Fixed-dose combination therapy-based protocol compared with free pill combination protocol: Results of a cluster...

Area of Science:

• Cardiovascular Medicine
• Public Health
• Clinical Pharmacy

Background:

• Hypertension management in Nigeria often relies on individual-level evidence for fixed-dose combination (FDC) therapy.
• Primary healthcare centers play a crucial role in managing hypertension within communities.

Purpose of the Study:

• To evaluate the effectiveness and safety of a treatment protocol using two-drug FDC therapy versus free pill combinations for hypertension control.
• To compare hypertension control rates and adverse events between FDC and free pill combination protocols in Nigerian primary care.

Main Methods:

• A cluster-randomized trial involving 60 primary healthcare centers in Nigeria's Federal Capital Territory.
• Patients (n=4427) with hypertension received either FDC therapy or free pill combinations as second and third steps of treatment over a 6-month follow-up period.
• The primary outcome was the odds of achieving controlled blood pressure at the last visit.

Main Results:

• Both FDC and free pill combination protocols led to improvements in hypertension control rates from baseline.
• After 6 months, the adjusted hypertension control rate was 53.9% for FDC and 47.9% for free pill combinations (p=0.29).
• Adverse events were low and comparable (<1%) in both treatment groups.

Conclusions:

• While both treatment protocols improved hypertension control, no significant difference was observed between fixed-dose combination therapy and free pill combinations in this Nigerian primary care setting.
• Further research is required to ascertain the potential benefits of initiating therapy with upfront FDC for improved hypertension control and efficiency.