evista
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Synonyms | |||
Raloxifene hydrochloride, marketed as Evista, represents one of the more nuanced tools in our endocrine arsenal. I remember first prescribing it back in ‘99 when it got FDA approval—we were all cautiously optimistic about this new selective estrogen receptor modulator (SERM) that promised osteoporosis protection without the uterine risks of tamoxifen. Over two decades and hundreds of patients later, I’ve seen its strengths, limitations, and those unpredictable clinical surprises that never make it into the official monographs.
Evista: Bone Protection and Breast Cancer Risk Reduction - Evidence-Based Review
1. Introduction: What is Evista? Its Role in Modern Medicine
Evista contains raloxifene hydrochloride, a benzothiophene derivative classified as a selective estrogen receptor modulator. What makes Evista particularly interesting is its tissue-specific activity—it acts as an estrogen agonist on bone and lipid metabolism while functioning as an antagonist in breast and uterine tissue. This dual nature gives it a unique position in postmenopausal management.
When we started using Evista in clinical practice, the initial focus was purely osteoporosis prevention. But the breast cancer risk reduction data that emerged from the MORE trial really changed how we viewed this medication. It became one of those rare drugs where the secondary endpoint findings arguably became more significant than the primary outcomes.
2. Key Components and Bioavailability of Evista
The active compound is raloxifene hydrochloride, with each tablet containing 60 mg of the base equivalent. The pharmacokinetics show about 60% oral absorption, but extensive first-pass glucuronidation reduces absolute bioavailability to just 2%. This is why we always advise patients to take it with or without food consistently—the high-fat meal effect isn’t clinically significant, but consistency matters for steady-state concentrations.
The drug is highly protein-bound (>95%) to albumin and α1-acid glycoprotein, with a volume of distribution of 2,348 L/kg. The elimination half-life ranges from 27.7 to 32.5 hours, allowing for once-daily dosing. What many clinicians don’t realize is that raloxifene undergoes extensive hepatic conjugation to glucuronide metabolites, which are excreted primarily through bile with minimal renal clearance—important for patients with renal impairment.
3. Mechanism of Action: Scientific Substantiation
The magic of Evista lies in its conformational effects on estrogen receptors. When raloxifene binds to ERα and ERβ, it induces a receptor conformation different from that induced by estradiol or tamoxifen. This altered conformation affects coactivator recruitment and ultimately gene transcription.
In bone tissue, it acts as an agonist, increasing expression of TGF-β3, which inhibits osteoclast differentiation and activity. Meanwhile, in breast tissue, it functions as an antagonist by blocking estrogen-stimulated proliferation of mammary epithelium. The uterine effects are particularly clever—it doesn’t stimulate endometrial proliferation because it fails to activate the AF-2 domain of the estrogen receptor in uterine tissue.
We had this fascinating case with Margaret, a 68-year-old with severe osteoporosis who’d failed bisphosphonate therapy due to GI intolerance. Her bone density improved dramatically on Evista, but what surprised us was the incidental finding of breast density reduction on her screening mammogram—a visible demonstration of its tissue-selective effects.
4. Indications for Use: What is Evista Effective For?
Evista for Osteoporosis Prevention and Treatment
In women with postmenopausal osteoporosis, Evista reduces vertebral fracture risk by approximately 30-50% across multiple studies. The MORE trial showed 68% reduction in new vertebral fractures after 3 years. The interesting part is that the fracture reduction exceeds what you’d expect from BMD changes alone—suggesting effects on bone quality beyond just density.
Evista for Breast Cancer Risk Reduction
The NSABP P-2 trial (STAR) demonstrated that Evista reduces invasive breast cancer risk by 38% in high-risk postmenopausal women, with particularly strong protection against ER-positive tumors. The risk reduction appears sustained with long-term use.
Off-label Applications
We’ve found Evista useful for osteoporosis in women who can’t tolerate bisphosphonates or have contraindications. Some evidence suggests benefits for cardiovascular risk reduction through lipid improvements, though it’s not formally indicated.
5. Instructions for Use: Dosage and Course of Administration
The standard Evista dosage is 60 mg once daily, with no need for dose adjustment in elderly patients or those with renal impairment. The timing relative to meals isn’t critical, but consistency helps maintain steady-state levels.
| Indication | Dosage | Frequency | Duration |
|---|---|---|---|
| Osteoporosis treatment | 60 mg | Once daily | Long-term |
| Osteoporosis prevention | 60 mg | Once daily | Indefinite |
| Breast cancer risk reduction | 60 mg | Once daily | Minimum 5 years |
We typically see BMD improvements within 6-12 months, but fracture risk reduction requires longer treatment. The bone effects are maintained with continued use but reverse after discontinuation.
6. Contraindications and Drug Interactions
Absolute contraindications include active or history of venous thromboembolism (VTE), pregnancy, and women who may become pregnant. The VTE risk is similar to HRT—about 3-4 cases per 1000 woman-years.
Significant drug interactions occur with cholestyramine (reduces absorption by 60%) and warfarin (may decrease PT time). We generally avoid concurrent systemic estrogen therapy, though the data here is limited.
The hot flash exacerbation is real—about 25% of women experience worsening vasomotor symptoms initially. I had one patient, Sarah, who discontinued after 2 weeks because of intolerable night sweats, despite explaining this usually improves over 3-6 months.
7. Clinical Studies and Evidence Base
The Multiple Outcomes of Raloxifene Evaluation (MORE) trial randomized 7,705 postmenopausal women with osteoporosis to raloxifene or placebo. After 3 years, vertebral fractures decreased by 30-50%, with BMD increases of 2-3% at spine and hip.
The Continuing Outcomes Relevant to Evista (CORE) trial followed MORE participants for 4 additional years, showing maintained fracture protection and 59% reduction in ER-positive breast cancer incidence.
The Study of Tamoxifen and Raloxifene (STAR) trial compared both agents in 19,747 high-risk postmenopausal women. Raloxifene was 76% as effective as tamoxifen in reducing invasive breast cancer risk but with better safety profile—fewer uterine cancers and thromboembolic events.
8. Comparing Evista with Similar Products and Choosing Quality
Compared to bisphosphonates, Evista provides slightly less robust fracture protection but better safety profile for long-term use. Versus tamoxifen for breast cancer risk reduction, it offers comparable protection for postmenopausal women with fewer serious side effects.
The manufacturing standards for brand-name Evista versus generics are identical, but we’ve observed some patient-reported differences in side effect profiles—likely nocebo effects rather than true pharmacological differences.
9. Frequently Asked Questions about Evista
How long does Evista take to show bone density improvements?
Typically 6-12 months for measurable BMD changes, though fracture risk reduction may begin earlier.
Can Evista be used in women with a family history of breast cancer?
Yes, it’s specifically indicated for breast cancer risk reduction in high-risk postmenopausal women.
What monitoring is required during Evista treatment?
Baseline bone density, regular breast screening per guidelines, and awareness of VTE symptoms. No specific laboratory monitoring is required.
Does Evista cause weight gain?
No significant weight changes are associated with Evista use—this distinguishes it from some other hormonal therapies.
10. Conclusion: Validity of Evista Use in Clinical Practice
The risk-benefit profile favors Evista for postmenopausal osteoporosis prevention and treatment, particularly in women with additional breast cancer risk concerns. The VTE risk requires careful patient selection, but for appropriate candidates, it remains a valuable option with dual benefits.
Looking back over my 20+ years with this medication, the most memorable case was Elena, a 72-year-old with osteoporosis and strong family history of breast cancer. She’d been on Evista for 8 years when her screening mammogram picked up early DCIS. The surgical pathology showed the tumor characteristics were less aggressive than typically seen in her family pattern. Was this Evista’s effect? We can’t prove it, but the timing was certainly suggestive. She’s 80 now, still on Evista, with stable bone density and no further breast issues. These are the cases that remind you why we bother with all the clinical trials and guidelines—because sometimes the right medication finds the right patient at the right time, and the outcomes speak for themselves.