Vasomotor symptoms (VMS), commonly known as hot flashes and night sweats, are cardinal symptoms of menopause, affecting up to 80% of postmenopausal women. While hormone therapy (HT) remains the gold standard for VMS treatment, many women have contraindications or prefer non-hormonal options. This article provides an up-to-date overview of non-hormone therapies, focusing on the neurokinin-3-receptor antagonist, fezolinetant, its efficacy, safety, and potential side effects, including its role in weight management.
Understanding Vasomotor Symptoms and Their Impact
VMS can significantly impact a woman's quality of life, causing disruption and discomfort. Beyond being bothersome, VMS may independently lead to adverse health consequences, including cardiovascular and metabolic changes such as:
- Increased carotid intima thickness
- Increased carotid and aortic calcifications
- Worsening lipid profiles
- Increased insulin resistance
- Increased risk of hypertension
Additionally, VMS have been linked to decreased bone mineral density and increased fracture incidence. Therefore, effective management of VMS is crucial for overall health and well-being.
Non-Hormone Therapies for Managing VMS
Given that some women may not be candidates for or may not want hormone therapy, non-hormone treatment options are essential for controlling VMS symptoms. These therapies can be used alone or in combination with hormone therapy.
Complementary and Alternative Therapies
Complementary and alternative therapies for managing menopausal symptoms have gained popularity, but concerns about their safety and effectiveness persist. Evidence supporting these therapies is often limited due to methodological deficiencies in studies, including a lack of randomized, sham or placebo-controlled trials.
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The Menopause Society recommends certain evidence-based lifestyle interventions, mind-body therapies, and procedures for managing VMS. These include:
- Weight Loss: Randomized controlled trials have demonstrated that weight loss can effectively reduce VMS, particularly earlier in the menopause transition.
- Cognitive Behavioral Therapy (CBT): CBT has been shown to reduce the degree to which women perceive VMS as a problem. Group and self-guided CBT can improve bothersome VMS, hot flash interference, and depressive symptoms.
- Clinical Hypnosis: Randomized controlled trials have shown that clinical hypnosis can reduce the severity and frequency of VMS and improve mood and sleep.
- Stellate Ganglion Blockade: This pain management treatment involves injecting an anesthetic agent to target the stellate ganglion, showing potential for alleviating VMS. However, larger randomized controlled trials are needed to confirm its risk-benefit ratio.
Other complementary and alternative therapies, such as trigger avoidance, cooling techniques, dietary modification, exercise, mindfulness-based interventions, acupuncture, electroacupuncture, and yoga, may offer potential benefits, but additional research is needed. Chiropractic treatments and paced respiration have not been shown to be effective. Moreover, current evidence is negative, inconclusive, or insufficient regarding the use of soy foods, S-equol, other soy extracts and derivatives, cannabinoids, and herbal supplements (such as black cohosh, ashwagandha, evening primrose oil) for VMS reduction. Women who choose to take black cohosh should be counseled about its potential hepatotoxicity.
Non-Hormone Pharmacologic Agents
While not as efficacious as hormone therapy, non-hormone medications can provide valuable VMS relief. Effective pharmacologic agents compared with placebo include selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), gabapentinoids, oxybutynin, clonidine, and neurokinin-receptor antagonists. These medications can be combined judiciously, considering tolerability and effectiveness, to improve control of VMS frequency and severity.
- SSRIs and SNRIs: These medications demonstrate mild to moderate improvement of VMS. Paroxetine, escitalopram, citalopram, venlafaxine, desvenlafaxine, and duloxetine have been found to reduce hot flashes, with composite hot flash frequency and severity improving. Sertraline and fluoxetine do not consistently demonstrate reductions in VMS. SSRIs and SNRIs may be beneficial for patients with concurrent mood issues. It is important to note that paroxetine and fluoxetine are potent cytochrome P450 CYP2D6 inhibitors and should not be used with tamoxifen. Common side effects include nausea, gastrointestinal disturbances, sleep disturbances, weight changes, sexual dysfunction, and headache.
- Gabapentinoids (Gabapentin and Pregabalin): Gabapentin is effective at reducing hot flash frequency and hot flash composite scores. It can be helpful in patients with neuropathic pain and can be an effective sleep aid when dosed before bedtime. Side effects include dizziness, coordination difficulties, edema, drowsiness, lethargy, weight gain, nausea, and gastrointestinal disturbances. Current recommendations do not support pregabalin as a treatment for reducing VMS due to limited evidence.
- Oxybutynin: This medication can effectively treat hot flashes, reducing hot flash frequency. It is also an effective treatment for overactive bladder symptoms, making it an ideal choice for women with prominent urinary conditions and VMS. Common side effects include dry mouth and eyes, urinary retention, dizziness, drowsiness, constipation, vision changes, and nausea. Caution should be exercised in older adults due to an association with impaired cognitive and physical functioning, risk of dementia, and risk of delirium.
- Clonidine: Studies demonstrate modest improvement in hot flashes with clonidine. Common side effects include fatigue and weakness, headache, dry eyes and mouth, hypotension, dizziness, and sedation. Rebound hypertension and withdrawal symptoms may occur with abrupt discontinuation. Clonidine is generally not recommended in patients 65 or older due to the high risk of adverse effects.
Fezolinetant: A Novel Neurokinin-3-Receptor Antagonist
Fezolinetant is a neurokinin-3-receptor antagonist that targets the thermoregulatory center in the hypothalamus through modulation of KNDy neurons. It was approved by the US Food and Drug Administration in May 2023 for treating moderate to severe VMS.
Clinical Efficacy and Safety
The SKYLIGHT 2 trial demonstrated that fezolinetant 45 mg reduced VMS frequency by more than 50% compared with placebo, with rapid onset of effect and sustained efficacy through week 52. At week 12, VMS frequency was reduced significantly more with fezolinetant than with placebo. The 45-mg dose also demonstrated clinically meaningful improvements in sleep measures.
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The most common side effects of fezolinetant in clinical studies included abdominal pain, diarrhea, headache, insomnia, and back pain.
Side Effects of Veozah (Fezolinetant)
Veozah (fezolinetant) is a prescription drug used to treat certain symptoms of menopause. While generally well-tolerated, Veozah can cause side effects ranging from mild to serious.
Common Side Effects:
- Abdominal pain
- Diarrhea
- Insomnia (difficulty sleeping)
- Back pain
- Hot flashes
Mild Side Effects:
These side effects are usually temporary and easily managed. However, consult your doctor if they persist or become bothersome.
- Abdominal pain
- Diarrhea
- Insomnia
- Back pain
- Hot flashes
Serious Side Effects:
If you develop serious side effects while taking Veozah, contact your doctor immediately.
- Elevated liver enzymes
- Severe allergic reaction
Allergic Reaction:
Although not reported in the drug's studies, Veozah can cause an allergic reaction in some individuals. Mild symptoms include a rash. Severe symptoms include swelling or difficulty breathing, requiring immediate medical care.
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Fezolinetant and Weight Management
Neither weight gain nor weight loss were reported as side effects in studies of Veozah. Gradual weight gain during menopause is common and influenced by genetics and lifestyle. Veozah is not expected to cause weight gain or weight loss.
Contraindications
Veozah has several contraindications:
- Cirrhosis: Severe scarring of the liver can lead to elevated levels of Veozah in the system, increasing the risk of side effects.
- Severe Renal Problems: Severe kidney problems, including end-stage kidney disease (ESRD), can cause Veozah to build up in the body, raising the risk of side effects.
- Use with CYP1A2 Inhibitors: Drugs that block the CYP1A2 enzyme can increase the level of Veozah in the system, increasing the risk of side effects. Examples include ciprofloxacin and fluvoxamine.
Managing Side Effects
- Hot Flashes: Identify and avoid triggers such as alcohol, caffeine, spicy foods, stress, and tight clothing. Strategies to relieve symptoms include sipping ice water and practicing stress reduction techniques.
- Elevated Liver Enzymes: Your doctor will monitor your liver enzyme levels before and during Veozah treatment. Notify your doctor immediately if you experience symptoms of liver problems, such as jaundice or dark-colored urine.
- Insomnia: This side effect may subside as your body adjusts to the medication. If it persists, consult your doctor for recommendations on improving sleep.
Important Considerations Before Taking Veozah
Discuss your health history with your doctor before taking Veozah, especially if you have:
- Kidney problems
- Liver problems
- Previous allergic reaction to Veozah
- Pregnancy or breastfeeding plans
Veozah and Alcohol Consumption
There is no known interaction between Veozah and alcohol. However, alcohol can worsen certain side effects of Veozah, such as hot flashes, and may increase the risk of liver damage.
Drug Interactions
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, as Veozah may affect the way other medicines work, and vice versa.
How Veozah Works
Veozah contains fezolinetant, which helps restore the balance between estrogens and neurokinin B (NKB), a brain chemical involved in regulating body temperature.
Dosing and Administration
Veozah is available as 45 mg oral tablets. Swallow the tablet whole with liquid. Take it at the same time every day. If you miss a dose, take it as soon as possible on the same day, with at least 12 hours before the next scheduled dose.
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