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First Line CombinAtion Therapy in the Treatment of Stage II and III Hypertension (FLASH)
David Spirk1, Sarah Noll2, Michel Burnier3
1Institute of Pharmacology, University of Bern, Bern, Switzerland.
Insights
Single-pill irbesartan/hydrochlorothiazide effectively lowers blood pressure (BP) in hypertensive patients. This combination therapy showed better systolic BP control when used as a first-line treatment compared to replacement therapy.
Area of Science:
- Cardiology
- Pharmacology
- Hypertension Management
Background:
- Lowering blood pressure (BP) is crucial for reducing cardiovascular events.
- Single-pill combination therapies offer potential advantages over monotherapy dose escalation or separate drug use for BP control.
Purpose of the Study:
- To evaluate the real-world effectiveness of first-line or replacement single-pill combination therapy with irbesartan and hydrochlorothiazide (HCTZ).
- To assess the systolic blood pressure (SBP) control rate in hypertensive patients using this combination.
Main Methods:
- An observational, prospective, nationwide cohort study (FLASH) included 780 patients with moderate to severe hypertension.
- Patients received irbesartan/HCTZ single-pill combination therapy, with BP measured at baseline and 8-week follow-up.
Main Results:
- Mean SBP/DBP reductions were 23.7/11.7 mmHg. First-line treatment yielded greater SBP/DBP reductions (26.9/13.0 mmHg) than replacement therapy (21.8/11.0 mmHg).
- Guideline-recommended BP goals were achieved in 47% for SBP, 63% for DBP, and 40% for both. SBP control rate was significantly higher with first-line use (52% vs. 44%).
- The combination was well-tolerated, with adverse events including hypotension (1.5%) and hypokalemia (1.2%).
Conclusions:
- Single-pill irbesartan/HCTZ is well-tolerated and effectively reduces both systolic and diastolic BP.
- Prescribing irbesartan/HCTZ as first-line therapy resulted in a higher SBP control rate, aligning with current hypertension guidelines.
Abstract:
Background: Lowering blood pressure (BP) leads to reduced risk of stroke, myocardial infarction, and cardiovascular mortality. Single-pill combination therapies may deliver better BP control than increasing the dose of monotherapies or using more drugs separately. Objectives: The aim of the present observational study was to investigate the real-life use and the effect of first line or replacement single-pill combination therapies containing irbesartan and hydrochlorothiazide (HCTZ) on systolic BP (SBP) control rate in patients with hypertension. Methods: Overall, 780 patients with moderate or severe hypertension either untreated (289; 37%) or uncontrolled (491; 63%) with previous therapy were included in the "First Line CombinAtion Therapy in the Treatment of Stage II and III Hypertension" (FLASH) prospective Swiss national-wide cohort study. All recruited patients received single-pill antihypertensive combination therapy containing HCTZ and irbesartan. BP was measured at baseline and after 8-weeks follow-up according to guidelines. Results: Mean reductions in office systolic/diastolic BP (SBP/DBP) were 23.7 ± 13.7/11.7 ± 8.5 mmHg, with reductions of 26.9 ± 14.1/13.0 ± 8.8 mmHg or 21.8 ± 13.1/11.0 ± 8.3 mmHg when the single-pill combination of irbesartan/HCTZ was given as first line or replacement treatment, respectively (p < 0.001 for differences between first line and replacement treatment in both SBP and DBP). The guidelines-recommended goals were reached in 368 (47%), 492 (63%), and 312 (40%) patients for SBP, DBP, and SBP/DBP, respectively. The SBP control rate was higher when the combination was used as first line treatment (52 vs. 44%; p = 0.043). Overall, 145 adverse events were recorded; hypotension in 12 (1.5%) cases, hypokalaemia in 9 (1.2%), and hyperkalaemia in 3 (0.4%). Conclusions: The single-pill combination of irbesartan/HCTZ was well-tolerated and achieved substantial reductions in both systolic and diastolic BP. The SBP control rate was greater when the combination was prescribed as first line treatment as suggested by recent ESC/ESH guidelines.
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