Co‐morbidity of ‘Clinical Trial’ versus ‘Real‐World’ patients using cardiovascular drugs

Wieringa, Nicolien; Vos, Rein; Werf, G.T. van der; Veen, Willem Jan van der; Graeff, Pieter A. de

doi:10.1002/pds.541.abs

Cited by 5 publications

(6 citation statements)

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“…Fourth, the 10% cutoff point was selected because this was the minimum difference that we thought would be clinically meaningful. It also was used in similar prior studies [9,24,25]. Other cutoffs might have led to different conclusions.…”

Section: Discussionmentioning

confidence: 99%

“…We decided, a priori, that a difference of 10% between the NHDS and NIS was meaningful. The 10% cutoff was chosen based on prior use in similar studies [9,24,25]. In bivariate analysis, in each dataset, mortality, adverse events, and days of care were the response variables and patient characteristics and comorbidities were the explanatory variables.…”

Section: Methodsmentioning

confidence: 99%

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The National Hospital Discharge Survey and Nationwide Inpatient Sample: The Databases Used Affect Results in THA Research

Bekkers

Bot

Makarawung

et al. 2014

Clinical Orthopaedics &Amp; Related Research

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Background The National Hospital Discharge Survey (NHDS) and the Nationwide Inpatient Sample (NIS) collect sample data and publish annual estimates of inpatient care in the United States, and both are commonly used in orthopaedic research. However, there are important differences between the databases, and because of these differences, asking these two databases the same question may result in different answers. The degree to which this is true for arthroplasty-related research has, to our knowledge, not been characterized. Question/purposes We tested the following null hypotheses: (1) there are no differences between the NHDS and NIS in patient characteristics, comorbidities, and adverse events in patients with hip osteoarthritis treated with THA, and (2) there are no differences between databases in factors associated with inpatient mortality, adverse events, and length of hospital stay after THA. Methods The NHDS and NIS databases use different methods of data collection and weighting to provide data representative of all nonfederal hospital discharges in the United States. In 2006 the NHDS database contained 203,149 patients with hip arthritis treated with hip arthroplasty, and the NIS database included 193,879 patients. Multivariable analyses for factors associated with inpatient mortality, adverse events, and days of care were constructed for each database. Results We found that 26 of 42 of the factors in demographics, comorbidities, and adverse events after THA in the NIS and NHDS databases differed more than 10%. Age and days of care were associated with inpatient mortality with the NHDS and the NIS although the effect rates differ more than 10%. The NIS identified seven other factors not identified by the NHDS: wound complications, congestive heart failure, new mental disorder, chronic pulmonary disease, dementia, geographic region Northeast, acute postoperative anemia, and sex, that were associated with inpatient mortality even after controlling for potentially confounding variables. For inpatient adverse events, atrial fibrillation, osteoporosis, and female sex were associated with the NHDS and the NIS although the effect rates differ One of the authors (SB) certifies that he or she has received, during the study period, funding from VU University Amsterdam, faculty fund. One of the authors (AGJB) certifies that he or she has received, during the study period, funding from an AnnaFonds Travel grant (Dutch Orthopaedic travel grant) (less than USD 10,000), VSB-fonds, a nonmedical study grant (USD 10,000 to USD 100,000) and Prins Bernhard Cultuurfonds, Banning-de Jong fonds, a nonmedical study grant for excellent Dutch students USD 10,000 to USD 100,000). One of the authors (DR) certifies that he or she, or a member of his or her immediate family, has received or may receive payments or benefits, during the study period, an amount of USD (less than USD 10,000), from Wright Medical Technologies, Inc (Arlington, TN, USA), Biomet, Inc (Warsaw, IN, USA), Skeletal Dynamics Inc (Miami, FL, USA), AO Nor...

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

The National Hospital Discharge Survey and Nationwide Inpatient Sample: The Databases Used Affect Results in THA Research

Bekkers

Bot

Makarawung

et al. 2014

Clinical Orthopaedics &Amp; Related Research

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“…This is not to deny that the risk-benefit ratio of a given intervention may be quite different in a population with significant comorbidities and/or comedication, including frail elderly patients. In another study, Wieringa et al showed a discrepancy in the presence of comorbidity between the preapproval cardiovascular trials and that encountered in routine clinical practice [134]. Martin et al confirmed the under-representation of the elderly and females in premarketing clinical trials but also extended their observations to show a similar discrepancy in the use of comedications [135].…”

Section: Determining the Right Dose In The Elderlymentioning

confidence: 94%

“…In another study, Wieringa et al. showed a discrepancy in the presence of comorbidity between the preapproval cardiovascular trials and that encountered in routine clinical practice [134]. Martin et al.…”

Section: Determining the Right Dose In The Elderlymentioning

confidence: 99%

Drug development and use in the elderly: search for the right dose and dosing regimen

Shah¹

2004

Brit J Clinical Pharma

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Across the globe over the last few decades, there has been a remarkable increase in the proportion of the population which is elderly, and this trend is set to continue. Data from 10 countries that accounted for about 55% of the world population of 6079 million in the year 2000 provide an overview of this significant shift in demography. Table 1 summarizes the projections for the next 25 years. Hitherto, increases in life expectancy have been most obvious in the affluent countries; however, improvements in public health and disease control are also leading to increases in life expectancy in the less affluent countries. As a result of relatively larger increases in life expectancy at birth, significant shifts in demography are also expected in countries that are at present economically less affluent. The number of elderly people in the world is therefore expected to continue to increase for some considerable time. Interestingly, the most dramatic increases in the proportion of the population who are elderly are anticipated in countries where total populations are projected to decrease (such as Japan, Germany and Italy).The 2001 population census of the UK revealed that since the census of 1951, the proportion of elderly population above 65 years and 85 years has increased from 16% and 0.4% respectively to 21% and 1.9%, respectively. These changes in demography will have significant effects on the economics generally as well as on the provisions for healthcare. Cardiovascular and neurological diseases and cancers are the most prevalent in the elderly. These three groups of diseases account for about 54% of the total burden of disease in Europe in terms of disability adjusted life years. Of the total gross Hospital and Community Health Services expenditure of £31.9 billion in the year 2001-2002 in the UK, 13% was expended on people aged 65-74 years, 16% on those aged 75-84 years and 10% for people aged 85 years or more. Furthermore, about 55% of the community prescriptions during 2001 in the UK were dispensed for the elderly. Cardiovascular and psychoactive drugs accounted for more than 40% of these prescriptions. In view of many age-related changes in the pharmacokinetics and pharmacodynamics of a drug, the safe and effective prescribing of medicines in the elderly will continue to present a major challenge.This review provides an overview of the issues relevant to development and clinical use of drugs in the elderly population, with particular reference to determining the right dosage and dose regimen and the regulatory requirements that facilitate this process. It also examines whether, as a result of advancing age per se, the dosing regimens in the elderly and the frail elderly might be different from those in the nonelderly.

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“…This age class had been excluded from premarketing studies [5]. Wieringa et al [6,7] have published two studies comparing pre-and postapproval settings and discussed possible consequences on effectiveness. In the first, they compared the demographic characteristics between patients participating in phase III trials of cardiovascular drugs and those of actual users after approval.…”

Section: Introductionmentioning

confidence: 99%

Differences between clinical trials and postmarketing use

Martin

Bégaud

Latry

et al. 2003

Brit J Clinical Pharma

129

102

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AimsClinical trials constitute the gold standard to assess the efficacy and safety of new medicines. However, because they are conducted in standardized conditions far from the real world of prescription and use, discrepancies in patient selection or treatment conditions may alter both the effectiveness and risks. On the basis of three examples, our objectives were to study the differences between the characteristics of treated populations and treatment patterns in clinical trials and in postmarketing settings and to discuss the potential consequences on actual efficacy and safety. MethodsTreated populations were compared with patients included in premarketing clinical trials. Comparisons were made on the basis of demographic characteristics and treatment patterns. ResultsWhatever the indicator and the drug studied, differences were observed: from 0.04% to 63% for tacrine, from 0% to 37% for celecoxib and from 6% to 52% for simvastatin, with possible consequences on the effectiveness and safety of the drug concerned. Our results confirm the under-representation of women and elderly patients in premarketing clinical trials, e.g. an M : F ratio of 4.6 in clinical trails of simvastatin vs 1.0 in the joint population. Moreover, the concomitant use of medicines was made extremely restrictive by the protocols of these trials while this was not the case in the postmarketing phase. This has possible consequences on the effectiveness and safety of the drug concerned. ConclusionsThese results plead for systematic ad hoc observational postmarketing studies for any novel and/or expensive medicine to assess the relevance of premarketing data.

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Co‐morbidity of ‘Clinical Trial’ versus ‘Real‐World’ patients using cardiovascular drugs

Cited by 5 publications

References 0 publications

The National Hospital Discharge Survey and Nationwide Inpatient Sample: The Databases Used Affect Results in THA Research

The National Hospital Discharge Survey and Nationwide Inpatient Sample: The Databases Used Affect Results in THA Research

Drug development and use in the elderly: search for the right dose and dosing regimen

Differences between clinical trials and postmarketing use

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