Trimetazidine was previously approved for the prevention of angina attacks and symptoms such as dizziness and tinnitus. However, after a reevaluation by the European Medicines Agency (EMA), considering both its efficacy and potential harm, Trimetazidine is now only used in specific cases.
1. What is Trimetazidine?
Trimetazidine (TMZ) is a medication used to treat heart-related conditions such as angina pectoris. It helps in the metabolism of fatty acids, allowing the body to utilize oxygen more efficiently. This mechanism increases blood flow to the heart and reduces sudden changes in blood pressure, which can help relieve chest pain caused by blocked arteries. Additionally, it may improve overall cardiac performance in individuals with heart disease.
Trimetazidine is approved for angina treatment in Europe but not in the United States.
- The World Anti-Doping Agency (WADA) banned the use of Trimetazidine in all sports in 2014.
- It is classified as a “hormonal and metabolic modulator”, a group of drugs prohibited for athletes.
- Athletes using Trimetazidine may experience enhanced cardiac performance, providing an unfair advantage in competitions.
- Several Olympic athletes have tested positive for Trimetazidine use over the years.
- Trimetazidine 20mg film-coated tablets.
- Trimetazidine 20mg/mL oral solution (60mL bottle).
- Trimetazidine 35mg modified-release (MR) tablets.
2. Special Warnings for Healthcare Professionals Regarding Trimetazidine
Trimetazidine was registered in Vietnam in 2003 under the brand name Vastarel, primarily for the prevention of angina attacks. However, following reports of its efficacy and associated adverse effects, the EMA conducted a safety reassessment on June 22, 2012. Based on their findings, the following recommendations were issued for healthcare professionals:
- No immediate changes are required for emergency treatment.
- However, the patient’s treatment plan should be reassessed during their next medical appointment.
Do not prescribe Trimetazidine to patients with the following conditions:
- Dizziness
- Tinnitus (ringing in the ears)
- Visual disturbances
Indications for Trimetazidine in Angina Treatment:
- Use only in patients who cannot tolerate first-line anti-anginal therapies.
- Consider as adjunct therapy for patients with stable angina that is not adequately controlled.
Caution When Prescribing Trimetazidine: Dose reduction may be necessary for:
- Patients with moderate renal impairment.
- Elderly patients.
- Parkinson’s disease or Parkinsonian symptoms.
- Severe renal impairment.
- Tremors, restless leg syndrome, or other movement disorders.
- Severe kidney failure.
- Patients under 18 years of age.
- Known allergy to Trimetazidine or its components.
- Parkinson’s disease or Parkinsonian symptoms.
- Severe renal impairment.
- Tremors, restless leg syndrome, or other movement disorders.
If a patient develops movement disorders (e.g., Parkinson’s symptoms), Trimetazidine should be permanently discontinued. If symptoms persist beyond four months after stopping the drug, consult a neurologist.
3. What Are the Side Effects of Trimetazidine?
Trimetazidine’s side effects vary from person to person.
- Dizziness.
- Headache.
- Abdominal pain.
- Diarrhea.
- Indigestion (dyspepsia).
- Nausea or vomiting.
- Skin rash.
- Itching (pruritus)
- Dizziness.
Rare Side Effects (may occur in 1 in 1,000 patients):
- Rapid or irregular heartbeat (palpitations).
- Orthostatic hypotension (low blood pressure upon standing, causing dizziness, lightheadedness, or fainting).
- General discomfort.
- Flushing or dizziness.
Other Possible Side Effects: Extrapyramidal symptoms:
- Uncontrolled movements (e.g., tremors, shaking hands or fingers, abnormal body twisting, gait disturbances, stiffness in arms and legs).
- These symptoms are often reversible after stopping treatment.
- Sleep disturbances (excessive sleepiness or difficulty sleeping).
- Constipation.
- Severe skin reactions (red rash with blistering).
- Swelling of the face, mouth, tongue, lips, or throat, potentially causing difficulty swallowing or breathing.
- Severe reduction in white blood cells, increasing infection risk.
- Low platelet count, increasing the risk of bruising or excessive bleeding.
- Liver disease.
If you experience any of these side effects while taking Trimetazidine—whether in the 35mg extended-release tablet, 20mg film-coated tablet, or 20mg/mL oral solution—contact your doctor immediately.
4. What Are the Drug Interactions with Trimetazidine?
Before Starting Trimetazidine, Inform Your Doctor If You Are Taking Any Other Medications
This includes prescription and over-the-counter drugs. To date, no significant drug interactions with Trimetazidine have been reported.
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