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  1. Article ; Online: Indirect treatment comparison of cenobamate to other ASMs for the treatment of uncontrolled focal seizures.

    Privitera, Michael / Richy, Florent F / Schabert, Vernon F

    Epilepsy & behavior : E&B

    2021  Volume 126, Page(s) 108429

    Abstract: Objective: The efficacy and safety of cenobamate relative to other antiseizure medications (ASMs) has not been evaluated. An indirect treatment comparison (network meta-analysis) was performed to determine if adjunctive cenobamate increases the odds ... ...

    Abstract Objective: The efficacy and safety of cenobamate relative to other antiseizure medications (ASMs) has not been evaluated. An indirect treatment comparison (network meta-analysis) was performed to determine if adjunctive cenobamate increases the odds ratio (OR) for ≥50% responder rate or for withdrawals due to treatment-emergent adverse events (TEAEs) leading to ASM discontinuation versus adjunctive therapy with other ASMs.
    Methods: A systematic literature review was conducted to identify randomized, double-blind, placebo-controlled trials (maintenance phase ≥ 12 weeks) assessing adjunctive ASMs in adults with uncontrolled focal seizures. Cenobamate was compared to a group of seven other ASMs, and to subgroups of branded (brivaracetam, eslicarbazepine acetate, lacosamide, and perampanel) and older (lamotrigine, levetiracetam, and topiramate) ASMs at FDA-recommended daily maintenance doses (FDA-RDMD), at all doses, and at maximum and minimum daily doses. Statistical significance was set at p < 0.05.
    Results: Twenty-one studies were eligible for analysis. The placebo-adjusted ≥ 50% responder rate for FDA-RDMD of cenobamate was superior (OR 4.200; 95% CI 2.279, 7.742) to FDA-RDMD of all seven assessed (OR 2.202 95% CI 1.915, 2.532; p = 0.044) and branded ASMs (OR 2.148; 95% CI 1.849, 2.494; p = 0.037). There was no significant difference for ≥50% responder rate between FDA-RDMD of cenobamate and FDA-RDMD of older ASMs (OR 2.617; 95% CI 1.767, 3.878; p = 0.202). No significant differences were identified for ≥50% responder rate when comparing all doses and maximum/minimum doses of cenobamate to all seven, branded, and older ASMs. Cenobamate demonstrated comparable TEAE withdrawal rates to all seven ASMs, branded ASMs, and older ASMs across each of the four dose ranges (all p > 0.05).
    Significance: Patients receiving FDA-RDMD of cenobamate were more likely to have ≥50% seizure reduction compared with FDA-RDMD of the seven assessed ASMs and branded ASMs, without an increase in treatment discontinuation due to TEAEs.
    MeSH term(s) Adult ; Anticonvulsants/adverse effects ; Carbamates/adverse effects ; Chlorophenols/adverse effects ; Double-Blind Method ; Drug Therapy, Combination ; Humans ; Randomized Controlled Trials as Topic ; Seizures/chemically induced ; Seizures/drug therapy ; Tetrazoles/adverse effects ; Treatment Outcome
    Chemical Substances Anticonvulsants ; Carbamates ; Chlorophenols ; Tetrazoles ; Cenobamate (P85X70RZWS)
    Language English
    Publishing date 2021-12-01
    Publishing country United States
    Document type Journal Article ; Meta-Analysis ; Research Support, Non-U.S. Gov't ; Review ; Systematic Review
    ZDB-ID 2010587-3
    ISSN 1525-5069 ; 1525-5050
    ISSN (online) 1525-5069
    ISSN 1525-5050
    DOI 10.1016/j.yebeh.2021.108429
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    Zs.A 5289: Show issues Location:
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  2. Article ; Online: Efficacy and safety profiles of manidipine compared with amlodipine: a meta-analysis of head-to-head trials.

    Richy, Florent F / Laurent, Stephane

    Blood pressure

    2010  Volume 20, Issue 1, Page(s) 54–59

    Abstract: Abstract The aim of this meta-analysis was to compare the efficacy and safety profile of manidipine 20 mg with that of amlodipine 10 mg. A systematic research of quantitative data produced or published between 1995 and 2009 was performed. Head-to-head ... ...

    Abstract Abstract The aim of this meta-analysis was to compare the efficacy and safety profile of manidipine 20 mg with that of amlodipine 10 mg. A systematic research of quantitative data produced or published between 1995 and 2009 was performed. Head-to-head randomized controlled trials (RCTs) of 12 months minimum duration reporting comparative efficacy (changes in systolic and diastolic blood pressure) and safety (total adverse events and ankle oedema), were included. Four high-quality RCTs, accounting for 838 patients (436 received manidipine and 402 received amlodipine) were included. The efficacy of manidipine and amlodipine was statistically equivalent: effect size for DBP = -0.08 (p = 0.22) and SBP = -0.01 (p = 0.83). The global safety of manidipine was significantly better than amlodipine: the relative risk (RR) for adverse event was 0.69 (0.56-0.85), and particularly for ankle oedema RR was 0.35 (0.22-0.54). Publication bias was not significant and the robustness of the analyses was good. These data suggest a better efficacy/safety ratio of manidipine over amlodipine.
    MeSH term(s) Adult ; Amlodipine/adverse effects ; Amlodipine/pharmacology ; Amlodipine/therapeutic use ; Ankle ; Antihypertensive Agents/adverse effects ; Antihypertensive Agents/pharmacology ; Antihypertensive Agents/therapeutic use ; Blood Pressure/drug effects ; Dihydropyridines/adverse effects ; Dihydropyridines/pharmacology ; Dihydropyridines/therapeutic use ; Edema/complications ; Humans ; Hypertension/drug therapy ; Hypertension/physiopathology ; Meta-Analysis as Topic ; Nitrobenzenes ; Piperazines ; Publication Bias ; Randomized Controlled Trials as Topic ; Treatment Outcome
    Chemical Substances Antihypertensive Agents ; Dihydropyridines ; Nitrobenzenes ; Piperazines ; Amlodipine (1J444QC288) ; manidipine (6O4754US88)
    Language English
    Publishing date 2010-10-14
    Publishing country England
    Document type Comparative Study ; Journal Article ; Meta-Analysis
    ZDB-ID 1170048-8
    ISSN 1651-1999 ; 1651-2480 ; 0803-7051 ; 0803-8023
    ISSN (online) 1651-1999 ; 1651-2480
    ISSN 0803-7051 ; 0803-8023
    DOI 10.3109/08037051.2010.518670
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    Zs.A 3843: Show issues Location:
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  3. Article ; Online: Incidence of lactic acidosis in patients with type 2 diabetes with and without renal impairment treated with metformin: a retrospective cohort study.

    Richy, Florent F / Sabidó-Espin, Meritxell / Guedes, Sandra / Corvino, Frank A / Gottwald-Hostalek, Ulrike

    Diabetes care

    2014  Volume 37, Issue 8, Page(s) 2291–2295

    Abstract: Objective: To determine whether the use of metformin in type 2 diabetic patients with various kidney functions is associated with an increased risk of lactic acidosis (LA).: Research design and methods: This study was a retrospective analysis of U.K. ...

    Abstract Objective: To determine whether the use of metformin in type 2 diabetic patients with various kidney functions is associated with an increased risk of lactic acidosis (LA).
    Research design and methods: This study was a retrospective analysis of U.K. patient records from the Clinical Practice Research Datalink database from 1 January 2007 to 31 December 2012. Inclusion criteria were 1) diagnosis of type 2 diabetes before 1 January 2007, 2) treatment with metformin, and 3) at least one assessment of renal function between 2007 and 2012. Renal function was assessed by glomerular filtration rate and categorized as normal (N), mildly reduced (Mi), moderately reduced (Mo), or severely reduced (Se) function. The outcome of the study was LA.
    Results: A total of 77,601 patients treated with metformin for type 2 diabetes were identified. There were 35 LA events (10.37 [95% CI 7.22-14.42] per 100,000 patient-years) of which none were fatal and 23 were linked to a comorbidity. No significant difference in the incidence of LA was observed across N, Mi, Mo and Se renal function groups (7.6 [0.9-27.5], 4.6 [2.00-9.15], 17 [10.89-25.79], and 39 [4.72-140.89] cases per 100,000 patient-years, respectively).
    Conclusions: The overall LA incidence rate for patients on metformin in this study was within the range of rates reported in the literature for patients with type 2 diabetes, and no significant difference was observed among patients with N, Mi, Mo, and Se function.
    MeSH term(s) Acidosis, Lactic/chemically induced ; Acidosis, Lactic/epidemiology ; Adolescent ; Adult ; Aged ; Aged, 80 and over ; Databases, Factual ; Diabetes Mellitus, Type 2/drug therapy ; Diabetes Mellitus, Type 2/epidemiology ; Diabetic Nephropathies/complications ; Diabetic Nephropathies/epidemiology ; Female ; Glomerular Filtration Rate ; Humans ; Hypoglycemic Agents/therapeutic use ; Incidence ; Male ; Metformin/therapeutic use ; Middle Aged ; Renal Insufficiency/epidemiology ; Retrospective Studies ; United Kingdom/epidemiology ; Young Adult
    Chemical Substances Hypoglycemic Agents ; Metformin (9100L32L2N)
    Language English
    Publishing date 2014-08
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 441231-x
    ISSN 1935-5548 ; 0149-5992
    ISSN (online) 1935-5548
    ISSN 0149-5992
    DOI 10.2337/dc14-0464
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    Zs.A 1434: Show issues Location:
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  4. Article ; Online: Compliance with pharmacotherapy and direct healthcare costs in patients with Parkinson's disease: a retrospective claims database analysis.

    Richy, Florent F / Pietri, Guilhem / Moran, Kimberly A / Senior, Emmanuelle / Makaroff, Lydia E

    Applied health economics and health policy

    2013  Volume 11, Issue 4, Page(s) 395–406

    Abstract: Background: Parkinson's disease (PD) is a progressive neurological disorder for which, at present, there is no cure. Current therapy is largely based on the use of dopamine agonists and dopamine replacement therapy, designed to control the signs and ... ...

    Abstract Background: Parkinson's disease (PD) is a progressive neurological disorder for which, at present, there is no cure. Current therapy is largely based on the use of dopamine agonists and dopamine replacement therapy, designed to control the signs and symptoms of the disease. The majority of current treatments are administered in tablet form and can involve multiple daily doses, which may contribute to sub-optimal compliance. Previous studies with small groups of patients suggest that non-compliance with treatment can result in poor response to therapy and may ultimately increase direct and indirect healthcare costs.
    Objective: To determine the extent of non-compliance within the general PD population in the USA as well as the patient characteristics and healthcare costs associated with compliance and non-compliance.
    Methods: A retrospective analysis from a managed care perspective was conducted using data from the USA PharMetrics patient-centric claims database. PharMetrics claims data were complete from 31 December 2005 to 31 December 2009. Patients were included if they had at least two diagnoses for PD between 31 December 2005 and 31 December 2008, were older than 18 years of age, were continuously enrolled for at least 12 months after the date of the most recent PD diagnosis, and had no missing or invalid data. The follow-up period was the most recent 12-month block of continuous enrollment that occurred between 2006 and 2009. Patients were required to have at least one PD-related prescription within the follow-up period. The medication possession ratio (MPR) was used to categorise patients as compliant or non-compliant. Direct all-cause annual healthcare costs for patients with PD were estimated for each patient, and regression analyses were conducted to determine predictors for non-compliance.
    Results: A total of 15,846 patients were included, of whom 46 % were considered to be non-compliant with their prescribed medication (MPR <0.8). Predictors of non-compliance included prescription of a medication administered in multiple daily doses (p < 0.0001), a period of <2 years since the initial PD diagnosis (p = 0.0002), a diagnosis of gastrointestinal disorder (p < 0.0001), and a diagnosis of depression (p < 0.0001). Non-compliance was also found to be related to age, with a lower odds of non-compliance in patients aged 41-80 years than in patients aged ≥81 years (p < 0.05). Although total drug mean costs were higher for compliant patients than non-compliant patients (driven mainly by the cost of PD-related medications), the mean costs associated with emergency room and inpatient visits were higher for patients non-compliant with their prescribed medication. Overall, the total all-cause annual healthcare mean cost was lower for compliant ($77,499) than for non-compliant patients ($84,949; p < 0.0001).
    Conclusion: Non-compliance is prevalent within the general USA PD population and is associated with a recent PD diagnosis, certain comorbidities, and multiple daily treatment dosing. Non-compliance may increase the burden on the healthcare system because of greater resource usage compared with the compliant population. Treatments that require fewer daily doses may have the potential to improve compliance, which in turn could reduce the economic burden associated with PD.
    MeSH term(s) Adolescent ; Adult ; Aged ; Aged, 80 and over ; Child ; Confidence Intervals ; Databases, Factual ; Drug Therapy/standards ; Female ; Guideline Adherence ; Humans ; Male ; Managed Care Programs ; Middle Aged ; Odds Ratio ; Parkinson Disease/drug therapy ; Practice Guidelines as Topic ; Retrospective Studies ; Young Adult
    Language English
    Publishing date 2013-05-07
    Publishing country New Zealand
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2171420-4
    ISSN 1179-1896 ; 1175-5652
    ISSN (online) 1179-1896
    ISSN 1175-5652
    DOI 10.1007/s40258-013-0033-1
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    Zs.A 6060: Show issues Location:
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  5. Article ; Online: Postmarketing Safety Profile of Subcutaneous Interferon Beta-1a Given 3 Times Weekly: A Retrospective Administrative Claims Analysis.

    Smith, Meredith Y / Sabidó-Espin, Meritxell / Trochanov, Anton / Samuelson, Mark / Guedes, Sandra / Corvino, Frank A / Richy, Florent F

    Journal of managed care & specialty pharmacy

    2015  Volume 21, Issue 8, Page(s) 650–660

    Abstract: Background: Health insurance administrative claims databases represent a valuable source of information regarding the safety profile of marketed products as used in actual clinical practice in a broader range of patients than that assessed in clinical ... ...

    Abstract Background: Health insurance administrative claims databases represent a valuable source of information regarding the safety profile of marketed products as used in actual clinical practice in a broader range of patients than that assessed in clinical trials. Interferon beta-1a administered subcutaneously 3 times weekly (IFN β-1a SC tiw), which was approved in 2002 by the FDA for the treatment of relapsing-remitting multiple sclerosis (MS), has over a decade of postmarketing experience. To date, however, its postmarketing safety profile has not been described using a real-world evidence source such as administrative claims data.
    Objective: To describe the safety profile of IFN β-1a SC tiw as presented in its U.S. prescribing information (PI) for patients with MS initiating IFN β-1a SC tiw therapy using data from U.S. health care administrative claims databases.
    Methods: This study featured an observational and retrospective "new start" cohort design using data from the Truven MarketScan Commercial and Medicare Supplemental health care administrative claims databases. Patients were eligible for inclusion if they were aged ≥ 18 years; had ≥ 1 diagnosis for MS recorded between January 1, 2006, and December 31, 2012; had ≥ 2 prescriptions for IFN β-1a SC tiw; and had ≥ 90 days of continuous eligibility pre-index date and ≥ 180 days of continuous eligibility post-index date. Patients with a prescription for IFN β-1a SC tiw without a MS diagnosis were excluded. Patients were followed from first prescription for IFN β-1a SC tiw (index date) until date of therapy switch or discontinuation, end of insurance eligibility, or end of observation period. Adverse events (AEs) examined were those listed in the Warnings and Precautions, Adverse Reactions, and Postmarketing Experience sections of the 2014 U.S. PI. Outcomes of interest were identified at the Medical Dictionary for Regulatory Activities (version 17.1) Preferred Term level and then coded to the corresponding ICD-9-CM criteria. Descriptive analyses of patient demographic, health status, health care utilization, and adherence status were performed, and incidence rates (IRs) per 100 person-years of labeled AEs with corresponding 95% CIs were calculated. The IR calculation was based on events that presented after therapy initiation and that were not present in the 90-day pre-index period.
    Results: The top 6 AEs included influenza-like symptoms (IR = 15.65, 95% CI = 14.96-16.36); malaise (IR = 15.33, 95% CI = 14.65-16.04; fatigue (IR = 15.02, 95% CI = 14.35-15.72); abdominal pain (IR = 10.18, 95% CI = 9.67-10.70); chest pain (IR = 8.48, 95% CI = 8.03-8.95); and depression (IR = 7.75, 95% CI = 7.32-8.20). In contrast, the 6 lowest IRs were for maculo-papular rash (IR = 0.01, 95% CI = 0.00-0.04; injection-site necrosis (IR = 0.01, 95% CI = 0.00-0.03); erythema multiforme (IR = 0.01, 95% CI = 0.00-0.04); hypoesthesia (IR = 0.00, 95% CI = 0.00-0.02); Stevens-Johnson Syndrome (IR = 0.00, 95% CI = 0.00-0.02); and xerophthalmia (IR = 0.00, 95% CI = 0.00-0.02).
    Conclusions: Study results show strong convergence between the real-world safety profile of IFN β-1a SC tiw and its U.S. label. Our findings demonstrate the value of using real-world evidence obtained from administrative claims to complement clinical trial and postmarketing surveillance data in order to characterize the safety profile of established products, such as IFN β-1a SC tiw, in the postmarketing context.
    MeSH term(s) Adult ; Databases, Factual ; Drug Administration Schedule ; Drug-Related Side Effects and Adverse Reactions/diagnosis ; Drug-Related Side Effects and Adverse Reactions/epidemiology ; Female ; Humans ; Immunologic Factors/administration & dosage ; Immunologic Factors/adverse effects ; Injections, Subcutaneous ; Insurance Claim Review ; Insurance, Pharmaceutical Services ; Interferon-alpha/administration & dosage ; Interferon-alpha/adverse effects ; Male ; Medicare ; Middle Aged ; Multiple Sclerosis, Relapsing-Remitting/drug therapy ; Patient Safety ; Product Surveillance, Postmarketing ; Retrospective Studies ; Risk Assessment ; Risk Factors ; Time Factors ; Treatment Outcome ; United States/epidemiology
    Chemical Substances Immunologic Factors ; Interferon-alpha
    Language English
    Publishing date 2015-10-16
    Publishing country United States
    Document type Journal Article ; Observational Study ; Research Support, Non-U.S. Gov't
    ISSN 2376-1032
    ISSN (online) 2376-1032
    DOI 10.18553/jmcp.2015.21.8.650
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  6. Article ; Online: Levetiracetam extended release and levetiracetam immediate release as adjunctive treatment for partial-onset seizures: an indirect comparison of treatment-emergent adverse events using meta-analytic techniques.

    Richy, Florent F / Banerjee, Soutrik / Brabant, Yves / Helmers, Sandra

    Epilepsy & behavior : E&B

    2009  Volume 16, Issue 2, Page(s) 240–245

    Abstract: The safety profiles of once-daily adjunctive levetiracetam (LEV) extended release (XR) (1000mg/day) and adjunctive LEV immediate release (IR) (500mg twice daily) were compared using data from three randomized, placebo (PBO)-controlled phase III clinical ... ...

    Abstract The safety profiles of once-daily adjunctive levetiracetam (LEV) extended release (XR) (1000mg/day) and adjunctive LEV immediate release (IR) (500mg twice daily) were compared using data from three randomized, placebo (PBO)-controlled phase III clinical trials in patients with partial-onset seizures. MedDRA 9.0 treatment-emergent adverse events (TEAEs) were indirectly compared using meta-analytic techniques, including calculation of risk difference (RD) and mixed-effects analysis. Statistical significance was set at 10% alpha risk, the normative value for these analyses. Data from 555 patients older than 16 (204 LEV IR, 70 LEV XR, 281 PBO) were analyzed. Following adjustment for incidence of placebo TEAEs, LEV XR showed statistically significantly lower rates of TEAEs than LEV IR across nervous system disorders (RD=-18%, P=0.03), psychiatric disorders (RD=-11%, P=0.08), and metabolism and nutrition disorders (RD=-3%, P=0.08). Among nervous system disorders, the RD for headache favored LEV XR (RD=-11%, P=0.08). These results suggest that adjunctive LEV XR may be associated with a lower incidence of nervous system, psychiatric, and nutritional and metabolic TEAEs as compared with LEV IR. However, this difference was observed at a broad scale and not at a specific TEAE level except for headache.
    MeSH term(s) Adolescent ; Adult ; Adverse Drug Reaction Reporting Systems ; Aged ; Anticonvulsants/administration & dosage ; Anticonvulsants/adverse effects ; Chemotherapy, Adjuvant ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug Administration Schedule ; Drug Delivery Systems/adverse effects ; Drug Delivery Systems/methods ; Epilepsies, Partial/drug therapy ; Female ; Humans ; Male ; Meta-Analysis as Topic ; Middle Aged ; Piracetam/administration & dosage ; Piracetam/adverse effects ; Piracetam/analogs & derivatives ; Severity of Illness Index ; Treatment Outcome ; Young Adult
    Chemical Substances Anticonvulsants ; etiracetam (230447L0GL) ; Piracetam (ZH516LNZ10)
    Language English
    Publishing date 2009-10
    Publishing country United States
    Document type Clinical Trial ; Clinical Trial, Phase III ; Comparative Study ; Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 2010587-3
    ISSN 1525-5069 ; 1525-5050
    ISSN (online) 1525-5069
    ISSN 1525-5050
    DOI 10.1016/j.yebeh.2009.07.013
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    Zs.A 5289: Show issues Location:
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  7. Article ; Online: Gastrointestinal disorders in Parkinson's disease: prevalence and health outcomes in a US claims database.

    Makaroff, Lydia / Gunn, Angus / Gervasoni, Christophe / Richy, Florent

    Journal of Parkinson's disease

    2011  Volume 1, Issue 1, Page(s) 65–74

    Abstract: The majority of patients with Parkinson's Disease (PD) will eventually develop gastrointestinal disorders (GIDs) such as dysphagia, constipation and gastroesophageal reflux. The objectives of this study were to examine the incidence of GIDs in PD ... ...

    Abstract The majority of patients with Parkinson's Disease (PD) will eventually develop gastrointestinal disorders (GIDs) such as dysphagia, constipation and gastroesophageal reflux. The objectives of this study were to examine the incidence of GIDs in PD patients in a US population, and to examine subsequent PD-related outcomes in patients with GIDs. In a US administrative health claims database, GID incidence increased over time to reach 65% at four years after PD diagnosis. To further investigate this relationship, a subset of patients was analysed in greater detail. Continuously treated PD patients with and without GIDs were matched by age, gender, comorbidities, treatment regime, US region and plan type. Their emerging health outcomes were followed up for two years. Outcomes included neuropsychiatric, motor and urogenital disturbances, as well as healthcare utilization and costs. Patients with GIDs had higher rates of psychosexual dysfunction, anxiety, depression, ataxia, pain, movement disorders, urinary incontinence and falls. Emergency room admissions, the number of drugs for pain, sleep and depression, PD-related healthcare costs and non PD-related healthcare costs also increased during the observation period in GID patients. This study indicated that GIDs may be associated with deleterious effects on some PD-related outcomes.
    MeSH term(s) Adolescent ; Adult ; Age Factors ; Aged ; Aged, 80 and over ; Child ; Child, Preschool ; Comorbidity ; Databases, Factual ; Female ; Gastrointestinal Diseases/complications ; Gastrointestinal Diseases/economics ; Gastrointestinal Diseases/epidemiology ; Health Care Costs/statistics & numerical data ; Humans ; Incidence ; Male ; Middle Aged ; Outcome Assessment (Health Care) ; Parkinson Disease/complications ; Parkinson Disease/economics ; Parkinson Disease/epidemiology ; Prevalence ; Psychiatric Status Rating Scales ; United States/epidemiology ; Young Adult
    Language English
    Publishing date 2011
    Publishing country Netherlands
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2620609-2
    ISSN 1877-718X ; 1877-7171
    ISSN (online) 1877-718X
    ISSN 1877-7171
    DOI 10.3233/JPD-2011-001
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    Zs.A 6964: Show issues Location:
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  8. Article: Differential effects of D-hormone analogs and native vitamin D on the risk of falls: a comparative meta-analysis.

    Richy, Florent / Dukas, Laurent / Schacht, Erich

    Calcified tissue international

    2008  Volume 82, Issue 2, Page(s) 102–107

    Abstract: The aim of this meta-analysis was to compare the antifall efficacy of native vitamin D to that of its hydroxylated analogs alfacalcidol and calcitriol. Randomized clinical trials comparing oral native vitamin D and its analogs alfacalcidol and calcitriol ...

    Abstract The aim of this meta-analysis was to compare the antifall efficacy of native vitamin D to that of its hydroxylated analogs alfacalcidol and calcitriol. Randomized clinical trials comparing oral native vitamin D and its analogs alfacalcidol and calcitriol to a placebo were included. Sources included the Cochrane Controlled Trials Register, EMBASE, MEDLINE, a hand search of abstracts, as well as reference lists. The time range was January 1995 to May 2007. Data were abstracted and scored by two investigators. The core analysis was based on double-blind trials, while open trials were included as a robustness analysis. Relative risks (RRs) for falls while allocated to D-hormone analogs or vitamin D were calculated. Publication bias and robustness were formally tested. Fourteen trials including 21,268 subjects were included. Using double-blind data only, vitamin D-hormone analogs provided a statistically significant lower level of risk for falling compared to native vitamin D: RR = 0.79 (95% confidence interval 0.64-0.96) vs. 0.94 (0.87-1.01) (intergroup difference P = 0.049). The dropout rates observed in the two sets of trials were comparable: 0.33% per month. Publication bias investigation did not report any significant trend for selective publication favoring active treatment arms. Upon current evidence, D-hormone analogs seem to prevent falls to a greater extent than their native compound. Long-term, prospective, head-to-head, confirmatory trials are required to address the exact role of vitamin D and D-hormone analogs in the prevention of falls and fractures.
    MeSH term(s) Accidental Falls/prevention & control ; Bone Density Conservation Agents/therapeutic use ; Calcitriol/therapeutic use ; Double-Blind Method ; Humans ; Hydroxycholecalciferols/therapeutic use ; Randomized Controlled Trials as Topic ; Risk Factors ; Vitamin D/analogs & derivatives ; Vitamin D/therapeutic use
    Chemical Substances Bone Density Conservation Agents ; Hydroxycholecalciferols ; Vitamin D (1406-16-2) ; Calcitriol (FXC9231JVH) ; alfacalcidol (URQ2517572)
    Language English
    Publishing date 2008-02
    Publishing country United States
    Document type Journal Article ; Meta-Analysis
    ZDB-ID 304266-2
    ISSN 1432-0827 ; 0171-967X ; 0944-0747 ; 0008-0594
    ISSN (online) 1432-0827
    ISSN 0171-967X ; 0944-0747 ; 0008-0594
    DOI 10.1007/s00223-008-9102-0
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  9. Article ; Online: Efficacy and safety of piroxicam revisited. A global meta-analysis of randomised clinical trials.

    Richy, Florent / Scarpignato, Carmelo / Lanas, Angel / Reginster, Jean-Yves

    Pharmacological research

    2009  Volume 60, Issue 4, Page(s) 254–263

    Abstract: Background: The relative efficacy/safety profiles of traditional (non-selective) NSAIDs (t-NSAIDs) have been repeatedly challenged. To better understand the efficacy and safety profile of piroxicam, a widely used NSAID, a meta-analysis of comparative ... ...

    Abstract Background: The relative efficacy/safety profiles of traditional (non-selective) NSAIDs (t-NSAIDs) have been repeatedly challenged. To better understand the efficacy and safety profile of piroxicam, a widely used NSAID, a meta-analysis of comparative RCTs was carried out according to the QUOROM guidance.
    Methods: A systematic comprehensive research (years 1980-2006) of any comparative randomised controlled trial (of over 7-day duration) with piroxicam for the treatment of osteoarticular conditions was conducted. Conservative analyses were stratified by comparator, outcome, indication, duration, and doses. Publication bias and robustness were exhaustively investigated.
    Results: Seventy-five comparative trials were ultimately included for analyses. Regarding global efficacy, piroxicam was more effective than naproxen [OR=1.37 (1.05; 1.77)] and nabumetone [OR=1.72 (1.26; 2.34)], while equivalent to other NSAIDS [OR=1.06 (0.96; 1.18)]. For pain and articular swelling, piroxicam was statistically equivalent to all other NSAIDs. For mobility, piroxicam appeared to be more effective than indomethacin, while equivalent to all other NSAIDs. Piroxicam was globally safer than other NSAIDs OR=0.83 [0.73; 0.96], notably indomethacin [OR=0.53 (0.43; 0.64], naproxen [OR=0.75 (0.65; 0.85)] and salicylates [OR=0.36 (0.17; 0.75)]. From a global GI safety point of view, piroxicam was better tolerated than indomethacin [OR=0.46 (0.36; 0.58)], naproxen [OR=0.66 (0.53; 0.83)] and salicylates [OR=0.45 (0.27; 0.78)] while less tolerated when compared to meloxicam [OR=1.49 (1.05; 2.13)]. Major GI effects were comparable among piroxicam users as in comparator drugs users [OR=1.33 (0.96; 1.84)], except for meloxicam [OR=2.37 (1.13; 4.97)]. The skin safety of piroxicam was statistically comparable to those of comparators [OR=1.01 (0.68; 1.51)].
    Conclusion: This meta-analysis of RCTs support a similar to more favourable efficacy/safety profile of piroxicam as compared to other t-NSAIDs.
    MeSH term(s) Adult ; Aged ; Anti-Inflammatory Agents, Non-Steroidal/adverse effects ; Anti-Inflammatory Agents, Non-Steroidal/therapeutic use ; Gastrointestinal Tract/drug effects ; Humans ; Middle Aged ; Musculoskeletal Diseases/drug therapy ; Piroxicam/adverse effects ; Piroxicam/therapeutic use ; Randomized Controlled Trials as Topic ; Skin/drug effects
    Chemical Substances Anti-Inflammatory Agents, Non-Steroidal ; Piroxicam (13T4O6VMAM)
    Language English
    Publishing date 2009-10
    Publishing country Netherlands
    Document type Comparative Study ; Journal Article ; Meta-Analysis ; Research Support, Non-U.S. Gov't
    ZDB-ID 1003347-6
    ISSN 1096-1186 ; 0031-6989 ; 1043-6618
    ISSN (online) 1096-1186
    ISSN 0031-6989 ; 1043-6618
    DOI 10.1016/j.phrs.2009.03.021
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  10. Article: Importance of alfacalcidol in clinical conditions characterized by high rate of bone loss.

    Reginster, Jean-Yves / Lecart, Marie-Paule / Richy, Florent

    The Journal of rheumatology. Supplement

    2005  Volume 76, Page(s) 21–25

    Abstract: In postmenopausal osteoporosis, the administration of alfacalcidol to women resulted in an increase in trabecular bone mineral density (BMD), prevention of cortical bone loss, and a significant reduction in the incidence of further vertebral fractures. ... ...

    Abstract In postmenopausal osteoporosis, the administration of alfacalcidol to women resulted in an increase in trabecular bone mineral density (BMD), prevention of cortical bone loss, and a significant reduction in the incidence of further vertebral fractures. There is now robust evidence that alfacalcidol may be particularly active in conditions characterized by an increased rate of bone loss. Alfacalcidol 1 microg/day fully prevented vertebral bone loss over 3 years in women after the first year of menopause. In a large cohort of individuals starting treatment with high dose corticosteroid (CS, 46.6 mg equivalent prednisolone per day), the spinal bone loss observed in untreated patients was fully prevented by administration of 1 microg/day alfacalcidol. In patients with established CS-induced osteoporosis, with or without prevalent vertebral fractures, 1 microg/day of alfacalcidol, given for 3 years, increased lumbar spine density, reduced back pain, and showed a significant reduction in the rate of new vertebral fractures, compared to native vitamin D. In cardiac transplant recipients, alfacalcidol and calcium reduced spinal and femoral bone loss, compared to a control group treated with etidronate and calcium. Alfacalcidol-treated patients experienced fewer new vertebral fractures over the 2-year followup. When alfacalcidol and vitamin D3 were compared in elderly women with radiologic evidence of vertebral fracture, fractional calcium absorption was increased after 3 months with alfacalcidol but was unchanged with vitamin D3. In a recent metaanalysis of 14 studies of native vitamin D and 19 studies of D-hormone analogs (alfacalcidol and calcitriol), the D-analogs exerted a higher preventive effect on bone loss and fracture rates in patients with no exposure to CS. In head-to-head studies comparing D-analogs and native vitamin D in patients receiving CS, this metaanalysis identified significant effects favoring D-analogs for femoral neck BMD and spinal fractures. In conclusion, improvement in bone turnover, increase in BMD, and reduction in fracture rates have been described during alfacalcidol treatment in situations characterized by a high rate of bone loss, including CS-induced osteoporosis, early postmenopausal bone loss, and organ transplant. Compared to plain vitamin D, alfacalcidol exerts higher bone-protective effects, thus allowing the doses to be minimized and lowering the risk of adverse effects, including hypercalcemia.
    MeSH term(s) Adrenal Cortex Hormones/adverse effects ; Animals ; Bone Density/drug effects ; Bone Density Conservation Agents/administration & dosage ; Bone Density Conservation Agents/therapeutic use ; Bone Remodeling/drug effects ; Cholecalciferol/administration & dosage ; Cholecalciferol/therapeutic use ; Clinical Trials as Topic ; Female ; Fractures, Bone/prevention & control ; Humans ; Hydroxycholecalciferols/administration & dosage ; Hydroxycholecalciferols/therapeutic use ; Osteoporosis/drug therapy ; Osteoporosis/etiology ; Osteoporosis/prevention & control ; Osteoporosis, Postmenopausal/drug therapy ; Osteoporosis, Postmenopausal/prevention & control ; Spinal Fractures/prevention & control ; Transplantation/adverse effects
    Chemical Substances Adrenal Cortex Hormones ; Bone Density Conservation Agents ; Hydroxycholecalciferols ; Cholecalciferol (1C6V77QF41) ; alfacalcidol (URQ2517572)
    Language English
    Publishing date 2005-09
    Publishing country Canada
    Document type Comparative Study ; Journal Article
    ISSN 0380-0903
    ISSN 0380-0903
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