The British Medical Journal has published an analysis of the growing pressure to prevent diabetes with medication. The BBC also reported this analysis.
The analysis pays particular attention to the DREAM Study, which has previously been discussed in detail. The conclusion made in this post was that, "based on current evidence the benefits of drug intervention do not outweigh the risks of treatment".
This analysis argues that using drugs to prevent diabetes will bring harms and additional costs while the benefits for patients remain questionable. It is further argued that lifestyle changes including weight loss, eating a healthy diet and taking regular exercise greatly reduce the risk of developing diabetes and are much safer.
Action: Clinicians should advise patients to make lifestyle changes to prevent diabetes. Clinical use of hypoglycaemic agents to prevent diabetes is not justified based on the current efficacy and safety data.
The National Institute of Health and Clinical Excellence has published new guidance for the month of April. There are updates to the existing Anxiety and Depression guidelines and a new guideline on the prevention of venous thromboembolism in inpatients undergoing surgery.
The Anxiety and Depression updates focus upon integrating the prescribing advice relating to venlafaxine issued by the Medicines and Healthcare products Regulatory Agency. Amended quick reference guidelines are available for both the anxiety and depression guidelines.
The Venous Thromboembolism (VTE) guideline details assessment of risk of VTE for inpatients undergoing surgery in order to guide treatment decisions for prevention of VTE. This may be of interest to primary care clinicians who are likely to be asked to prescribe or administer continued treatment following discharge.
Action: Clinicians who treat anxiety or depression will find the updates useful in integrating the latest safety advice regarding the use of venlafaxine. Clinicians in primary care who are involved in the provision of preventative treatments for venous thromboembolism will find the new guidelines a useful reference source.
PLoS Medicine has published an article detailing many of the tricks of the trade used by pharmaceutical company sales representatives. A former pharmaceutical sales representative and a physician who researches pharmaceutical marketing wrote the article.
The article cites the US$4.8 billion investment made by pharmaceutical companies in 2000 in direct promotional activity to prescribers from an overall budget of US$15.7 billion for promoting all prescription drugs. It also provides an insight into the training these individuals undergo and some of the data they are trained to collect and report back to their respective companies. All of this activity is aimed at changing prescribing habits to favour the promoted drug.
Of particular interest is the table (Part 1 and Part 2) that categorises different types of clinicians and the techniques used to overcome the barriers to changing prescribing habits.
Clinicians may find it interesting to categorise themselves using the table and see if the marketing activity they encounter is being tailored to them. Learning how promotional activity works will allow clinicians to recognise and counter these tactics.
In conclusion the article points out that while sales representatives appear friendly, charming and sympathetic all of this is carefully constructed to increase sales and market share for particular drugs. They recommend that clinicians find an unbiased source for information on drugs.
Action: Clinicians will have their own views on the benefits provided by sales representatives in terms of education, samples and service provision. It is important that all clinicians consider the potential for bias in any information provided during these encounters.
Sitagliptin (Januvia®), the first in a new class of hypoglycaemics has been launched. The Summary of Product Characteristics is available on the Electronic Medicine Compendium.
Sitagliptin is licensed for adjunctive use with metformin or a glitazone in patients with type 2 diabetes to improve glycaemic control. It is available as a 100mg tablet with dosing as a single daily administration. It is the first in a new class of agents called dipeptidyl peptidase 4 (DPP-4) inhibitors which enhance the levels of the incretin hormones naturally secreted after eating food. These hormones act physiologically to increase insulin secretion and decrease glucagon secretion.
As this is a new drug data are limited, however based on research experience:
- It is not recommended for use in anyone under 18 years old due to insufficient safety and efficacy data
- Care should be used in patients aged over 75 years old as only limited data are available. No dose adjustment is expected to be necessary
- No dose adjustment is required in mild renal insufficiency (creatinine clearance greater than 50ml/min). Sitagliptin should not be used in patients with moderate to severe renal insufficiency
- No dose adjustment is required for mild to moderate hepatic insufficiency. No data are available in severe hepatic insufficiency, use is not recommended
- No data are available in pregnancy or breast feeding, use is not recommended
In clinical studies in 2,700 patients of up to 2 years in duration the most commonly observed side effects included nausea, upper abdominal pain, diarrhoea, somnolence, anorexia, weight loss and hypoglycaemia.
As with all new drugs, initial use should be cautious. This drug is a useful addition to the currently available hypoglycaemics. It may be useful in patients already on metformin who are contraindicated to or suffer intolerable side effects from sulphonylureas or glitazones.
Action: Clinicians should be aware of this new class of drugs. An initially cautious approach to use would place them as last line agents when contraindications or side effects are limiting use of existing therapies.
The British Medical Journal has published a paper examining the long-term benefits of reducing intake of dietary sodium on cardiovascular outcomes.
The study is an observational follow-up of the two Trials of Hypertension Prevention (TOHP I and TOHP II). These studies included 744 and 2,382 patients respectively. Data were collected for 2,415 (77%) of the participants from the combined studies for a primary cardiovascular outcome of consisting of myocardial infarction, stroke, coronary revascularisation or cardiovascular death. The data were analysed to compare patients who had reduced their daily sodium intake (by 44 mmol/24 h in TOHP I and 33 mmol/24 h in TOHP II) to those who received usual care.
The risk of a cardiovascular event was 25% lower (p=0.04) over 10-15 years in the intervention arm after correcting for trial, clinic, age, race and sex. The difference increased to a 30% reduction in risk after additionally correcting for baseline sodium excretion and weight.
All observational studies have inherent limitations and usually the results should be viewed with some caution. However, a large randomised controlled trial investigation the efficacy of reduced sodium intake would be a logistical challenge and is probably not feasible.
Reducing sodium intake is already known to have benefits on blood pressure. A cautious assessment of these results would indicate that reducing sodium intake may be beneficial in preventing cardiovascular events and is unlikely to cause harm.
Action: When providing verbal and written dietary advice, clinicians should incorporate recommendations to reduce dietary sodium intake.