Publications by authors named "Monika Stender"
Background: Achondroplasia (ACH) is a rare, genetic condition and is the most common skeletal dysplasia resulting in disproportionate short stature and numerous multi-systemic comorbidities. As we enter an era of new treatment options which may impact comorbidities, it is important to understand the background rates of these events to aid evaluation of potential treatment effects. Thus, the aim of this literature review was to provide a comprehensive quantification of prevalence estimates of comorbidities in achondroplasia by age for use as a compiled reference to assist in quantifying the risk/benefit of new treatment options and informing timely management of ACH.
View Article and Find Full Text PDFBackground: Bupropion hydrochloride (Zyban) is an effective aid to smoking cessation; however, its use has previously been associated with neuropsychiatric adverse events. Here we report results of the patient Knowledge, Attitudes, and Behavior survey that forms part of the Year 7 Risk Evaluation and Mitigation Strategy (REMS) assessment for Zyban.
Objective: Assess participants' understanding of the neuropsychiatric risks associated with branded bupropion hydrochloride products that are used for smoking cessation, as described in the Medication Guides.
Background: The risk of pancreatitis and potential risk of medullary thyroid carcinoma associated with glucagon-like peptide-1 receptor agonists prompted the US Food and Drug Administration to require a Risk Evaluation and Mitigation Strategy for albiglutide, including education for prescribers and subsequent assessment of their knowledge of the risks and safe use of albiglutide via a quantitative survey.
Objective: The objective of this study was to assess prescribers' knowledge of the risks related to medullary thyroid carcinoma, pancreatitis, and the appropriate patient population for albiglutide.
Methods: Two Risk Evaluation and Mitigation Strategy surveys were conducted 18 months and 3 years after albiglutide was launched.
Survey of Physicians' Understanding of Specific Risks Associated with Retigabine.
Drugs Real World Outcomes
June 2016
Background: Following reports of discoloration, including retinal pigmentation, in addition to known significant risks of urinary retention, central nervous system effects, and QTc prolongation, the retigabine indication was restricted to adjunctive treatment of partial onset seizures where other appropriate drug combinations have proved inadequate or have not been tolerated.
Objective: To ascertain the effectiveness of educational initiatives as reflected in physicians' understanding of retigabine-associated risks, management, and patient selection.
Methodology: An online, cross-sectional survey, designated a post-authorization safety study (24/9/2014-30/1/2015), recruited retigabine prescribers (RP) and retigabine non-prescribers (RNP) in seven countries, who had been sent a retigabine Dear Health Care Professional letter (June 2013).
Background: There is limited information in the literature regarding the risk of severe hypersensitivity reactions due to different β-blocking agents. Most of the available information addresses the potential for increased severity of anaphylaxis or poor response to treatments among patients receiving β-blocking agents.
Objective: The objective of this study was to estimate the incidence rates of severe hypersensitivity reactions (angioedema and anaphylactic reactions) for various β-blockers and to examine the risk of severe hypersensitivity reactions in patients exposed to carvedilol extended-release compared with carvedilol and compared with other β-blockers.
An assessment of the effect of thiazolidinedione exposure on the risk of myocardial infarction in type 2 diabetic patients.
Pharmacoepidemiol Drug Saf
October 2008
Purpose: To determine the likelihood of myocardial infarction (MI) in type 2 diabetic patients exposed to rosiglitazone and pioglitazone, separately, compared to other antidiabetic therapies.
Methods: A case-control analysis nested within the cohort of type 2 diabetic subjects from the Integrated Healthcare Information Services (IHCIS) claims database. Incident cases of MI were matched to three controls each on age (+/-5 years), gender, and year of first diabetes diagnosis.
Background: The implementation of more aggressive goals for low-density lipoprotein cholesterol lowering in subjects with type 2 diabetes (T2D) and the expected increase in the use of statins is likely to increase the concomitant use of thiazolidinediones (TZDs) and statins.
Objective: This study evaluated whether concomitant use of TZDs and statins is associated with an increased risk of myopathic events in subjects with T2D.
Methods: This was a nested case-control study in subjects with T2D.
Objective: To assess the effects of antidiabetic drugs on the risk of heart failure in patients with type 2 diabetes.
Research Design And Methods: We conducted a retrospective cohort study with a newly diagnosed diabetes cohort of 25,690 patients registered in the U.K.
Objective: This study examined health care resource utilization and direct health care costs among patients diagnosed with bipolar I disorder in a privately insured population.
Methods: Health care claims data for 2883 patients with a primary diagnosis of bipolar disorder were compared over a 1-year period (1997) with claims data for 2883 randomly selected, age- and sex-matched, non-bipolar patients, all covered under the same large private insurer in USA. Resource use (i.
Background: Detailed assessments of the direct costs related to bipolar disorder and of the burden it places on the health care system are limited.
Objective: In this retrospective, cross-sectional, descriptive analysis, we assessed prescription medication and other medical resource use in bipolar disorder in an insured population in the northeastern United States.
Methods: Number and types of prescription drugs, medical encounters, and respective costs were derived from a New England insurer database for 1996.