Vraylar Found to Be Less Risky Than Risperdal, Comparable to Abilify
Abstract
The three drugs had 67 adverse events in common, including suicidal ideation, anxiety, weight gain, dyslipidemia, extrapyramidal disorder, agranulocytosis, and diabetes mellitus.
The recently approved atypical antipsychotic Vraylar (cariprazine) appears to be a safer alternative to Risperdal (risperidone) with a similar risk profile to Abilify (aripiprazole), according to a recent analysis by the health informatics firm Advera Health Analytics Inc.
“This is something that we typically do when new drugs are being approved,” Robert Kyle, J.D., chief product officer at Advera, told Psychiatric News. Vraylar was approved in September for the treatment of manic and mixed episodes of bipolar I disorder as well as schizophrenia.
“We look at the safety profile of the newly approved drug, which was generated from clinical trials, and compare [this information] with the safety profile of drugs of the similar class that are currently in the marketplace,” Kyle said. “We are trying to give physicians, other health care providers, and [medical insurance] payers an estimate on how the safety of the new drug fairs against those popular ones already on the market.”
Kyle explained to Psychiatric News that when a drug is first approved, the adverse events that are added to the drug’s label are derived from clinical trial experiences and known risks from other drugs in the same class. After the drug gets approved, additional postmarketing risks (known as nonlabeled adverse events) that are reported can also be added to the label.
In the current comparison study, adverse events that were listed on Vraylar’s label were compared with labeled and nonlabeled adverse events for Abilify and Risperdal.
Measuring Vraylar’s labeled adverse events against reporting odds ratio (ROR) values—a comparison of the number of side effects reported for a particular medicine with how many side effects are expected—of Abilify and Risperdal, the researchers found Vraylar to be less risky than Risperdal, with a risk profile comparable to Abilify.
Risperdal had the highest number of labeled adverse reactions—177—as well as additional nonlabeled associated adverse events. Abilify had 150 labeled adverse reactions and additional nonlabeled events, and Vraylar had 76 labeled adverse reactions.
Sixty-seven adverse events were shared among the labeling of the three drugs, which included suicidal ideation, anxiety, weight gain, dyslipidemia, extrapyramidal disorder, agranulocytosis, and diabetes mellitus. Potential adverse events that were present on labels for Abilify and Risperdal but absent on the labels of Vraylar included anaphylactic shock, aspiration pneumonia, atrial fibrillation, electrocardiogram prolonged QT interval, and respiratory tract infection.
“Vraylar was relatively safe with potential health risks similar to those of Abilify,” said Kyle, who noted that rare cases of stroke associated with the newly approved antipsychotic were observed in clinical trials—but prevalence rates for the event did not reach statistical significance.
According to Kyle, this is just the beginning of exploring the safety profile of Vraylar. As postmarketing safety data for the drug become available, Advera will continue to examine how the medication compares with the others on the market.
The study was funded by Advera. ■
