Stroke, also known as Cerebrovascular accident (CVA) is an abrupt onset of neurological deficit due to decreased or interrupted blood flow to the brain causing cell death.⁽¹⁾ It is one of the most common neurological disorders and the leading cause of morbidity, chronic disability, and mortality worldwide.^(2–4) The two types of stroke are Ischemic stroke (due to clot/plaque formation and decreased blood supply to the brain) and Hemorrhagic stroke (due to blood vessel rupture and bleeding).⁽⁵⁾ In recent years, there has been a significant rise in the incidence of stroke due to excessive stress, dietary habits, and lifestyle.⁽⁶⁾ The signs and symptoms of stroke include hemi- or mono-paresis, aphasia, dizziness, vertigo, dysarthria, severe headache, double vision, visual field defects, and altered levels of consciousness.⁽⁷⁾

Many research studies have found that hypertension is the most prevalent risk factor and other risk factors include, smoking, alcohol consumption, elevated cholesterol levels, diabetes mellitus, obesity, diet, physical inactivity, coronary artery disease, other cardiovascular diseases, and previous history of transient ischemic attack.^(8,9) Several diagnostic procedures are used to diagnose stroke, they include neurological examination, CT scan, MRI scan, and Doppler ultrasound, etc.^(10,11)

Pharmacoepidemiology is defined as the study of the use, utilization, and effects/side-effects of drugs in a greater number of patient populations to assess their effectiveness and benefits to promote rational use of drugs.⁽¹²⁾ Drug Utilization Research (DUR) is an essential part of pharmacoepidemiology and is defined by the WHO as the marketing, distribution, prescription, and use of drugs in society, with special emphasis on resulting medical, social, and economic implications.⁽¹³⁾ The DUR studies help in determining the prescription pattern of drugs to promote quality of care, therapeutic drug efficacy, effectiveness, cost-effectiveness, and avoiding adverse effects of the drugs.⁽¹⁴⁾

Proper diagnosis and clinical evaluation of the severity of stoke helps in effective and optimal drug therapy by ensuring the right choice of drug, their rational use, and minimizing side effects/adverse effects. This study assesses the severity of stroke in the patients and evaluates the prescription pattern of drugs prescribed for stroke patients.⁽¹⁵⁾

A prospective, observational, monocenter study was conducted between June 2023 to March 2024 at Konaseema Institute of Medical Sciences & Research Foundation (KIMS) Hospital, Amalapuram, India. The study was conducted upon prior approval from the Institutional Ethics Committee (IEC) and all the participants were asked to sign an Informed Consent Form before inclusion into the study.

Inclusion Criteria: All the patients aged above 18 years, of both genders, and who are diagnosed with stroke (both ischemic and hemorrhagic) were included in the study. Patients with other comorbid conditions were also included in this study.

Exclusion Criteria: Outpatients, pediatric patients, pregnant and lactating women, patients unable to answer/complete the questionnaire, and patients unwilling to participate were excluded from the study.

The patient’s demographic data and the prescription data were collected from the patient Case Sheet/Case Report Form (CRF), and the severity of stroke was analyzed using the National Institute of Health Stroke Scale (NIHSS). The NIH Stroke Scale is a standardized questionnaire developed by NIH National Institute of Neurological Disorders and Stroke (NINDS) as a tool for health professionals to measure the severity of stroke in patients and also helps in measuring the neurological function and deficits in stroke patients by asking the patients to answer the questions and perform several physical and mental tests as per the questionnaire.^(16,17) The NIH Stroke Scale includes instructions for different categories - Level of Consciousness (LOC), LOC questions and commands, Best Gaze, Visual fields, Facial Palsy, Motor Arm, Motor Leg, Limb Ataxia, Sensory, Best Language, Dysarthria, and Extinction & Inattention. The NIH Stroke Scale score recorded for each patient was interpreted using standard guidelines. The NIHSS score 0 represents “No Stroke Symptoms”, 1-4 represents “Minor Stroke”, 5-15 represents “Moderate Stroke”, 16-20 represents “Moderate to Severe Stroke”, and 21-42 represents “Severe Stroke”.^(18–20)

All the collected data was entered into MS Excel Spreadsheet and analyzed for descriptive statistics and the results were obtained in the form of tables, graphs, charts/figures.

A total of 126 stroke patients participated in this study. Out of these, 92 (73%) were males and 34 (27%) were females. The mean age of the study participants was 59.86 ± 10.24 years. In this study, most of the patients were diagnosed with Ischemic stroke 114 (90%), whereas 12 (10%) patients were diagnosed with Hemorrhagic stroke.

Figure 1. Gender-wise Distribution of Study Participants.

Table 1. Age group and Gender-wise Distribution of Study Participants.

Figure 2. Incidence of Ischemic and Hemorrhagic stroke in study participants.

The socio-demographic data of the study population reported that hypertension (71%) is the most common comorbidity followed by diabetes mellitus (38%). Other comorbid conditions observed in stroke patients include coronary artery disease (5%), LV dysfunction (5%), bronchial asthma (5%), Parkinson’s disease (2%), pneumonia (2%), seizures (3%), thyroid (2%), anemia (2%), and chronic kidney disease (3%).

Figure 3. Co-morbidities in study participants

.

Figure 4. Social habits of study participants.

The severity of stroke was measured in the study participants using the NIH Stroke Scale. In the majority of the patients, the severity of stroke was found to be Moderate to Severe (46.1%), followed by Moderate (27.8%), Severe (21.4%), and Minor (4.7%). Physiotherapy is given to 74% of stroke patients with Severe to Moderate severity. The gender-wise analysis of the severity of stroke in the patients is given in Table 2.

Figure 5. The severity of Stroke in study participants.

Table 2. Gender-wise categorization of study participants based on Severity of Stroke.

The neurological outcome of the stroke patients was assessed and categorized into four groups, improved, static, deteriorated, and expired. Most of the stroke patients (85.7%) improved their condition, while 11.1% were static, 2.4% deteriorated, and 0.8% expired.

Table 3. Neurological Outcomes of Study Participants.

In our study, we observed that 342 drugs were prescribed in 126 stroke patients. The average number of drugs per prescription was found to be 7.2. The percentage of generic drugs prescribed was found to be very low(2.5%). The percentage of injections prescribed was found to be 49.14% and the percentage of antibiotics prescribed to the patients was found to be 22.2%.

Table 4. WHO Prescribing Indicators.

The drug utilization study reported that 29 different drug classes with 78 different drugs were prescribed in 126 stroke patients. The number of drugs prescribed varies with the severity of stroke in individual patients. The drug classes prescribed to the stroke patients were antiplatelets (11.47%), Hypolipidimics (10.21%), anticoagulants (2.83%), Nootropics (7.65%), antihypertensives (9.22%), antidiabetic (4.46%). The overall utilization pattern of drug classification is given in Table 5.

Table 5. Utilization Pattern of Drugs - Classification.

About 78 different drugs were prescribed for 126 stroke patients. Most frequently prescribed drugs were Atorvastatin (8.93%), Pantoprazole (8.29%), Piracetam (7.65%), Cerebrolysin (6.65%), Citicoline (5.83%), Telmisartan (4.83%), Aspirin+Clopidogrel (4.64%), Aspirin (4.46%), Clinidipine (2.91%), Lactulose (2.64%), Clopidogrel (2.37%), Heparin (2.37%), Insulin (2.37%), Syp.Cremaffin (2.09%), Cognolin (1.55%), Furosemide (1.54%), Ondansetron (1.37%), Rosuvastatin (1.28%), Metformin + Glimepiride (1.28%). The list of drugs prescribed to stroke patients is given in Table 6.

Table 6. Utilization Pattern of Drugs

There are only a few studies conducted to assessthe severity, drug utilization, and prescription pattern in stroke patients. A clear understanding of the prescription trends in the therapy of stroke is not very fully elucidated. The severity assessment of stroke patients helps in optimal and effective drug therapy with rational use of drugs and avoids adverse effects or side effects. It also helps to ensure individualized drug therapy by prescribing the most suitable choice of drugs for each patient.

In our study, most of the stroke patients are diagnosed with ischemic stroke which is similar to the study results reported by Sasikalaet al.⁽²¹⁾ and Karishmaet al.⁽²²⁾ The mean age of the study participants was found to be 59.86 ± 10.24 years which shows similarity with study results reported by Wagleet al.⁽²³⁾Naik M et al.⁽¹¹⁾ and AKet al.⁽¹⁰⁾ Hypertension (71%) and Diabetes Mellitus (38%) were found to be the most common risk factors and co-morbidities in stroke patients.^(24,25)

The severity of stroke was assessed using the NIH Stroke Scale (NIHSS), which showed that in most of the patients (46.1%) the severity of stroke was found to be “Moderate to Severe” followed by Moderate (27.8%), Severe (21.4%), and Minor (4.7%).⁽²⁰⁾ Physiotherapy was given to 74% of patients with severe to moderate severity. The neurological outcome of the stroke patients after therapy was observed and the disease condition was improved in most of the patients. These results were also similar to the study findings observed by Sasikalaet al.⁽²¹⁾ and Khan et al.⁽²⁶⁾

The WHO prescription indicators help in assessing the problems related to drug use concerning the rational use of medications. The average number of drugs per prescription is relatively high 7.2 and the prescriptions written with the generic name are very low (2.5%). WHO recommends prescriptions with the generic name of the drugs, to avoid medication errors, and increase patient compliance to the medications. More number of drugs per prescription increases the risk of potential drug-drug interaction which can further deteriorate the condition of the patient. These results were also found similar to studies conducted by Wagleet al.⁽²³⁾ and Jithet al.⁽²⁷⁾

The drug utilization study revealed that antiplatelet agents (aspirin, clopidogrel, and aspirin+clopidogrel) were the most prescribed drugs for stroke patients. Besides antiplatelet agents, antihypertensives, proton pump inhibitors, antidiabetic drugs, nootropics, and hypolipidemic agents are the most commonly prescribed drugs. These results were also found similar to the studies conducted by Wagleet al.⁽²³⁾ Mathewet al.⁽²⁸⁾ and Sprthiet al.⁽²⁹⁾ Nootropic drugs such as Piracetam, Cerebrolysin, and Cognolin were prescribed for most of the patients and these drugs are neuroprotective agents and are found effective in restoring the cognitive and language functioning of the brain. Pantoprazole (8.29%) is the most commonly prescribed proton pump inhibitor, and Telmisartan (4.83%) is commonly prescribed drug for hypertension. Heparin is prescribed in 2.37% of patients, and Furosemide (1.54%) and Mannitol (0.45%) were prescribed as anti-edema therapy for hemorrhagic stroke. Our drug utilization study results were found in compliance with the studies conducted by Karishmaet al. Silverman et al.⁽³⁰⁾Wagleet al.⁽²³⁾ Po H L et al.⁽³¹⁾ Mohammad YA et al.⁽³²⁾ and Kumar SV et al.⁽³³⁾

Ischemic stroke is the most predominant type of stroke in the Indian population. NIH Stroke Scale is a standardized, reliable, and valid scale for predicting neurological outcomes in stroke patients. Assessment of the severity of stroke in patients helps in providing rational, individualized, effective, and optimal drug therapy. Hypertension and diabetes are major risk factors and comorbidities found in stroke patients. Antiplatelet agents are the most prescribed drugs for stroke patients. The high number of drugs per prescription and lack of generic drug prescribing are the major concerns that should be dealt with to promote rational drug therapy.

1. Frey D. Harrison’s Principles of Internal Medicine, 15th Edition. Shock. 2002 Apr;17(4):343.
2. Donkor ES. Stroke in the 21st Century: A Snapshot of the Burden, Epidemiology, and Quality of Life. Stroke Res Treat. 2018;2018:3238165.
3. Burton KJ, Allen S. A review of neurological disorders presenting at a paediatric neurology clinic and response to anticonvulsant therapy in Gambian children. Ann Trop Paediatr. 2003 Jun;23(2):139–43.
4. Raina S, Razdan S, Nanda R. Prevalence of neurological disorders in children less than 10 years of age in RS Pura town of Jammu and Kashmir. Journal of pediatric neurosciences. 2011 Jul 1;6:103–5.
5. Bamford J, Sandercock P, Dennis M, Burn J, Warlow C. Classification and natural history of clinically identifiable subtypes of cerebral infarction. Lancet. 1991 Jun 22;337(8756):1521–6.
6. Kamalakannan S, Gudlavalleti ASV, Gudlavalleti VSM, Goenka S, Kuper H. Incidence & prevalence of stroke in India: A systematic review. Indian J Med Res. 2017 Aug;146(2):175–85.
7. Murphy SJX, Werring DJ. Stroke: causes and clinical features. Medicine (Abingdon). 2020 Sep;48(9):561–6.
8. Mustacchi P. Risk factors in stroke. West J Med. 1985 Aug;143(2):186–92.
9. Setyopranoto I, Bayuangga HF, Panggabean AS, Alifaningdyah S, Lazuardi L, Dewi FST, et al. Prevalence of Stroke and Associated Risk Factors in Sleman District of Yogyakarta Special Region, Indonesia. Stroke Research and Treatment. 2019 May 2;2019:e2642458.
10. Ak C, Gupta R, Warkade V. Study of Clinical Profile and Risk Factors for Ischemic Stroke in Young Adults. J Assoc Physicians India. 2022 Apr;70(4):11–2.
11. Naik M, Rauniyar RK, Sharma UK, Dwivedi S, Karki DB, Samuel JR. Clinico-radiological profile of stroke in eastern Nepal: a computed tomographic study. Kathmandu Univ Med J (KUMJ). 2006;4(2):161–6.
12. Sabaté M, Montané E. Pharmacoepidemiology: An Overview. J Clin Med. 2023 Nov 10;12(22):7033.
13. Introduction to drug utilization research [Internet]. [cited 2024 Apr 29]. Available from: https://www.who.int/publications-detail-redirect/8280820396
14. Carver N, Jamal Z, Dering Anderson AM. Drug Utilization Review. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 [cited 2024 Apr 30]. Available from: http://www.ncbi.nlm.nih.gov/books/NBK441869/
15. Laporte JR, Porta M, Capella D. Drug utilization studies: a tool for determining the effectiveness of drug use. Br J ClinPharmacol. 1983 Sep;16(3):301–4.
16. Cummock JS, Wong KK, Volpi JJ, Wong ST. Reliability of the National Institutes of Health (NIH) Stroke Scale Between Emergency Room and Neurology Physicians for Initial Stroke Severity Scoring. Cureus. 15(4):e37595.
17. Grönberg A, Henriksson I, Lindgren A. Accuracy of NIH Stroke Scale for diagnosing aphasia. ActaNeurol Scand. 2021 Apr;143(4):375–82.
18. Wouters A, Nysten C, Thijs V, Lemmens R. Prediction of Outcome in Patients With Acute Ischemic Stroke Based on Initial Severity and Improvement in the First 24 h. Front Neurol. 2018;9:308.
19. Chalos V, van der Ende NAM, Lingsma HF, Mulder MJHL, Venema E, Dijkland SA, et al. National Institutes of Health Stroke Scale: An Alternative Primary Outcome Measure for Trials of Acute Treatment for Ischemic Stroke. Stroke. 2020 Jan;51(1):282–90.
20. Kogan E, Twyman K, Heap J, Milentijevic D, Lin JH, Alberts M. Assessing stroke severity using electronic health record data: a machine learning approach. BMC Med Inform DecisMak. 2020 Jan 8;20:8.
21. Sasikala P, Anitha PS, Charan KJ, Rao MT, Mounika G, Boniface AC. A Study on the Assessment of Severity of Stroke Patients at an Indian Tertiary Care Hospital. Journal of Clinical and Pharmaceutical Research. 2021 Apr 27;26–8.
22. Sk K, D RBR, B NK, K MB, K SS, S S. ASSESSMENT OF RISK FACTORS AND DRUG UTILIZATION PATTERN OF STROKE PATIENTS IN NEUROLOGY DEPARTMENT. World Journal of Current Medical and Pharmaceutical Research. 2020 Mar 27;53–62.
23. Wagle L, Thomas AA, Shrestha S. DRUG UTILISATION STUDY OF STROKE AND OTHER PATIENTS ADMITTED TO GENERAL WARD OF NEUROLOGY UNIT AT QUATERNARY CARE PRIVATE HOSPITAL. International Journal of Current Pharmaceutical Research. 2017 Jul 14;23–8.
24. Wajngarten M, Silva GS. Hypertension and Stroke: Update on Treatment. EurCardiol. 2019 Jul;14(2):111–5.
25. Jena S, Jena M, Mishra S, Meher B. Utilization Pattern of Different Drugs in Different Types of Stroke in A Tertiary Care Teaching Hospital. In 2018 [cited 2024 Apr 30]. Available from: https://www.semanticscholar.org/paper/Utilization-Pattern-of-Different-Drugs-in-Different-Jena-Jena/2dd959a9c63306e34691490245c72aeb75496a3f
26. Khan MSA, Ahmad S, Ghafoor B, Shah MH, Mumtaz H, Ahmad W, et al. Inpatient assessment of the neurological outcome of acute stroke patients based on the National Institute of Health Stroke Scale (NIHSS). Ann Med Surg (Lond). 2022 Oct;82:104770.
27. Jith A, Kumar CT, Joy JS, P KS, R SK. A PROSPECTIVE STUDY OF DRUG–DRUG INTERACTIONS AND ADVERSE DRUG REACTIONS AMONG STROKE PATIENTS IN A TERTIARY CARE HOSPITAL. Asian Journal of Pharmaceutical and Clinical Research. 2016 Dec 1;100–4.
28. Mathew E, C C, Karanath PM, R S. A PROSPECTIVE OBSERVATIONAL STUDY ON PRESCRIBING TRENDS AND ADVERSE DRUG REACTIONS IN STROKE PATIENTS. International Journal of Pharmacy and Pharmaceutical Sciences. 2017 Jul 1;25–30.
29. T S, B G, D K, G V. RISK ELEMENTS AND DRUG UTILIZATION IN STROKE PATIENTS. International Journal of Pharmacy and Pharmaceutical Sciences. 2016 Oct 1;290–2.
30. Silverman IE, Restrepo L, Mathews GC. Poststroke seizures. Arch Neurol. 2002 Feb;59(2):195–201.
31. Po HL, Lin YJ, Hseuh IH. The prescribing patterns of antithrombotic agents for prevention of recurrent ischemic stroke. ActaNeurol Taiwan. 2009 Jun;18(2):98–103.
32. Abbasi MY, Ali M. Prescribing pattern of drugs in stroke patients: A prospective study. Archives of Pharmacy Practice. 2012 Jan 1;3:283.
33. Kumar V, Gaddam D, Ravikanth S, Vijayakumar G. DRUG UTILIZATION PATTERN OF STROKE PATIENTS IN A TERTIARY CARE HOSPITAL. International Journal of Current Pharmaceutical & Clinical Research. 2012 Jan 1;2:3–7.