PROSPECTIVE ANALYSIS OF IMPACT OF PHARMCOTHERAPY ADHERENCE ON TREATMENT EFFECTIVENESS IN POST OPERATIVE HEART PATIENTS

Myocardial infarction is the irreversible damage of myocardial tissue caused by prolonged ischemia and hypoxia. This most commonly occurs when a coronary artery becomese blocked following the rupture of an atherosclerotic plaque, which then leads to the formation of a blood clot (coronary thrombosis). This event can also trigger coronary vasospasm. Ischemia induces profound metabolic and ionic perturbations in the affected myocardium and causes rapid depression of systolic function. Prolonged myocardial ischemia activates a "wavefront" of cardiomyocyte death that extends from the subendocardium to the subepicardium. Mitochondrial alterations are prominently involved in apoptosis and necrosis of cardiomyocytes in the infarcted heart. This prospective, pilot, observational study performed confirmed the hypothesis that systematic identifications and interventions administered through continued physician follow-up and patients counselling will improve adherence to therapy and therefore improvement in treatment effectiveness by lowering especially Troponin level ,CPK and quality of life in MI patients. Study was shown that lack of proper knowledge about disease and patients counseling and chronic treatment, most of patients takes disease and its treatment lightly and shows lower adherence attitude. The study analysis shown that female are generally more aware than males for adherence. Study analysis concluded that there was significant reduction in their Troponin level and CPK values in different comparison groups after each level of follow up. Statistical analysis concluded that patients with adherence ˃ 95% showed significant reduction in Troponin level and CPK values and patients with age group ≤50 shows more adherence than older. Most heart patients recorded with hypertension and Coronary Artery Diseases only few ones with diabetic complications. During study patients shows good control over their blood pressure and only few adverse events but no complications occur during study period.


INTRODUCTION
Heart attack is a medical emergency, usually occurs when a blood clot blocks blood flow to the heart leads to the death of a segment of heart muscle. When it happens, a person experiences chest pain and electrical instability of heart tissue. Blockage is most often a build up of fat, cholesterol and other substances. Heart attack can also be termed as myocardial infraction, cardiac infraction and coronary thrombosis. Myocardial infarction ("heart attack") is the irreversible damage of myocardial tissue caused by prolonged ischemia and hypoxia. This most commonly occurs when a coronary artery becomes blocked following the rupture of an atherosclerotic plaque, which then leads to the formation of a blood A prospective pilot study has been carried out between January 2020 and June 2020 in outdoor unit of the Heart & General Hospital, Jaipur.

Study population/ Research subjects:
A total of 60 individuals that are included in this study are diagnosed with myocardial infraction and had undergone surgery ,who are matched for Inclusion criteria consecutively attending the outpatient care clinic of the Heart & General Hospital, established through consultation with treating physicians are reviewed. They are over 45 years of age and underwent heart surgery and treatment is majorly done by anti platlets and antianginal drugs . All study subjects gave written and oral informed consent as they were recruited at the heart care clinic. Subjects are randomly selected in this study who meets the Inclusion criteria.

Patient enrolment:
All patients who were hospitalized at HEART AND GENERAL HOSPITAL(a tertiary care public teaching hospital) between JANUARY 2020 and MAY 2020 with established diagnosis of heart failure (for at least 3 months' prior enrollment) and undergone heart surgery were consecutively enrolled for this study. Sociodemographic, clinical, laboratory, echocardiographic, and adherence data were gathered using a structured questionnaire during the hospital admission of enrollment. Framingham criteria was used to screen participants for heart failure symptoms and a 2-dimensional echocardiography was utilized for diagnosis reconfirmation . Diagnosis of anemia utilized the WHO criteria i.e. Hemoglobin (Hb) concentration of < 13.0 g/dL and < 12.0 g/ dL for males and females respectively To estimate the effect of heart attack drugs, post operation patient's were continuously monitored and recorded by follow up of patients for after 3 months and 6 months study

Patient counseling and Follow up
The all patients will be counselled regarding disease, medication, nutrition, exercise, foot care, eye care, personal hygiene, self monitoring of basic symptoms of heart attack , glucose & hypertension and self care. The patients will be counselled in the presence of concern treating physician of the Hospital. The patients will be asked to come back for followup once in a 3 month, for a period of 90 days. During each follow-up, the patients will be educated, regarding their disease, medication and life style modification.
Initially, troponin levels , CPK ,ECG, base line blood plasma glucose level, BP were recorded for all 60 patients with the help of lab test record. Second intervention will be followed by collection of variable data record after 60 days of the first intervention. The dependent biochemical variable were troponin,  creatine kinase, myoglobin, and lactate dehydrogenase , total Cholesterol, Triglycerides. The independent variables were the Treatment Adherence Behaviour, Attitude toward Treatment Adherence. Age, gender, educational level, marital status, hypertensive and Anti MI prescription were used as control variables.

Data collection:
After getting informed consent, patients were invited to participate when they had an appointment with their physician follow up via phone calls, and then interviewed in order to complete a CRF regarding certain personal characteristics, as well as to register the medical prescription (Antiplatlet drugs, Anti -anginal agents especially nitrates and beta blockers.)Three month later, the patients again visited to record study variables and treatment satisfaction and thereafter 6 months for the final data collection 3. RESULTS

Study Population
A baseline data of MI patients (n=60) were recorded initially and were followed up to Eight week for improvement in heart conditions and quality of life. Only patients (n=49) responded in 1 st follow up (4 weeks) and patients (n=36) responded in 2 nd follow up (next 4 weeks). Total 11 and 24 patients were failed to respond in 1 st and 2 nd follow up respectively. Patients received counseling for adherence at each follow up.

Baseline Demographic Detail of Patients 3.2.1 Age
Out of total enrolled 60 study patients, 32 patients (53.3%) with age ≤50 yr and 28 patients (46.7%) with age >50 yr were found, represented in table  (Table 1).

Obesity Details between Male and Female
Obesity details of patients of both sex, based on their BMI Data showed that 14 patients (23.3%) were obese as shown in table 5.

Medical History of MI Patients
All 60 patients were questioned for previous medical history i.e. complications and comorbid conditions and were collected for all enrolled patients. Hypertension and other chronic diseases considered as comorbid conditions whereas CAD, retinopathy, neuropathy, nephropathy, ED and diabetic foot considered as complications. About 21.66% patients without complaint and 78.33% with complaint were recorded. Under this study, total 60 patients were enrolled who undergone heart surgery and treated with anti anginal drugs, anti platlet drugs, antihypertensives, hypolipidemics and oral hypoglycaemic drugs and Insulin. Baseline data recorded at the initiation of study shows that out of total 60 patients, majority of patients were between 40-60 yr age group and were 78% male patients and 22% female patients. Most patients were belonged to urban area (79%) and had heart disease for long periods. Five male patients were newly diagnosed and were under 39 yr. of age. Out of 60 patients, 28 patients were ˃ 50 yr of age and 32 patients were ≤ 50 yr of age. Out of 60 patients of both sexes, there were 25 patients with 6-15 yr duration of heart disease , 21 patients with ˂5 yr duration and 14 patients with ˃15 yr duration of heart disease were found. Under study, 14 patients (23.3%) were found obese and 38.3% were overweight and prone to obesity and rest were normal weight individuals. Baseline data shows that out of total 60 patients, majority of patients (47 patients) were recorded with complications and only thirteen patients without any complications. It was observed that patients were suffered from acute metabolic complications like arrhythmias and cardiogenic shock. Similarly, out of total 60 patients, 46.66% patients with retinopathy, 26.66% with neuropathy, 3.33% with nephropathy, 35%% only male patients with erectile dysfunction and only 16.6% patients with diabetic foot or ulcer were reported. Baseline data most importantly focused that majority of patients were suffered from coronary artery disease followed by MI. About 48.33% patients reported that they had CAD and are cured. Similarly 46.66% patients were with comorbid condition i.e. Hypertension out of total 60 patients. Only four female patients reported with thyroid dysfunction. Follow up observations especially fasting and post prandial blood glucose and systolic and diastolic blood pressure, Cholesterol,CPK, Troponin level, body mass index were statistically analyzed with simple mean comparison method and adherence to pharmacotherapy in percentage was also recorded. Findings of this study are consistent with the previous observations that proper management and treatment adherence improves heart conditions. Descriptive statistics of whole population (male) shows significant reduction in different variable as an impact of patient counselling on adherence and adherence to pharmacotherapy itself. Troponin level and CPK values were reduced significantly 16 Quality of life data were recorded at Pre and post surgical procedures , pharmacotherapy and then compared. When QOL data before and after therapy was compared for five dimensions viz. mobility, self care, usual activity, pain & discomfort and anxiety & depression, they revealed that there was improvement in patients with all five dimensions. Out of total 60 Patients, 83.7%, 91.8%, 75.5%, 69.4% and 65.3% Patients reported no problem for mobility, self care, usual activity, pain & discomfort and anxiety & depression respectively in Post surgical QOL that was 75%, 86.7%, 68.3%, 23.3% and60% in Pre surgical QOL. No patient reported severe problem for mobility and usual activity in after QOL that was 8.3% and 8.3% for mobility and usual activity in before QOL. Reduction was seen in severe problems of patients with self care, pain & discomfort and anxiety & depression. Similarly reduction in complaints of some problem was also observed. Maximum improvement was seen in self care activity where 91.8% patients reported no problem after QOL. Maximum patients (21.7%) complained for severe problem of pain & discomfort in before QOL but after QOL it reduced to only 2% that was significant reduction. Self care was the only dimension for which highest no of patients (86.7%) were reported no problem in before QOL. Similarly pain & discomfort dimension received minimum 23.3% patients with no problem in before QOL. Study also revealed that patients affected with anxiety and depression reported that these complications are largely linked with heart patients. Study data revealed that male were with fewer attitudes to adherence than females and under study majority of patients of both sexes showed no attitude to give adherence during whole study period. Although improvement in adherence was seen for both sexes but females were observed with more adherence (93.75 and 96% for 1 st and 2 nd follow up respectively) than males after patients counselling.
Females showed significant improvement than males in 91-95% and ˃ 95% adherence group. No change was observed under adherence group 86-90% for both sexes. Comparison of different adherence groups for their Troponin levels and CPK values revealed that significant reduction was seen in Troponin level and CPK values when patients showed adherence more than 95%. Study data for pharmacotherapy revealed that majority of patients received Antiplatlets and anti-anginals than little difference with combination therapy. It was revealed that combination of clopidogrel and aspirin , beta blockers and statins received more faith of physician to treat MI thus majority of patients received above said combination. Under insulin treatment, both short and long acting insulin were used in combinations with oral hypoglycaemic drugs for majority of patients suffering from diabetes as well. Along with these drugs ACE inhibitors and Calcium channel blockers was also prescribed for few patients. Study data showed that 91.7% patients were without any reaction or event. Only five cases of adverse event or reaction were reported under whole period of study. During study period only one female patient complaint for allergic reactions whereas four male complained for MI attack and were hospitalized. No acute complications and other comorbid conditions except hypertension and diabetes were observed. Study showed that about 100% patients were fully satisfied with treatment prescribed to them. 5. DISCUSSION Patients with heart disease require self management and a life time struggle to maintain and increase the QOL .Post surgical heart patients requires special care and a good medical adherence regarding pharmacotherapy and counselling. Although treatment plans improves or include strategies to enhance patients QOL. Prospective analysis of impact of pharmacotherapy adherence on treatment effectiveness in post surgical heart patients is associated with post surgical treatment adherence ,behaviour, self care , quality of life and patients counselling. Under this study, total 60 patients were enrolled who undergone heart surgery and treated with anti anginal drugs, anti platlet drugs, antihypertensives, hypolipidemics and oral hypoglycaemic drugs and Insulin. Baseline data recorded at the initiation of study shows that out of total 60 patients, majority of patients were between 40-60 yr age group and were 78% male patients and 22% female patients. Most patients were belonged to urban area (79%) and had heart disease for long periods. Five male patients were newly diagnosed and were under 39 yr. of age. Out of 60 patients, 28 patients were ˃ 50 yr of age and 32 patients were ≤ 50 yr of age. Out of 60 patients of both sexes, there were 25 patients with 6-15 yr duration of heart disease , 21 patients with ˂5 yr duration and 14 patients with ˃15 yr duration of heart disease were found. Under study, 14 patients (23.3%) were found obese and 38.3% were overweight and prone to obesity and rest were normal weight individuals. Baseline data shows that out of total 60 patients, majority of patients (47 patients) were recorded with complications and only thirteen patients without any complications. It was observed that patients were suffered from acute metabolic complications like arrhythmias and cardiogenic shock. Similarly, out of total 60 patients, 46.66% patients with retinopathy, 26.66% with neuropathy, 3.33% with nephropathy, 35%% only male patients with erectile dysfunction and only 16.6% patients with diabetic foot or ulcer were reported. Baseline data most importantly focused that majority of patients were suffered from coronary artery disease followed by MI. About 48.33% patients reported that they had CAD and are cured. Similarly 46.66% patients were with comorbid condition i.e. Hypertension out of total 60 patients. Only four female patients reported with thyroid dysfunction. Follow up observations especially fasting and post prandial blood glucose and systolic and diastolic blood pressure, Cholesterol,CPK, Troponin level, body mass index were statistically analyzed with simple mean comparison method and adherence to pharmacotherapy in percentage was also recorded. Findings of this study are consistent with the previous observations that proper management and treatment adherence improves heart conditions. Descriptive statistics of whole population (male) shows significant reduction in different variable as an impact of patient counselling on adherence and adherence to pharmacotherapy itself. Troponin level and CPK values were reduced significantly 16 complained for severe problem of pain & discomfort in before QOL but after QOL it reduced to only 2% that was significant reduction. Self care was the only dimension for which highest no of patients (86.7%) were reported no problem in before QOL. Similarly pain & discomfort dimension received minimum 23.3% patients with no problem in before QOL. Study also revealed that patients affected with anxiety and depression reported that these complications are largely linked with heart patients. Study data revealed that male were with fewer attitudes to adherence than females and under study majority of patients of both sexes showed no attitude to give adherence during whole study period. Although improvement in adherence was seen for both sexes but females were observed with more adherence (93.75 and 96% for 1 st and 2 nd follow up respectively) than males after patients counselling.
Females showed significant improvement than males in 91-95% and ˃ 95% adherence group. No change was observed under adherence group 86-90% for both sexes. Comparison of different adherence groups for their Troponin levels and CPK values revealed that significant reduction was seen in Troponin level and CPK values when patients showed adherence more than 95%. Study data for pharmacotherapy revealed that majority of patients received Antiplatlets and anti-anginals than little difference with combination therapy. It was revealed that combination of clopidogrel and aspirin , beta blockers and statins received more faith of physician to treat MI thus majority of patients received above said combination. Under insulin treatment, both short and long acting insulin were used in combinations with oral hypoglycaemic drugs for majority of patients suffering from diabetes as well. Along with these drugs ACE inhibitors and Calcium channel blockers was also prescribed for few patients. Study data showed that 91.7% patients were without any reaction or event. Only five cases of adverse event or reaction were reported under whole period of study. During study period only one female patient complaint for allergic reactions whereas four male complained for MI attack and were hospitalized. No acute complications and other comorbid conditions except hypertension and diabetes were observed. Study showed that about 100% patients were fully satisfied with treatment prescribed to them. 6. CONCLUSION This prospective, pilot, observational study performed confirmed the hypothesis that systematic identifications and interventions administered through continued physician follow-up and patients counselling will improve adherence to therapy and therefore improvement in treatment effectiveness by lowering especially Troponin level ,CPK and quality of life in MI patients. Study conclusion shows lack of proper knowledge about disease and patients counselling and chronic treatment, most of patients takes disease and its treatment lightly and shows lower adherence attitude. From study analysis it can be concluded that female are generally more aware than males for adherence. Study analysis concluded that there was significant reduction in their Troponin level and CPK values in different comparison groups after each level of follow up. Statistical analysis concluded that patients with adherence ˃ 95% showed significant reduction in Troponin level and CPK values and patients with age group ≤50 shows more adherence than older. Thus it can be concluded that for better control of MI attack and therefore quality of life, patient should have 100% adherence to pharmacotherapy and what advice has been given to him. Study conclusion shows that most heart patients recorded with hypertension and Coronary Artery Diseases only few ones with diabetic complications. During study patients shows good control over their blood pressure and only few adverse events but no complications occur during study period. Similarly study analysis concluded that post operative heart patients were fully satisfied with the treatment, had been given to them by physician at study site.