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1. Differences in Importance Attached to Drug Effects Between Patients With Type 2 Diabetes From the Netherlands and Turkey: A Preference Study

Author

Sonia Roldan Munoz, Douwe Postmus, Sieta T. de Vries, Arna H. Arnardottir, İlknur Dolu, Hans Hillege, and Peter G. M. Mol

Subjects
type 2 diabetes mellitus, patient preferences, discrete-choice experiment, The Netherlands, Turkey, Therapeutics. Pharmacology, RM1-950
Abstract

Objective: The aim of this study was to compare the importance that patients with type 2 diabetes mellitus from the Netherlands and Turkey attach to certain drug effects of oral anti-diabetic drugs.Methods: Data were collected through a cross-sectional survey containing demographic questions and a discrete choice experiment assessing preferences for oral anti-diabetic drugs. Adults from the Netherlands and Turkey were included if they had type 2 diabetes mellitus and had received a prescription of an oral anti-diabetic drug in the last 4 months. The oral anti-diabetic drugs in the discrete choice experiment were described in terms of six attributes: effects on HbA1c, cardiovascular diseases, weight change, gastrointestinal adverse drug events hypoglycemic events, and bladder cancer. Multinomial logit models with country as an interaction factor were fitted.Results: In total, 381 patients were included, 199 from the Netherlands and 182 from Turkey. Patients’ preferences toward drug effects varied between the countries. Turkish patients attached the highest importance to reducing the risk of cardiovascular diseases (relative weight: 0.51, 95% CI 0.45–0.55), followed by reducing hypoglycemic events (relative weight: 0.16, 95% CI 0.11–0.22), and reducing gastrointestinal adverse drug events (relative weight: 0.11, 95% CI 0.07–0.18). Patients from the Netherlands attached the highest importance to gastrointestinal ADEs (relative weight: 0.22, 95% CI 0.14–0.39), followed by reducing hypoglycemic events (relative weight: 0.22, 95% CI 0.16–0.25), and reducing the risk of cardiovascular diseases (relative weight: 0.20, 95% CI 0.13–0.23).Conclusion: Patient preferences may differ across countries. Such differences should be acknowledged in regulatory decisions and clinical practice.

Published
2021
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2. Post-approval safety issues with innovative drugs: a European cohort study

Author

Peter G. M. Mol, Sabine M. J. M. Straus, Patrick J. Vrijlandt, Ruben G. Duijnhoven, Flora M. Haaijer-Ruskamp, Domenico Motola, Petra Denig, Pieter A. de Graeff, Arna H. Arnardottir, Mol PG, Arnardottir AH, Motola D, Vrijlandt PJ, Duijnhoven RG, Haaijer-Ruskamp FM, de Graeff PA, Denig P, Straus SM., Obstetrics and Gynaecology, Medical Informatics, and Methods in Medicines evaluation & Outcomes research (M2O)

Subjects
Consumer Product Safety, Drug-Related Side Effects and Adverse Reactions, UNION, RISK-MANAGEMENT, Toxicology, Cohort Studies, Safety-Based Drug Withdrawals, Drug withdrawal, innovative drugs, Environmental health, Product Surveillance, Postmarketing, REGULATORY ACTIONS, Humans, Medicine, BENEFIT, Pharmacology (medical), Drug Approval, Risk management, Proportional Hazards Models, Pharmacology, Descriptive statistics, business.industry, Proportional hazards model, DECADE, Hazard ratio, safety issue, medicine.disease, Europe, business, Algorithms, Cohort study
Abstract

Background At time of approval, knowledge of the full benefit risk of any drug is limited, in particular with regards to safety. Post-approval surveillance of potential drug safety concerns is recognized as an important task of regulatory agencies. For innovative, often first-in-class drugs, safety knowledge at time of approval is often even less extensive and these may require tighter scrutiny post approval.Objective We evaluated whether more post-approval serious safety issues were identified for drugs with a higher level of innovation.Methods A cohort study was performed that included all new active substances approved under the European Centralized Procedure and for which serious safety issues were identified post-approval from 1 January 1999 to 1 January 2012. Serious safety issues were defined as issues requiring a Direct Healthcare Professional Communication to alert individual healthcare professionals of a new serious safety issue, or a safety-related drug withdrawal. Data were retrieved from publicly available websites of the Dutch Medicines Evaluation Board and the European Medicines Agency. The level of innovation was scored using a validated algorithm, grading drugs as important (A), moderate (B) or modest (C) innovations or as pharmacological or technological (pharm/tech) innovations. The data were analyzed using appropriate descriptive statistics and Kaplan-Meier analysis, with a Mantel-Cox log-rank test, and Cox-regression models correcting for follow-up duration, to identify a possible trend in serious safety issues with an increasing level of innovation.Results In Europe, 279 new drugs were approved between 1999 and 2011. Fifty-nine (21 %) were graded as important, 63 (23 %) moderate, or 34 (12 %) modest innovations and 123 (44 %) as non-innovative (pharm/tech), while 15 (25 %), 13 (21 %), 8 (24 %) and 17 (14 %) had post-approval safety issues, respectively (p = 0.06, linear-by-linear test). Five drugs were withdrawn from the market. The Kaplan-Meier-derived probability for having a first serious safety issue was statistically significant, log-rank (Mantel-Cox) p = 0.036. In the final adjusted Cox proportional hazard model there was no statistically significant difference in occurrence of a first serious safety issue for important, moderate and modest innovations versus non-innovative drugs; hazard ratios 1.76 (95 % CI 0.82-3.77), 1.61 (95 % CI 0.76-3.41)], and 1.25 (95 % CI 0.51-3.06), respectively.Conclusion A higher level of innovation was not clearly related to an increased risk of serious safety issues identified after approval.

Published
2013

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