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New drug class lowered blood pressure by affecting two receptors
The single-molecule receptor antagonist was also found to be safe and well tolerated.
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NEW ORLEANS – A dual-acting receptor antagonist compound effectively lowered systolic and diastolic blood pressure in patients with stage I and II hypertension, according to study results.
The DARA molecule, known as compound PS433540 (Pharmacopia, Inc.), targets specific angiotensin-1 and endothelin receptors. Results from a randomized, double blind study examining the DARA compound’s safety and efficacy were reported at the American Society of Hypertension 23rd Annual Scientific Meeting here last month.
“What we see here is a new class of drug that effectively lowers systolic and diastolic blood pressure in stage I and II patients with hypertension,” Joel M. Neutel, MD, associate professor of medicine at the University of California–Irvine, said at a press conference. “It appears that the reductions are greater than we have seen with other monotherapeutic agents, which provides evidence that this really has a dual pharmacological effect in a single molecule, and we saw that is was also safe and well tolerated.”
Dual-action lowered BP
Researchers originally enrolled 234 patients with stage I and II hypertension into the study, 108 of whom were evaluated and 93 of whom had follow-up ambulatory BP data available. Patients were randomized in either placebo group (n=25), a 200 mg low-dose DARA group (n=35) and a 500 mg high-dose DARA group (n=33).
According to the presentation, mean change in systolic BP in the placebo group was 0.3 for diastolic and –0.40 for systolic. Both groups of DARA recipients demonstrated changes in BP, with –9.3 diastolic and –12.20 systolic in the 200 mg dose group, and –10.1 diastolic and –14.80 in the 500 mg dose group. The reductions in BP were consistent both day and night.
Neutel also reported that the DARA compound’s safety profile was positive overall, and the drug was well-tolerated in the study population. The researchers reported that 26.5% (nine out of 34) patients in the placebo group reported adverse events, with 18.9% (seven out of 37) in the 200 mg group and 27% (10 out of 37) in the 500 mg group.
“I was pleased to find that the side effect profiles in the treated patients were no different than placebo,” Neutel reported. “Some of the concern with endothelin and angiotensin has been edema. We did not see anything different in the treated groups compared to placebo; only two patients out of 93 had reported edema, and there was no significance of any of other adverse events.”
Neutel hopes that the new therapy can have an effect on the heart as well as on BP.
“There is no doubt that it is becoming increasingly attractive to treat patients more quickly to get to the goal more quickly, so that they will be more likely to be compliant,” Neutel said. “The less that you have to change medications to increase compliance, the fewer tablets you have to give them per day, and there is recent data to suggest that if you get control of their blood pressure more rapidly, there is some benefit tin terms of long-term cardiovascular events.” — by Eric Raible
For more information:
- Neutel JM. Results of a prospective, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of PS433540, a Dual Angiotensin and Endothelin Receptor Antagonist (DARA compound) in subjects with hypertension. Recent and Late Breaking Trials. Presented at: American Society of Hypertension 23rd Annual Scientific Meeting; May 14 – 17, 2008; New Orleans.