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On The Pulse   - November 2019

On The Pulse

Tertius Lydgate

Friday, 29 November 2019

‘New short-term treatment option for hand osteoarthritis flare-ups’
10 mg prednisolone for six weeks appears ‘efficacious and safe’

Hand osteoarthritis is a prevalent joint condition with a high burden of disease. Research, published in The Lancet, sought to address the unmet medical need for effective therapeutic options by investigating the efficacy and safety of short-term prednisolone. For this double-blind, randomised, placebo-controlled trial, eligible patients with symptomatic hand osteoarthritis and signs of inflammation in their distal and proximal interphalangeal joints were randomly assigned (1:1) to receive 10 mg prednisolone or placebo orally once daily for 6 weeks, followed by a 2-week tapering scheme, and a 6-week follow-up without study medication. 42 patients in each group completed the 14-week study. The mean change between baseline and week 6 on visual analogue scale-reported finger pain was −21·5 in the prednisolone group and −5·2 in the placebo group, with a mean between-group difference (of prednisolone vs placebo) of −16·5 (95% CI −26·1 to −6·9). The authors conclude the results of their study provide clinicians with a new short-term treatment option for patients with hand osteoarthritis who report a flare-up of their disease.

Tool may accurately predict end-stage renal disease in primary care
Adjusted Kidney Failure Risk Equation may reduce unnecessary referrals

The Kidney Failure Risk Equation (KFRE) has been developed in multinational chronic kidney disease (CKD) cohorts to predict end-stage renal disease (ESRD) events over 2- and 5-year time periods. Research in PLOS Medicine sought to externally validate the KFRE’s prediction of ESRD events in primary care, perform model recalibration if necessary, and assess its projected impact on referral rates to secondary care renal services. The study included 35,539 individuals (57.5% female, mean age 75.9 years, median CKD-EPI eGFR 51 ml/min/1.73 m2, median ACR 3.2 mg/mmol). Findings suggest KFRE has largely accurate performance for predicting ESRD, but requires adjustments for a primary care setting. Compared to current referral criteria, using hybrid criteria of a ≥5% risk of ESRD over 5 years from the recalibrated KFRE and/or a urine albumin-to-creatinine ratio of ≥70 mg/mmol would reduce the number of individuals eligible for referral without increasing the number who later develop ESRD and are not initially eligible for referral. The authors point that further validation studies in more diverse cohorts of the clinical impact projections and suggested referral criteria are required before the latter can be clinically implemented.

Testosterone replacement in cancer survivors
Linked with better body composition; no reported improvements in quality of life

Young male cancer survivors have lower testosterone levels than the healthy population and frequently close to or just below the lower limit of the reference range. Research in PLOS Medicine looked at the general health benefits testosterone replacement could have for these patients. For this 6-month trial, 136 male survivors of testicular cancer (88%), lymphoma (10%), and leukaemia, aged 25–50 years and with morning total serum testosterone 7–12 nmol/l were randomised 1:1 to receive testosterone (Tostran 2% gel) or placebo for 26 weeks. A dose titration was performed after 2 weeks. At 6 months, participants treated with testosterone had a decrease in their fat mass, on average, of 1.8 kg and an increase in lean mass of 1.5 kg; however, the quality-of-life questionnaires did not show any difference between those treated with placebo or testosterone. The authors suggest testosterone replacement be considered in these patients in the context of other interventions to improve body composition.

Gastric bypass found superior to sleeve gastrectomy for DMT2 remission
Both procedures had similar beneficial effect on β-cell function 1 year after surgery

Research in The Lancet Diabetes and Endocrinology sought compare the effects of the two most common bariatric procedures on remission of diabetes and β-cell function. For this triple-blind, randomised controlled trial, 109 patients (aged ≥18 years) with type 2 diabetes and obesity were randomly assigned (1:1) to receive gastric bypass or sleeve gastrectomy. 98% of patients completed 1-year follow-up, with one patient in each group withdrawing after surgery (per-protocol population). In the intention-to-treat population, diabetes remission rates were higher in the gastric bypass group than in the sleeve gastrectomy group (risk difference 27% [95% CI 10 to 44]; relative risk 1·57 [1·14 to 2·16]); results were similar in the per-protocol population. Both procedures had a similar beneficial effect on β-cell function. The authors conclude the use of gastric bypass as the preferred bariatric procedure for patients with obesity and type 2 diabetes could improve diabetes care and reduce related societal costs.

Apremilast for oral ulcers in Behçet’s syndrome
Fewer oral ulcers than with placebo, but associated with adverse events

Apremilast is a small-molecule phosphodiesterase 4 inhibitor that modulates cytokines that are up-regulated in Behçet’s syndrome. For their phase III trial, researchers, writing in the NEJM, randomly assigned 207 patients (1:1) who had Behçet’s syndrome with active oral ulcers but no major organ involvement to receive either apremilast at a dose of 30 mg or placebo, administered orally, twice daily for 12 weeks, followed by a 52-week extension phase. Patients receiving apremilast compared to placebo had a greater reduction in their number of oral ulcers (least-squares mean difference, −92.6; 95% CI −130.6 to −54.6). The change from baseline in the Behçet’s Disease Quality of Life score was also better in the apremilast group: −4.3 points as compared with −1.2 points in the placebo group (higher scores indicating greater impairment in quality of life). The authors note however that adverse events with apremilast included diarrhoea, nausea, and headache.

Intranasal corticosteroids for non‐allergic rhinitis
Are they effective?

Non‐allergic rhinitis is common, with an estimated prevalence of around 10% to 20% and several subgroups of can be distinguished, depending on the trigger responsible for symptoms. People with non‐allergic rhinitis often lack an effective treatment as a result of poor understanding and lack of recognition of the underlying disease mechanism. Intranasal corticosteroids are one of the most common types of medication prescribed in patients with rhinitis or rhinosinusitis symptoms, including those with non‐allergic rhinitis. A Cochrane Systematic Review of 34 studies (4,452 participants) concludes that it is unclear whether intranasal corticosteroids reduce patient‐reported disease severity in non‐allergic rhinitis patients compared with placebo when measured at up to three months. Overall, the certainty of the evidence for most outcomes in the review was low or very low. However, the authors note intranasal corticosteroids probably have a higher risk of the adverse effect epistaxis. Further research is therefore warranted.

Bempedoic acid may help lower LDL-C levels in some patients 
Reduction seen over 12 weeks in patients with high-risk CVD and on statins

For patients who do not achieve sufficient reduction in low-density lipoprotein cholesterol (LDL-C) level with maximally-tolerated statin therapy, there is a need for novel lipid-lowering therapies that can be used in conjunction with existing treatment options. Researchers writing in JAMA investigated the benefits of bempedoic acid, an oral, once-daily, first-in-class drug being developed for the treatment of hyperlipidemia. For this Phase III trial, 779 eligible patients were randomised 2:1 to treatment with bempedoic acid (180 mg) (n = 522) or placebo (n = 257) once daily for 52 weeks. Results showed that the addition to stable background lipid-lowering therapy of bempedoic acid compared with placebo resulted in mean LDL-C levels of 97.6 mg/dL vs 122.8 mg/dL at 12 weeks, a difference that was statistically significant. The authors note however a study limitation being that, although adherence to study drug was monitored, adherence to background therapy was not. They also call for further research to assess durability and clinical effect as well as long-term safety. Separate ongoing research should also provide greater clarity regarding event risk reduction.

New surgical treatments for BPH: how are they performing?
Eight new methods appeared superior in safety compared with monopolar TURP

Since the 1970s, monopolar transurethral resection of the prostate (TURP) has been the preferred surgical method for the treatment of benign prostatic hyperplasia (BPH). However, it is a risky procedure. A systematic review and network meta-analysis, in The BMJ, sought to assess the efficacy and safety of new endoscopic surgical treatments. Results from 109 trials with a total of 13,676 participants were identified. Nine surgical treatments were evaluated. Among other finding, the research shows that enucleation achieved better maximal flow rate and international prostate symptoms score values than resection and vapourisation methods at six and 12 months after surgical treatment, and the difference maintained up to 24 and 36 months after surgical treatment. The best three methods, versus monopolar TURP, were diode laser enucleation, bipolar enucleation, and holmium laser enucleation. The worst performing method was diode laser vapourisation. Some methods were better at controlling bleeding than monopolar TURP. The authors conclude eight new endoscopic surgical methods for BPH therefore appeared to be superior in safety compared with monopolar TURP.

Author's Image

Tertius Lydgate

Originally from Northumberland, Tertius Lydgate studied medicine in Edinburgh, London and Paris. There he developed a special interest in communicable diseases and hoped to make great advances in treating and preventing them. But, after a promising start in a provincial centre of excellence in middle England, he was forced by circumstances (please, don't inquire) to abandon his high ideals. He now scrapes a living by pouring cold water on the over-enthusiastic at his private cryohydrotherapy clinic. Dreaming of the contributions he once hoped to make himself, he finds consolation in the latest medical journals and is happy to share his discoveries with his readers. He thinks that his creator, George Eliot, would have approved.
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