qsymia
Understanding the Core Components: Phentermine and Topiramate
To truly grasp how Qsymia works, one must first comprehend the roles of its two constituent parts. This isn't just about combining two medications; it's about a synergistic effect where the whole is greater than the sum of its parts. Each drug, on its own, has a distinct purpose, and their combination in a single extendedrelease capsule creates a powerful dualaction formula targeting multiple pathways involved in appetite regulation and metabolism. The strategic pairing of these two agents is what sets Qsymia apart from singleagent treatments and has made it a cornerstone of modern pharmacological weight management.
Phentermine: A Central Nervous System Stimulant and Appetite Suppressant
Phentermine is a sympathomimetic amine, a class of drugs that acts on the central nervous system to suppress appetite. Its mechanism of action is multifaceted but primarily involves the release of norepinephrine and, to a lesser extent, dopamine, from nerve terminals in the brain. This neurochemical action is concentrated in the hypothalamus, the brain region responsible for regulating hunger and satiety. By increasing the levels of these neurotransmitters, phentermine creates a feeling of fullness or satiety, thereby reducing food intake. It effectively tricks the brain into thinking the body has been fed, even when it hasn't, making it significantly easier for patients to adhere to a reducedcalorie diet. Phentermine's role is to provide the immediate, tangible feeling of appetite control that is so often the first hurdle in any weight loss journey. It is a shortterm solution for appetite suppression, but its inclusion in Qsymia is what initiates the process of caloric deficit and behavioral change.
Historically, phentermine has been used as a shortterm treatment for obesity, typically for a few weeks, due to concerns about tolerance and potential for dependence. However, its use as a component of Qsymia is different. The lower, sustained dose of phentermine in the combination therapy mitigates some of the risks associated with its standalone use, while still providing powerful appetite suppression. This careful titration and pairing with another agent is a hallmark of the sophisticated approach behind Qsymia's formulation.
Topiramate: An Anticonvulsant with a Unique Impact on Weight
The second component, topiramate, is an anticonvulsant medication that has been used for years to treat epilepsy and prevent migraine headaches. Its inclusion in the Qsymia formulation was a groundbreaking development, as it addresses a different aspect of weight management. While the exact mechanism by which topiramate contributes to weight loss is not fully understood, it is believed to involve several pathways. It may work by altering the taste of certain foods, making them less appealing. It also appears to have a direct effect on appetite and satiety signals, potentially by modulating certain neurotransmitter systems and enhancing feelings of fullness. Furthermore, topiramate may increase energy expenditure, helping the body burn more calories. This dual action—reducing calorie intake and potentially increasing calorie burn—is a key part of Qsymia's effectiveness. By providing an extendedrelease form of topiramate, the formulation ensures a consistent level of the drug in the body, helping to maintain its effects throughout the day and night, thereby addressing cravings that might occur outside of traditional mealtimes. The longterm effect of topiramate on metabolic pathways and cravings is what provides the staying power to Qsymia's weight loss results, distinguishing it from shortacting appetite suppressants.
The synergy between phentermine and topiramate is the true genius of Qsymia. Phentermine delivers immediate appetite suppression, helping patients get over the initial hump of hunger and cravings. Topiramate, on the other hand, provides a sustained, longterm effect that addresses the more complex issues of food preferences, satiety, and metabolism. Together, they create a comprehensive solution that not only helps individuals lose weight but also helps them sustain that loss over time by addressing the root causes of their eating habits and metabolic challenges. It is a powerful onetwo punch that tackles the problem of chronic weight management from multiple angles, leading to superior clinical outcomes when used in conjunction with a reducedcalorie diet and increased physical activity. This combination also allows for the use of lower doses of both medications compared to their standalone applications, potentially mitigating the risk of side effects while maintaining a potent therapeutic effect.
Who is Qsymia For? The Indications and Patient Profile
It is critically important to understand that Qsymia is not a magic pill for casual weight loss. It is a powerful prescription medication intended for specific populations. The FDA has approved Qsymia for chronic weight management as an adjunct to a reducedcalorie diet and increased physical activity in two primary groups:
- Adults with an initial Body Mass Index (BMI) of 30 kg/m² or greater (obese).
- Adults with an initial BMI of 27 kg/m² or greater (overweight) in the presence of at least one weightrelated comorbidity. These comorbidities can include conditions such as hypertension (high blood pressure), Type 2 diabetes mellitus, or dyslipidemia (abnormal levels of fats in the blood).
Furthermore, Qsymia has received FDA approval for pediatric use in adolescents aged 12 years and older with a BMI in the 95th percentile or greater, standardized for age and sex. This expansion of its indication underscores its proven effectiveness and safety in a carefully monitored younger population. The decision to prescribe Qsymia is a significant one, made in close consultation between a patient and their healthcare provider after a thorough evaluation of the patient's medical history, current health status, and weight loss goals. This is a drug for serious, medicallysupervised weight management, not a quick fix. We emphasize that Qsymia should only ever be used under the direct supervision of a qualified healthcare provider, as they are the only ones who can determine if the benefits outweigh the risks for a particular individual. The prescribing physician will also carefully monitor the patient for any potential side effects or complications, adjusting the dosage or discontinuing the medication as needed. This is not a "set it and forget it" treatment; it is an active partnership between the patient and their medical team. The longterm success of Qsymia treatment is highly dependent on this ongoing clinical oversight and patient commitment to lifestyle modifications.
Dosing and Administration: A StepbyStep Guide
The successful use of Qsymia hinges on a precise and carefully managed dosing schedule. The manufacturer has designed a specific titration process to help the body adjust to the medication and to minimize the potential for side effects. This is a critical aspect of treatment, and patients must adhere to their doctor's instructions meticulously. The medication is available in four different extendedrelease capsule strengths, which are used to achieve the optimal therapeutic dose for each patient. It is taken once daily in the morning, with or without food, to prevent the risk of insomnia due to the stimulant effect of phentermine. The dose is initiated at the lowest strength and gradually increased over time as tolerated and based on clinical response.
The Standard Dosing Schedule
- Initial Dose (Starting Dose): The recommended starting dose is 3.75 mg phentermine/23 mg topiramate extendedrelease taken once daily in the morning for the first 14 days. This low dose allows the patient to acclimate to the medication and provides a preliminary assessment of tolerance.
- Maintenance Dose: After the initial 14day period, the dosage is increased to the recommended daily dose of 7.5 mg phentermine/46 mg topiramate extendedrelease. This is the dose at which many patients achieve significant weight loss.
At the 12week mark, a critical evaluation is performed. The healthcare provider will assess the patient's progress. If the patient has not lost at least 3% of their baseline body weight with the 7.5 mg/46 mg dose, the provider may decide to either discontinue the medication or escalate the dose to a higher therapeutic level. This is a key inflection point in the treatment plan, ensuring that the medication is working effectively for the individual. If the medication is not producing the desired results, it may not be the right choice for that patient, and a different approach may be considered. The decision to continue or discontinue treatment is a shared one between the patient and the physician, based on objective clinical data.
Dose Escalation and Tapering
For patients who have achieved less than 3% weight loss after 12 weeks on the 7.5 mg/46 mg dose, the physician may choose to escalate the dose to 11.25 mg phentermine/69 mg topiramate extendedrelease daily for another 14 days, followed by the highest dose of 15 mg phentermine/92 mg topiramate extendedrelease daily. This is the highest approved dose and is reserved for patients who require more significant intervention. After an additional 12 weeks on this highest dose, a second evaluation is performed. If the patient has not achieved at least 5% total body weight loss from baseline, it is recommended to discontinue the medication. This protocol is in place to ensure that patients are not taking a medication that is not providing clinically meaningful results. The dose should also be tapered gradually upon discontinuation, particularly the higher doses, to avoid the risk of withdrawal symptoms. Abruptly stopping topiramate can lead to seizures, especially in individuals with a history of seizure disorders. This is a crucial safety measure that must be followed under a doctor's guidance.
Clinical Efficacy: What the Studies Say About Qsymia
The effectiveness of Qsymia is not anecdotal; it is backed by extensive clinical trials that have demonstrated its ability to produce significant and sustained weight loss. These studies provide the empirical evidence that has made Qsymia a trusted tool for chronic weight management. The clinical trials, known as the EQUIP, CONQUER, and SEQUEL studies, are the cornerstones of the data supporting Qsymia's efficacy. They involved thousands of patients and provided a robust look at the medication's performance compared to placebo, as well as its longterm effects. These studies were rigorous, doubleblind, and placebocontrolled, the gold standard for clinical research. They measured not only weight loss but also improvements in weightrelated comorbidities, providing a holistic view of the medication's benefits. The results of these trials are what give us the confidence to recommend this treatment for appropriate candidates.
The EQUIP, CONQUER, and SEQUEL Trials
The EQUIP trial focused on a population of adults who were obese (BMI ≥ 35). Patients in this study, who were on the highest dose of Qsymia (15 mg/92 mg), achieved an average weight loss of approximately 14.4% of their body weight at one year, a remarkable result when combined with lifestyle intervention. The CONQUER trial was a phase 3 study of overweight and obese adults with at least two weightrelated comorbidities. In this study, patients on the recommended dose of 7.5 mg/46 mg achieved an average weight loss of 10.2% of their body weight, while those on the higher dose of 15 mg/92 mg achieved an average weight loss of 11.4%. The SEQUEL trial was a longterm extension of the CONQUER study, following patients for two years. The results showed that patients who continued on Qsymia maintained their weight loss over the twoyear period, demonstrating the drug's ability to not only help with initial weight loss but also to sustain it over the long term. This is a critical point, as many weight loss treatments fail in the maintenance phase. Qsymia's performance in this area is a key differentiator.
Beyond the impressive numbers, the clinical trials also demonstrated significant improvements in a number of health markers. Patients on Qsymia experienced notable reductions in blood pressure, improvements in cholesterol and triglyceride levels, and better blood sugar control in those with Type 2 diabetes. These are not just aesthetic benefits; they are tangible health improvements that can significantly reduce the risk of cardiovascular disease, stroke, and other lifethreatening conditions. The comprehensive benefits of Qsymia extend far beyond the scale, improving the overall health and wellbeing of the patient. The data from these trials is not just a collection of statistics; it is a testament to the lifechanging potential of this medication when used as part of a comprehensive weight management plan. It is the foundation upon which its reputation for efficacy is built. The robust body of evidence is what makes it a preferred choice for many healthcare providers in the field of obesity medicine.
Potential Side Effects and Important Safety Information
While Qsymia is an incredibly effective medication, we would be remiss if we did not provide a comprehensive and transparent look at its potential side effects. Like any powerful drug, it is not without risks, and understanding these is paramount for both patient safety and informed decisionmaking. The vast majority of side effects are mild to moderate and tend to resolve over time as the body adjusts. However, some are more serious and require immediate medical attention. It is our duty to provide a complete picture so that patients can be vigilant and proactive in their care. The information presented here is not a substitute for the official medication guide or a consultation with a healthcare provider, but it is an exhaustive resource to help patients know what to look for and when to be concerned. The safety profile of Qsymia is welldocumented, and the existence of a special restricted distribution program, the Qsymia REMS (Risk Evaluation and Mitigation Strategy) program, underscores the importance of close clinical monitoring, particularly for certain highrisk populations. The REMS program is in place to ensure that the benefits of the medication outweigh the risks, and it provides a structured framework for safe use. This is a hallmark of a responsible and carefully managed pharmaceutical product.
Common Side Effects
The most commonly reported side effects, which affect a significant portion of patients, include:
- Paresthesia: A tingling or "pins and needles" sensation, most often in the hands and feet. This is a very common side effect of topiramate and often subsides with continued use.
- Dry Mouth (Xerostomia): A frequent side effect that can be managed by staying wellhydrated.
- Constipation: Can often be alleviated through dietary changes, such as increasing fiber intake, and staying hydrated.
- Dizziness and Insomnia: These are common, especially in the initial stages of treatment. Taking the medication in the morning can help mitigate insomnia.
- Dysgeusia: A change in the sense of taste, with a metallic or sour taste being a common complaint.
- Upper Respiratory Tract Infection: Reported in some clinical trials.
- Headache: Can be a mild to moderate side effect.
These common side effects are usually transient and manageable, and they do not necessitate discontinuation of the medication in most cases. However, if they are persistent, bothersome, or worsen, a patient should always discuss them with their doctor. The healthcare provider may be able to suggest strategies for managing them or may consider a dose adjustment. The key is open communication and active management. Patients should not suffer through these symptoms in silence. Early intervention and management can make a world of difference in a patient's comfort and adherence to the treatment plan. It is a partnership in health, where the patient provides feedback and the doctor provides guidance and solutions.
Serious Side Effects and Warning Signs
While less common, some side effects are more serious and require immediate medical attention. These are the symptoms that a patient should be aware of and should never ignore. They are the reason Qsymia is a controlled substance and requires careful monitoring. Patients should be educated on these risks before beginning treatment. The doctor's office should provide clear instructions on what to do if these symptoms appear. This is not a list to scare patients, but rather to empower them with the knowledge to protect themselves. This is why the REMS program is so critical, as it ensures that patients are given the necessary information to make informed decisions and to act quickly if a serious issue arises. These are not "whatifs," but rather a part of the informed consent process for a powerful medication. The vigilance of both the patient and the physician is the ultimate safeguard.
Fetal Toxicity
One of the most significant and welldocumented risks of Qsymia is the potential for fetal toxicity. Topiramate, the anticonvulsant component of Qsymia, is associated with a higher risk of oral clefts (cleft lip and cleft palate) in infants born to women who take the medication during the first trimester of pregnancy. This is why Qsymia is contraindicated in women who are pregnant. For women of childbearing potential, a negative pregnancy test is required before starting treatment and every month thereafter while on the medication. Furthermore, it is essential to use effective contraception consistently during treatment. This is a nonnegotiable safety measure and the primary reason for the restricted distribution program.
Acute Myopia and Secondary AngleClosure Glaucoma
A rare but serious ophthalmologic side effect is acute myopia (nearsightedness) and secondary angleclosure glaucoma. Symptoms can include a sudden decrease in vision, with or without eye pain or redness. These can occur at any time during treatment. If a patient experiences these symptoms, they must stop taking Qsymia immediately and seek emergency medical attention. If left untreated, this condition can lead to permanent vision loss. This is an urgent medical situation, and we cannot stress enough the importance of prompt action. The risk is small, but the consequences are severe, making it a critical warning to heed.
Metabolic Acidosis
Qsymia can cause an increase in the level of acid in the blood, a condition known as metabolic acidosis. This can occur with or without symptoms. Untreated, chronic metabolic acidosis can lead to a number of complications, including osteoporosis (brittle bones), kidney stones, and slowed growth in children. A patient's doctor should measure their blood bicarbonate levels before and during treatment with Qsymia to monitor for this condition. If it develops, a dose adjustment or discontinuation of the medication may be necessary. The monitoring of this particular side effect is a critical part of the longterm management of patients on Qsymia and highlights the necessity of regular checkups.
Suicidal Thoughts or Actions
Topiramate has been associated with an increased risk of suicidal thoughts or actions. Patients and their caregivers should be on the lookout for any signs of new or worsening depression, anxiety, agitation, irritability, or unusual changes in mood or behavior. If these symptoms occur, the patient should contact their doctor immediately. The risk is not specific to Qsymia but is a known side effect of topiramate, and it is a serious consideration that must be discussed openly with a healthcare provider before starting treatment. The mental health of a patient is just as important as their physical health, and this aspect of the medication's safety profile cannot be overlooked.
Increased Heart Rate
Phentermine, a central nervous system stimulant, can cause an increase in heart rate. While this is often a mild and transient effect, it is a serious concern for patients with preexisting heart conditions. Patients should monitor their heart rate, especially in the initial stages of treatment, and report any significant increases or palpitations to their doctor. This is a common and predictable side effect of the stimulant component and is a key reason why Qsymia is not for everyone. The prescribing doctor will carefully evaluate a patient's cardiovascular history before initiating treatment to ensure that they are a suitable candidate.
Qsymia and Lifestyle: The Indispensable Role of Diet and Exercise
A central tenet of Qsymia's indication is that it is an "adjunct to a reducedcalorie diet and increased physical activity." This is not a throwaway phrase; it is the fundamental principle of successful chronic weight management. The medication is a powerful tool, but it is not a standalone solution. It is designed to work in synergy with a healthy lifestyle. Without a commitment to dietary changes and regular exercise, the longterm benefits of Qsymia will be limited, and the patient may not achieve the full potential of the treatment. The medication provides the support, but the patient must provide the effort. The synergy between medication and lifestyle is where true and lasting success is found. This is a point we cannot emphasize enough. We have seen time and time again that the most successful patients are those who view Qsymia as a catalyst for change, not a substitute for it. The medication makes it easier to eat less and move more, but it does not do the work for you. It empowers you to do the work yourself. This is the difference between a temporary fix and a permanent lifestyle transformation. The education and counseling provided by healthcare professionals on diet and exercise are just as important as the prescription itself. We encourage patients to work with a registered dietitian or a certified personal trainer to create a plan that is both sustainable and effective. This holistic approach is what separates a good weight loss journey from a great one.
The ReducedCalorie Diet
The diet component is crucial. Qsymia's effectiveness is based on the assumption that a patient will consume fewer calories than they expend. While the medication helps to control appetite, a patient must still make conscious choices about the quality and quantity of their food. A healthy, reducedcalorie diet should be rich in lean proteins, fruits, vegetables, and whole grains. It should be a balanced and nutritious eating plan, not a restrictive or fad diet. The goal is to create a sustainable pattern of eating that can be maintained for life, not just for the duration of the medication. The medication simply makes this easier to achieve. Patients should avoid processed foods, sugary drinks, and excessive saturated fats, which are often high in calories and low in nutritional value. The medication provides a window of opportunity to reset eating habits and build new, healthier ones. The satiety signals from Qsymia make it easier to say no to highcalorie, lownutrient foods, and to feel satisfied with smaller portions. This is a powerful behavioral tool that can be leveraged for longterm success. The patient should not see this as a deprivation, but rather as an opportunity to discover new foods and a healthier way of eating.
The Role of Physical Activity
Physical activity is the second pillar of the treatment. Regular exercise, whether it's walking, running, swimming, or strength training, is vital for several reasons. It increases energy expenditure, helping to create a larger caloric deficit. It also builds muscle mass, which boosts metabolism. Exercise has profound mental health benefits, reducing stress and improving mood, which can be critical for maintaining motivation. Furthermore, it improves cardiovascular health, blood pressure, and blood sugar control, complementing the benefits of the medication. The combination of Qsymia and exercise is a powerful onetwo punch against obesity. The medication can provide the energy and motivation to exercise, and the exercise amplifies the effects of the medication. We recommend that patients find an activity they enjoy so that it becomes a sustainable part of their routine. This is not about being a gym rat; it is about finding a way to incorporate movement into daily life, whether that is through gardening, dancing, or taking the stairs instead of the elevator. Every little bit of movement counts, and with Qsymia, that movement becomes more effective in the fight against excess weight. The partnership between medication, diet, and exercise is the formula for longterm victory over obesity. It is a commitment, a journey, and a transformation.
Cost, Accessibility, and the Qsymia Engage Program
When considering any prescription medication, cost and accessibility are major factors. Qsymia's manufacturer, Vivus, has implemented several programs to make the medication more affordable and accessible to patients. This is a critical part of the patient experience and a significant barrier for many. The company has recognized this and has worked to create a system that addresses these concerns. The Qsymia Engage program is a multifaceted initiative designed to support patients on their weight management journey, providing not only financial assistance but also educational resources and community support. The program is designed to create a comprehensive ecosystem of care, extending beyond the pharmacy counter to provide ongoing support and motivation. This is a modern approach to healthcare, where the patient is not just given a prescription but is also provided with the tools and support needed to succeed. This is a key differentiator from many other weight loss medications, and it demonstrates a commitment to patient success that goes above and beyond the standard. We highly recommend that all patients prescribed Qsymia enroll in the Engage program to take advantage of its full suite of benefits. It is a powerful resource that can make a world of difference in a patient's journey. The program is a testament to the fact that effective weight management is a team effort, and the manufacturer is a key member of that team.
Savings and Financial Assistance
The cost of Qsymia can vary depending on insurance coverage. However, the Qsymia Engage program offers significant savings and a variety of options for patients, whether they have commercial insurance or are paying with cash. The program provides a retail savings card that can bring the cost down to a more manageable price for many patients. The manufacturer has also partnered with a home delivery pharmacy that can offer an even lower cash price and hasslefree, discreet delivery. For patients who struggle to afford the medication, these programs can be a lifeline, making a lifechanging treatment accessible. The financial aspect of healthcare is often a major hurdle, and the Qsymia Engage program is a proactive attempt to remove that barrier. It shows a commitment to patient access that is commendable and can make a real difference in the lives of those who need this medication. We have found that for many patients, the financial assistance provided by the program is a key factor in their ability to adhere to the treatment plan and achieve their weight loss goals. The program is a powerful example of a company putting the patient first, and it is a model that we hope to see more of in the pharmaceutical industry.
Educational and Community Support
Beyond the financial benefits, the Qsymia Engage program offers a wealth of educational resources. These include information on diet and nutrition, exercise tips, and strategies for managing the psychological aspects of weight loss. The program also offers access to coaches and community forums, providing a platform for patients to connect with others on a similar journey. This sense of community and shared experience can be incredibly motivating and can provide the emotional support that is so often needed in a weight loss journey. The program recognizes that weight management is not just a physical process; it is also a mental and emotional one. The support systems provided by the Engage program are a powerful complement to the medication itself, helping patients stay on track and overcome the inevitable challenges that arise. The program is a comprehensive tool for success, addressing the physical, financial, and emotional aspects of weight management. It is a holistic approach to care that we believe is essential for longterm success. The educational component of the program is also critical for ensuring that patients have the knowledge they need to make informed decisions about their health. It is a powerful example of a company providing more than just a pill; it is providing a pathway to a healthier life. The support system is a key part of the patient's success story, and it is a testament to the fact that no one should have to go on this journey alone.
The Future of Qsymia and Chronic Weight Management
The landscape of chronic weight management is constantly evolving, with new research and new treatments emerging regularly. Qsymia has been a trailblazer in this field, demonstrating the power of a combination therapy approach. The success of this medication has paved the way for other innovative treatments and has changed the conversation around obesity from one of willpower and personal failure to one of a complex, treatable medical condition. The future of Qsymia and similar medications is likely to focus on even greater personalization, with genetic and metabolic testing guiding the choice of medication for individual patients. We may see new formulations that further reduce side effects or target specific metabolic pathways. The integration of medication with digital health tools, such as mobile apps and wearable technology, will also likely become more commonplace, allowing for realtime monitoring and personalized feedback. Qsymia's role as a leader in this field is secure, and its continued success will no doubt inspire the next generation of weight management solutions. The journey of Qsymia is a powerful story of innovation and a commitment to helping people live healthier, happier lives. It is a testament to the power of science to address some of the most complex and challenging health issues of our time. The continued research and development in this area hold great promise for the millions of people who struggle with weight. The future is bright for chronic weight management, and Qsymia is at the forefront of that movement. The conversation is shifting from "how can I lose weight?" to "how can I manage my health for life?", and Qsymia is a key part of that new paradigm. The focus is no longer on a number on a scale, but on a lifetime of improved health and wellbeing. This is a powerful and important shift, and Qsymia is a major reason why it is happening. The future of medicine is about personalized care, and Qsymia is a great example of that principle in action. The progress is not just in the medication itself, but in the entire ecosystem of care and support that surrounds it. This is a truly holistic approach to a chronic disease, and it is a model for the future of healthcare. The journey is far from over, but the path forward is clear, and Qsymia is leading the way. The continued evolution of weight management is a powerful story of hope and progress, and we are proud to be a part of it. The conversation is shifting from "how can I lose weight?" to "how can I manage my health for life?", and Qsymia is a key part of that new paradigm. The focus is no longer on a number on a scale, but on a lifetime of improved health and wellbeing. This is a powerful and important shift, and Qsymia is a major reason why it is happening. The future of medicine is about personalized care, and Qsymia is a great example of that principle in action. The progress is not just in the medication itself, but in the entire ecosystem of care and support that surrounds it. This is a truly holistic approach to a chronic disease, and it is a model for the future of healthcare. The journey is far from over, but the path forward is clear, and Qsymia is leading the way. The continued evolution of weight management is a powerful story of hope and progress, and we are proud to be a part of it. The ultimate goal is to empower patients to take control of their health, and Qsymia is a tool that makes that possible. The journey is a long one, but with the right tools and the right support, success is within reach. We have seen it happen time and time again. The future is bright, and Qsymia is a shining example of what is possible when science and a commitment to patient wellbeing come together. The future of weight management is here, and it is more hopeful and effective than ever before. This is a new chapter in the fight against obesity, and Qsymia is writing a powerful new story.
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