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Lundstrom M.,Lund University | Goh P.-P.,Clinical Research Center | Henry Y.,VUmc | Salowi M.A.,Sarawak General Hospital | And 4 more authors.
Ophthalmology | Year: 2015

Purpose: The aim of this study was to describe changes over time in the indications and outcomes of cataract surgery and to discuss optimal timing for the surgery. Design: Database study. Participants: Patients who had undergone cataract extraction in the Netherlands, Sweden, or Malaysia from 2008 through 2012. Methods: We analyzed preoperative, surgical, and postoperative data from 2 databases: the European Registry of Quality Outcomes for Cataract and Refractive Surgery (EUREQUO) and the Malaysian National Cataract Registry. The EUREQUO contains complete data from the national cataract registries in the Netherlands and Sweden. Main Outcome Measures: Preoperative and postoperative corrected distance visual acuity, preoperative ocular comorbidity in the surgery eye, and capsule complications during surgery. Results: There were substantial differences in indication for surgery between the 3 national data sets. The percentage of eyes with a preoperative best-corrected visual acuity of 20/200 or worse varied from 7.1% to 72%. In all 3 data sets, the visual thresholds for cataract surgery decreased over time by 6% to 28% of the baseline values. The frequency of capsule complications varied between the 3 data sets, from 1.1% to 3.7% in 2008 and from 0.6% to 2.7% in 2012. An increasing postoperative visual acuity was also seen for all 3 data sets. A high frequency of capsule complication was related significantly to poor preoperative visual acuity, and a high frequency of decreased visual acuity after surgery was related significantly to excellent preoperative visual acuity. Conclusions: The 5-year trend in all 3 national data sets showed decreasing visual thresholds for surgery, decreasing surgical complication rates, and increasing visual outcomes regardless of the initial preoperative visual level. Cataract surgery on eyes with poor preoperative visual acuity was related to surgical complications, and cataract surgery on eyes with excellent preoperative visual acuity was related to adverse visual results. © 2015 by the American Academy of Ophthalmology.


Lundstrom M.,Lund University | Barry P.,University of Victoria | Henry Y.,VUmc | Rosen P.,Oxford Eye Hospital | Stenevi U.,Sahlgrens University Hospital
Journal of Cataract and Refractive Surgery | Year: 2013

Purpose: To analyze the visual outcome after cataract surgery. Setting: Cataract surgery clinics in 15 European countries. Design: Database study. Methods: Data were drawn from case series of cataract extractions reported to the European Registry of Quality Outcomes for Cataract and Refractive Surgery database. These data were entered into the database via the Web by surgeons or by transfer from existing national registries or electronic medical record systems. The database contains individual anonymous data on preoperative, intraoperative, and postoperative measurements. Results: Data on 368 256 cataract extractions were available for analysis. The best visual outcome was achieved in age groups 40 to 74 years, and men showed a higher percentage of excellent vision (1.0 [20/20] or better) than women. A corrected distance visual acuity (CDVA) of 0.5 (20/40) or better and of 1.0 (20/20) or better was achieved in 94.3% and 61.3% of cases, respectively. Ocular comorbidity and postoperative complications were the strongest influences on the visual outcome; however, surgical complications and ocular changes requiring complex surgery also had a negative influence. Deterioration of visual acuity after the surgery (n= 6112 [1.7% of all cases]) was most common in patients with a good preoperative visual acuity. Conclusions: The visual outcomes of cataract surgery were excellent, with 61.3% of patients achieving a corrected distance visual acuity of 1.0 (20/20) or better. Age and sex influenced the visual outcomes, but the greatest influences were short-term postoperative complications, ocular comorbidity, surgical complications, and complex surgery. A weakness of the study could be that some of the data is self-reported to the registry. Financial Disclosure: No author has a financial or proprietary interest in any material or method mentioned. © 2013 ASCRS and ESCRS.


Petzold A.,VUmc | Petzold A.,University College London | Plant G.T.,Moorfields Eye Hospital
Autoimmunity Reviews | Year: 2014

The spectrum of autoimmune optic neuropathies (ON) is extending. The phenotypic spectrum includes single isolated optic neuritis (SION), relapsing isolated optic neuritis (RION), chronic relapsing inflammatory optic neuropathy (CRION), the neuromyelitis optica (NMO) spectrum disorder, multiple sclerosis associated optic neuritis (MSON) and unclassified optic neuritis (UCON) forms. Epidemiological data suggests a slight female predominance. The ethnic heritage is relevant as Caucasian patients are more likely to suffer from MSON, whilst SION, RION, CRION and NMO are more frequent in non-Caucasian patients. Importantly, prognosis for recovery of visual function is good in MSON, but poorer in NMO and CRION which also have a high chance for recurrent episodes. Testing for serum anti-AQP4 autoantibodies is advised in all patients with severe, atypical or recurrent ON because of the high diagnostic specificity. The diagnostic specificity may be aided by testing for glial biomarkers in the CSF and prognostic accuracy by testing for biomarkers for neuroaxonal degeneration. Optical coherence tomography is a highly accurate tool to document the final outcome. The current clinical classification criteria rely on the phenotype, response to treatment and presence of anti-AQP4 autoantibodies. © 2014 Elsevier B.V.


Saad F.,Bayer AG | Saad F.,Gulf Medical University | Aversa A.,University of Rome La Sapienza | Isidori A.M.,University of Rome La Sapienza | Gooren L.J.,VUmc
Current Diabetes Reviews | Year: 2012

Objective: Obesity negatively affects human health. Limiting food intake, while producing some weight loss, results in reduction of lean body mass. Combined with moderate exercise it produces significant weight loss, maintains lean body mass and improves insulin sensitivity, but appears difficult to adhere to. Bariatric surgery is clinically effective for severely obese individuals compared with non-surgical interventions, but has limitations. Clinical and pre-clinical studies have implicated a role for testosterone (T) in the patho-physiology of obesity. Methods: Evidence Acquisition and Synthesis: A literature search in PubMed on the role of T in counteracting obesity and its complications. Results: Obesity per se impairs testicular T biosynthesis. Furthermore, lower-than-normal T levels increase accumulation of fat depots, particularly abdominal (visceral) fat. This fat distribution is associated with development of metabolic syndrome (MetS) and its sequels, namely type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD). T treatment reverses fat accumulation with significant improvement in lean body mass, insulin sensitivity and biochemical profiles of cardiovascular risk. The contribution of T to combating obesity in hypogonadal men remains largely unknown to medical professionals managing patients with obesity and metabolic syndrome. Many physicians associate T treatment in men with risks for prostate malignancy and CVD. These beliefs are not supported by recent insights. Conclusion: While overall treatment of obesity is unsuccessful, T treatment of hypogonadal men may be effective, also because it improves mood, energy, reduces fatigue and may motivate men to adhere to diet and exercise regimens designed to combat obesity. © 2012 Bentham Science Publishers.


HALLE (SAALE), Germany,  8 December  2016 - Probiodrug AG (Euronext Amsterdam: PBD), a biopharmaceutical company developing novel therapeutic solutions to treat Alzheimer's disease (AD), announced today that the study design of the ongoing Phase IIa SAPHIR trial comparing PQ912 to placebo will be presented as a poster on Thursday, December 8, 2016 at the  9th Clinical Trials on Alzheimer's disease (CTAD) meeting in San Diego, USA. The SAPHIR study is a 3 month study in treatment naïve patients with early AD. PQ912 targets the inhibition of the Glutaminylcyclase (QC) resulting in a reduction of the production of neurotoxic pyroGlu-Abeta (pGlu-Abeta) and related oligomers. PQ912 has been extensively investigated in Phase 1 Multiple ascending dose studies (MAD) showing good tolerability and a dose dependent QC-inhibition in the spinal fluid. The SAPHIR study has been designed and is conducted in collaboration with Philip Scheltens, M.D., Ph.D., the VUmc Amsterdam (NL) and the CRO Julius Clinical ( NL). The primary objective of the SAPHIR study is to investigate the safety of PQ912 in the target population and the secondary objective is to assess the pharmacodynamic profile. The publication at CTAD reveals that the study applies a series of methodological innovations which in this combination has not been executed before in an early AD study. Specific in and exclusion criteria based on diagnostic biomarkers of Abeta and tau were required to be met by all patients to ensure a high confidence of the diagnosis of early AD. Mini-Mental State Examination (MMSE) and Cogstate test battery assessments at baseline are monitored blindly every 30 patients to ensure consistency and reliability of ratings. A number of exploratory endpoints like EEG, fMRI and a series of CSF based biomarkers including QC-activity, pGlu-Abeta, Abeta oligomers, neurogranin as well as  inflammation markers are centrally analysed. Based on an exploratory analysis of 86 randomised patients, a low standard deviation for the Neuro-psychological test battery and functional EEG at baseline has been observed. Prof Philip Scheltens, Director of the Alzheimer Center at the VUmc  in Amsterdam and Chairman of the SAPHIR study, said: "The combination of in and exclusion criteria together with the primary and innovative exploratory outcome parameter in the SAPHIR study is unique for an early AD study. We are excited to see the full results in the second quarter of 2017." For more information, please contact: Notes to Editors: About Probiodrug AG Headquartered in Halle (Saale), Germany, Probiodrug AG (Euronext Amsterdam: PBD) is a biopharmaceutical company focused on the development of new therapeutic products for the treatment of Alzheimer's disease. Founded in 1997, the company successfully developed a novel therapeutic concept for diabetes - the DP4 inhibitors - which provided the basis for a novel class of antidiabetics - the gliptins. Its core capabilities are based on its long-standing expertise in the elucidation of the structure and function of enzymes involved in the modification of proteins and peptides, which play a central role in pathological conditions. Today Probiodrug's aim is to become a leading company in the development of Alzheimer's disease treatments and to thereby provide a better life for Alzheimer's disease patients. It has identified a new therapeutic concept linked to disease initiation and progression. The development approaches are targeting pyroglutamate-Abeta (pGlu-Abeta) as a therapeutic strategy to fight Alzheimer's disease. The Company has medical use and composition of matter patents related to the inhibition of Glutaminyl Cyclase (QC) and anti-pGlu-Abeta- specific monoclonal antibodies, providing it, in the Company's view, with a leading position in this field of research. Probiodrug's lead product candidate, PQ912, is a highly specific and potent inhibitor of Glutaminyl Cyclase (QC), which has shown therapeutic effects in Alzheimer's animal models. PQ912 is currently in a Phase 2a study, the SAPHIR trial. In a preceding Phase 1 study with healthy young and elderly volunteers, PQ912 has shown to be safe and well tolerated and also revealed high QC-inhibition. About Alzheimer's disease Alzheimer's disease is a neurological disorder, which is the most common form of dementia, and ultimately leads to death. Because Alzheimer's disease cannot be cured and is degenerative, the affected patients must increasingly rely on others for assistance. . Today, 47 million people live with dementia worldwide, and this number is projected to treble to more than 131 million by 2050, as populations age. Dementia also has a huge economic impact. Alzheimer's has an estimated, global societal cost of US$ 818 billion, and it will become a trillion dollar disease by 2018. (World Alzheimer Report 2016). Forward Looking Statements Information set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgment of Probiodrug AG as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.


Jamnitski A.,Jan Van Breemen Research Institute READE | Symmons D.,ARC Epidemiology Unit | Peters M.J.L.,VU University Amsterdam | Sattar N.,University of Glasgow | And 2 more authors.
Annals of the Rheumatic Diseases | Year: 2013

Objective: Data regarding cardiovascular comorbidity and cardiovascular risk factors in patients with psoriatic arthritis (PsA) are limited. To evaluate the cardiovascular risk profile, a systematic literature search was performed to provide an extensive summary of all studies available on cardiovascular risk in PsA. Methods: Medline, EMBASE and the Cochrane library were searched from January 1966 to April 2011 for English language articles on data concerning cardiovascular diseases and cardiovascular risk factors in PsA. Review articles, case reports and studies on psoriasis alone were excluded. Results: Twenty-eight articles were included in this review. Studies on all-cause mortality revealed mixed results. Available data on cardiovascular disease appeared more consistent, indicating an increased cardiovascular mortality and morbidity in PsA. Commensurate with this, surrogate markers of subclinical atherosclerosis, arterial stiffness and cardiovascular risk factors, for example hypertension, dyslipidaemia, obesity and metabolic-related factors, were more prominent in PsA compared with controls. Suppression of inflammation was linked with a favourable effect on cardiovascular surrogate markers, for example carotid intima media thickness and endothelial dysfunction, in several (un) controlled studies. Conclusion: Most studies point towards an increased cardiovascular risk in PsA, broadly on a par with the risk level in rheumatoid arthritis, emphasising the need for similar cardiovascular risk management in both conditions. Further studies are needed to indicate whether inflammatory suppression or modification of traditional cardiovascular risk factors, or both, will reduce cardiovascular risk.


Hypophosphatemia is an important finding in the evaluation of patients with chronic bone pain. Fibroblast-growth factor 23 (FGF23) plays a role in the differential diagnosis of hypophosphatemia. A 34-year-old man had progressive pain in both shoulders and hips due to hypophosphatemic osteomalacia. He had elevated FGF23 levels, induced by a FGF23-producing tumour in the right acetabulum. Thus, he had tumour-induced hypophosphatemic osteomalacia. A 50-year-old man had had bowed legs and joint pains since his youth due to osteomalacia. Several family members also had osteomalacia. His phosphate concentration was low. Genetic testing revealed a mutation on the PHEX gene which results in high FGF23 levels. Thus, he had X-linked hereditary hypophosphatemic osteomalacia. In patients with bone pain, the measurement of a phosphate concentration is important. In renal phosphate loss, the measurement of FGF23 is an important next step if parathormone concentrations are low or normal.


In the Dutch maternity care system women at low risk of complications in pregnancy and birth are distinguished from women at an increased risk. Primary care midwives are responsible for the care in the low-risk group, whereas obstetricians are responsible for care when the risk is increased. Most professionals and stakeholders agree that more continuity of care is warranted but there is no consensus on the ideal organization of care. A midwife-led continuity model of care has been shown to offer several health benefits compared with other models, such as 'shared care'. We argue that this model would be appropriate for the Netherlands. Midwives should provide care where possible and obstetricians where necessary in order to use the expertise of both professions most effectively. This requires an extension of the scope of practice for primary care midwives. This model requires good cooperation between midwives and obstetricians.


Jonker M.,VUmc | Van Der Vaart A.,Leiden University
International Journal of Biostatistics | Year: 2014

In practice, nuisance parameters in statistical models are often replaced by estimates based on an external source, for instance if estimates were published before or a second dataset is available. Next these estimates are assumed to be known when the parameter of interest is estimated, a hypothesis is tested or confidence intervals are constructed. By this assumption, the level of the test is, in general, higher than supposed and the coverage of the confidence interval is too low. In this article, we derive the asymptotic distribution of the likelihood ratio statistic if the nuisance parameters are estimated based on a dataset that is independent of the data used for estimating the parameter of interest. This distribution can be used for correctly testing hypotheses and constructing confidence intervals. Four theoretical and practical examples are given as illustration. © by De Gruyter 2014.


Compier A.H.,VUmc
Medical History | Year: 2012

Andreas Vesalius' (1514-64) first publication was a Paraphrasis of the ninth book of the Liber ad Almansorem, written by the Arab-Persian physician and alchemist Rhazes (854-925). The role of Rhazes in Vesalius' oeuvre has thus far been much disregarded. The different ways Rhazes recurs reveal an intellectual evolution in Vesalius' work. In the Paraphrasis, Vesalius subjects Rhazes to the authority of Galen in the context of the early sixteenth-century humanist campaign for the substitution of Arab influences by Greek 'originals'. Over the years Vesalius continues his work on Rhazes, but his approach becomes more internationalistic. Ultimately, Vesalius criticises Galen while expressing sympathy for the Arab author. This may be the more significant as Rhazes could have influenced Vesalius in the act of criticising Galen - critical discussions of Galen were available to Vesalius in Latin translations of Rhazes's Liber Continens. Although Vesalius never refers to the work, it is hardly possible he was unaware of it: similarities in structure, rhetoric and form between the Continens and the De humani corporis fabrica could support this hypothesis. © Abdul Haq Compier, 2012.

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