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Assessment of Prescribing Patterns and Health-Related Quality of Life in Cerebral Stroke Patients

International Journal of Pharmaceutical Sciences Review and Research International Journal of Pharmaceutical Sciences Review and Research Available online at www.globalresearchonline.net ©Copyright protected. Unauthorised republication, reproduction, distribution, dissemination and copying of this document in whole or in part is strictly prohibited. Available online at www.globalresearchonline.net 209 Proveen Kothagundla, Kammili Radhika, Kumar.V.S.Nemmani, Mavulati Sri Chandana 1. Pharm D Intern, Shri Vishnu College of Pharmacy, Bhimavaram, West Godavari District, Andhra Pradesh, India. 2. Director (M.Pharm, PhD), Shri Vishnu College of Pharmacy, Bhimavaram, West Godavari District, Andhra Pradesh, India. 3. Assistant professor (M.Pharm), Department of pharmacology, Shri Vishnu College of Pharmacy, Bhimavaram, West Godavari District, Andhra Pradesh, India. *Corresponding author’s E-mail: proveen195@gmail.com


INTRODUCTION
troke is a term used to describe an abrupt onset of focal neurologic deficit that lasts at least 24 hours and is assumed to be of vascular origin. Stroke can be either ischemic or hemorrhagic in origin. Transient ischemic attacks (TIAs) are focal ischemic neurologic deficits lasting less than 24 hours and are usually less than 30 minutes 1 .
Types of Strokes include: -Ischemic stroke, Hemorrhagic stroke (SAH / ICH) and Transient Ischemic Attack (TIA). [2][3][4][5][6] The estimated adjusted prevalence rate of stroke range in rural and urban areas was 84-262 / 100,000 and 334-424 / 100,000, respectively and the incidence rate is 119-145 / 100, according to stroke factsheet 2012 7,8,9 . The third commonest cause of death worldwide after coronary heart disease (CHD) and cancer of all types was a stroke 10,11,12 . The mortality rate due to stroke in India was 22 times that of malaria and 1.4 times that of tuberculosis. Risk factors can be modifiable and non-modifiable. Smoking, alcoholism, atrial fibrillation, hyperlipidemia, hypertension, physical inactivity, obesity and postmenopausal hormone therapy constitutes modifiable risk factors whereas non-modifiable risk factors include old age, males and family history of stroke, race (African American, Asian, Hispanic). High blood pressure and diabetes are common risk factors among Indians 13,1,4,7,8 .
Nowadays, the diagnosis of stroke is done by FAST examination which includes weakness of the face, arm, speech disturbance and essentially time. CT scan, MRI scan, PET and ultrasound were the other means of diagnosis 14,3,10 . Symptoms and physical findings most often include sudden onset of facial weakness, arm drift, and abnormal speech, severe headache 15 .
For acute thrombotic stroke, proven treatments include IV thrombolysis within 3 hours of the onset of symptoms, use of aspirin within 48hours and decompressive surgery for malignant middle cerebral artery infarction 3 . Stroke can cause myriad of negative consequences on an individual's life ranging from institutionalization, loss of independence to cognitive and communication difficulties 16 . Stroke in young causes economic, social burdens on families and society and also deteriorates the quality of life of a person by its functional limitations 17,2 . The greater the morbidity and disability, the lesser the quality of life of stroke survivors 18 .
Pharmacists are in a key role to provide pharmaceutical care to stroke survivors, review patients profile for risk factors, whenever necessary either to recommend or initiate appropriate drug therapy if indicated. To improve patient outcomes, integrating the pharmacist in the management of stroke patients and also educating them plays a vital role 4 .
It would be better to review stroke preventive ways, as there will be a rapid increase in the burden of stroke in the coming years and restricted accessibility of stroke care in India. The present study aims to provide a broad review of gender differences, demographics, risk factors, symptoms, prescribing pattern and Health-Related Quality of Life (HRQoL) of cerebral stroke patients.

Study site and design
A prospective observational study was carried out over hospitalized cerebral stroke patients from July to December 2019 at Sivaranjani super speciality hospital. It is a tertiary care hospital specialized in neurology department which treats the patients in Bhimavaram town and nearby areas regarding various neurological disorders. Every day 100 to 150 patients were treated either in inpatient (IPD) or outpatient department (OPD).

Inclusion criteria
• Male and female patients of age ≥ 20 years • Patients who are diagnosed with cerebral stroke (Ischemic, Hemorrhagic and TIA) • Patients who are willing to give consent form to participate in the study

Exclusion criteria
• Children, Pregnant women, patients who are having a seriously debilitating condition like End-stage renal disease, HIV, Cancer • Patients with disabilities before the incident of stroke due to various other diseases

Data collection
An approval of ethical clearance has been obtained from the Institutional Ethical Committee before the initiation of the study. Subjects who met the inclusion criteria (150) were enrolled for the study. Details regarding the sociodemographics, past medical and medication history and current medications were obtained by patient or care giver interview and by observing case notes and captured in valid data collection form, patient's health-related quality of life information was measured by using SF-36 questionnaire.

Data Analysis / Statistics
Descriptive statistics of demographic and clinical variables included percentages, mean and standard error of the mean (S.E.M). Mean scores before and after treatment and mean changes were calculated for the domains of SF-36. A paired t-test was used to determine if the change detected from the before and after treatment was significant. The probability value of ≤ 0.05 was set as significant and ≤ 0.001 as highly significant. All statistical analysis was performed using Graph Pad Prism version 8.3.0 (San Diego, California, USA).

Ethical consideration
The study was carried out from July 2019 to December 2019 after due permission from the Institutional Ethics Committee (Ref No: SVCP/IEC/16/12; dated: 29/07/2019) and after getting consent (in written form) from all the participating subjects.

RESULTS
Demographics:

Risk factor
This study revealed that, out of 150 patients the risk factor of hypertension is about 30%, diabetes mellitus is about 18% followed by alcohol 16%, smoking 13%, history of stroke (old CVA) 10%, obesity 5%, hyperlipidemia 3%, head injury 2%, CAD 2% and seizures 1%. Hypertension and diabetes mellitus were the most common risk factors for the cause of cerebral stroke ( Figure 1).

International Journal of Pharmaceutical Sciences Review and Research
Available online at www.globalresearchonline.net ©Copyright protected. Unauthorised republication, reproduction, distribution, dissemination and copying of this document in whole or in part is strictly prohibited.
212 Health related quality of life The mean value of physical functioning before treatment is 56.4 and after treatment is 78.9. The difference in means is highly statistically significant (P˂0.0001). The mean role limitation due to physical health pre-treatment is 45.7 and post-treatment was 82.0. The difference in means is highly statistically significant (P˂0.0001). The mean role limitation due to emotional problem pre-treatment is 43.6 and post-treatment is 73.3. The difference in means is highly statistically significant (P=0.0001). The mean energy/ fatigue pre-treatment is 56.8 and post-treatment are 73.9. The difference in means is highly statistically significant (P=0.0001). The mean Emotional wellbeing pretreatment is 62.6 and post-treatment is 79.2. The difference in means is highly statistically significant (P=0.0001). The mean social functioning pre-treatment is 54.1 and post-treatment is 79.4. The difference in means is highly statistically significant (P=0.0001). The mean pain score pre-treatment is 62.9 and post-treatment is 85.4. The difference in means is highly statistically significant (P=0.0001). The mean general health score pre-treatment is 51.7 and post-treatment is 70.1. The difference in means is highly statistically significant (P=0.0001). The mean health change pre-treatment is 47.7 and post-treatment is 70.7. The difference in means is highly statistically significant (P=0.0001). The response score of all scales increased significantly (p < 0.0001), which indicates the improvement in Quality of life of stroke survivors after treatment (Table 5). Multiple therapies using patients have an improvement in the quality of life in all domains compared to monotherapy patients except in the domains of physical functioning and role limitation due to physical health where monotherapy using patients have shown best results than combination therapy (Table 6).

DISCUSSION
The present study is done to assess the symptoms, risk factors, prescribing pattern of drugs and to evaluate their impact on the quality of life of cerebral stroke patients admitted in a tertiary care hospital, Bhimavaram.
The total number of patients enrolled under this study group were N = 150, the distribution of males (63%) is greater than females (37%). The observation is in agreement with the findings of the study conducted by Jithin kc et al (2016) and Mathew E et al (2017) where males are affected more than females. Which can be attributed due to a) Estradiol has potent effects on endothelia that promote dilation of blood vessels and blood flow, whereas testosterone has opposite effects. This indicates women are protected by endogenous estrogens b) Males are more prone to HTN and DM than females c) Smoking 12,19 .
The data from this study shows that major type stroke observed in our patients was Ischemic (88%) followed by Hemorrhagic (8%) and TIA (4%) which was in accordance with study by Prathyusha B et al (2014) and Vurumadla S et al (2015) 4,13 .
Most patients in our study presented with complaints of weakness of limbs (32%), slurred speech (15%), hemiparesis (7%), giddiness (6%), difficulty walking (6%) etc., Similarly, in the study by Dc RAL et al (2010) in Mississippi chiropractic practice patients presented with complaints of unilateral arm weakness and slurred speech, other complaints included episodic loss of vision, dysphagia, dysphonia, and same-sided leg weakness 15 . Contrastingly the study results of Vurumadla S et al (2015) showed that symptoms like slurred speech, followed by weakness on the right side in 97 (65%) patients, headache in 88 (59%) patients, change in a speech in 87 (58%) patients, weakness on the left side in 58 (39%) patients and deviation of mouth in 48 (32%) patients 13 .
The data of our study regarding risk factors of cerebral stroke in our patients showed that hypertension (30%) is the major cause followed diabetes mellitus (18%), alcohol (16%) and smoking (13%). A study conducted by Vurumadla S et al (2015) shows similar results where the most common risk factors associated with the stroke was hypertension in 102 (68%) patients, followed by dyslipidemia in 81 (54%) patients, diabetes mellitus in 51 (35%) patients and heart disease in 49 (33%) patients 13 .
A thorough screening was made into all the prescriptions of our study participants where cognitive enhancers (16%) as supportive therapy are mostly present in every prescription followed by antiplatelets (14%), PPIs (14%), dyslipidemic agents (12%), antihypertensives (12%), anticoagulants (8%), analgesics (7%) for pain and antidiabetics (7%) for patients with elevated blood sugar levels, for post-stroke seizures and depression drugs such as antiepileptics and antidepressants were given respectively, for hospital born infection prophylaxis antibiotics (2%) were given, similar results were obtained in the study of Jithin kc et al (2016) where the patients are  prescribed  with  antiplatelets,  anticoagulant,  antihypertensive, statins, and antidiabetics, antidepressants, antiepileptics, multivitamins, and laxatives, GI protectants 19 .
Our study results show that majorly prescribed combination drug was aspirin + clopidogrel (86%) and least prescribed was atorvastatin + aspirin, atorvastatin + clopidogrel, rosuvastatin + clopidogrel combining 14%. A study conducted by Konduru SST et al (2017) shows aspirin + clopidogrel was the major prescribed combination therapy in stroke patients which favours our study 22 .
A study by Rajan B et al (2019) said that QoL showed significant improvements in all physical, psychological and social domains by the end of the 6th month of followup, the results were similar with our study where response score of all scales increased significantly (p < 0.0001), which indicates the improvement in Quality of life of stroke survivors after treatment 9 . Whereas Mahran S et al (2015) study says that low mean scores of all the nine domains of SF-36 were found which is opposite to our study result. This may be due to poor adherence of patients regarding their medications and lifestyle modifications designed by their physicians, stringent implementation of awareness and counselling regarding the effectiveness of treatment should be implemented 21 .
Patients taking mono and combination therapy are assessed for their health score before and after therapy and the change in score was noted and compared. Multiple therapies using patients have an improvement in the quality of life in all domains compared to monotherapy patients except in the domains of physical functioning and role limitation due to physical health where monotherapy using patients have shown best results than combination therapy. Although clopidogrel-aspirin therapy seems to have substantially reduced the risk of stroke in the patients in comparison with aspirin-alone therapy, there is still a large proportion of patients at high risk of stroke despite clopidogrel treatment. Wang Y et al (2015) study shows that there was a slight benefit in patients taking combined therapy compared with monotherapy which is similar to the findings in our study 20 .

CONCLUSION
Cerebral stroke is a multi-factorial health problem, and its prevalence and risk factors have changed considerably within the past century. The study finds the higher prevalence of cerebral stroke among males and in the age group of 51-60 years with major risk factors constituting hypertension, DM. The weakness of limbs, slurred speech and hemiparesis were the most commonly reported symptoms. Antiplatelets (clopidogrel), dyslipidemic agent (atorvastatin) and anticoagulants (enoxaparin sodium) were mostly prescribed single drugs along with cognitive enhancers and gastro protectives; in multiple therapy aspirin + clopidogrel constitutes major proportion. There was a statistical improvement in the health-related quality of life in cerebral stroke patients by the course of treatment and self-care. Prevalent cerebrovascular risk factors (hypertension, DM) increased the risk of getting a stroke, thereby identifying and managing them priorly with rational use of treatment decreases the worsening of the disease and co-morbidities. Long term studies are further required to evaluate the benefit of combinational therapy over monotherapy and to develop standard guidelines for better management. Integration of the role of a pharmacist in the management of the disease is crucial and improves clinical outcomes of patients.