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Prolia vs Evista
Introduction
For patients dealing with osteoporosis, certain drugs that affect bone remodeling processes can be beneficial in reducing the risk of fractures. Prolia and Evista are two such drugs often recommended for osteoporosis treatment. They each impact different aspects of bone metabolism but both have significant effects on improving bone strength and decreasing fracture risk. Prolia is a monoclonal antibody that inhibits RANKL (Receptor Activator of Nuclear factor Kappa-B Ligand), a protein essential for the formation, function, and survival of osteoclasts - cells responsible for breaking down bone tissue during remodeling processes. On the other hand, Evista is classified as a selective estrogen receptor modulator (SERM) which mimics some actions of estrogen to increase density and reduce breakdown in bones while not affecting or potentially having opposite effects on other tissues sensitive to estrogens like breast and uterus.
Prolia vs Evista Side By Side
| Attribute | Prolia | Evista |
|---|---|---|
| Brand Name | Prolia | Evista |
| Contraindications | Allergic reactions to Prolia, low calcium levels (hypocalcemia), patients receiving immunosuppressive therapy may face an increased risk of infections. | Allergic reactions to Evista, blood clotting disorders. |
| Cost | Around $1250 for a single injection (60 mg) every six months, approximately $6.94 per day. No generic version available. | Around $200 for 30 tablets (60 mg each), approximately $6.67 per day. Generic version available at significantly lower costs: $.50 - $1/day. |
| Generic Name | Denosumab | Raloxifene |
| Most Serious Side Effect | Hypocalcemia (low levels of calcium in your blood), serious infections, severe jaw bone problems (osteonecrosis), unusual thigh bone fractures. | Blood clots in the legs (deep vein thrombosis) and lungs (pulmonary embolism), stroke. |
| Severe Drug Interactions | Not specifically mentioned, but immunosuppressive therapy might increase infection risk. | Patients on warfarin therapy should be monitored closely due to potential changes in prothrombin time. |
| Typical Dose | 60 mg via injection every six months | 60 mg/day orally |
What is Prolia?
Denosumab (the generic name for Prolia) is a first-in-class drug that belongs to the class of RANKL inhibitors and was approved by the FDA in 2010. Prolia works by binding to a protein involved in the formation, function, and survival of osteoclasts (cells that break down bone), thereby inhibiting their activity. It is prescribed primarily for postmenopausal women with high risk of fractures or those who have failed or are intolerant to other osteoporosis therapies.
On the other hand, raloxifene (Evista’s generic name) falls under selective estrogen receptor modulators' category, which mimics estrogen's beneficial effects on bones. This medication received its approval from FDA back in 1997. Evista reduces bone loss by replacing some lost estrogen without stimulating breast or uterine tissues like actual estrogens do; this makes it less likely than hormone therapy to cause certain types of cancer.
Both drugs have been proven effective at reducing fracture risk; however, they work differently and may have different side effects. While Prolia can lead to serious complications such as hypocalcemia and infections due its immune-suppressing effect, Evista has fewer severe side-effects but could increase risks related to blood clots and strokes.
What conditions is Prolia approved to treat?
Prolia is approved for the treatment of several conditions related to bone health:
- Postmenopausal women with osteoporosis at high risk for fracture
- Increase bone mass in men with osteoporosis at high risk for fracture
- Treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy (ADT) for nonmetastatic prostate cancer
- Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy (AIT) for breast cancer.
How does Prolia help with these illnesses?
Prolia helps manage osteoporosis by reducing the activity of osteoclasts, cells that break down bone tissue. It does this by binding to and inhibiting a protein known as RANKL, which is vital for the formation, function, and survival of osteoclasts. This results in less bone resorption and an overall increase in bone mass and strength. Bone is a living tissue that constantly undergoes remodeling - with old bone being broken down by osteoclasts and new bone being formed by other cells called osteoblasts. In individuals with osteoporosis, there's an imbalance in this process leading to greater loss than gain of bone density over time. Hence, Prolia can slow or stop the progression of this condition and help patients maintain their skeletal health.
What is Evista?
Evista, also known as Raloxifene, is a selective estrogen receptor modulator (SERM) that was first approved by the FDA in 1997 for the prevention of osteoporosis in postmenopausal women. Evista mimics some of the beneficial effects of estrogen on bone density without affecting other tissues such as the uterus or breasts where estrogen could have undesirable effects. Its lack of action on these tissues means its side-effect profile is different from traditional hormone replacement therapies; it does not increase the risk of uterine or breast cancer and might even reduce breast cancer risk in certain populations. This can make Evista a more attractive option than drugs like Prolia (Denosumab), an antibody that works differently by inhibiting cells called osteoclasts which break down bone tissue. Though both are effective at reducing fracture risk, patients may prefer Evista if they're concerned about potential side effects associated with Prolia such as hypocalcemia (low blood calcium levels) and serious infections.
What conditions is Evista approved to treat?
Evista, also known by its generic name raloxifene, is a medication approved for the treatment of:
- Osteoporosis in postmenopausal women
- Reducing the risk of invasive breast cancer in postmenopausal women with osteoporosis and postmenopausal women at high risk for invasive breast cancer.
How does Evista help with these illnesses?
Evista, similar to Prolia, is a medication that plays an integral role in the body's bone turnover process. Specifically, Evista acts as a selective estrogen receptor modulator (SERM). It helps maintain bone density by mimicking the positive effects of estrogen on bone tissue without affecting other tissues where estrogen activity may have undesired consequences. This means it can help decrease the rate of bone loss and reduce the risk of fractures - particularly important for postmenopausal women at risk for osteoporosis. While Prolia also aids in slowing down bone loss, it does this by blocking a hormone that causes destruction of bone cells; however, its effects are much more pronounced and persistent than those of Evista. So if patients need milder or more controlled treatment options with fewer potential side effects – such as those with less severe osteoporosis or who are at lower fracture risks – they might respond better to SERMs like Evista.
How effective are both Prolia and Evista?
Both Denosumab (Prolia) and Raloxifene (Evista) have established histories of success in treating patients with osteoporosis, and were initially approved by the FDA within a decade of each other. Since they act on different biological mechanisms, they may be prescribed under different circumstances. The effectiveness of Prolia and Evista in preventing bone loss was directly studied in several clinical trials; both drugs exhibited similar efficacy in reducing fractures as well as promising safety profiles.
A 2007 meta-analysis report on Prolia demonstrated that it significantly reduced vertebral, non-vertebral, and hip fractures among postmenopausal women with osteoporosis. Its side effect profile is generally favorable over many other osteoporosis treatments, including bisphosphonates due to its unique mechanism of action – inhibiting a protein involved in the formation and function of cells that break down bone.
On the other hand, an updated review from 2011 indicated that Evista seems to be more effective than placebo at preventing spinal fractures specifically but not necessarily better at preventing non-spinal fractures or all types of fractures when taken collectively. Nonetheless, due to its additional benefit against invasive breast cancer risk reduction for post-menopausal women with osteoporosis or those at high risk for invasive breast cancer makes it a preferred choice for this demographic group.
Significant research involves using these medications independently rather than co-prescribed together so data confirming their combined efficacy is less robust compared to individual use treatment studies. Further evidence supporting one drug's superiority over another still needs further exploration but due to their distinct pharmacology profiles, choosing between Prolia or Evista would depend upon specific patient characteristics such as fracture risks sites (spine versus hip), tolerability issues related to bisphosphonates drugs class or presence/absence of increased breast cancer risks.
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At what dose is Prolia typically prescribed?
Prolia is administered via injection at a dosage of 60 mg every six months, and it has been proven to be effective in reducing the risk of fractures in patients with osteoporosis. It's important that calcium and vitamin D are adequately supplied while taking Prolia. On the other hand, Evista can be taken orally once daily at a dose of 60 mg. This medication is also beneficial for treating osteoporosis and reducing fracture risk but may have different side effects compared to Prolia. In both cases, the dosages should not be altered without consulting with a healthcare provider.
At what dose is Evista typically prescribed?
Evista treatment is typically initiated at a standard dosage of 60 mg/day. The tablet can be taken with or without meals, and at any time of the day. It's important to take it consistently either always with food or always without food. There isn't usually a need to increase the dose as this medication is designed for long-term use in treating osteoporosis and reducing breast cancer risk. However, regular monitoring by your healthcare provider will determine if adjustments are necessary based on efficacy and tolerability over time. It should also be noted that Evista may not produce noticeable results immediately but its benefits will become evident over an extended period of consistent usage.
What are the most common side effects for Prolia?
Common side effects of Prolia may include:
- Fatigue or general weakness
- Back pain, joint pain, and muscle pain
- High cholesterol levels
- Bladder infection (urinary tract infection)
- Nausea
- Constipation or diarrhea
- Skin problems such as eczema and dry skin
- Vertigo (dizziness)
On the other hand, Evista can cause side effects like:
- Hot flashes
- Leg cramps
- Swelling in your hands, feet, ankles
- Flu-like symptoms
- Joint pain
- Excessive sweating
Bear in mind that every individual responds differently to medication; some people might experience these side effects while others might not. Always consult with your healthcare provider for medical advice.
Are there any potential serious side effects for Prolia?
While both Prolia and Evista are used to treat osteoporosis, they can have different side effects. Some of the rare but serious side effects that could be experienced with Prolia include:
- Serious allergic reactions: Skin problems such as hives, swelling in your face or throat, difficulty breathing.
- Hypocalcemia (low levels of calcium in your blood): Symptoms might involve muscle spasms, twitches or cramps; numbness or tingling in fingers, toes or around the mouth.
- Severe jaw bone problems (osteonecrosis): Signs may incorporate jaw pain, tooth loosening, poor healing after teeth are pulled out.
- Unusual thigh bone fractures: Look for new or unusual pain in your hip or thigh.
On the other hand, use of Evista could result into:
- Blood clots in the legs (deep vein thrombosis) and lungs (pulmonary embolism): Watch for signs like leg swelling; warmth over skin where clot is located; chest pain on deep breathing; shortness of breath.
- Stroke: Sudden severe headache unlike past headaches; weakness/paralysis on one body half; vision changes etc., should prompt immediate medical consultation.
Whenever you notice any such symptoms while using either medication mentioned above it's crucial that you seek urgent medical attention.
What are the most common side effects for Evista?
Evista, also known as Raloxifene, can be associated with a series of side effects including:
- Hot flashes or leg cramps
- Swelling in your hands, feet, or ankles
- Joint pain or sweating
- Sleep problems (insomnia)
- Headache, dizziness
- Nausea and vomiting
- Stomach upset or weight gain
- Breast pain or tenderness.
It's important to note that these are potential side effects: not every individual taking Evista will experience them. If any of these symptoms persist for extended periods of time while using Evista, it is highly recommended to consult with your healthcare provider promptly.
Are there any potential serious side effects for Evista?
While Evista is generally well-tolerated, it's important to be aware of potential serious side effects. These may include:
- Signs of an allergic reaction such as hives, difficulty breathing, swelling in your face or throat
- Leg pain or warmth coupled with swelling - these could indicate a possible blood clot
- Unusual bleeding or bruising
- Chest pain, sudden cough, rapid breathing and/or heart rate potentially indicative of a pulmonary embolism
- Changes in vision including blurred vision which might signal a stroke
- Increased levels of calcium in the blood manifesting as muscle weakness/contractions, nausea/vomiting and constipation.
If you experience any of these symptoms while on Evista therapy, seek immediate medical attention.
Contraindications for Prolia and Evista?
Prolia and Evista, much like other osteoporosis medications, may cause adverse effects in some individuals. If you notice any severe side effects such as intense bone/joint/muscle pain, new or unusual thigh/hip/groin pain, or jaw pain/swelling/numbness (possible signs of a rare but serious condition called osteonecrosis), please seek immediate medical attention.
Neither Prolia nor Evista should be taken if you are allergic to them or if you have conditions such as low calcium levels (hypocalcemia) for Prolia and blood clotting disorders for Evista. Always inform your healthcare provider about the medications you are taking; certain drugs could interact negatively with both Prolia and Evista.
For instance, patients on warfarin therapy should be monitored closely while taking Evista due to potential changes in prothrombin time. Similarly, those simultaneously receiving immunosuppressive therapy might face an increased risk of infections when on Prolia because it is known to suppress bone turnover which can impact the immune system. Therefore, always share your medication history with your doctor before starting these treatments.
How much do Prolia and Evista cost?
For the brand name versions of these drugs:
- The price of a single injection (60 mg) of Prolia averages around $1250, which is given once every six months. Thus, it works out to approximately $6.94 per day.
- The price for 30 tablets (60 mg each) of Evista averages around $200, working out to approximately $6.67 per day.
Thus, if you are prescribed one dose every six months for Prolia as typically recommended by health professionals, then branded Evista is slightly less expensive on a per-day treatment basis. However, cost should not be your primary consideration in determining which of these drugs is right for you.
As far as generic versions go:
- There currently isn't an available generic version for Denosumab(Prolia).
- Raloxifene HCL(Evista), on the other hand, has its generic form with costs significantly lower: It ranges from about $.50 - $1/day depending upon where and how much you buy at once.
Popularity of Prolia and Evista
Denosumab, in its brand form Prolia, is a widely used medication for osteoporosis and was estimated to have been prescribed to about 2.3 million people in the US in 2020. Denosumab accounted for nearly 16% of prescriptions for osteoporosis treatments in the US last year. It appears to be a commonly-prescribed "biologic" drug (a medicine produced using living organisms). Since its approval by the FDA in 2010, denosumab has generally seen an increase in prevalence.
Raloxifene, including brand versions such as Evista, was prescribed to around 1 million people in the USA during the same period. In America, raloxifene accounts for just under 7% of prescriptions specifically aimed at treating postmenopausal women with osteoporosis and preventing invasive breast cancer among high-risk individuals. The trend regarding raloxifene use has largely remained constant over recent years.
Conclusion
Both Prolia (denosumab) and Evista (raloxifene) are commonly prescribed treatments for osteoporosis, a condition that weakens bones and makes them prone to fracture. They have been backed by multiple clinical trials indicating their efficacy compared to placebo treatments in reducing the risk of fractures. Due to their differing mechanisms of action - with Prolia acting as a RANK ligand inhibitor to prevent bone resorption, and Evista mimicking estrogen's beneficial effects on bone density without some of the risks associated with hormones - they may be used under different circumstances.
Prolia is often recommended when other treatments haven't worked or aren't suitable, while Evista is typically considered for postmenopausal women who are at high risk for invasive breast cancer or those intolerant to other osteoporosis therapies.
While both drugs do come in generic forms offering cost savings, it's worth noting that this can vary depending on location and insurance coverage. Like many medications, there may be an adjustment period where full effects aren't immediately noticeable.
Though generally well-tolerated, both drugs have potential side effects: Prolia may cause hypocalcemia (low calcium levels), serious infections, skin problems or jawbone problems; whereas Evista might lead to hot flashes or increase the risk of blood clots. As always patients should monitor any changes closely after starting treatment and seek medical help if they notice severe side effects like chest pain (Evista) or signs of infection including fever or chills (Prolia).
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Refrences
- Prestwood, K. M., Gunness, M., Muchmore, D. B., Lu, Y., Wong, M., & Raisz, L. G. (2000, June 1). A Comparison of the Effects of Raloxifene and Estrogen on Bone in Postmenopausal Women1. The Journal of Clinical Endocrinology & Metabolism. The Endocrine Society.http://doi.org/10.1210/jcem.85.6.6654
- Moen, M. D., & Keating, G. M. (2008). Raloxifene. Drugs. Springer Science and Business Media LLC.http://doi.org/10.2165/00003495-200868140-00008
- Moen, M. D., & Keam, S. J. (2011, January). Denosumab. Drugs & Aging. Springer Science and Business Media LLC.http://doi.org/10.2165/11203300-000000000-00000
- Moen, M. D., & Keam, S. J. (2011, August). Spotlight on Denosumab in Postmenopausal Osteoporosis†. BioDrugs. Springer Science and Business Media LLC.http://doi.org/10.2165/11207100-000000000-00000
- Eng-Wong, J., & Zujewski, J. A. (2004, August). Raloxifene and its role in breast cancer prevention. Expert Review of Anticancer Therapy. Informa UK Limited.http://doi.org/10.1586/14737140.4.4.523
- Martino, S., Costantino, J., McNabb, M., Mershon, J., Bryant, K., Powles, T., & Secrest, R. J. (2004, April 1). The Role of Selective Estrogen Receptor Modulators in the Prevention of Breast Cancer: Comparison of the Clinical Trials. The Oncologist. Oxford University Press (OUP).http://doi.org/10.1634/theoncologist.9-2-116