Original article / research
Atorvastatin as an Add-on Therapy in Episodic Migraine Prophylaxis: A Randomised Controlled Study
FC01-FC05
Correspondence
V Arun Kumar,
142, Mettur Bhavani Road, Nerinjipettai, Erode-638311, Tamil Nadu, India.
E-mail: arksmc05@gmail.com
Introduction: Migraine is a primary headache disorder with an estimated frequency of 12% in the world population, ranked fifth among causes of disability worldwide in both sexes under 50 years. Conventional prophylactic agents are limited by adverse effects and poor tolerability. Atorvastatin, a HMG-CoA (3-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitor with pleiotropic anti-inflammatory and endothelial-protective properties, has been proposed as a potential prophylactic agent in migraine.
Aim: To assess the efficacy and tolerability of Atorvastatin 20 mg/day as add-on therapy on frequency, intensity and duration of migraine attacks over a 3-month treatment period compared with standard therapy alone.
Materials and Methods: The present prospective, parallel group, open-labelled, randomised controlled study was conducted at the Outpatient Department of Neurology, Government Kilpauk Medical College and Hospital, Chennai, Tamil Nadu, India, over eight months from November 2020 to June 2021. A total of 63 participants with episodic migraine (4-15 attacks/month for ≥1 year) were randomised into a control group (n=32, standard prophylaxis alone) and an atorvastatin group (n=31, standard prophylaxis + Atorvastatin 20 mg Once Daily (OD) for 3 months). Primary outcome was ≥50% responder rate in frequency of attacks at end of treatment. Secondary outcomes included 50% responder rate in pain intensity (Numerical Rating Scale) and mean headache duration. Statistical analysis was performed using IBM Statistical Package for the Social Sciences (SPSS) version 28. A p-value of <0.05 was considered statistically significant.
Results: The mean age of participants was 39.65±8.56 years in Atorvastatin group and 40.06±8.61 years in Control group. Out of 63 participants 56 (88.9%) were female. At the end of the third month, 50% responder rate in frequency of attacks was 58.06% in Atorvastatin group vs 18.75% in the control group (p<0.001). Mean frequency of attacks declined significantly from baseline 5.77±1.18 to 2.58±1.09 in the Atorvastatin group versus 5.81±1.12 to 3.75±1.22 in the control group (p<0.001). Significant reduction was also observed in pain intensity (p=0.004) and headache duration (p<0.001) at the end of the third month. No serious adverse events were reported; statin-induced myalgia was the most common Adverse Drug Reaction (12.9%).
Conclusion: Atorvastatin 20 mg/day as add-on therapy significantly reduces the frequency, intensity and duration of migraine attacks with good tolerability. It offers added cardiovascular protection in a population at elevated vascular risk, making it a promising option for migraine prophylaxis.