Widaplik is a medicine used to treat high blood pressure (hypertension). High blood pressure is a common condition. Blood pressure is the force of blood pressing against the walls of your arteries. When it’s too high, your heart must work harder. This can damage your arteries. Over time, uncontrolled high blood pressure makes you more likely to get heart disease, stroke, and kidney disease. High blood pressure is called a silent killer because it doesn’t always have symptoms. If your blood pressure is very high, you may have signs such as severe headaches, pain in your chest, feeling dizzy, trouble breathing, vision changes, weakness, or abnormal heartbeat or rhythm. Treatment may include medicines and lifestyle changes such as diet, exercise, and stress management.
How Does Widaplik Work for High Blood Pressure?
Widaplik is a combination of three medicines in one pill that work together to lower blood pressure. The main ingredients in Widaplik are telmisartan, amlodipine, and indapamide. Telmisartan is an angiotensin II blocker (ARB). It blocks receptors in your body that normally bind to a hormone called angiotensin II. Blocking this hormone helps your blood vessels relax so that blood can flow more easily through your body. Amlodipine is a calcium channel blocker. It also helps relax your blood vessels so that blood can move through them more easily. Indapamide is a thiazide diuretic or “water pill.” It causes your kidneys to remove extra water and salt.
What Should I Do Before Starting Treatment?
Your health care provider will likely evaluate your kidney function and your salts (electrolytes) by performing blood work prior to starting Widaplik. Your health care provider will also periodically check your blood during Widaplik therapy to make sure your kidney function and your salts (electrolytes) are normal.
How Do I Take Widaplik?
Widaplik is a tablet that should be taken once daily by mouth. Tablets can be taken with or without food but must be taken whole and not split, chewed, or crushed.
When you start taking Widaplik, your health care provider might start you on the lower dose of Widaplik and increase your dose slowly over time until your blood pressure is controlled.
How Was Widaplik Studied for High Blood Pressure?
Two clinical studies were done to see if Widaplik was safe and effective for the treatment of high blood pressure.
The first study compared two doses of Widaplik to a placebo that contained no medicine in 295 people who were 19 to 83 years old. The people in the study did not know if they were getting Widaplik or a placebo. Widaplik or a placebo was taken every day in the morning at about the same time each day, right after taking a morning home blood pressure reading. The study lasted four weeks. People were not included in the study if their home blood pressure readings were greater than or equal to 160 (systolic) over 100 (diastolic) or if they had stage 2 kidney disease (estimated glomerular filtration rate (eGFR) less than 60). The average age of people in the study was 51, and 56% were female. Most (61%) were White, 21% were Asian, 17% were Black or African American, and less than 1% were American Indian, Alaska Native, native Hawaiian, or other Pacific Islander. People in these studies had an average home blood pressure reading of 139/86 and were either taking one blood pressure medicine or no blood pressure medicine. About 47% of people were taking one medicine to help control their blood pressure before the study started. The main goal of the study was to see the difference in blood pressure from Widaplik or the placebo at four weeks. The safety goal was to see the percentage of people who stopped taking the study medicine due to a side effect.
The second study compared Widaplik to combinations of two medicines in 2,242 people aged 20 to 91. Widaplik was compared to telmisartan plus indapamide, telmisartan plus amlodipine, or amlodipine plus indapamide. The study lasted 12 weeks. The average age of people in the study was 59, and 51% were female. About 45% were White, 48% were Asian, 5% were Black or African American, and less than 1% were American Indian, Alaska Native, native Hawaiian, or other Pacific Islander. People in this study were taking zero to three blood pressure medicines before the study started and had an average blood pressure reading of 142/85. The people who were taking other blood pressure medicines at the start of the study were taken off their medicines and started on a half-dose of Widaplik for four weeks. This was called the run-in period. After the run-in period, all people in the study took half-doses of either Widaplik, telmisartan plus indapamide, telmisartan plus amlodipine, or amlodipine plus indapamide for two weeks. At week six, the doses in all the groups were doubled. The main goal of the study was to see the difference in the blood pressure from Widaplik or the double combination medicines at 12 weeks. The safety goal was to see the percentage of people who stopped taking the study medicine due to a side effect.
What Benefits Were Seen With Widaplik?
People in the first study who took Widaplik for four weeks had lower blood pressure readings compared to placebo. The systolic blood pressure readings were lowered by 2.2 for the placebo, 9.6 for the low dose of Widaplik, and 10.4 for the high dose of Widaplik. The number of people who stopped the study medicine due to a side effect was very low in all groups. This was not considered to be significantly different between the groups.
People in the second study who took Widaplik for 12 weeks had lower home systolic blood pressure readings compared to those who took any of the combinations of two medicines. The home systolic blood pressure readings were 2.5 points lower for Widaplik compared to telmisartan plus indapamide, 5.4 points lower for Widaplik compared to telmisartan plus amlodipine, and 4.4 points lower for Widaplik compared to amlodipine plus indapamide. There were no noticeable differences in safety between the groups.
Most of the blood pressure effects from Widaplik were seen within the first two weeks of taking the medicine.
Your results may differ from what was seen in clinical studies.
What Is Its Place in Therapy?
Current treatment guidelines support the use of each of the medicines in Widaplik in adults with high blood pressure. Combination treatment with multiple medicines is often needed to reach blood pressure goals. Widaplik is convenient for people who need to take combination treatment because it has three medicines in one pill. Lowering blood pressure lowers the risk of heart disease, mainly stroke and heart attack.
Are There Any Reasons I Should Not Use Widaplik?
Make sure your health care provider is aware of all your current or past health conditions, especially kidney disease.
Do not take Widaplik if you have diabetes and are taking a medicine called aliskiren. This will not have any benefit and may cause harm, especially if you have kidney disease.
You should not take Widaplik if you are pregnant. Widaplik can cause harm or death to an unborn baby. If you get pregnant while you are taking Widaplik, stop taking the medicine and call your health care provider right away.
Some people with a sulfa allergy may also be allergic to indapamide, one of the medicines in Widaplik. A sulfa allergy is a rash or more serious reaction to sulfa, or sulfonamide, medicines. Sulfa medicines include sulfamethoxazole, sulfadiazine silver, or sulfasalazine. Tell your health care provider if you have any allergies to medicines.
What Types of Interactions Can Happen?
Some medicines can affect the blood levels of Widaplik. Medicines called CYP3A inhibitors can increase the amount of Widaplik in the blood, which can increase your risk of side effects.
Widaplik may also change the levels of other medicines in the body.
- If you take digoxin or lithium, Widaplik can increase the amount in your blood and cause side effects. Your health care provider may need to check your blood levels and adjust your dose.
- Widaplik can interact with nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen. Taking them together may increase the risk of kidney damage and may decrease the blood pressure-lowering effects of Widaplik. Talk to your health care provider or pharmacist about other medicines you can take.
- Widaplik increases the amount of simvastatin in the blood. Your health care provider may need to lower your dose of simvastatin while you are taking Widaplik.
- Widaplik may increase the amount of immunosuppressant medicines in the blood, such as cyclosporine or tacrolimus. Your health care provider may need to check your blood levels and adjust your dose.
This is not a complete list of medicines that may interact with Widaplik. Tell your pharmacist or other health care provider about all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken. This will help them determine if there are any interactions or if you need a dosage adjustment.
