Introduction - Evaluating the Efficacy of Combination Medications
A polypill is defined as a pill that has contents of different medicines combined. It is used in treating heart disease and maintaining high blood pressure. The health care professionals and health workers are not sure about the use of the drug polypill or what is the best combination of that drug that is suited for treating the diseases. In cases like this, the dose of the drug becomes low. The polypill is effective in reducing blood pressure levels and the level of cholesterol. Several studies are associated with the combination of the drug and whether it will lower the rate of death from cardiovascular disease or strokes. There are some concerns regarding polypill. There are some side effects of using this drug. However, the rate of side effects increases if the drug is taken individually without combining it with any other components of the medicine. The side effects of polypill include muscle aches, irritation in the stomach, dry cough etc. The doses of polypill cannot be adjusted with any other medicines. It is considered a drawback of using this drug.
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Mechanism, Potential Risks And Rationale Of The Combination Drugs
Aspirin
The preventive effect of polypills on cardiovascular diseases is done in a widespread way in the current times. The main causes of cardiovascular diseases are the increased level of cholesterol, high blood pressure, and also a risk of accumulated fats in the arteries that block the smooth blood flow. The polypill is the combination of two or more treatment-based medicine which is widely used as preventive care for cardiovascular diseases, one of which is Aspirin. Aspirin helps in reducing the cholesterol level which helps in eliminating the accumulated cholesterol-based protein-accumulated fats that block the smooth functioning of the heart (Pereira et al., 2019). Additionally, it reduces the risk of cancer which is also one of the main causes being investigated for treatment. Thereafter, research pieces of evidence from the drug trials that were conducted show that polypill has been effective in reducing the causes of neurodegenerative diseases in humans, and thus, they can be effectively used as preventive care for the treatment of cardiovascular diseases. Moreover, the preventive percentage has been comparatively high in treating these three diseases.
Ace Inhibitors are generally effective in the treatment of cardiovascular diseases as it helps reduce the high blood pressure in humans with these diseases. It also helps in relaxing the arterial muscles that contribute to increased blood pressure. Additionally, the pressure created on blood vessels which is another cause for irregular heartbeats that can cause cardiovascular diseases can be prevented with the help of Ace inhibitors. Furthermore, ace inhibitors help in preventing dementia in patients and them also help with Alzheimer's disease. Lewy body dementia, specifically, is treated with the help of ace inhibitors (Elefthiaridis et al., 2021). Moreover, it works in the brain by counteractive actions on cholinesterase that helps in preventing the degeneration process, hence, improvising the cognitive processes of that patient. Furthermore, Ace inhibitors have been successfully examined for preventing cancer in humans through drug trials. Yet research evidence does not show successful or high rates of prevention in cancer but actually, increases the risk of cancer by its administration. Moreover, the ace inhibitors do not successfully guarantee the reduction of the mass tissues that causes cancer and they also do not guarantee the prevention of cancer at a successful rate.
Statin
Statins are combined as a group of medicines that affect lowering the level of cholesterol and the level of low-density lipoprotein which is termed as "LDL" Various Statin drugs are present which are appropriate for the management of diseases and have five benefits besides some risks and benefits. “Atorvastatin (Roshandel et al. 2019))” is known as the most common statin drug which is used for the management of the cholesterol level and triglycerides in the human blood (). Therefore, management of the body's cholesterol level helps to prevent cardiac disease which is known as age-associated disease. In the analysis of the impacts of the selected drug, Statin is identified that helps to manage cholesterol levels for the patient with higher cholesterol levels. Cholesterol-related plaques are deposited in the blood vessels which raise the risk for cardiovascular disease and that is managed by the use of statin (Coca et al. 2020). On the other side, the use of statin drugs is lower in incidence related to "neurodegenerative conditions or NDD" with the fluvastatin exceptions. Therefore, in the critical analysis effectiveness is identified for use of statin drugs for the management of those. An analysis based on the working effect of polypill statin therapy is associated with the minimizing effect of mortality rate in the year between 2 to 6 years, which is not significant evidence.
In the analysis of the effectiveness of statin in the management of cancer situations, metastasis in vivo is reduced in various types of cancer. Therefore, osteolytic lesions are prevented which helps to manage the extreme situation of cancer.
Existing evidence of polypill as a Preventive Agent against Age-Related Conditions (CVD, Neurogenerative Conditions and Cancer)
Polypills have been approved in different countries. The experience and the availability of polypills have been limited and with the fixed dose of combinations they have been associated with many diseases are CVD, neurodegenerative diseases and cancer. There is a purpose of the drug polypill to use in future research and activities related to clinical uses. The availability of the drug polypill remains limited so it is used in limited diseases to cure (Patel et al. 2020). The use of polypills can be distributed in the populations for providing indication which can influence the balance that is in between the benefits and the risk. The population includes secondary prevention and primary prevention of diseases which is in the high-risk category. The population for each specific purpose is taken for the assessment of the risk which includes the age and is treated in a mass community. The primary measurement of polypill is to measure the factors that are associated with risk. Cardiovascular disease is a vital cause of death and disability that happens all over the world (Miranda, 2022). The burden of the disease has decreased in developing countries using preventive measures and treatment based on the strategies that are implemented. The drug polypill is a combination of fixed doses of medicines that have been detected with benefits that have been proven to prevent cardiovascular diseases. In the community, population-based strategies are implemented to see the advantages of the drug polypill that has potential and also the pharmacotherapy of the drug polypill (Yusuf and Pinto, 2022). The polypill is a management strategy that is used as an alternative to treat or diagnose diseases. The dose of polypill has been set with a fixed amount to provide the therapy as an approach to relief the pain in cardiovascular disease (Stanciu et al. 2020). There are four components present in polypill that have an effect in treating the diseases. The components include aspirtin,hydrochlorothiazide, enalapril and atorvastatin. These components and their effects have proven evidence in preventing cardiovascular disease in both primary and secondary prevention. In the primary prevention of the disease, there are some concepts regarding the hypothesis of using polypills. The trials are done randomly to find the levels of folic acid that do not affect event rates and the component aspirin may have some effects on the benefit to proven risk (Wahl et al. 2021). The adherence to the drug polypill is well anticipated. The drug has a screening based on the age of the population that is intended to screen the absolute risk. The state of adherence can get better with the changing formulation of the drug polypill (Joseph and Yusuf, 2022). It is one of the main reasons for the growth of the research interest. There are many issues regarding polypills and for that FDA has not approved the polypill to prevent cardiovascular disease. The patients with cardiovascular diseases have shown the rate of mortality is lower in comparison with the patients who do not take the polypill drug (Cosin-Sales et al. 2021). There is a comparison of two or more drugs with single components. There are different studies about the effects of polypills in treating cardiovascular disease in a specific population.
Need for RCT
RCT or Randomized Controlled Trials are eventually the blueprints that help in evaluating the effects of a specific drug that would help in the treatment or prevention of certain diseases in human patients. The journey of a medical drug starts with randomized controlled trials that help in analyzing and observing the effects it produces in humans. Additionally, each drug is conducted by a trial that would help in observing the effects of these drugs and thus, generalizing these results as soon as possible (Pereira et al., 2019). The generalization of the results would then permit the use of drugs in the population by the government. For example, the covid vaccines were first put through various stages of trials before finalizing and permitting their use on the population by the government. Thereafter, the significance of RCT is that it is necessary for conducting the trials of the drugs that would then be permitted to use on the population.
The explanation for Choice of Comparators
The choice of comparators is necessary as it would give the necessary details when evaluating a drug against the other. The comparative drugs are used as placebos to see the effects of the original drug that has to be observed when the drug is administered. The randomized controlled trials would pave the way for the administering of the sample chosen from the population. Thereafter, the drug polypill is proposed to have the combination of the above three medicines that are aspirin, ace inhibitors, and statin (Elefthiaridis et al., 2021). The polypill is also known as the magic pill as it determines the effect on the three major diseases cardiovascular diseases, neurodegenerative diseases, and cancer. Therefore, the drug trials will help put light on the effects this drug is producing along with any side effects. Moreover, it also helps in depicting the preventive measures it might have in controlling these diseases.
Set-Up-Stage Foreseeable Risks and Corresponding Mitigations
The benefits and effects of polypill which is identified as the drug which is developed as a combination drug in the population. “Cough, muscle aches, and stomach irritation” are the common risk factors that are identified as the side effects of the mentioned combination drugs. The mentioned side effects or risks are identified based on the RCT of the drug. The drugs which are combined in the treatment of mentioned three diseases are provided with some side effects which are related to the management of diseases. As an example, prolonged use of statin-identified "colorectal cancer" is developed in the patient (Beg et al., 2020). Therefore, the mentioned risk factors are not only relevant to cancer management but also relevant to the management of this situation such as CVD or enzyme diseases. Therefore, management of those mentioned risk factors during the RCT process may add value to the management of risk factors.
Use of the appropriate management strategy for mitigation of the risk-oriented risk of age-related diseases is essential. Primary prevention of CVD is managed effectively with the appropriate use of USPSTF recommendations that may help to manage the appropriate situation (Pereira et al., 2020). Therefore, the identified strategy may be appropriate for the management of the diseases which are mentioned and they are adding values more with more research with the use of RCT.
Moreover, the blueprints of RCT will also help in further application on the population who are expected to have these diseases in the future. Thereafter, the drug trials also help in analyzing the effects in the future in how they will have any preventive measures or drastic side-effects (Bacskay et al., 2022). Therefore, the combination of the three medicines along with the preventive measures is encompassed in the polypill drug, and it is said to have preventive measures. Hence, the magic pill is thus tested to have preventive measures for the three diseases mentioned above.
References
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Coca, A., Kreutz, R., Manolis, A.J. and Mancia, G., 2020. A practical approach to switch from a multiple-pill therapeutic strategy to a polypill-based strategy for cardiovascular prevention in patients with hypertension. Journal of hypertension, 38(10), pp.1890-1898.
Cosin-Sales, J., Murcia-Zaragoza, J.M., Pereyra-Rico, H.O., la Guía-Galipienso, F.D., Hermans, K. and Rubio, G., 2021. Evaluating patients' satisfaction and preferences with a secondary prevention cardiovascular polypill: the Aurora Study. Journal of Comparative Effectiveness Research, 10(13), pp.975-985.
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