The FDA changed the drug label for lisinopril to reflect findings from a study conducted by PTN investigators. Results from the study were published in the journal, Clinical Pharmacology &Therapeutics.
Lisinopril
PTN lisinopril study and subsequent label change highlighted in DCRI News.
Pediatric Trials Network study results in label change for hypertension drug
May 11, 2016 – The change could affect the hundreds of children who are prescribed lisinopril after kidney transplants each year.
A study conducted by the Pediatric Trials Network (PTN) has resulted in a labelling change for a widely used drug.
Lisinopril is an angiotensin converting enzyme inhibitor that is commonly prescribed to treat high blood pressure or heart failure in adults. It is also given to children who have hypertension, including children who have undergone kidney transplants. As with many other drugs, however, there has been little research to suggest the optimal dose for pediatric transplant patients. The PTN was established to answer these types of questions about drugs given to children and adolescents.
“There is a great medical need but a small market for these types of studies,” said Daniel Benjamin, Jr., MD, MPH, PhD, the PTN’s principal investigator (pictured). “This is why the PTN was formed—to conduct the studies that no one else will.”
A study led by DCRI researcher Uptal Patel, MD, and other researchers for the PTN recently resulted in a decision by the the U.S. Food and Drug Administration (FDA) to update the label for lisinopril. In addition to Patel, the study’s authors included Howard Trachtman, MD, of New York University; Adam Frymoyer, MD, of Stanford University; Laurence Greenbaum, MD, PhD, of Emory University; Daniel Feig, MD, PhD, of the University of Alabama at Birmingham; Debbie Gipson, MD, of the University of Michigan; Bradley Warady, MD, of Children’s Mercy Hospital of Kansas City; Jens Goebel, MD, of Cincinnati Children’s Hospital; and George Schartz, MD, of the University of Rochester.
The study was a multicenter, open-label pharmacokinetic study of daily oral lisinopril in 22 children, aged 7–17 years, with stable kidney function following transplant.
The researchers found that the pharmacokinetics of lisinopril in children who underwent kidney transplant were similar to hypertensive children who did not receive kidney transplants. Lisinopril was generally well tolerated by the patients and was accompanied by a lowering of blood pressure at approved pediatric doses in the study population.
The results of the study were published in the July 2015 issue of Clinical Pharmacology & Therapeutics.
Approximately 1,200 children in the United States develop end-stage renal disease (ESRD) each year. Because kidney transplantation has become the primary method of treating ESRD for children, many of these patients will be prescribed lisinopril. As a result of the FDA’s recent decision, Benjamin noted, doctors will now have a better understanding of the correct dose.
“This has been a problem for over 60 years, and we’re only now addressing it,” he said. “With the PTN, we now a have a vehicle to make those changes.”
Pharmacokinetics, Pharmacodynamics, and Safety of Lisinopril in Pediatric Kidney Transplant Patients: Implications for Starting Dose Selection
Clinical Pharmacology Therapy • July 2015.
Trachtman H, Frymoyer A, Lewandowski A, Greenbaum LA, Feig DI, Gipson DS, Warady BA, Goebel JW, Schwartz GJ, Lewis K, Anand R, Patel UD; Best Pharmaceuticals for Children Act-Pediatric Trials Network Administrative Core Committee.
Hypertension in pediatric kidney transplant recipients contributes to long-term graft loss, yet treatment options–including angiotensin-converting enzyme inhibitors–are poorly characterized in this vulnerable population. We conducted a multicenter, open-label pharmacokinetic (PK) study of daily oral lisinopril in 22 children (ages 7-17 years) with stable kidney transplant function. Standard noncompartmental PK analyses were performed at steady state.
The PTN lisinopril study completes enrollment
In spite of the challenges posed by its complex protocol, the “Safety and Pharmacokinetics of Lisinopril in Pediatric Kidney Transplant Recipients” study has completed enrollment, with a total of 26 patients contributing data to this study of lisinopril use for the control of high blood pressure in kids receiving kidney transplants.
This accomplishment is due to the exceptional efforts of the study teams at 8 sites: University of Alabama–Birmingham, Arkansas Children’s Hospital in Little Rock, University of Michigan at Ann Arbor, New York University Langone Medical Center, Albert Einstein University Hospital in New York, Cincinnati Children’s Hospital, Children’s Mercy Hospital in Kansas City, and Emory University & Children’s Healthcare of Atlanta.
Lisinopril is a drug used in children ages 6 and up to treat high blood pressure, a condition commonly seen among children and adolescents who receive kidney transplants. Unfortunately, the appropriate dose of lisinopril in these especially vulnerable patients is not currently known. This PTN study is evaluating the safety of lisinopril in pediatric participants who have a stable functioning kidney transplant and high blood pressure. It is also examining what young bodies do to the drug (a.k.a. the drug’s pharmacokinetics).
Preliminary results are expected later this year.
PTN lisinopril study enrolls first participant
Principal investigator Daniel Feig, MD, PhD, of University of Alabama-Birmingham has successfully enrolled the first participant into the PTN study of lisinopril use for the control of high blood pressure in kids with kidney transplants.
Seven sites are currently recruiting participants into this study: Arkansas Children’s Hospital in Little Rock, Cincinnati Children’s Hospital, Children’s Mercy Hospital in Kansas City, Emory University & Children’s Healthcare of Atlanta, New York University Langone Medical Center, University of Alabama-Birmingham, and University of Michigan at Ann Arbor.
Results from the lisinopril study are expected by summer 2013.
The PTN lisinopril study is now looking for participants to enroll at four active sites
Four sites are now actively seeking participants to enroll into the PTN study of lisinopril for the control of high blood pressure in kids with kidney transplants: University of Alabama–Birmingham, Arkansas Children’s Hospital in Little Rock, University of Michigan at Ann Arbor, and New York University Langone Medical Center.
Lisinopril is a drug used in children ages 6 and up to treat high blood pressure, a condition commonly seen among children and adolescents who receive kidney transplants. Unfortunately, the appropriate dose of lisinopril in these especially vulnerable patients is not currently known.
This PTN study will evaluate the safety of lisinopril in pediatric participants who have a stable functioning kidney transplant and high blood pressure. It will also examine what young bodies do to the drug (a.k.a. the drug’s pharmacokinetics).
An eventual total of eight sites will recruit participants into this study. Future sites include Albert Einstein University Hospital in New York, Cincinnati Children’s Hospital, Children’s Mercy Hospital in Kansas City, and Emory University & Children’s Healthcare of Atlanta.
The PTN lisinopril study nears the start of enrollment
The PTN study of the safety and pharmacokinetics of lisinopril in pediatric kidney transplant recipients will begin enrolling patients at the end of April. At that time, 4 of the anticipated 8 sites should be activated.
Lisinopril use is FDA-approved in children aged 6+ years for the treatment of high blood pressure, a condition that is common among children and adolescents who receive kidney transplants. Unfortunately, the appropriate dose of lisinopril in these especially vulnerable patients is not currently known.
Enrolling sites in the PTN lisinopril study will eventually include: Albert Einstein University Hospital in New York, Cincinnati Children’s Hospital, Children’s Mercy Hospital in Kansas City, Emory University & Children’s Healthcare of Atlanta, University of Alabama–Birmingham, Arkansas Children’s Hospital in Little Rock, University of Michigan at Ann Arbor, and New York University Langone Medical Center.
This study will evaluate the safety of oral lisinopril in pediatric participants who have a stable functioning kidney transplant and high blood pressure. It will also examine what young bodies do to the drug (a.k.a. the drug’s pharmacokinetics). The trial team plans to recruit a total of 24–28 children ages 2–17 years.
The PTN lisinopril study to begin enrolling patients in April 2012
A study to determine the safety and pharmacokinetics of lisinopril in children and adolescents receiving kidney transplants will begin enrolling participants in April 2012.
Lisinopril is approved by the U.S. Food and Drug Administration for the treatment of children aged 6 years and older and adults with high blood pressure, heart failure, and heart attack. High blood pressure is also common among children and adolescents who have received a kidney transplant, but the appropriate dose of lisinopril in this group is not well known.
In this PTN study, lisinopril will be given to children and adolescents who have received a kidney transplant and have high blood pressure. The levels of lisinopril in each participant will be measured, thereby helping to determine the best dose of the drug to reduce high blood pressure in this unique group. Up to 28 children and adolescents between 2 and 17 years of age with a successful kidney transplant will be enrolled at 8 sites across the United States.
Click here to learn more about this study.