Study of Adverse Drug Reaction of Low dose Atorvastatin in Patients With Metabolic Syndrome and Comparison With the usual Care Group
Shubhangam Sharma1, Hemlata Verma2 and Manish Jain31Department of Pharmacology, M LB Medical College, Jhansi, UP, India.
2Department of Pharmacology, Gandhi Medical College, Bhopal, MP, India.
3Community medicine people dental academy Bhopal MP India.
Corresponding Author E-mail: vkverma0505@gmail.com
Abstract: Statins are the most widely prescribed drugs for the correction of dyslipidaemia and prevention of cardiovascular events in patients of Metabolic syndrome, so early detection of Adverse drug reactions(ADR) becomes necessary. This prospective, comparative study done in OPD setting in a tertiary care centre of central India aimed at finding out the ADRs of low dose atorvastatin in patients with metabolic syndrome versus the usual care group. Patients satisfying NCEP-ATPIII criteria for metabolic syndrome were divided into two groups in which one received statin therapy (Group A) and other did not(Group B). A total of 33 ADRs were recorded out of which 26 (38.23%) were in Group A and 7 (31.81%) were in Group B, with no significant difference in the ADRs recorded in both the groups. In patients with statin therapy, most common adverse effects were dyspepsia (10.29%) and elevation of hepatic transaminases(10.29%), followed by constipation (5.8%), sleep disturbances, myalgia and headache (2.9%). The adverse effect profile of group B was nearly similar with dyspepsia in 3 cases (13%) followed by constipation in 2 cases (9%) ,elevation in hepatic transaminases and headache in 1 case (4.5%). Definite (certain) relationship was established in 12% patients while probable in 23% and 65% ADRs were categorized as possible. Severity assessment recorded 73% of the total ADR as mild, 23% as moderate and only 3.8% as severe. Although statins are one of the safest medications for dyslipidaemia and metabolic syndrome as also proved in the present study; further studies of ADRs is needed for early detection, prevention and management of ADRs and reduced morbidity.
Keywords: ADRs; Atorvastatin; Metabolic syndrome; Dyslipidemia Back to TOC