVE

The main objective of the current study was to investigate the efficacy and safety of pitavastatin in subjects with dyslipidemia for the primary prevention of cardiovascular diseases based on total cardiovascular risk.

METHODS

This was a multicentre (four private hospitals) prospective cohort study to analyze data on the use of pitavastatin for dyslipidemia in adult outpatients in Abu Dhabi and Dubai, United Arab Emirates. We have followed up the clinical profiles of subjects in four hospitals for six-weeks during the period from June 2015 to June 2017. Efficacy was based on the evaluation of the mean (± standard deviation) change in low-density lipoprotein cholesterol between baseline and week six after the initiation of pitavastatin therapy. Safety was reported with respect to the incidence of adverse events occurring with the use of pitavastatin and the development of new-onset diabetes.

RESULTS

A total of 400 subjects who were receiving pitavastatin 4 mg were included. The mean age of subjects was 50.7 ±10.8 years; of these, 79.0% were males. At the baseline, the mean level of total cholesterol was 185.4 ±41.5 mg/dL, low density lipoprotein was 154.9 ±48.55 mg/dL, high- -density lipoprotein cholesterol was 40.5 ±11.23 mg/dL and fasting blood glucose was 115.0 (±16.63) mg/dl. At the end of six weeks, low density lipoprotein levels significantly decreased to 112.09 ±41.90 mg/dl (standard mean difference (SMD) (-42.8%), 95% CI: -42.88 [-49.17 to -36.58] mg/dl, P <0.001), while high density lipoprotein levels improved (SMD, 95% CI: 1.77% [0.25 to 3.28] mg/dl, P <0.022). There were 55 subjects (13.7%) who reported various adverse events such as myalgia (7.5%), sleep disorders (2.5%), and myopathy (2.2%). Furthermore, 4 (1.0%) have had developed new-onset diabetes post-six-weeks of initiation of pitavastatin therapy.

CONCLUSION

Pitavastatin 4 mg showed robust efficacy in reducing LDL-C levels and improving HDL-C levels in subjects with dyslipidemia. The use of pitavastatin was associated with a low discontinuation rate, fewer adverse events, and very limited cases of new-onset diabetes.