scholarly journals Timing of Bisphosphonate (Alendronate) Initiation after Surgery for Fragility Fracture: A Population-Based Cohort Study

2021 ◽  
Vol 10 (12) ◽  
pp. 2541
Author(s):  
Meng-Huang Wu ◽  
Yu-Sheng Lin ◽  
Christopher Wu ◽  
Ching-Yu Lee ◽  
Yi-Chia Chen ◽  
...  
Keyword(s):  
Cohort Study ◽  
Adverse Events ◽  
Fragility Fracture ◽  
Data Science ◽  
Population Based ◽  
Science Center ◽  
First Line ◽  
Subdistribution Hazard ◽  
Late Initiation ◽  
First Time

Bisphosphonates are used as first-line treatment for the prevention of fragility fracture (FF); they act by inhibiting osteoclast-mediated bone resorption. The timing of their administration after FF surgery is controversial; thus, we compared the incidence of second FF, surgery for second FF, and adverse events associated with early initiation of bisphosphonates (EIBP, within 3 months of FF surgery) and late initiation of bisphosphonates (LIBP, 3 months after FF surgery) in bisphosphonate-naïve patients. This retrospective population-based cohort study used data from Taiwan’s Health and Welfare Data Science Center (2004–2012). A total of 298,377 patients received surgeries for FF between 2006 and 2010; of them, 1209 (937 EIBP and 272 LIBP) received first-time bisphosphonates (oral alendronate, 70 mg, once a week). The incidence of second FF (subdistribution hazard ratio (SHR) = 0.509; 95% confidence interval (CI): 0.352–0.735), second FF surgery (SHR = 0.452; 95% CI: 0.268–0.763), and adverse events (SHR = 0.728; 95% CI: 0.594–0.893) was significantly lower in the EIBP group than in the LIBP group. Our findings indicate that bisphosphonates should be initiated within 3 months after surgery for FF.

scholarly journals Metformin use and long-term risk of benign prostatic hyperplasia: a population-based cohort study

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e041875
Author(s):  
Mette Nørgaard ◽  
Bianka Darvalics ◽  
Reimar Wernich Thomsen
Keyword(s):  
Cohort Study ◽  
Benign Prostatic Hyperplasia ◽  
Cox Regression ◽  
Population Based ◽  
Prostatic Hyperplasia ◽  
Haemoglobin A1c ◽  
First Line ◽  
Intention To Treat ◽  
Lowering Drug

ObjectiveTo assess whether metformin use affects risk of benign prostatic hyperplasia (BPH) by comparing the risk of BPH in men with type 2 diabetes who initiated first-line treatment with either metformin or sulfonylurea monotherapy between 2000 or 2006 in Northern Denmark. In this period, sulfonylurea and metformin were both frequently used as first-line glucose-lowering drug (GLD) treatment.DesignA population-based cohort study.SettingNorthern Denmark.ParticipantsAll men who filled at least two prescriptions for metformin or for sulfonylurea, respectively, during their first 6 months of GLD treatment. Follow-up started 6 months after treatment start.Primary outcome measuresRates of subsequent BPH, identified based on community prescriptions for BPH-related treatment or hospital BPH diagnoses, and rates of transurethral resection of the prostate (TURP). Rates in metformin and sulfonylurea users were compared overall and stratified by 6-month haemoglobin A1c (HbA1c) using Cox regression and an intention-to-treat (ITT) approach and an as-treated analysis.ResultsDuring follow-up, less than five persons were lost to follow-up due to emigration. In 3953 metformin initiators with a median follow-up of 10 years, the 10-year cumulative BPH incidence was 25.7% (95% CI 24.2 to 27.1). Compared with 5958 sulfonylurea users (median follow-up 8 years, 10-year cumulative incidence 27.4% (95% CI 26.2 to 28.6)), the crude HR for BPH was 0.83 (95% CI 0.77 to 0.89) and adjusted HR in the ITT analyses was 0.97 (95% CI 0.88 to 1.06). For TURP, the adjusted HR was 0.96 (95% CI 0.63 to 1.46). In the as-treated analysis, adjusted HR for BPH was 0.91 (95% CI 0.81 to 1.02).ConclusionsCompared with sulfonylurea, metformin did not substantially reduce the incidence of BPH in men with diabetes.

scholarly journals Comorbidity and risk of venous thromboembolism after hospitalization for first‐time myocardial infarction: A population‐based cohort study

2020 ◽  
Vol 18 (8) ◽  
pp. 1974-1985
Author(s):  
Morten Würtz ◽  
Erik Lerkevang Grove ◽  
Priscila Corraini ◽  
Kasper Adelborg ◽  
Jens Sundbøll ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Cohort Study ◽  
Venous Thromboembolism ◽  
Population Based ◽  
First Time

Retrospective cohort study on the safety and efficacy of bevacizumab for metastatic colorectal cancer patients: The HGCSG0801 study—Analysis of bevacizumab beyond progression (BBP).

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 684-684
Author(s):  
Hiraku Fukushima ◽  
Satoshi Yuki ◽  
Yoshimitsu Kobayashi ◽  
Kazuteru Hatanaka ◽  
Takaya Kusumi ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Cohort Study ◽  
Adverse Events ◽  
Metastatic Colorectal Cancer ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
Phase Iii ◽  
Second Line ◽  
First Line ◽  
Line Chemotherapy

684 Background: Bevacizumab (BV) is widely used in first-line chemotherapy for metastatic colorectal cancer in Japan, but the use of beyond bevacizumab first progression (BBP) has been controversial yet. Methods: Of patients treated with first-line BV in our retrospective cohort study (HGCSG0801), patients treated with BBP (n=22) and those without BBP ( n=19) in second-line setting were analyzed. The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was used to assess adverse events. The Response Evaluation in Solid Tumors (RECIST) criteria version 1.0 was used to assess tumor response. The Kaplan–Meier method was used to determine PFS and OS. Log-rank test was used to compare each group in terms of PFS and OS. All statistical tests were performed using SPSS. Results: PS (0/1/2) before second line chemotherapy was 18/3/1 in BBP and 10/8/1 in NBBP, respectively. In the safety analysis, five patients in BBP showed a worsening/newer hypertension, which wasn’t a clinical problem. In the efficacy analysis, the response rate was 22.8% in BBP and 0% in NBBP. The median PFS was better in BBP (6.7 months in BBP and 2.7 months in NBBP), but there was no significant difference in median OS from first BV administration between two groups (27.3 months in BBP and 22.2 months in NBBP). Conclusions: We analyzed BBP in daily practice in Japan. Adverse events were well tolerated, but survival advantage of BBP was not suggested. About the efficacy of BBP, we are waiting the results of ongoing Phase III trials.

Observational cohort study of first-line bevacizumab combined with chemotherapy in metastatic colorectal cancer (HGCSG0802): Comparison of infusional FU/oxaliplatin(OX)+BV and oral FU/OX+BV.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 527-527 ◽  
Author(s):  
Kazuteru Hatanaka ◽  
Satoshi Yuki ◽  
Hiroshi Nakatsumi ◽  
Hiraku Fukushima ◽  
Hirohito Naruse ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Cohort Study ◽  
Adverse Events ◽  
Metastatic Colorectal Cancer ◽  
Observational Cohort Study ◽  
Rank Test ◽  
First Line ◽  
Eligibility Criteria ◽  
Significant Difference ◽  
Observational Cohort

527 Background: A few reports have shown no difference between the efficacy of infusional FU and that of oral FU (Capecitabine/S-1) for colorectal cancer, and some studies have reported the non-inferiority between infusional FU/Oxaliplatin (OX) and oral FU/OX for metastatic colorectal cancer (mCRC). We performed a sub-group comparison between infusional FU/OX (mFOLFOX6 + BV: iFU) and oral FU/OX (CapeOX/SOX + BV: oFU) from the HGCSG0802 observational cohort study with investigated Japanese patients (pts) treated with first line BV for mCRC. Methods: The objective of HGCSG0802 was to evaluate progression-free survival (PFS), overall survival (OS), time to treatment-failure (TTF), response rate (RR), safety and so on. The key eligibility criteria of HGCSG0802 were with evaluable lesions, older than 20 years, ECOG PS 0-2, and this analysis used the cohort treated with OX-based regimens.In this analysis, pts characteristics, RR and safety were compared using Fisher’s exact test. PFS and TTF were compared using log-rank test. Results: Of 108 pts (the full analysis set), 95 pts were evaluable for treated with OX-based regimens. Forty-eight pts (50.5%) were treated with iFU and 47 pts (49.5%) were treated with oFU (CapeOX + BV 42 pts/SOX + BV 5 pts). The pts characteristics between those were generally balanced except for PS 0-1 (72.9% in iFU/93.6% in oFU; p=0.012) and synchronous liver metastases (mets) (93.8% in iFU/78.8% in oFU; p=0.040). Adverse events ≥grade 3 were balanced except for leucopenia (25.0% in iFU versus 2.1% in oFU; p=0.002) and neutropenia (43.5% in iFU and 10.9% in oFU; p=0.001). Hand-foot skin reaction was not different between two cohorts. RR was 62.5% in iFU versus 71.1% in oFU (p=0.835). The median PFS was 8.3 months in iFU versus 8.2 months in oFU (p=0.835). Conclusions: The HGCSG0802 could be a database to investigate first line BV for mCRC in clinical practice. As a result of this analysis, in Japanese daily practice, efficacy was no significant difference between infusional FU/OX and oral FU/OX, and the profiles of adverse events varied from each regimens.

Observational cohort study of first-line bevacizumab combined with chemotherapy in metastatic colorectal cancer (HGCSG0802): Sub-group analysis by KRAS Exon2 status.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 782-782
Author(s):  
Takenori Takahata ◽  
Satoshi Yuki ◽  
Hiroshi Nakatsumi ◽  
Kazuaki Harada ◽  
Hiraku Fukushima ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Multivariate Analysis ◽  
Cohort Study ◽  
Adverse Events ◽  
Group Analysis ◽  
Observational Cohort Study ◽  
First Line ◽  
Mutational Status ◽  
Significant Difference ◽  
Observational Cohort

782 Background: A few reports have shown the efficacy of bevacizumab (BV) independent of the KRAS Exon2 mutational status (KRAS). We performed a sub-group analysis by KRAS from the HGCSG0802 observational cohort study with investigated 115 patients (pts) treated with first line BV for metastatic colorectal cancer (mCRC). Methods: The objective of HGCSG0802 was to evaluate progression-free survival (PFS), overall survival (OS), time to treatment-failure (TTF), response rate (RR), safety, etc. The key eligibility criteria were with evaluable lesions, older than 20 years, ECOG PS 0-2. In this analysis, pts characteristics, RR and safety were compared using Fisher’s exact test. Univariate and multivariate analysis for PFS were performed using patient characteristics. Survival analyses were performed with Kaplan-Meier method, log-rank test, and Cox proportional hazards model. Results: Of 108 pts (the full analysis set), 98 pts were evaluable for KRAS. Sixty-one pts (62.2%) had KRAS wild-type (wt) and 37 pts (37.8%) had mutation (mt). The pts characteristics between those with wt and with mt were generally balanced except for PS 0 (91.8% in wt, 75.7% in mt; p=0.037) and lung metastasis (34.4% in wt, 62.2% in mt; p=0.012).The median TTF was 7.4 months in wt versus 6.6 months in mt, and RR was 69.5% in wt versus 65.7% in mt. Adverse events related to BV were almost balanced except for bleeding (any grade) (31.1% in wt, 13.5% in mt; p=0.056).The median PFS was 9.9 months in wt versus 7.9 months in mt (HR=1.506; p=0.071). Although KRAS mt showed shorter PFS, there were not significant difference regardless of KRAS in Cox multivariate analysis (HR 1.314, 95% CI, 0.820-2.107, p=0.257). Conclusions: The HGCSG0802 could be a database to investigate first line BV for mCRC in clinical practice. Depending on the KRAS Exon2 mutational status, efficacy, and adverse events were no significant difference. We plan to conduct further follow up for survival, and to perform this analysis again.

Breast cancer risk in hyperprolactinemia: a population-based cohort study and meta-analysis of the literature

2015 ◽  
Vol 173 (2) ◽  
pp. 269-273 ◽  
Author(s):  
O M Dekkers ◽  
V Ehrenstein ◽  
M Bengtsen ◽  
D Kormendine Farkas ◽  
A M Pereira ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cohort Study ◽  
Meta Analysis ◽  
Population Based ◽  
Incidence Rates ◽  
Increased Risk ◽  
Combining Data ◽  
First Time ◽  
Time Diagnosis

ObjectiveTo enhance the precision of the risk estimate for breast cancer in hyperprolactinemia patients by collecting more data and pooling our results with available data from former studies in a meta-analysis.DesignPopulation-based cohort study and meta-analysis of the literature.MethodsUsing nationwide registries, we identified all patients with a first-time diagnosis of hyperprolactinemia during 1994–2012 including those with a new breast cancer diagnoses after the start of follow-up. We calculated standardised incidence ratios (SIRs) as a measure of relative risk (RR) using national cancer incidence rates. We performed a meta-analysis, combining data from our study with data in the existing literature.ResultsWe identified 2457 patients with hyperprolactinemia and 20 breast cancer cases during 19 411 person-years of follow-up, yielding a SIR of 0.99 (95% CI 0.60–1.52). Data from two additional cohort studies were retrieved and analyzed. When the three risk estimates were pooled, the combined RR was 1.04 (95% CI 0.75–1.43).ConclusionsWe found no increased risk of breast cancer among patients with hyperprolactinemia.

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