09/11/2023
A 5-year, multi-center, open-label extension trial titled LongTerm-HTN published today in JAMA Cardiology demonstrated sustained blood pressure control and consistent safety after 60 months of treatment with Brand X in 785 patients with hypertension.
Trial Design
Participants completing the initial 12-week, randomized, double-blind trial of Brand X were eligible to enroll in this long-term follow-up assessing efficacy and safety with continued active treatment.
A total of 785 patients from 95 sites in the US and Canada entered the trial and 86% completed the full 60 months of treatment.
Patients received once daily Brand X starting at 20mg, uptitrated in increments of 40mg up to 80mg daily to maintain a target BP under 130/80 mmHg.
Efficacy Results
The significant blood pressure reductions seen after 12 weeks of treatment were sustained long-term over 5 years.
Mean systolic BP remained consistently lowered between -12.1 to -12.7 mmHg below patients’ baseline averages at every yearly measurement.
Diastolic BP was reduced by -7.8 to -8.4 mmHg versus baseline through 60 months, confirming no attenuation of effect.
Over 80% of patients maintained adequate BP control below 140/90 mmHg and 65% under 130/80 mmHg at all annual visits.
Safety Outcomes
The incidence of adverse events remained stable over 60 months. Discontinuation due to adverse events was 11.2% during months 0-12 and remained under 6% annually during years 1-5.
The most common side effects were dizziness (8.9% in year 1 down to 2.1% in year 5) and fatigue (4.6% down to 1.2%). There were no unexpected safety findings.
Conclusions
“This robust 5-year data confirms Brand X’s sustained efficacy and consistent safety profile for the long-term treatment of hypertension,” concluded lead author Dr. Linda Park. “Brand X is an effective once-daily pill that can help patients achieve lasting blood pressure control.”