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Lovastatin proves safe with limited efficacy in dengue patients
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Lovastatin was safe and well-tolerated in adult patients with dengue; however, the drug did not provide a beneficial impact on clinical symptoms of dengue or dengue viremia, according to recent findings.
“While the study findings do not endorse adjunctive statin therapy for dengue, the data provide reassurance to clinicians about the safety of continuing statin therapy in patients who develop dengue,” the researchers wrote.
Researchers initially demonstrated the safety of lovastatin in a pilot study in November and December 2012. Thirty patients with dengue who received either 40 mg lovastatin or placebo experienced similar adverse events.
After the initial review, the researchers enrolled 300 Vietnamese adults with dengue to a randomized, double blind trial to compare the effects of a 5-day regimen of 80 mg lovastatin (n = 149) vs. placebo (n = 151). Participants presented within 72 hours of fever onset. The primary outcome was the incidence of adverse events (AEs) or serious adverse events (SAEs) between treatment arms.
No significant difference in AEs between the lovastatin and placebo groups (55% vs. 64%) was observed, and SAEs occurred in four patients in the lovastatin arm vs. eight patients in the placebo arm. All events were fully resolved. At least one grade three or four laboratory AE was identified in 74% of patients in the placebo group and 75% of those assigned lovastatin.
The researchers commonly found biochemical evidence of comparable hepatic dysfunction in the placebo (21%) and lovastatin (26%) groups that exceeded the prespecified alanine aminotransferase cutoff (250 U/L). There also was a high prevalence of minor mucosal bleeding, none considered significant.
Fever clearance did not differ significantly between groups, and lovastatin had no discernable impact on overall dengue viremia kinetics or quality of life scores, according to the researchers.
“As in other recent trials of antiviral and immunomodulatory agents for dengue, we administered the study drug within 72 hours of illness onset,” they wrote. “It is possible that even initiating a therapeutic within this time frame is too late to modulate the disease pathways.
“Early diagnosis and recognition of severe features together with good supportive care remain central to effective clinical management [of dengue].” – by Jen Byrne
Disclosure: Whitehorn reports that his institution, Oxford University clinical research unit in Vietnam, receives consulting fees on his behalf from Janssen Pharmaceuticals. Please see the full study for a list of all other authors’ relevant financial disclosures.
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