Clinical Trial Service Unit and Epidemiological Studies Unit CTSU

Oxford, United Kingdom

Clinical Trial Service Unit and Epidemiological Studies Unit CTSU

Oxford, United Kingdom
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De Lemos J.,AFCAPS TEXCAPS AirForce Texas Coronary Atherosclerosis Prevention Study | Braunwald E.,AFCAPS TEXCAPS AirForce Texas Coronary Atherosclerosis Prevention Study | Blazing M.,AFCAPS TEXCAPS AirForce Texas Coronary Atherosclerosis Prevention Study | Murphy S.,AFCAPS TEXCAPS AirForce Texas Coronary Atherosclerosis Prevention Study | And 91 more authors.
PLoS ONE | Year: 2012

Background: Statin therapy reduces the risk of occlusive vascular events, but uncertainty remains about potential effects on cancer. We sought to provide a detailed assessment of any effects on cancer of lowering LDL cholesterol (LDL-C) with a statin using individual patient records from 175,000 patients in 27 large-scale statin trials. Methods and Findings: Individual records of 134,537 participants in 22 randomised trials of statin versus control (median duration 4.8 years) and 39,612 participants in 5 trials of more intensive versus less intensive statin therapy (median duration 5.1 years) were obtained. Reducing LDL-C with a statin for about 5 years had no effect on newly diagnosed cancer or on death from such cancers in either the trials of statin versus control (cancer incidence: 3755 [1.4% per year [py]] versus 3738 [1.4% py], RR 1.00 [95% CI 0.96-1.05]; cancer mortality: 1365 [0.5% py] versus 1358 [0.5% py], RR 1.00 [95% CI 0.93-1.08]) or in the trials of more versus less statin (cancer incidence: 1466 [1.6% py] vs 1472 [1.6% py], RR 1.00 [95% CI 0.93-1.07]; cancer mortality: 447 [0.5% py] versus 481 [0.5% py], RR 0.93 [95% CI 0.82-1.06]). Moreover, there was no evidence of any effect of reducing LDL-C with statin therapy on cancer incidence or mortality at any of 23 individual categories of sites, with increasing years of treatment, for any individual statin, or in any given subgroup. In particular, among individuals with low baseline LDL-C (<2 mmol/L), there was no evidence that further LDL-C reduction (from about 1.7 to 1.3 mmol/L) increased cancer risk (381 [1.6% py] versus 408 [1.7% py]; RR 0.92 [99% CI 0.76-1.10]). Conclusions: In 27 randomised trials, a median of five years of statin therapy had no effect on the incidence of, or mortality from, any type of cancer (or the aggregate of all cancer). © 2012 CTT Collaboration. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.


Aung T.,Royal Berkshire NHS Foundation Trust | Haynes R.,Clinical Trial Service Unit and Epidemiological Studies Unit CTSU | Barton J.,Clinical Trial Service Unit and Epidemiological Studies Unit CTSU | Cox J.,Clinical Trial Service Unit and Epidemiological Studies Unit CTSU | And 5 more authors.
Trials | Year: 2016

Background: Clinical trials require cost-effective methods for identifying, randomising, and following large numbers of people in order to generate reliable evidence. ASCEND (A Study of Cardiovascular Events iN Diabetes) is a randomised '2 × 2 factorial design' study of aspirin and omega-3 fatty acid supplements for the primary prevention of cardiovascular events in people with diabetes; this study used central disease registers and a mail-based approach to identify, randomise, and follow 15,000 people. In collaboration with UK consultants and general practitioners (GPs), researchers identified potentially eligible people with diabetes from centrally held registers (e.g. for retinopathy screening) and GP-held disease registers. Permission was obtained under section 251 of the National Health Service Act 2006 (previously section 60 of the NHS act 2001) to allow invitation letters to be generated centrally in the name of the holder of the register. In addition, with the collaboration of the National Institutes for Health Research (NIHR) Diabetes and Primary Care Research Networks (DRN and PCRN), general practices sent pre-assembled invitation packs to people with a diagnosis of diabetes. Invitation packs included a cover letter, screening questionnaire (with consent form), information leaflet, and a Freepost envelope. Eligible patients entered a 2-month, pre-randomisation, run-in phase on placebo tablets and were only randomised if they completed a randomisation form and remained willing and eligible at the end of the run-in. Follow-up is ongoing, using mail-based approaches that are being supplemented by central registry data. Results: Information on approximately 600,000 people listed on 58 centrally held diabetes registers was obtained, and 300,188 potentially eligible patients were invited to join the study. In addition, 785 GP practices mailed invitations to 120,875 patients. A further 2,340 potential study participants were identified via other routes. In total, 423,403 people with diabetes were invited to take part; 26,462 entered the 2-month, pre-randomisation, run-in phase; and 15,480 were randomised. Conclusion: If sufficient numbers of potentially eligible patients can be identified centrally and the trial treatments do not require participants to attend clinics, the recruitment and follow-up of patients by mail is feasible and cost-effective. Wider use of these methods could allow more, large, randomised trials to be undertaken successfully and cost-effectively. Trial registration: Current Controlled Trials, ISRCTN60635500 , registered on 14 July 2005 © 2016 Aung et al.


PubMed | Imperial College London, Mother and Infant Research Activities MIRA, Clinical Trial Service Unit and Epidemiological Studies Unit CTSU, University College London and University of Birmingham
Type: Journal Article | Journal: Environmental pollution (Barking, Essex : 1987) | Year: 2016

Household Air Pollution (HAP) from biomass cooking fuels is a major cause of morbidity and mortality in low-income settings worldwide. In Nepal the use of open stoves with solid biomass fuels is the primary method of domestic cooking. To assess patterns of domestic air pollution we performed continuous measurement of carbon monoxide (CO) and particulate Matter (PM


Pirie K.,Cancer Epidemiology Unit | Peto R.,Clinical Trial Service Unit and Epidemiological Studies Unit CTSU | Green J.,Cancer Epidemiology Unit | Reeves G.K.,Cancer Epidemiology Unit | Beral V.,Cancer Epidemiology Unit
International Journal of Cancer | Year: 2016

To assess directly the effects of various risk factors on lung cancer incidence among never smokers, large prospective studies are needed. In a cohort of 1.2 million UK women without prior cancer, half (634,039) reported that they had never smoked. Mean age at recruitment was 55 (SD5) years, and during 14 (SD3) years of follow-up, 0.2% (1,469) of these never smokers developed lung cancer. Cox regression was used to estimate relative risks (RRs) of lung cancer for 34 potential risk factors, of which 31 were nonsignificant (p>0.05). The remaining three risk factors were associated with a significantly increased incidence of lung cancer in never smokers: non-white vs. white ethnicity (RR=2.34, 95% CI 1.55-3.52, p<0.001), asthma requiring treatment vs. not (RR=1.32, 1.10-1.58, p=0.003) and taller stature (height≥165 cm vs. <160 cm: RR=1.16, 1.03-1.32, p=0.02). There was little association with other sociodemographic, anthropometric or hormonal factors, or with dietary intakes of meat, fish, fruit, vegetables and fiber. The findings were not materially affected by restricting the analyses to adenocarcinomas, the most common histological type among never smokers. © 2016 UICC.

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