In Potential Breakthrough, Dutch Study Shows How Use Of a “DNA Medication Pass” Can Significantly Reduce Adverse Events..

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Since the unveiling of the human genome more than two decades ago, precision medicine has advanced to the point where it’s now integral to clinical drug development.

Equally important is the use of genetic information to diagnose disease and tailor treatment. Dutch researchers at the Leiden University Medical Center are doing just that. In a study published this week in The Lancet they point to a possible breakthrough in precision medicine. They used a so-called DNA medication pass to custom fit treatments across a wide range of disease areas. Adjusting the dosage of medications based on patients’ DNA profiles led to 30% fewer serious side effects.

In many areas of medicine, a one-size-fits all approach for prescribing medicines is becoming obsolete. This especially holds true in oncology. Due to variations in our genetic make-up, patients often respond differently to certain anti-neoplastics. Take the breast cancer drug Herceptin (trastuzumab), for instance. Only those with a HER2 positive oncogene stand to benefit from the treatment.

In its simplest form, precision medicine reveals which patients are likely to benefit or experience adverse events from taking a drug.

But, it’s often more complicated that. Due to differences in metabolism, for example, some patients may process certain drugs faster than others and consequently require a higher dose to achieve benefit.

Researchers at the Leiden University Medical Center developed a “DNA medication pass” that connects a patient’s genetic profile to drugs of which it’s been established that metabolic processing is influenced by DNA. Scanning the pass enables doctors and pharmacists to know what the optimal medication dose is for the patient.

The research scientists say that patients who actively and appropriately make use of the medication pass, and whose doses are titrated in accordance with their DNA profile, experienced 30% fewer serious adverse events than patients who were prescribed a standard dose of medication.

Approximately 7000 patients from seven European countries were assessed over several medical specialities, including oncology, cardiology, psychiatry and general medicine.

The study was coordinated by Henk-Jan Guchelaar, Professor of Clinical Pharmacy at Leiden University. He has conducted research in the field of pharmacogenetics for more than 20 years. Referencing the study, Guchelaar said: “For the first time we have proven that a tailored strategy works at a large scale within clinical practice. There is now enough evidence for us to proceed with implementation,” meaning to start utilizing the DNA medication pass.

The participants in the study all received a DNA medication pass, based on their DNA profile. By scanning the pass, doctors and pharmacists were able to determine exactly which drug dose was optimal for each patient. Not only did the test subjects suffer less side effects, they also felt the pass gave them a sense of empowerment, because they were actively involved in their own treatment.

This raises questions such as whether in future – if the pass becomes a mainstay – it should be reimbursed by payers and be considered part of standard care and therefore an essential benefit. The pass would cost between 300 and 600 euros per patient. But, it may deliver cost savings in the healthcare system.

The work being carried out by Guchelaar’s team is contributing to the personalization of medicine, which is part of the broader precision medicine trend in healthcare. This involves more than just DNA profiling. Gender differences and ethnicity play a role. And things like body size, differences in people’s intestinal microflora, drug-drug interactions, and other non-genetic factors can also lead to different people taking the same drug having markedly different responses.

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