In this post hoc exploratory analysis, adjunctive lacosamide demonstrated significant seizure reduction over placebo regardless of the inclusion of 'traditional' sodium channel blockers in the concomitant AED regimen. Future prospective studies evaluating single AED combinations (e.g. lacosamide plus one other drug) are needed to better evaluate the potential for additive or synergistic effects of lacosamide in combination with AEDs not considered 'traditional' sodium channel blockers.
Various health care bodies (regulatory, health technology assessment, academia, health care providers, scientific journals) request patient input in their decision-making processes. This represents a shift from disease-centered to patient-centered approaches to health care. What does this "patient centricity" mean for the pharmaceutical industry? A panel of senior pharmaceutical industry representatives discussed the following key issues: why the pharmaceutical industry needs to be part of the patient-centric movement; how the industry can become patient-centric; and what a patient-centric company actually does. We summarize the panel's point of view on these key questions. The industry's role has been to develop the science and medicines for prevention or treatment of disease. In response to changes in the current health care environment, the industry should focus its efforts on initiatives that will improve impact and value for patients and carers. True patient centricity requires a change in the industry's cultural mindset, an increase in public trust, clearer roles and responsibilities within pharmaceutical organizations, openness to learn from others, and a framework to measure success. There are examples of industry engagement with patients throughout the drug discovery and development process. Patient-reported outcomes are becoming increasingly important endpoints in trials; they capture information of relevance to patients, identify preferences, and better inform treatment decision making. Understanding the patient experience can improve disease management at critical points in the disease course. The future of patient centricity lies in coordinated efforts by and alignment of multiple health care stakeholders, which can only be achieved through collaborations and consortia, with the industry playing a key role.
Dixon et al. reported the results of the most thorough study of lamotrigine effects on electrocardiogram (ECG) intervals that has been published to date [1]. In this placebo-and moxifloxacin-controlled trial, lamotrigine monotherapy at doses up to 400 mg day -1 was shown to not prolong the QTc interval in healthy subjects.The report stated that additional ECG conduction intervals were measured, including the PR interval and the QRS duration. While QRS duration results were reported in the paper, the PR interval results from the study were neither reported nor discussed.Approved labelling for lamotrigine does not include evidence indicating that lamotrigine has any effect on PR interval [2, 3]; however, the literature contains at least two trials where lamotrigine was reported to be associated with a small increase in mean PR (or PQ) interval in patients with epilepsy. Matsuo et al. reported a mean 5 ms increase in PR interval in epilepsy patients randomized to treatment with lamotrigine [4]. Recently, Saetre et al. reported that lamotrigine was associated with a mean 8.8 ms increase in PQ interval in a group of elderly epilepsy patients treated with a relatively low mean daily lamotrigine dose (~110 mg day -1 , serum concentration~2.6 mg ml -1 ) [5]. Given these findings, a complete reporting of the ECG data, including PR interval, is important for an accurate assessment of the cardiac profile of lamotrigine.The extensive ECG data acquisition and relatively high steady-state plasma concentrations of lamotrigine (9.6 mg ml -1 for the 400 mg day -1 dose group) evaluated in the Dixon et al. trial [1] would provide the specific data needed to determine whether there is an effect of lamotrigine on PR interval. As such, we respectfully request an addendum to this publication that would allow the inclusion of a graphical presentation of PR interval data, such as that used in the report for QRS duration, as well as a quantitative statement of the mean placebosubtracted change from baseline for PR interval at steady state (Cmax) for the three lamotrigine doses that were studied. Competing interestsGDR and JKS are UCB employees and hold UCB shares. REFERENCES1 Dixon R, Job S, Oliver R, Tompson D, Wright JG, Maltby K, Lorch U, Taubel J. Lamotrigine does not prolong QTc in a thorough QT/QTc study in healthy subjects. Br J Clin
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