Evaluating the safety and effectiveness of a four-in-one blood pressure pill early-on in patients with hypertension.

This study investigated whether a single blood pressure (BP) pill containing 4 drugs (quadpill) at quarter doses is more effective than the standard dose of a single drug as initial treatment in patients with hypertension. The data showed that a quadpill was safe and more effective in getting BP under control than the standard therapy.

Hypertension or high blood pressure (BP) is a common and serious condition. Managing BP levels is important to prevent organ damage and cardiac events such as heart attack or stroke. Managing BP can sometimes require multiple medications. There are many ways to target BP. Combining treatment can be very effective. Some products have been developed to combine multiple drugs. The idea is that combining drugs will improve adherence to medication. It may also reduce the dose of drugs required to manage BP.

One of these is an ultra-low-dose quadruple combination therapy (LDQT). It combines 4 drugs at low doses (quadpill). These included irbesartan (Avapro), amlodipine (Norvasc), indapamide (Natrilix), and bisoprolol (Zebeta). However, whether a single pill combining 4 drugs at quarter doses is more effective than the standard dose of a single drug (irbesartan) as initial treatment in patients with hypertension is still unknown.

This study involved 591 patients with hypertension. Patients were either not undergoing treatment or taking a single drug for hypertension. Patients were randomly assigned into 2 groups. Group 1 included 300 patients who received a quadpill containing quarter doses of irbesartan (37.5 mg), amlodipine (1.25 mg), indapamide (0.625 mg), and bisoprolol (2.5 mg). Group 2 included 291 patients who received a standard dose of a single pill (irbesartan at 150 mg).

By 12 weeks, 44 (15%) patients in group 1 required additional BP medications compared to 115 (40%) patients in group 2.

At 12 weeks, patients in group 1 had an average systolic blood pressure (SBP; blood pressure when the heart beats) of 6.9 mmHg lower compared to group 2. 76% of patients in group 1 had BP control compared to 58% in group 2. Patients in group 1 were 1.3 times more likely to achieve BP control.

At 52 weeks, patients in group 1 had an average SBP of 7.7 mmHg lower compared to group 2. The BP control rates were higher in group 1 (81%) versus group 2 (62%). Patients in group 1 were 1.32 times more likely to achieve BP control at 52 weeks.

4% of patients in group 1 stopped treatment due to side effects compared to 2.4% of the patients in group 2.

This study concluded that a single BP pill containing 4 drugs at quarter doses was safe and more effective in getting BP under control than the standard dose of a single drug as initial treatment in patients with hypertension.

This study only included patients from Australia. It could not recruit the target number of patients due to the COVID-19 pandemic.