Monday, January 30, 2006

Endodiabology 2006; Issue 1 (February)

ENDODIABOLOGY
endodiabology.blogspot.com

NORTHEAST NEWSLETTER
FOR SPRs AND BOSSES TRAPPED IN THE NORTHERN DEANERY

February 2006

Editors: Shahid Wahid and Petros Perros

Associate Editors: Freda Razvi, Akheel Syed and Ebaa Al-Ozairi

SpR PLACEMENTS (NTN year of training from 1st October 2005)
RVI:- Arun(5), Salman Razvi (3), Akheel Syed (4), Andrew Advani (3/4), Ebaa Al-Ozairi (3/4), Suresh Vaikkakara (visiting SpR)
Freeman:- Eelin Lim(3), Reena Thomas (4), Vishmawitra Sharma
North Tyneside/Wansbeck:- Muthu Jayapaul (3) /Chandima Idampitiya (1)
South Tyneside:- Ibrahim M Ibrahim (4)
Gateshead:- Ravi Erukalapati(1)
Sunderland:-Isha Malik(1), Subir Ray (2)
North Tees/Hartlepool:- Sony Anthony(4)/ Peter Carey(3)
Middlesbrough:- Simon Ashwell(5), Sukesh Chandran(2), Asgar Madathil (2)
Carlisle:- Khaled Mansur-Dukhan (2)
Bishop Auckland/Durham:- Beas Bhatacharya (3)/Jeevan Metayil (1)
NGH/QEH:- Ravikumar Balasubramanian (2)
Research with numbers (supervisor):- Latika Sibal (Prof Home), Arutchelvan Vijayaraman (Prof Home)
Acting up:- David Woods (5)

MEETINGS/LECTURES/ANNOUNCEMENTS
15th February 2006 Society for Endocrinology Clinical Cases meeting, London. Contact Ann Lloyd
2nd March 2006 Incretins Symposium incorporating the 29th Novo Nordisk Annual Lecture by David Mathews, Lumley Castle, Durham. Contact Sally Marshall
11th March 2006 Association of Physicians meeting, University Hospital of North Tees. Contact Roy Taylor .
22nd March 2006 GIM training ½ day-Freeman Hospital. Contact Lorraine Waugh 0191 223 1247
29th March 2006 Clinical Endocrinology Trust Visiting Lecturer, Bill Crowley, James Spence Lecture Theatre-RVI, 0900-1300. Contact Andy James
29th-31st March 2006 DUK Annual Professional Conference, NEC, Birmingham. Contact Ben Holdstock or Diabetes UK website
1st-5th April 2006 European Congress for Endocrinology Congress incorporating the British Endocrine Societies Conference, SECC, Glasgow. Contact ECE 2006 website
5th-6th April 2006 ABCD Spring Meeting, SECC, Glasgow. Contact P Winocour or ABCD website
26TH April 2006 Acute Medical Emergencies RCP Symposium, Freeman Hospital. Contact Lorraine Waugh
3rd May 2006 Northern Diabetes Audit Group (NorDAG) meeting, 1330-1630, Collingwood College, Durham University. This follows the NRDSAG meeting. Contact K Narayanan
22nd May 2006 GIM training ½ day. Contact Lorraine Waugh 0191 223 1247 Lorraine Waugh
1st June 2006 Northern Endocrine & Diabetes Summer CME, Freeman Hospital. Contact Simon Ashwell Simon Ashwell
24th-27th June 2006 ENDO 2006, Boston, USA. Contact ENDO email or ENDO website
9th-13th June 2006 American Diabetes Association 66th Annual Scientific Sessions, Washington DC, USA. Contact ADA Meetings email
11th-14th July 2006 The Society For Endocrinology Summer School, Cambridge. Contact Ann Lloyd
12th July 2006 GIM training ½. Contact Lorraine Waugh 0191 2231247
3-7th December 2006 IDF World Diabetes Congress, Cape Town SA. IDF website

TRAINING ISSUES
Registering with JCHMT/PMETB It is essential that all new SpRs (even LATs) register with the PMETB (used to be JCHMT). Not doing so means your training is not counted and you cannot have a RITA.
RITAs 2006 The RITAs will be held on Weds 17th, Thurs 18th and Fri 19th May 2006. The Wednesday and Thursday will be paper based with PYA interviews held on Friday. It is essential that the following documentation be forwarded to the PIMD by Friday 5th May 2006, 12pm at the latest:
1. Portfolio (If you have developed one)
2. Training Log Book (to include any assessments, eg MSF)
3. Three copies of an Evidence of Achievement Form
4. Three copies of an Annual Appraisal Record
5. Structured CV
Failure to adhere to the deadline can result in a RITA D. It is essential that all the necessary Supervisor Signatures be obtained for the above documentation to count towards your RITA. More detailed instructions have been circulated.
SpR Feedback Recently feedback forms for training posts have been circulated to all SpRs. Please complete one form for each training post you have been to in the region as an SpR and return electronically to Shaz Wahid. The results for each individual unit will be sent to them along with a regional summary for comparison. This will allow individual units to improve training. The summary results and examples of practice will be discussed at the annual Trainers meeting. The process will be completed every 3-yrs (to coincide with planned Programme Director change over) so as to maintain SpR anonymity.
SpR Database The STC are building an updated database of trainees. Could all SpRs with a number forward their NTN details and CCT date ASAP to Shaz Wahid.
Log Book/Portfolio Documentation It is a trainees responsibility to make sure their portfolio/log book is prospectively completed and the necessary signatures obtained. Any experience that is not signed off by your educational supervisor at the time cannot be counted towards training.
SpR adverts for NTNs/LATs New PIMD regulations mean that each specialty will be allowed only 2 advertisements per year for Numbers/LAT appointments. The adverts for DM/Endo will be scheduled for end of Middle of April and End of September. We therefore will only have 2 appointment panels per year for SpRs with a limited window. This has major implications:

All SpRs wishing to undertake an out of programme experience (formal research/travel abroad/acting up) or leave the rotation in 2006 are to give Shaz Wahid notice of the exact dates of absence(in writing) by the 1st March 2006. This will then allow the appropriate advertisement to be placed in April 2006 with an appointments panel convened in May/June 2006. Be warned that once SpRs have gave formal notice and the interviews have taken place with a replacement appointed for the period of absence from the rotation there is no going back. Any SpR missing this deadline will not be allowed to come off the rotation until the next appointments panel in October/November 2006 can appoint a replacement.
Assessment tools Please see the JCHMT website. As of October 2005 Multisource feedback (MSF) and Directly Observed Procedural Skills (DOPS) have been formally introduced and Mini Clinical Evaluation Exercise (Mini-CEX) will go live from October 2006.
Trainee Representative With Simon Ashwell moving on from July 2006 a 2nd Trainee Representative is needed on the STC. If you wish to undertake this role please forward a 500 word application to Shaz Wahid , outlining what you believe this role entails and your personal qualities that you believe will fit in with this role. The STC will announce a replacement in June 2006.
Improving Recruitment In an effort to improve the appeal of our specialty the Programme Director will be setting up a stand and undertaking a presentation at the Medical Students Careers Fair at the University on Wednesday 26th April 2006 1-5pm. If any trainees wish to make a brief appearance to promote the specialty please let Shaz Wahid know. Furthermore if any one has some useful pictures that I can utilize in a poster or presentation please e-mail them to Shaz Wahid.
Training Committee Chair: Jola Weaver; Regional Speciality Advisor: Richard Quinton; Programme Director: Shaz Wahid; Consultant members: Jean Macleod, Simon Pearce (Research Advisor), Simon Eaton & Ronan Canavan; SpR representatives: Simon Ashwell & Andrew Advani.

OLD FACES ON THE GO
Bill Kelly will be retiring in April 2006. Bill has made a huge contribution to training, teaching and clinical care in our region over the years. The ENDODIABOLOGY team wish him all the best for the future. Rudy Bilous is planning a small festschrift at JCUH on Friday 5th May at 1430, with a dinner afterwards. If you wish to attend either event please contact Rudy Bilous ASAP to reserve a place.
NEWS FROM THE NORTHEAST
Prof Home will be the clinical lead on the NICE/RCP Type 2 diabetes Guidelines due publication in 2007. He will also be the international lead investigator on the Sanofi-Aventis multinational observational study(CHIEF) of insulin treated people with Type 2 Diabetes 2006-2014.
Congratulations to Sony Anthony, Ibrahim and Salman Razvi on sweeping 3 of the 4 awards at the recent British Thyroid Association meeting in London.
Welcome back to Ebaa Al-Ozairi on her return from research at Harvard.

LETTERS
Contributions for this section can include meeting reports, research experiences, book reviews, experiences abroad, and anything else you feel may benefit trainees and trainers around the region. The success of this section really does depend on YOU.

The Newcastle Magnetic Resonance Centre-Roy Taylor
The NMR centre is on course for the planned handover date of 20th February 2006. Bookings are brisk with funding from major sources and most of the first year scanning slots are full. Any projects can be discussed informally with Roy Taylor in the early planning stages.

A Topical debate-John Parr, Shaz Wahid & Philip Home
There has been a lot of change in the political landscape which has/will effect Service provision for Diabetes Care. John Parr and myself have been trying to make sense of and engage with these changes. We wish to share a recent electronic conversation between ourselves in relation to payment by results and practice based commissioning:

Dear Philip
You wrote an excellent article a few years ago in the J of MDU on the medico-legal aspects of diabetes. Thus as our local expert your opinion on the medico-legal position on the following would be valuable. Our PCT has set up an "intermediate level" diabetes care team consisting of some local GPs and chronic disease management nurses. We have no objection to this and indeed have welcomed and supported this development. Provided it is targeted to defined groups of patients. The level of the GPs and CDM Nurses experience in diabetes is varied and in the case of the nurses, very limited. So far they have taken referrals of new patients from other GPs(39 in 9 months - so not very cost-effective!). Their/PCTs current proposal is however to "expand" their services taking "more complex" cases, which concerns us. The finance arrangements do look remarkably like they will take patients away from secondary care (i.e we lose £85 per f.u.visit per patient) and use the funds saved to fund the intermediate care service. My concerns are:
a) patients we see we do so because they need to be seen by a consultant physician and we may have seen for many years for their problems. However with practice-based commissioning, patients with "specialist" problems may be "transferred" to the care of people they don't know and who have less expertise to look after patients with such problems. Accepted the patients are ultimately the responsibility of their GP who must ensure that health care professionals who see his/her patients are properly trained and expert enough, and they all have medico-legal responsibility for ensuring they practice within their own capabilities.
b) That the patient would have good grounds for compliant against myself if their care was transferred to someone not expert enough to look after their condition, as the patient may wrongly believe that I had agreed to the transfer of their care. In order to cover myself I would have to write a fairly forceful note to the GP objecting to the transfer of care where I felt it was to the patient's detriment. This raises problems where we are supposed to be copying such letters to patients, which might actually precipitate the complaint. These problems are doubtless being raised across the country - so far I haven't heard of a consultant colleague being taken to task for such events but fear it will probably come with time. Your opinions would be welcome and helpful.

John Parr
==============
Dear John
Legally and morally you have two responsibilities, the first of which is to people already under your care and the second as an authority on diabetes care in your district. My view is that you are obliged to discharge both of those properly, but that no liability arises to people you have never seen if your advice in the second instance is not acted on by those in authority (effectively they assume responsibility for not accepting your advice). A difficulty comes if you are asked to pass on responsibility for care in circumstances where you are not satisfied that the patient will not suffer as a result (poorer health through poorer care advice). I think that the authority can direct you that it would no longer support your seeing someone under the NHS, and that in those circumstances you could not be criticised for not doing so. However that leaves open the question as to what comments you should make on the individual case both to the patient and to the patient's GP.

My feeling is that you should in these circumstances tell a patient what care they need, and that you would advise them to discuss getting that care with their GP. This would be couched in terms of positives - 'need for advice from someone with specialist expertise in the choice and adjustment of insulin regimens and doses for a patient with erratic blood glucose control' for example - and not any statement that X or Y could not provide that. This would need to be in writing or recorded in your clinical records as advice given. You would of course copy this to the patient's GP, and where predictable (as in the current situation) I would have explained beforehand in a brief letter to the Trust/PCT Medical Director that you have a professional obligation to do that.

You allude to the issue of loss of money for the service. This is a different kind of issue, and generally you are only expected to provide medical care within the bounds of the funding and resources available to you. If for example someone dies as a lack of an endoscope no liability falls on the doctor who could have done the gastroscopy (provided they made every reasonable attempt to find one). However where a very significant treatment was unavailable but would benefit the patient you might in some circumstances be obliged to tell them. This would certainly apply to items advised for example as part of NICE guidance or guidelines.

Lastly you are not obliged to take political action - egg to encourage people to write to their local MP. You would rather suggest they discuss the matter with their GP, and would point out that it is always open to them to write to the CE of the Trust/PCT if they felt they had cause for complaint. If they asked it would be reasonable of you to support them in that.

Hope that helps.

Philip
=================
We hope that the above results in a regional debate and would value comments to Shaz Wahid

Book Review-Shaz Wahid
Psychology in Diabetes Care. Eds. Frank Snoek & T Chas Skinner. 2nd Edition, 2005, John Wiley & Sons.ISBN-13 978-0-470-02384-8.
This is an excellent read, which I believe should be a compulsory read for all SpRs. It includes an excellent overview of the evidence base (of which there is a paucity) and provides practical tips that can be used in individual consultations or help drive/improve service change. Although it does contain a lot of “redundant” information that might seem obvious (not surprising as it does have a wide readership), by the time one sifts through this the “golden nuggets” are worth it. There are some annoying aspects of the book (bland diagrams and sometimes too much of an “American” style that is not practical to my own service), but these apart I highly recommend this book to all trainers and trainees.

Training Issues: Grumpy SpR :) By Ebaa Al-Ozairi
Regional CME Event: It was delightful to see Reena and Arut wonderful effort. The choice of speakers and topics were fantastic, however, I did notice that there was only a thin consultant’s presence. I know many are tied up with clinics and administration issues but for SpRs educational values consultant presence should be encouraged, if only to stir up the discussion and increase the learning driving force.
RITA and new assessment tools: Shaz presentation was concise and well to the point. I agree assessment drives learning. I believe the use of technology can ease the matters in accomplishing our tasks. For example, surely MSF can be completed via email or online, similar to the current Scottish Foundation program where MSF, workplace assessments and e-portfolio (reflective writing) are online via a centralized database and you can visualize your results via your username and password
Reflective Writing: This has been shown over the years to be a valuable tool as an educational tool. Currently it is used in all adult learning technique teaching. This has been in the nursing curriculum for years. However I think this should be introduced at the medical school curriculum similar to the communication skills courses.
I know assessment tools seems to be more hassle then of benefit but without adequate summative assessment we cannot fulfil our obligation to society to assure physicians trained meet the higher state of knowledge, competence and professionalism. So do not give up!!!!

Book Review-Ebaa Al-Ozairi
Bittersweet: Diabetes, insulin and transformation of illness. By Chris Feudtner.
This is a great book for medical and non-medical. Though written by physicians, the book uses the patient’s reflection on impact of the diabetes on their daily lives. It has fascinating collections of the original letters from Joslin notes even before the 1921. The book nicely illustrates how medicine transforms disease and how medical systems solve one problem by creating another. Although it has some pessimistic tone and published back in 2003 but I found it thrilling

Meeting announcement-Petros Perros
2nd EUGOGO Teaching Course on Graves’ Orbitopathy, Pisa (Italy) June 6-8, 2006. Hands-on learning with real patients, great success last year and this is appropriate for trainees and consultants and a great venue. For further info see the EUGOGO website.

Meeting announcement-Mark Walker
2006 Anglo-Danish-Dutch Diabetes Group meeting. For those of you who are not familiar with ADDDG, this is a small and friendly meeting for young researchers in the field of Diabetes. The meeting is mainly aimed at clinicians undergoing MD/PhD studies, but abstracts are also invited from those in clinical posts, medical students and non-clinical PhD students/young post-docs. The meeting was initially set up more than 20 years ago to encourage young researchers who at large international meetings might not have the opportunity to present and discuss their work. As the name suggests, delegates are from the UK, the Netherlands and Denmark, with the meeting rotating between the 3 countries. Each delegate will give a 20 minute presentation of their work and is encouraged to join in the discussion of the other abstracts. Each country also supplies a "senior discussant" to help the debate along. In addition one afternoon is given over to a social activity!

The 23rd annual ADDDG meeting will be held from 16th - 19th May 2006, at the Hotel Lauswolt in Friesland (the north of the Netherlands). All costs (apart from a £50 registration) are covered by Novo Nordisk and they will also make travel arrangements for UK delegates. Deadline for submission of abstracts is February 15th 2006. Registration and abstract submission is via the ADDDG website. The UK organizing committee contacts are Katharine Owen, John Porter or Peter George (Novo Nordisk UK).

RECENT PUBLICATIONS FROM THE NORTHEAST
Please send us your recent publication for inclusion in the next newsletter.

Advani A, Taylor R. Life-threatening hypokalaemia on a low-carbohydrate diet associated with previously undiagnosed primary hyperaldosteronism. Diabet Med. 2005 Nov;22(11):1605-7.
Ashwell SG, Gebbie J, Home PD. Optimal timing of injection of once-daily insulin glargine in people with Type 1 diabetes using insulin lispro at meal-times. Diabet Med. 2006 Jan;23(1):46-52.
Bilous R. Will ASCOT change the form of anti-hypertensive therapy? Diabet Med. 2006 Jan;23(1):13-4.
Chinnery PF, Elliott HR, Patel S, Lambert C, Keers SM, Durham SE, McCarthy MI, Hitman GA, Hattersley AT, Walker M. Role of the mitochondrial DNA 16184-16193 poly-C tract in type 2 diabetes. Lancet. 2005 Nov 5;366(9497):1650-1.
Hart RH, Kendall-Taylor P, Crombie A, Perros P. Early response to intravenous glucocorticoids for severe thyroid-associated ophthalmopathy predicts treatment outcome. J Ocul Pharmacol Ther. 2005 Aug;21(4):328-36.
Jones SE, White KE, Flyvbjerg A, Marshall SM. The effect of intrauterine environment and low glomerular number on the histological changes in diabetic glomerulosclerosis. Diabetologia. 2005 Dec 9;:1-9 [Epub ahead of print]
Pearce SH, Merriman TR. Genetic progress towards the molecular basis of autoimmunity.Trends Mol Med. 2006 Jan 10; [Epub ahead of print]
Perros P. Thyrotoxicosis and pregnancy. PLoS Med. 2005 Dec;2(12):e370. Epub 2005 Dec 27.
Perros P. A 69-year-old female with tiredness and a persistent tan. PLoS Med. 2005 Aug;2(8):e229. Epub 2005 Aug 30.
Perros P, Kendall-Taylor P, Neoh C, Frewin S, Dickinson J. A prospective study of the effects of radioiodine therapy for hyperthyroidism in patients with minimally active graves ophthalmopathy. J Clin Endocrinol Metab. 2005 Sep;90(9):5321-3.
Walker M, Mari A, Jayapaul MK, Bennett SM, Ferrannini E. mpaired beta cell glucose sensitivity and whole-body insulin sensitivity as predictors of hyperglycaemia in non-diabetic subjects. Diabetologia. 2005 Dec;48(12):2470-6. Epub 2005 Nov 1.
Razvi S, McMillan CV, Weaver JU. Instruments used in measuring symptoms, health status and quality of life in hypothyroidism: a systematic qualitative review. Clin Endocrinol (Oxf). 2005 Dec;63(6):617-24.
Vaidya B, Shenton BK, Stamp S, Miller M, Baister E, Andrews CD, Dickinson AJ, Perros P, Kendall-Taylor P. Analysis of Peripheral Blood T-Cell Subsets in Active Thyroid-Associated Ophthalmopathy: Absence of Effect of Octreotide-LAR on T-Cell Subsets in Patients with Thyroid-Associated Ophthalmopathy. Thyroid. 2005 Sep;15(9):1073-8.

RECENT PUBLICATIONS IN DIABETES & ENDOCRINOLOGY THAT HIT THE NEWS OR THAT MAY HAVE A SIGNIFICANT IMPACT ON MANAGEMENT

Nathan DM et al. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005 Dec 22;353(25):2643-53.
The authors studied whether the use of intensive therapy as compared with conventional therapy during the Diabetes Control and Complications Trial (DCCT) affected the long-term incidence of cardiovascular disease. The DCCT randomly assigned 1441 patients with type 1 diabetes to intensive or conventional therapy, treating them for a mean of 6.5 years between 1983 and 1993. 93% were subsequently followed until February 1, 2005, during the observational Epidemiology of Diabetes Interventions and Complications(EDIC) study. Cardiovascular disease (defined as nonfatal MI, stroke, death from cardiovascular disease, confirmed angina, or the need for coronary-artery revascularisation) was assessed with standardized measures and classified by an independent committee. During the mean 17 years of follow-up, 46 cardiovascular disease events occurred in 31 patients who had received intensive treatment in the DCCT, as compared with 98 events in 52 patients who had received conventional treatment. Intensive treatment reduced the risk of any cardiovascular disease event by 42% (95% confidence interval, 9 -63; P=0.02) and the risk of nonfatal MI, stroke, or death from cardiovascular disease by 57%(95%CI, 12-79; P=0.02). The decrease in HbA1c values during the DCCT was significantly associated with most of the positive effects of intensive treatment on the risk of cardiovascular disease. Microalbuminuria and albuminuria were associated with a significant increase in the risk of cardiovascular disease, but differences between treatment groups remained significant after adjusting for these factors. In conclusion this trial has shown that intensive diabetes therapy has long-term beneficial effects on the risk of cardiovascular disease in patients with type 1 diabetes.

Adam DJ et al. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet. 2005 Dec 3;366(9501):1925-34.
In this important trial the authors compared the outcome of bypass surgery and balloon angioplasty in 452 randomly assigned patients presenting with severe limb ischaemia due to infra-inguinal disease, to receive surgery-first (n=228) or angioplasty-first (n=224). The primary endpoint was amputation (of trial leg) free survival. Analysis was by intention to treat. The trial ran for 5.5 years, and follow-up finished when patients reached an endpoint (amputation of trial leg above the ankle or death). Seven individuals were lost to follow-up after randomisation (three assigned angioplasty, two surgery); of these, three were lost (one angioplasty, two surgery) during the first year of follow-up. 195 (86%) of 228 patients assigned to bypass surgery and 216 (96%) of 224 to balloon angioplasty underwent an attempt at their allocated intervention at a median (IQR) of 6 (3-16) and 6 (2-20) days after randomisation, respectively. At the end of follow-up, 248 (55%) patients were alive without amputation (of trial leg), 38 (8%) alive with amputation, 36 (8%) dead after amputation, and 130 (29%) dead without amputation. After 6 months, the two strategies did not differ significantly in amputation-free survival (48 vs 60 patients; unadjusted hazard ratio 1.07, 95%CI 0.72-1.6; adjusted hazard ratio 0.73, 0.49-1.07). We saw no difference in health-related quality of life between the two strategies, but for the first year the hospital costs associated with a surgery-first strategy were about one third higher than those with an angioplasty-first strategy. This trial has shown that in patients presenting with severe limb ischaemia due to infra-inguinal disease and who are suitable for surgery and angioplasty, a bypass-surgery-first and aballoon-angioplasty-first strategy are associated with broadly similar outcomes in terms of amputation-free survival, and in the short-term, surgery is more expensive than angioplasty. This trial provides an evidence base for my strategy of referring diabetic pts with recalcitrant ulcers to radiology for an angiogram +/- angioplasty. This strategy is backed up with the vascular surgeon providing input at the monthly MDT meeting between the radiologists and themselves. Next aim is to get the foot clinics in synchronisation with the vascular clinics, thus speeding up the process of care and providing an educational resource for the MDT foot team.

Chris Salisbury et al. Evaluation of a general practitioner with special interest service for dermatology: randomised controlled trial BMJ 2005;331:1441
AND
Joanna Coast et al. Economic evaluation of a general practitioner with special interest led dermatology service in primary care BMJ 2005;331:1444
AND
Martin Roland. Commentary: general practitioners with special interest-not a cheap option. BMJ;331:1448.
I would highly recommend reading this series of articles and try to extrapolate to Diabetes. The comments which followed this series of articles in letters to the BMJ are also well worth reading (the majority were scathing and sent in by primary care!).

Rollnick S et al. Consultations about changing behaviour. BMJ 2005;331:961-963.
An excellent read, providing practical advice and the references can be used as a reading list for any one wishing to delve further.

Cam Donaldson and Danny Ruta. Should the NHS follow the American way? BMJ 2005;331:1328
AND
Chris Ham. Does the district general hospital have a future? BMJ 2005;331:1331
Regardless of what you think about it medicopolitics is firmly entrenched in most things a Consultant wishes to do. It is therefore essential to keep up to date with NHS reforms and their implications for ones practice. These 2 articles are a good read and provide background reading for trainees.

Keech A et al. Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (the FIELD study): randomised controlled trial. Lancet. 2005 Nov 26;366(9500):1849-61.
The randomised controlled fenofibrate Intervention and Event Lowering in diabetes (FIELD) study assessed the effect of fenofibrate on cardiovascular disease events in 9795 type 2 diabetic pts aged 50-75 years not taking statin therapy at study entry. After a placebo and a fenofibrate run-in phase, pts were randomly assigned (2131 with previous cardiovascular disease and 7664 without) with a total-cholesterol concentration of 3.0-6.5 mmol/L and a total-cholesterol/HDL-cholesterol ratio of 4.0 or more or plasma triglyceride of 1.0-5.0 mmol/L to micronised fenofibrate 200 mg daily (n=4895) or matching placebo (n=4900). The primary outcome was coronary events (coronary heart disease death or non-fatal MI); the outcome for prespecified subgroup analyses was total cardiovascular events (the composite of cardiovascular death, MI, stroke, and coronary and carotid revascularisation). Analysis was by intention to treat. Averaged over the 5 years' study duration, similar proportions in each group discontinued study medication (10% placebo vs 11% fenofibrate) and more patients allocated placebo (17%) than fenofibrate (8%; p<0.0001) commenced other lipid treatments, predominantly statins. 5.9% (n=288) of patients on placebo and 5.2% (n=256) of those on fenofibrate had a coronary event (relative reduction of 11%; hazard ratio [HR] 0.89, 95% CI 0.75-1.05; p=0.16). This finding corresponds to a significant 24% reduction in non-fatal myocardial infarction (0.76, 0.62-0.94; p=0.010) and a non-significant increase in coronary heart disease mortality (1.19, 0.90-1.57; p=0.22). Total cardiovascular disease events were significantly reduced from 13.9% to 12.5% (0.89, 0.80-0.99; p=0.035). This finding included a 21% reduction in coronary revascularisation (0.79, 0.68-0.93; p=0.003). Total mortality was 6.6% in the placebo group and 7.3% in the fenofibrate group (p=0.18). Fenofibrate was associated with less albuminuria progression (p=0.002), and less retinopathy needing laser treatment (5.2%vs 3.6%, p=0.0003). There was a slight increase in pancreatitis (0.5%vs 0.8%, p=0.031) and pulmonary embolism (0.7%vs 1.1%, p=0.022), but no other significant adverse effects. This study has shown that fenofibrate did not significantly reduce the risk of the primary outcome of coronary events. It did reduce total cardiovascular events, mainly due to fewer non-fatal myocardial infarctions and revascularisations. The authors argue that the higher rate of starting statin therapy in patients allocated placebo might have masked a moderately larger treatment benefit. Certainly the results are not as impressive as any of the mega statin trials, but at least there is now some available end point data even though it is not statistically as robust as the statin data. I can still envisage problems explaining to primary care colleagues that the total cholesterol of 7 is mainly due to the Triglycerides of 9 and that fenofibrates after controlling hyperglycaemia are the better option than statins. However, with the word on the grapevine that GMS (2) may include Triglycerides in QUOF payments this may improve the treatment of the commonest lipid defect of raised Trigs and low HDL in our Type 2 pts.

Dormandy JA et al. Secondary prevention of macrovascular events in patients with type 2 diabetes inthe PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial. Lancet. 2005 Oct 8;366(9493):1279-89.
This prospective, randomised controlled trial in 5238 patients with type 2 diabetes who had evidence of macrovascular disease, assigned patients to oral pioglitazone titrated from 15 mg to 45 mg (n=2605) or matching placebo (n=2633), to be taken in addition to their glucose-lowering drugs and other medications. The primary endpoint was the composite of all-cause mortality, non fatal MI (including silent myocardial infarction), stroke, acute coronary syndrome, endovascular or surgical intervention in the coronary or leg arteries, and amputation above the ankle. Analysis was by intention to treat. The average time of observation was 34.5 months. 514 of 2605 patients in the pioglitazone group and 572 of 2633 patients in the placebo group had at least one event in the primary composite endpoint (HR 0.90, 95% CI 0.80-1.02, p=0.095). The main secondary endpoint was the composite of all-cause mortality, non-fatal MI, and stroke. 301 patients in the pioglitazone group and 358 in the placebo group reached this endpoint (0.84, 0.72-0.98, p=0.027). Overall safety and tolerability was good with no change in the safety profile of pioglitazone identified. 6% (149 of 2065) and 4% (108 of 2633) of those in the pioglitazone and placebo groups, respectively, were admitted to hospital with heart failure (p<0.05); mortality rates from heart failure did not differ between groups. This trial has shown that pioglitazone reduces the composite of all-cause mortality,non-fatal MI, and stroke in patients with type 2 diabetes who have a high risk of macrovascular events. PROactive has led to a lot of debate, which is a good thing but in my mind there are still more questions than answers:
1. Can these results apply to other ethnic groups (97% pts were Caucasian)?
2. Would similar effects be observed if similar pts are treated with pioglitazone alone?
3. Is pioglitazone effective as primary prevention of CVD?
4. If blood pressure, lipids and glycaemic control were optimal would these effects of pioglitazone still be observed?
5. What effect does piopglitazone have on the natural history of postischaemic myocardial function?
6. Is there a differential effect on the different CVD risk factors of pioglitazone treatment?
7. Would comparable effects be observed on lower doses of pioglitazone?
8. Do the TZDs reduce CVD or non-CVD mortality per se?
9. Do other TZDs provide similar benefits and risks?
Personally, I believe it is all about good glycaemic control achived at an early stage whether using TZDs or not.

NEXT NEWSLETTER Due out beginning of June 2006, so keep the gossip coming.

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