Here are some examples of use of Standardised MedDRA Queries (SMQs) to address safety issues.
Analysis of SMQs for Signal Detection
The EMA researchers in this study compared the timing of onset of a known safety signal (hyperglycaemia) for a marketed product using various MedDRA term levels (PT, HLT, HLGT) and for SMQ Hyperglycaemia/new onset diabetes mellitus. Proportional reporting ratios (PRRs) over time (“dynamic PRRs”) for each term level and for the SMQ were calculated and used for the comparison. The researchers reported that a significant PRR was found using SMQ Hyperglycaemia/new onset diabetes mellitus earlier than for any other term level studied. The study highlighted the potential for SMQs to be used early on in signal detection for risk management, and that further research in this area would be useful.
Newbould V, Halsey N, Tsintis P, Lerch M, Mozzicato P. Standardised MedDRA® Queries: Analysis of their signal detection capability. 22nd ICPE Meeting; 2006 Aug; Lisbon, Portugal; Abstract 87.
Comparison of Risk of Seizures Using a SMQ
In this study, researchers mined the Spanish pharmacovigilance system for case reports of seizures to compare the rates of reports of these events in first generation (FGAs) vs. second generation antipsychotics (SGAs). Although the risk of seizures is well known among FGAs, the risk for SGAs to date is largely unknown. Using a Standardised MedDRA Query (SMQ Convulsions), the researchers compared the incidence of reporting for both types of antipsychotics using the same list of MedDRA PTs provided in the SMQ. Given well known caveats for incidence calculations related to spontaneous reporting, the researchers nonetheless concluded that there is a suggestion of increased risk of seizures for SGAs compared to FGAs, and that further research is needed.
Lertxundi U, Hernandez R, Medrano J, Domingo-Echaburu S, Garcıa M, Aguirre C. Antipsychotics and seizures: Higher risk with atypicals? Seizure 2013 March;22(2):141-3. doi: 10.1016/j.seizure.2012.10.009. Epub 2012 Nov 10.
Risk of Depression and Suicide/Self Injurious Behaviour Using a SMQ
In this study, researchers mined data from the US FDA’s AERS database for serious spontaneous reports for two marketed products indicated for smoking cessation. The objective was to determine the risk of depression and suicide/self injurious behaviour with these two products and compare the risks between them. Using a Standardised MedDRA Query – SMQ Depression and suicide/self-injury – the study authors determined that both products carry a risk of these types of events, with the risk for one product somewhat higher than the other. Based on their data, the authors provided a statement concerning the use of one of the products for first-line smoking cessation therapy.
Moore TJ, Furberg CD, Glenmullen J, Maltsberger JT, Singh S. Suicidal behavior and depression in smoking cessation treatments. PLoS ONE 2011 Nov 2;6(11):e27016.