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 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 emirates, 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 as the incidence of adverse
events occurred 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%) 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 had howed robust efficacy in reducing LDL-C levels and improving HDL-C levels in
subjects with dyslipidemias. The use of pitavastatin was associated with a low discontinuation rate, fewer adverse events,
and very limited cases of new-onset diabetes.
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