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Introduction: Cardiovascular diseases (CVDs) are a range of blood vessel and heart problems. Cardiovascular complications are any situations that may cause cardiac muscle injury. In terms of mortality rates, cardiovascular disease (CVD) ranks high. Our study's primary objective was to examine the effect of polypill on future cardiovascular events in a sizable group of post-MI patients. Methodology: A single-blind, randomized controlled trial was done from June 2021 and July 2022. Randomization assigned 1104 patients (552 males and females) to either the polypill group (100 mg Aspirin, 40 mg Atorvastatin, and 10 mg Ramipril) or standard treatment group. The two sample student's t- test and chi-square test were used to compare the groups. Results: Participants in the experimental group were found to age of 43.44 ± 5.78 years old, while control group were 52.98 ± 5.76 years old. Regarding the outcome measures, the study group showed better results compared to the control group. The study group had lower systolic blood pressure (M = 141.36, SD = 2.46) and lower levels of LDL cholesterol (M = 42, SD = 4.76), as well as higher levels of HDL cholesterol (M = 66, SD = 5.65) and lower levels of triglycerides (M = 129, SD = 4.85) compared to the control group. 165 patients (29.89%) died in study group & 247 (44.74%) patients had improved quality of life. 214 (38.76%) patients died in control group and only 127 (23%) patients had improved quality of life. Conclusion: Combination therapy has been shown to reduce the risk of vascular events and overall mortality in a clinical trial. Although it is important to use caution when interpreting treatment impact in observational studies, the findings of this investigation provide credence to the idea that combination therapy is beneficial. Keywords: Cardiovascular diseases, polypill, secondary prevention, Aspirin, Atorvastatin, Ramipril METHODS Trial design and trial population We conducted choice randomization to randomly show the response alternatives to study participants. It avoids sequence bias induced by respondents' propensity to select the first choice when an identical order is provided to various respondents. It was a single blinded; randomized controlled clinical trial comparing a Polypill to Standard Practice (defined as usual care administered to patients with similar conditions). This single centered study was conducted at the department of Medicine at KRL hospital, Islamabad from June 2021 till July 2022. The online randomization software was used to generate randomization plan using block randomization procedure was presented. Randomization via online randomization method was used, so that every patient had equal chances of falling into any of the two groups. All patients presenting post-MI were eligible for the study and excluded if they did not have a recent history of MI. Our study is fully compliant with the CONSORT 2010 guidelines [13]. A complete STROCSS 2021 checklist has been provided as a supplementary file. Our research adheres to the principles outlined in the Helsinki Declaration. Ethical review board committee of the hospital was approached to get the ethical approval for this study. A written informed consent was taken from all the potential participants of this study before the start of study after complete description of the trial and clear understanding of both forms of treatment. They were told about their right to withdraw themselves at any time from this trial. Intervention A Polypill (containing 100 mg Aspirin, 40 mg Atorvastatin, and 10 mg Ramipril) was compared to the level of Standard Practice as defined by the study investigators. Standards of practice are the "how-to" of a field or clinical specialty. These comprised medical policy recommendations, standards of practice, basic clinical practice methods, and diagnostic methods. Decisions related to discontinuing the study interventions or adding medications during study participation were made at the discretion of the specialist physicians who were in charge of patient care. Outcomes Outcomes were changes in Lipid profile, cholesterol level and systolic blood pressure from baseline to study end. Statistical analysis SPSS 24.0 was used to analyze the data for this study. Mean and standard deviation was calculated for age of the study participants. Frequency and percentages were calculated for gender, number of patients which were included in both groups after the process of randomization and patients with complete, partial and no response to the treatment. Comparison in the groups was made with the help of two sample student's t- test & chi-square test keeping p-value of less than or equal to 0.05 as significant. The p-value p=0.05 was considered significant as p values give a measure of the degree of data compatibility with the null hypothesis. |
