Heidi Wicks

Drug research doesn’t end after Health Canada gives pharmacies the go-ahead to stock their shelves.

And with the plethora of pills that saturate the pharmaceutical sales industry, it’s difficult to know which choice is right.

Dr. John-Michael Gamble, a pharmacist and pharmacoepidemiologist (a specialist who studies drug effects on the population) in the School of Pharmacy, is beginning a research initiative that is backed by the Heart and Stroke Foundation of Canada, the Newfoundland and Labrador Research Development Corporation, and the Canadian Institutes of Health Research (CIHR). 

Dr. Gamble, who holds a New Investigator Award in Drug Safety and Effectiveness from the CIHR and is a Clinician Scientist with the Canadian Diabetes Association, is collaborating with researchers from across the country. The research will explore the post-marketing safety and effectiveness of medications used to treat type 2 diabetes.

“Although medications are studied extensively before they hit the pharmacy shelves, there are inherent limitations in pre-approval studies,” Dr. Gamble explains.

“Specifically, those trials are often of short duration and do not capture the long-term effects of medications. They also have a limited number of participants and are not able to precisely measure uncommon, adverse side effects.”

This means that the chance of rare adverse effects such as acute kidney injury, pancreatitis or hepatitis, is unknown.

On the flip side, the potential long-term benefits of certain medications - such as a reduction of cardiovascular disease - are also unidentified.

“People living with type 2 [diabetes] are at a higher risk for heart disease and stroke, which is the leading cause of ill health and death in this country,” Dr. Gamble explains.

Given that Newfoundland and Labrador holds the highest rate of type 2 diabetes in Canada, his findings will be particularly applicable to the residents of this province.

Dr. Gamble will assess the benefits and risks of traditional treatments such as insulin injections, as well as emerging treatments like incretin-based medications.

Chartering new territory

The study is focused on areas that have either not been studied or have very little research.

Dr. Gamble says the comparison of contemporary medications amongst real-world patients is understudied and very important for clinical decision-making.

“We have several ongoing studies that evaluate unique outcomes in patients using different types of diabetes medications,” he says. “These studies measure the risk of not only classic complications of diabetes such as heart attacks, strokes, and cardiovascular, but also the risk of other complications that are more common in people with diabetes such as depression, fractures, and pneumonia.”

His method will include a study using detailed healthcare records for patients with type 2 diabetes, which will include information on their diagnosis and prescription medication use, as well as lab tests, hospitalizations and deaths.

Dr. Gamble’s research will inform clinicians, patients, and policymakers.

“Information obtained from this study will provide front-line pharmacists and physicians with high level evidence on the use of treatments for this disease,” Dr. Gamble says.

“Ultimately, the impact of cardiovascular disease on individuals living in Canada may be reduced by increasing our understanding of both the benefits and the risks of medications that are currently being used to treat type 2 diabetes.”