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Durability of improvement achieved in a clinical trial. Is compliance an issue?
I Enström1, K Pennert, L H Lindholm
1Kävlinge Health Centre, Lund AB, Sweden. Inger.Enstrom@dalby.lu.se
Insights
Blood pressure improvements from clinical trials often don't last in real-world practice. This study shows hypertension treatment benefits may fade over time, highlighting potential issues with long-term patient compliance.
Area of Science:
- Cardiology
- Clinical Trials
- Hypertension Management
Background:
- Clinical trial results may not reflect real-world patient outcomes.
- Investigated the long-term persistence of blood pressure control after a clinical trial.
Purpose of the Study:
- To assess if blood pressure reductions achieved in a clinical trial are maintained in clinical practice over 31 months.
- To compare blood pressure readings from a clinical trial to those in long-term clinical practice.
Main Methods:
- 19 middle-aged men with hypertension underwent office and ambulatory blood pressure monitoring.
- Measurements were taken after placebo, 4 weeks of active treatment in a trial, and after 31 months in clinical practice.
Main Results:
- Mean 24-hour blood pressure increased from 128/85 mm Hg post-trial to 136/87 mm Hg after 31 months in practice.
- Daytime hypertension (>=140/90 mm Hg) rose from 24% to 39% in clinical practice.
- 6 out of 19 patients showed higher blood pressure in practice than post-trial.
Conclusions:
- Significant blood pressure reductions from trials did not persist in clinical practice.
- One-third of patients had blood pressure similar to pre-treatment levels at follow-up.
- Inconsistent patient compliance may explain the lack of durable blood pressure improvements.
Background:
The effects seen in clinical trials may not translate to actual practice situations. We examined the persistence of blood pressure effects 31 months after a clinical trial of treatment with hypotensive agents.
Methods:
Nineteen previously untreated middle-aged men with hypertension had their office and ambulatory blood pressure recorded after 4 weeks of placebo treatment, 4 weeks of active treatment in a clinical trial, and 31 months of treatment in clinical practice. All recording was done by the same physician (IE).
Results:
Mean 24-hour blood pressure was 138/92 mm Hg after 4 weeks of placebo treatment, 128/85 mm Hg after 4 weeks of active treatment in the clinical trial, and 136/87 mm Hg after a mean of 31 months of treatment in clinical practice. The corresponding blood pressure values > or =140/90 mm Hg during the daytime were 47%, 24%, and 39%, and office blood pressures were 155/101, 145/93, and 150/91 mm Hg. Individual comparison revealed that 6 of the 19 patients had higher mean 24-hour blood pressure after several months of treatment in clinical practice than after 4 weeks of active treatment in the clinical trial.
Conclusions:
In our study, the significantly reduced blood pressure in the clinical trial did not persist when followed up in clinical practice. At follow-up, one third of the patients had blood pressure values similar to those before active treatment. The reason for this is unclear, but inconsistent compliance may play a part in the lack of durability of the improvements. Our results indicate that effects seen in short-term clinical trials may not translate to long-term benefits in clinical practice.