Title:A Multicenter Prospective Hospital-based Cohort Study on the Efficacy and Safety of Pitavastatin
Volume: 17
Issue: 7
Author(s): Abdullah Shehab*, Asim Ahmed Elnour, Akshaya Srikanth Bhagavathula, Joseph Pulavelil Kurian, Gazi Hassan, Shareen AlZaabi, Huburt Gilbert and Khalid Al-Rasadi
Affiliation:
- Department of Internal Medicine, College of Medicine, United Arab Emirates University (UAEU), Al Ain,United Arab Emirates
Keywords:
Dyslipidemia, efficacy, low density lipoprotein (LDL-C), multicenter, new-onset diabetes, pitavastatin.
Abstract: 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.
