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Clevidipine effectively reduced BP, improved dyspnea in acute HF
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In patients with hypertensive acute HF, early treatment with clevidipine yields better results than standard of care in BP management and dyspnea control, according to findings from the PRONTO study.
The multicenter, randomized, open-label, active-control study evaluated clevidipine (Cleviprex, The Medicines Company) vs. standard of care in 104 ED patients with hypertensive acute HF. The study participants had systolic BP ≥160 mm Hg and a sitting dyspnea score ≥50 mm on a 100 mm visual analog scale.
Patients were randomly assigned to clevidipine (n=51) or standard of care (n=53), with the type of hypertensives and clevidipine dosage administered determined by the attending physician in each case. Most (87%) of the standard of care group received IV nitroglycerin (57%) or nicardipine (30%), titrated to reach the systolic BP in a previously established target BP range.
The researchers defined the co-primary endpoints as median time to, and the proportion of patients achieving, a systolic BP within the targeted range. The secondary endpoint was decrease in dyspnea, with exploratory endpoints including the percentage of ED patients admitted, the number of procedures performed, duration of hospital and ICU stay, and 30-day readmission rates.
The baseline mean systolic BP and dyspnea score were 186.5 mm Hg and 64.8 mm, respectively.
The target BP range was achieved by a higher percentage of clevidipine patients than in the standard of care group (71% vs. 37%; P=.002), and the clevidipine group achieved the target range more quickly (P=.0006). Patients required additional BP management via IV therapy less frequently in the clevidipine group (16% of patients vs. 51%; P=.0005). Therapeutic procedures also were required less frequently by the clevidipine group (zero patients vs. 17%; P=.003).
At 45 minutes, the clevidipine patients had greater mean improvement to dyspnea than the standard of care patients (–37 mm vs. –28 mm; P=.02), and this significant difference persisted for up to 3 hours.
There were similar rates of serious adverse events (24% of patients in the clevidipine group vs. 19%) and 30-day mortality (three patients vs. two), and no deaths occurred during treatment administration. Adverse events considered related to treatment occurred in 10% of the clevidipine group and 13% of the standard of care group, with mild-to-moderate headache the most frequently reported event.
The researchers wrote that, besides the promising results observed with clevidipine, the PRONTO study also established the importance of early treatment for hypertensive acute HF patients.
“PRONTO is one of the first randomized [acute HF] trials to enroll patients within 3 hours of hospital arrival,” they wrote. “While early intervention benefits are supported by several large registry analyses, no large prospective randomized trial has demonstrated similar [acute HF] outcomes. That marked and rapid dyspnea improvement occurred in both PRONTO treatment groups suggests that time to treatment may be an important parameter to consider in the management of hypertensive AHF patients.”
Disclosure: The PRONTO study was sponsored by The Medicines Company. The researchers report no relevant financial disclosures.
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