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CHOL003 and CHOL004 Explained: The New QOF Cholesterol Indicators for 2024/25 and 2025/26

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CHOL001 and CHOL002 are no longer in the Quality and Outcomes Framework. From April 2024 they were replaced by CHOL003 and CHOL004, and for 2025/26 these two indicators became some of the highest-point earners in the entire QOF. Between them they now carry 82 points, more than any other clinical area in the framework.

This post is a clean reference for UK general practice teams: what the indicators measure, the new LDL and non-HDL thresholds, points and payment thresholds, exception reporting rules, and the small but important changes that landed for 2025/26.

(If you previously read our 2023/24 cholesterol indicators post on CHOL001 and CHOL002, this post replaces it for current practice.)

Quick summary

Indicator What it measures 2024/25 points 2025/26 points Thresholds 2025/26
CHOL003 Statin (or alternative) prescribing in CVD/CKD 14 38 70%-95%
CHOL004 LDL ≤2.0 mmol/L (or non-HDL ≤2.6 mmol/L) in established CVD 16 44 20%-50%

The headline change is the points uplift. CHOL004 alone is worth 44 points in 2025/26, up from 16. That makes cholesterol target achievement the single most valuable clinical indicator in QOF.

What changed when CHOL001 became CHOL003

The wording of the statin-prescribing indicator was kept almost identical when CHOL001 was renumbered to CHOL003 for 2024/25. The register population is the same: patients on the CHD, PAD, Stroke/TIA or CKD registers. Patients with diabetes on these registers are still excluded (they sit under DM034/DM035 instead).

The substantive 2025/26 change is small but worth knowing:

  • Icosapent ethyl was removed from the list of acceptable alternative lipid-lowering therapies. Bempedoic acid, ezetimibe, inclisiran and PCSK9 inhibitors remain valid alternatives where a statin is declined or unsuitable, but only where there is a documented adverse reaction to a statin.

Everything else in CHOL003 carries over from CHOL001:

  • Patients on the palliative care register are excepted.
  • Codes for maximum tolerated lipid-lowering therapy, adverse reaction, not indicated/contraindicated or declined trigger personalised care adjustments (PCA).
  • Patients registered in the last three months of the QOF year are excepted.
  • Two invites at least seven days apart can also trigger an exception.

What changed when CHOL002 became CHOL004, and why it matters more

CHOL004 is the indicator that needs careful attention because the rules have meaningfully shifted.

1. LDL is now the primary measurement

In 2023/24, CHOL002 looked for non-HDL first, and only if that wasn’t recorded would it check LDL. From 2024/25, CHOL004 reverses this: LDL is the primary test, and non-HDL is only checked if no LDL reading exists. For 2025/26 the wording clarifies that if multiple readings exist on the latest date, LDL takes priority.

This is the change most likely to catch practices out. If your local lab still reports non-HDL as a default and your templates don’t prompt for LDL, you may have patients with non-HDL at target who fall outside the indicator because LDL was never requested.

2. The thresholds have been raised

Measurement 2023/24 (CHOL002) 2024/25 onwards (CHOL004)
LDL cholesterol <1.8 mmol/L (exclusive) ≤2.0 mmol/L (inclusive)
Non-HDL cholesterol <2.5 mmol/L (exclusive) ≤2.6 mmol/L (inclusive)

The shift from exclusive to inclusive matters: a patient on exactly 2.0 mmol/L LDL now passes. This is a slightly easier indicator to achieve in clinical practice, although the upper payment threshold also rose for 2025/26.

3. Payment thresholds have moved

CHOL004 in 2024/25 had a lower threshold of 20% and an upper threshold of 35%. For 2025/26 the upper threshold has been raised to 50%, with 20% still the lower bound. Coupled with the rise from 16 to 44 points, this is where the real income shift is.

4. Exception reporting expanded

For 2024/25 onwards, exception reports that previously only applied to CHOL003 (statin prescribing) now also apply to CHOL004 (cholesterol target). This was a significant relaxation. Practices can now exception-report CHOL004 patients for:

  • Declining a cholesterol blood test (with the correct code).
  • Invites: two invites at least seven days apart, with the most recent invite after the latest cholesterol blood test. This is in line with HYP008 and DM020.
  • Patients with a haemorrhagic stroke, who are now automatically excluded from both cholesterol indicators.
  • Patients on maximum tolerated lipid-lowering therapy.
  • Adverse reaction codes, not-indicated codes, and informed dissent.
  • Registration in the last three months of the QOF year.

The combination of higher thresholds plus broader exception reporting is intended to make CHOL004 genuinely achievable rather than aspirational.

Register populations: who counts for which indicator

This is the part that still trips practices up.

CHOL003 register (statin prescribing):

  • CHD
  • PAD
  • Stroke/TIA
  • CKD (stage 3-5)
  • Excludes patients aged 17+ with diabetes (covered by DM034/DM035)

CHOL004 register (cholesterol target):

  • CHD
  • PAD
  • Stroke/TIA
  • Excludes CKD
  • Includes patients with diabetes or on the palliative care register if they are also on the CHD, PAD or Stroke/TIA register

So a patient with CKD alone is in scope for CHOL003 but not CHOL004. A patient with diabetes and CHD is excluded from CHOL003 but included in CHOL004. The populations overlap but they are not the same set.

Practical workflow for hitting the new thresholds

The CHOL004 uplift to 44 points changes the maths for the whole practice year. A few priorities:

1. Audit your lab requesting. If your CVD review templates default to a non-HDL request, switch them to request LDL where the lab supports it. The indicator now looks at LDL first.

2. Identify patients above target early. Run a search on CHD/PAD/Stroke registers for any patient with LDL >2.0 mmol/L (or non-HDL >2.6 mmol/L where LDL isn’t recorded) in the last 12 months. Treatment titration, recheck, and re-review takes time, start in Q1, not Q4.

3. CKD register is the soft spot for CHOL003. CHD, PAD and stroke patients are usually statinised. CKD patients are statinised less reliably. Target this subgroup at the start of the year.

4. Use the new invite-based exception rule for CHOL004. Two invites at least seven days apart, with the second invite after the most recent cholesterol test, will exception a non-responder. This is the route to recover patients who simply will not attend.

5. Make sure haemorrhagic stroke is correctly coded. These patients are now removed automatically from both indicators, but only if the haemorrhagic-stroke code is on the record.

6. Code the alternatives correctly. Bempedoic acid, ezetimibe, inclisiran and PCSK9 inhibitors only count for CHOL003 if there is also a documented adverse reaction to a statin. Icosapent ethyl no longer counts at all from 2025/26.

Bottom line

CHOL003 and CHOL004 are not a small renaming exercise. The thresholds are easier to hit, the exception reporting is broader, and the points have roughly tripled. For most practices, CHOL004 is now the single largest available clinical indicator in QOF, and the practices that organise their lab requesting and recall systems around LDL ≤2.0 mmol/L will do significantly better than those that don’t.

If your CVD review templates, search reports, and invite letters were built around the old CHOL001/CHOL002 rules, they need updating before the end of the QOF year.

Sources

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Reducing Low-Value Care in Primary Care: What a BMJ Medicine Review Shows

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Low-value care is one of the quiet drains on primary care: it can expose patients to unnecessary treatment, add avoidable workload, and consume resources that could be used for higher-value clinical work. A BMJ Medicine systematic review and meta-analysis brings useful evidence to a practical question for general practice: what actually helps reduce low-value tests and treatments?

The review, titled Effectiveness of different de-implementation strategies in primary care, analysed 140 randomised trials of interventions designed to reduce care that offers little or no benefit to patients. The trials covered common primary care targets including antibiotic prescribing, other drug treatments, imaging, and laboratory testing.

Key takeaway

The clearest signal was not that one simple educational message solves the problem. The review found moderate-certainty evidence that provider education combined with audit and feedback reduced targeted low-value care. Other strategies, including provider education alone, audit and feedback alone, patient education, decision support, and combinations of these approaches, may also reduce low-value care, but the certainty of evidence was generally lower.

In practical terms, this points towards a familiar lesson in quality improvement: changing clinical behaviour usually needs more than information. Clinicians need clear standards, usable data, feedback loops, and support for conversations with patients.

Why low-value care matters in general practice

Low-value care is not just a policy phrase. In day-to-day primary care, it can mean antibiotics for likely viral infections, repeat investigations that do not change management, imaging where harms outweigh benefits, or prescribing patterns that continue because stopping is harder than starting.

For patients, low-value care can create false reassurance, incidental findings, adverse effects, and anxiety. For practices, it can mean extra appointments, follow-up results, prescribing reviews, and administrative work. For the wider NHS, it diverts capacity from care that is more likely to improve outcomes.

What the BMJ Medicine review found

The authors screened more than 13,000 abstracts and included 140 randomised trials. Median follow-up was 287 days. More than half of the trials aimed to reduce antibiotic use, while others focused on drug treatments, imaging, and laboratory testing.

Across the evidence base, de-implementation strategies reduced targeted low-value care by roughly 10-35% in relative terms. Multi-strategy approaches appeared more promising, particularly where patient education was combined with clinician-focused education and feedback. The review also noted that provider education plus audit and feedback had moderate-certainty evidence, making it one of the more defensible choices for service improvement.

What this means for clinicians

For GPs, appraisers, and practice leaders, the review supports a pragmatic approach: choose a specific low-value activity, measure it, give clinicians feedback, and pair that with concise education that explains both the evidence and the intended alternative.

The patient side matters too. Many low-value interventions persist because they are easier to offer than to explain. Patient-facing information, shared decision making, and consistent practice messaging can help reduce the pressure to prescribe, refer, scan, or test when the likely benefit is small.

Questions for appraisal and revalidation

This paper also offers useful material for reflective practice. Clinicians could use it to consider:

  • Which low-value interventions are most common in my clinical setting?
  • Do I have feedback data that shows my own prescribing, testing, or referral patterns?
  • Where could patient information make it easier to avoid unnecessary care?
  • What would be a realistic quality improvement project for my practice or PCN?

Bottom line

The BMJ Medicine review suggests that reducing low-value care in primary care is possible, but it needs structured de-implementation rather than vague encouragement. The strongest practical message is to combine clinician education with audit and feedback, then support patients with clear explanations about why more care is not always better care.

Source: BMJ Medicine: Effectiveness of different de-implementation strategies in primary care. DOI: 10.1136/bmjmed-2025-001343

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Inequalities in HRT Prescribing in UK Primary Care: What a BMJ Medicine Study Means for Menopause Care

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A BMJ Medicine cohort study of nearly 2 million women aged 40–60 in UK primary care suggests that hormone replacement therapy (HRT) prescribing varies by ethnicity, deprivation, and region. Published in September 2025 and drawing on a decade of electronic health records from the QResearch database, the study found that only about 19% of women in this age group received two or more HRT prescriptions; and that uptake differed markedly across population groups. The finding matters because it points to a familiar problem in general practice and women’s health: access to menopause care is not always experienced equally. For clinicians, commissioners, and practice teams, this is useful appraisal material. It shifts the conversation away from whether HRT matters and toward a harder question: who is able to access evidence-based menopause care consistently, and who is not?

Key Takeaway

Across a cohort of 1.98 million women, fewer than one in five received sustained HRT prescriptions over a 10-year period. Patterns of prescribing were not evenly distributed: differences linked to ethnicity, deprivation, and geographical region raise concern that menopause care may still be shaped by structural inequality as much as by clinical need; even eight years after NICE menopause guidance was published in 2015.

Why This Matters for UK General Practice

  • Menopause care is now a major primary care workload area, with growing public awareness and patient expectation.
  • Variation in HRT prescribing may reflect barriers in access, consultation quality, continuity, clinician confidence, or service design.
  • If prescribing patterns differ systematically by deprivation or ethnicity, practices may need to look beyond individual consultations and examine population-level equity.

Questions for Reflection

  • Are menopause consultations equally accessible across different patient groups in primary care?
  • Could continuity, appointment access, or local prescribing culture be influencing who receives HRT?
  • What would an equity-focused review of menopause care look like in a GP practice or PCN?

Bottom Line

This BMJ Medicine paper is a reminder that good menopause care is not only about having effective treatments. It is also about making sure access to those treatments is fair, timely, and consistent across the population.

Source: Hirst JA, Mtika WM, Coupland C, Dixon S, Hippisley-Cox J, Hillman S. Inequalities in hormone replacement therapy prescribing in UK primary care: population based cohort study. BMJ Medicine 2025;4:e001349. DOI: 10.1136/bmjmed-2025-001349

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Relational Continuity in England: Why Seeing a Preferred GP Still Matters

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A study from BJGP Open suggests that relational continuity in English general practice is stronger for some groups, including older adults with polypharmacy and patients who are more likely to see a preferred GP. That matters because continuity is not just a sentimental ideal. It is closely tied to trust, context, and safer long-term care. In an NHS under pressure, access often dominates the conversation. But this paper is a useful reminder that speed of access and continuity of care are not interchangeable. For many patients, especially those with more complex needs, seeing a familiar clinician may still carry real value.

Key Takeaway

The study suggests that relational continuity in England is unevenly distributed and appears stronger where patients repeatedly see a preferred GP. Older adults with polypharmacy may be more likely to experience that continuity, which raises important questions about who benefits from it and who misses out.

Why This Matters for General Practice

  • Relational continuity can improve clinical context, reduce repetition, and support better shared decision making.
  • Patients with multimorbidity or complex prescribing may particularly benefit from a clinician who knows their history.
  • Current access models can unintentionally erode continuity if practices optimise only for speed or volume.

Questions for Reflection

  • Are current booking systems helping patients see their preferred GP when it matters most?
  • Which patient groups in a practice are most likely to lose continuity under high-demand access models?
  • How should practices balance rapid access with relationship-based care for patients with complex needs?

Bottom Line

This BJGP Open paper is a timely reminder that relational continuity still matters in English general practice. If access reform sidelines continuity, the patients with the greatest need for joined-up care may be the ones who lose most. Source: BJGP Open – view the original article.

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Colchicine: 3,000 Years of Poison, Panacea and Policy Lessons

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When Benjamin Franklin asked his contacts in France to send over a mysterious elixir for his gout in the 1760s, he probably did not realise he was ordering a medicine that had already been known, mainly as a poison, for more than a millennium. The concoction, sold as Eau Medicinale by French officer Nicolas Husson, crossed the Atlantic as a fashionable gout cure. What Franklin could not have foreseen is that the same substance would one day appear in the New England Journal of Medicine as a tool for preventing myocardial infarction.

The active ingredient in Husson’s remedy was colchicine, derived from the autumn crocus (Colchicum autumnale). Few medicines in routine UK practice can claim a lineage stretching from ancient Greek botanists to modern cardiology guidelines, but colchicine is one of them.

From ‘One-Day Killer’ to Medical Curiosity

The earliest descriptions of colchicum-like plants sit deep in classical literature. Theophrastus, writing in the 4th century BC, described a deadly plant known as ephemeron, literally “the one-day killer” (Theophrastus, Historia Plantarum). By the 1st century AD, Dioscorides had formalised the name kolchikon after the Black Sea region of Colchis (Dioscorides, De Materia Medica). His warnings were unambiguous: used unwisely, colchicum “kills by choking”.

For more than 1,500 years, Western physicians largely followed this advice. Medieval herbals listed colchicum among plants to be admired but not consumed. Renaissance herbalist John Gerard summed it up neatly when he wrote that its roots were “very hurtfull to the stomacke” (Gerard, Herball, 1597).

The 18th Century Breakthrough: Eau Medicinale

Colchicum’s reputation shifted dramatically in the late 1700s when Nicolas Husson marketed Eau Medicinale as a secret gout remedy. It sold at a premium, 22 shillings per tiny bottle, and was widely imitated but poorly understood. European physicians debated its contents, suggesting everything from digitalis to white hellebore.

In 1814, Londoner John Want solved the mystery. Using a mix of literature review, analysis, and possibly a little espionage, Want identified colchicum as the active ingredient. His findings reshaped gout management across Europe almost immediately.

A plant long classified as a poison had become one of medicine’s most reliable abortive treatments for gout flares.

Why Colchicine Works, and Why It Sometimes Does Not

Colchicine binds to tubulin, preventing microtubule formation. This slows or halts cellular processes that depend on structural scaffolding. For neutrophils, this means impaired migration, reduced endothelial adhesion, and blunted inflammatory signalling. Clinically, this results in anti-inflammatory activity at low doses.

Neutrophils conveniently accumulate colchicine because they express low levels of P-glycoprotein. Other tissues pump it out more effectively, which partly explains why the drug can reduce inflammation without universally causing harm.

However, the mechanism also explains the gastrointestinal side effects familiar to clinicians. Blocking microtubules disrupts cell division in rapidly renewing tissues, particularly the gut and bone marrow. Hence, diarrhoea remains as ancient a side effect as the drug itself.

Modern Evidence: From FMF to MI Prevention

Familial Mediterranean Fever

Colchicine’s modern renaissance began in the 1970s when researchers discovered that daily colchicine prevents the attacks of Familial Mediterranean Fever and reduces the risk of secondary amyloidosis (Ozen et al., N Engl J Med, 2016). This marked the transition of colchicine from simple gout treatment to targeted anti-inflammatory therapy.

Acute Gout

Surprisingly, despite centuries of use, high-quality evidence arrived only recently. The AGREE trial (Terkeltaub et al., Arthritis Rheum, 2010) showed that a low-dose regimen (1.8 mg over one hour) was nearly as effective as traditional high-dose therapy while causing fewer adverse effects. This finding rapidly changed practice worldwide.

Pericarditis

Cardiology then embraced colchicine. The ICAP trial (NEJM, 2013) demonstrated that combining colchicine with standard therapy halved recurrence rates in acute pericarditis. This led to its incorporation into ESC guidelines and rapid uptake across Europe.

Coronary Disease

The LoDoCo2 (NEJM, 2020) and COLCOT (NEJM, 2019) trials further broadened interest. Daily low-dose colchicine (0.5 mg) reduced cardiovascular events, including myocardial infarction and stroke, by roughly 23 to 30 percent. These results positioned colchicine as a serious contender in long-term cardiovascular risk reduction.

A once-feared botanical toxin had become a frontline anti-inflammatory drug across multiple specialties.

Regulatory Plot Twist: When Safety Creates a Monopoly

For decades, colchicine in the United States existed in a regulatory grey zone. It was widely manufactured, rarely questioned, and astonishingly cheap.

The FDA’s 2006 Unapproved Drugs Initiative changed that. The programme encouraged companies to fund modern studies in exchange for temporary market exclusivity. URL Pharma undertook the necessary research, including pharmacokinetic studies and the AGREE trial, and gained approval for Colcrys in 2009.

Once approved, the FDA ordered all other unapproved colchicine products off the market. Overnight, a ten-cent pill became a five-dollar pill.

The backlash was swift. US senators accused URL Pharma of exploiting regulation to create a monopoly. Analysts estimated that if all gout patients required daily colchicine at the new price, annual costs could exceed 11 billion dollars.

Generics eventually returned after exclusivity expired, but prices have never returned to the pre-2009 level. The episode became a case study in how well-intended policy can distort markets.

In 2020, partly because of such cases, the programme was formally discontinued.

The Road Ahead

Colchicine’s journey mirrors the evolution of medicine itself. It has travelled from ancient herbal lore to modern pharmacology, from empirical remedies to targeted anti-inflammatory therapy. Its expanding role in cardiovascular medicine continues to attract attention, and further repurposing trials are underway.

Yet the Colcrys episode remains a lasting reminder that the scientific merit of a drug can be overshadowed by regulatory and economic forces. Poorly designed incentives can restrict patient access to medicines that humanity has relied on for centuries.

For UK doctors, colchicine’s story is more than an interesting historical footnote. It is a window into how policy, economics, and pharmacology intersect, and how even the most familiar medicines can have dramatic backstories.

Selected References

  • Theophrastus. Historia Plantarum, 4th century BC

  • Dioscorides. De Materia Medica, 1st century AD

  • Gerard J. The Herball, 1597

  • Terkeltaub R et al. AGREE Trial. Arthritis Rheum. 2010

  • Ozen S et al. FMF Review. N Engl J Med. 2016

  • Imazio M et al. ICAP Trial. N Engl J Med. 2013

  • Nidorf SM et al. LoDoCo2 Trial. N Engl J Med. 2020

  • Tardif J et al. COLCOT Trial. N Engl J Med. 2019

  • FDA Unapproved Drugs Initiative, US HHS, 2006 to 2020

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Gut Check: How Your Intestinal Bacteria Could Secretly Be Causing Heart Disease

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Heart disease remains the leading cause of death globally. Despite advancements in understanding risk factors like high cholesterol and blood pressure, a groundbreaking discovery from Spanish researchers at the National Center for Cardiovascular Research (CNIC) in Madrid has unveiled an unexpected villain: your gut bacteria.

Fifteen years ago, researchers set out to study thousands of Banco Santander employees, hoping to unlock the mysteries behind cardiovascular disease. The results, recently published in the prestigious scientific journal Nature, uncovered a startling link. Scientists found that certain gut bacteria produce a molecule called imidazole propionate (C₆H₈N₂O₂), which directly causes atherosclerosis—the dangerous buildup of fat and cholesterol in arteries that leads to heart attacks and strokes.

A Silent Threat: Widespread Hidden Disease

The comprehensive study involved detailed medical imaging (using CAT and PET scans) of apparently healthy volunteers aged between 40 and 55. Shockingly, 63% showed signs of early-stage atherosclerosis. The culprit behind these hidden dangers turned out to be imidazole propionate, a molecule released by certain gut microbes, including strains from Escherichia, Shigella, and Eubacterium.

This molecule, researchers found, doesn’t just correlate with heart disease—it actively triggers it. Imidazole propionate enters the bloodstream, stimulates inflammation in arteries, and initiates the formation of fatty plaques.

From Molecule to Disease: Confirming the Link

Lead scientist David Sancho explains, “Imidazole propionate induces atherosclerosis on its own. There’s a causal relationship.” Experiments in mice confirmed the findings: animals exposed to the molecule rapidly developed artery-clogging plaques. Crucially, these effects occurred even in mice without elevated cholesterol levels, highlighting a previously unknown inflammatory and autoimmune component of heart disease.

Moreover, approximately one in five human volunteers with active, dangerous forms of atherosclerosis showed elevated levels of imidazole propionate, strengthening the real-world relevance of these findings.

Prevention and New Treatment Possibilities

Thankfully, the discovery isn’t all bad news. Scientists also identified how imidazole propionate interacts with our cells, paving the way for potential treatments. By blocking the molecule’s receptor with an experimental drug, researchers completely prevented disease progression in mice—even on a high-cholesterol diet.

This promising development offers hope for preventing heart disease in humans by targeting gut bacteria directly. Dietary changes also appear beneficial: individuals consuming diets rich in vegetables, fruits, whole grains, fish, and low-fat dairy showed lower imidazole propionate levels.

Broader Implications: Beyond Cholesterol

Swedish biologist Fredrik Bäckhed previously linked high imidazole propionate levels with type 2 diabetes, reinforcing the broader health impact of gut microbes. Independent research from Ruhr University Bochum recently validated these cardiovascular findings, further underscoring their significance.

The research suggests that heart disease isn’t solely driven by traditional factors like cholesterol. Instead, our gut bacteria might silently orchestrate damage even in those who appear healthy.

Future Steps and Continued Research

While the current findings are groundbreaking, further research is essential to pinpoint specific bacterial strains responsible for producing imidazole propionate. Still, scientists are optimistic about the potential to revolutionize heart disease prevention, diagnosis, and treatment.

This groundbreaking study, made possible by thousands of volunteers and significant funding from institutions like the “la Caixa” Foundation and the European Research Council, marks a pivotal moment in cardiovascular medicine. Understanding and managing our gut microbiome could soon become as routine as checking cholesterol levels.

Your gut health might just hold the key to a healthier heart.

References

Sancho, D., Mastrangelo, A., Robles, I., Fuster, V., et al. (2025). Gut microbiota–derived imidazole propionate drives atherosclerosis. Nature. https://www.nature.com/articles/s41586-025-09263-w

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Recurrent UTIs : a non antibiotic path

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Breaking the Cycle of Recurrent UTIs: An Innovative Non-Antibiotic Approach

Recurrent urinary tract infections (rUTIs) are among the most common and frustrating clinical conditions faced by healthcare professionals. Not only do they impair patients’ quality of life, but they also significantly contribute to antibiotic resistance—a growing global health crisis. A recent groundbreaking study published in Probiotics and Antimicrobial Proteins offers promising evidence that a carefully designed non-antibiotic “bundle” treatment can effectively manage rUTIs, drastically reducing antibiotic use while improving patient outcomes.

Tackling the rUTI Challenge

Women suffering from rUTIs often find themselves in a relentless cycle of infections, symptoms, and antibiotics. The overuse of antibiotics is especially concerning due to the rising prevalence of multidrug-resistant organisms. Recognizing this, researchers from the ASFO Santa Maria degli Angeli Hospital in Pordenone, Italy, investigated a multimodal non-antibiotic strategy, targeting both infection prevention and overall patient wellness.

The Non-Antibiotic Bundle: A Holistic Intervention

The study enrolled 47 women experiencing recurrent UTIs, testing a comprehensive six-month intervention that combined:

  • Behavioral Changes: Enhanced hydration (minimum 2 liters daily), improved bowel management, and optimized intimate hygiene practices.
  • Phytotherapy: Regular consumption of cranberry extract and D-mannose, both known to inhibit bacterial adhesion to urothelial surfaces.
  • Probiotics: A combination of oral and vaginal probiotics containing strains such as Lactobacillus, Bifidobacterium, and Saccharomyces boulardii, aimed at restoring healthy vaginal and intestinal microbiota.

Remarkable Results: Reduced Antibiotic Use and Improved Quality of Life

After six months, the results were impressive:

  • 76% reduction in urinary tract infections compared to the previous six months.
  • Over 90% decrease in antibiotic exposure, significantly minimizing the risk of antimicrobial resistance.
  • Significant improvement in chronic symptoms like abdominal discomfort, urinary urgency, and suprapubic pain.
  • Enhanced quality of life reported by over 80% of participants.

Clinical Implications: A Paradigm Shift in UTI Management

The findings suggest that a holistic, multimodal strategy can profoundly change the standard approach to managing rUTIs. By focusing on patient education, lifestyle adjustments, and microbiota health rather than solely relying on antibiotics, clinicians have a powerful new tool to combat recurrent infections.

Moving Forward

Although this initial study had a modest sample size, the outcomes strongly support further large-scale trials. By reducing antibiotic dependence, healthcare providers can not only manage rUTIs more effectively but also contribute to global antibiotic stewardship efforts.

This study represents an important step toward a future where non-antibiotic solutions play a central role in infectious disease management. It’s time to shift our clinical focus towards strategies that not only address symptoms but also promote long-term health and resilience against infections.

Reference:
Venturini, S., Reffo, I., Avolio, M. et al. (2024). The Management of Recurrent Urinary Tract Infection: Non-Antibiotic Bundle Treatment. Probiotics & Antimicro. Prot., 16, 1857–1865. https://doi.org/10.1007/s12602-023-10141-y

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Mirtazapine for Insomnia in the Older Adult

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A Fresh Look at an Old Ally:


Mirtazapine for Insomnia in the Older Adult
(7.5mg superior than 15mg)

https://doi.org/10.1093/ageing/afaf050

1. Why This Conversation Won’t Go Away

Anyone running a geriatric clinic knows the nightly battle cry: “Doctor, I just can’t sleep.” Benzodiazepines and so-called “Z-drugs” remain common fixes, yet both families bring cognitive haze, falls, and dependency. For years clinicians have quietly pivoted to low-dose mirtazapine—an antidepressant whose antihistaminic and serotonergic blockade leaves most patients yawning within the hour. Until now, hard data were scarce. The MIRAGE trial, published 26 March 2025, finally puts numbers behind this off-label ritual.

2. Trial in One Breath

Design: single-centre, double-blind, randomized, placebo-controlled
Population: 60 community-dwelling adults ≥ 65 y with chronic insomnia (per ICSD-3)
Intervention: mirtazapine 7.5 mg nightly vs identical placebo for 28 days
Primary endpoint: change in Insomnia Severity Index (ISI) from baseline to day 28
Key safety endpoints: any adverse event (AE) and AEs causing discontinuation

3. Efficacy: More than a Sedative Fog

After four weeks, ISI scores fell by a mean 6.5 points in the mirtazapine arm versus 2.9 with placebo (p = 0.003). In practical terms, roughly half the treated patients slid from the “clinical insomnia” range into the “sub-threshold” zone. Subjective reports mirrored the index: wake-after-sleep-onset shortened, total sleep time lengthened, and sleep efficiency nudged upward.
Take-home: At 7.5 mg, mirtazapine delivers a clinically meaningful, moderate-to-large improvement—something cognitive behavioural therapy matches but few pills can boast in this age group.

4. Safety: The Price of a Quiet Night

No severe AEs surfaced, but tolerability was not trivial. Six of thirty mirtazapine recipients (20 %) quit early because of side-effects—primarily morning grogginess, dizziness, and next-day confusion—versus one in the placebo cohort. Nobody fell or fractured, yet the signal reminds us: histamine blockade plus age-related pharmacokinetics equals prolonged hangover.

5. Clinical Pearl—Dose Matters More Than You Think

Why 7.5 mg? At this level, α2-adrenergic auto-receptors are only partially blocked, while H1 and 5-HT2A/C antagonism dominates—key for sleep promotion. Climbing to 15 mg or 30 mg may paradoxically lift noradrenergic tone and lighten sedation, but also raises metabolic baggage (weight gain, lipids). For insomnia, start low, stay low.

6. Where Does MIRAGE Fit into the Landscape?

Factor Mirtazapine 7.5 mg Z-Drugs Low-dose Doxepin
Evidence in ≥ 65 y Now RCT-supported Sparse, mostly extrapolated One pivotal RCT
Cognitive impact Mild, transient Moderate Minimal
Fall risk Possible (orthostasis) Documented Minimal
Typical half-life 20–40 h 1–7 h 15 h
Insurance coverage (UK)* Generic Generic Branded (high-cost)

*Formulary differences apply; check local guidance.

7. Limitations Worth a Minute of Skepticism

  • Single centre – practice patterns and patient profiles may differ outside an academic geriatric clinic.
  • Short intervention – 28 days answers “can it work?”, not “does it keep working?”.
  • Subjective sleep metrics – polysomnography was not employed; misperception of sleep may inflate gains.
  • Modest N – the confidence interval, though statistically tight, still leaves room for over- or under-estimation.

8. Putting It into Practice—A Mini Algorithm

  1. First-line remains CBT-I. Refer whenever feasible.
  2. Rule out mimics. Pain, nocturia, REM behaviour disorder, OSA.
  3. If pharmacotherapy is unavoidable:
    • Start mirtazapine 7.5 mg HS.
    • Reassess after two weeks (ISI ≥ 6-point drop is a “response”).
    • At four weeks, taper off if ineffective; continue up to three months if benefit outweighs sedation.
  4. Monitor weight, orthostatic BP, and cognition at each visit.
  5. Document taper plan to minimise long-term, off-label drift.

9. Future Directions—Beyond the Mirage

  • Long-range outcomes: Does the ISI advantage persist at six or twelve months?
  • Objective sleep metrics: Actigraphy or at-home EEG could clarify true sleep architecture effects.
  • Frailty-stratified safety: Are discontinuation rates higher in prefrail or sarcopenic elders?
  • Comparative head-to-head: How does mirtazapine fare against low-dose doxepin or lemborexant in this cohort?

10. Bottom Line for the 17:00 Ward Round

For older adults wrestling with chronic insomnia, low-dose mirtazapine now carries randomized evidence of benefit, shaving roughly 6–7 ISI points over four weeks. Yet one in five may abandon therapy owing to next-day somnolence or dizziness. Use it prudently, monitor closely, and remember: sedative is not synonymous with benign.

ClinicalTrials.gov Identifier NCT05247697 — Published 26 March 2025.

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Anastrozole and Breast Cancer Prevention

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Anastrozole’s repurposing as a preventive treatment marks a significant advancement in breast cancer care. This post examines Anastrozole’s action, effectiveness, side effects, dosage, UK cost, and eligibility criteria.

Mechanism of Action Anastrozole is an aromatase inhibitor. It works by blocking aromatase, reducing estrogen production. Since some breast cancers are estrogen-dependent, lowering estrogen levels can prevent these cancer cells from growing.

Efficacy Research shows that Anastrozole cuts the risk of developing breast cancer by 50% in high-risk postmenopausal women when taken daily for five years. This significant reduction underscores its role as a primary preventive measure.

Side Effects Side effects are a consideration with Anastrozole use. While it can cause symptoms like joint pain and hot flushes, these are typically manageable. The potential benefit of reducing breast cancer risk is a compelling reason for its use despite these side effects.

Dosage The recommended dose of Anastrozole for breast cancer prevention is one 1 mg tablet daily. It can be taken with or without food, offering flexibility for incorporation into daily life.

Cost in the UK The cost is low due to its off-patent status. A five-year course is about £78, a small price for the potential health benefits and the cost savings to the healthcare system by preventing cancer.

Eligibility The treatment is aimed at postmenopausal women who are at a moderate to high risk of breast cancer, which includes those with a family history of the disease. The goal is to offer protection to those most likely to benefit from the drug.

Conclusion Anastrozole offers a cost-effective, preventive option for breast cancer in a targeted group of women. Its introduction is a proactive step in cancer prevention, promising to reduce the incidence and the associated healthcare costs.

References

  • Data on Anastrozole’s efficacy and cost-effectiveness are available from NHS England and Cancer Research UK.
  • Information on dosage and side effects can be found in medical guidelines provided by the National Institute for Health and Care Excellence (NICE).

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QOF 2023/24 and New Cholesterol Indicators

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Cholesterol constitutes a component within the clinical domains section of the Quality and Outcomes Framework (QOF).

There exist two QOF indicators concerning Cholesterol:

  1. CHOL001 – This indicator encompasses patients listed in the QOF registers for Coronary Heart Disease (CHD), Peripheral Arterial Disease (PAD), Stroke/Transient Ischemic Attack (TIA), or Chronic Kidney Disease (CKD). It pertains to individuals who, during the last six months of the fiscal year, receive a prescription for a statin. Alternatively, if a statin is declined or deemed clinically unsuitable, another form of lipid-lowering therapy is prescribed. Patients aged 17 years or older, who are on any of these registers and concurrently diagnosed with diabetes, are excluded from this particular indicator.Personalized care adjustments (PCA) come into effect when patients meet certain criteria and have been properly coded with any of the following situations:
    • The patient possesses a palliative care code on their medical record dated on or after April 1, 2008.
    • They decline or are clinically unsuitable for both statin treatment and all available alternative lipid-lowering therapies within the current fiscal year.
    • The patient’s medical record indicates they are on the maximum tolerated cholesterol-lowering treatment within this fiscal year.
    • The patient’s medical record indicates an adverse reaction to lipid-lowering therapy or a code indicating that lipid-lowering therapy is not indicated, contraindicated, or declined within this fiscal year.
    • Patients newly registered at the medical practice within the final three months of the fiscal year.
  2. CHOL002 – This indicator encompasses patients listed in the QOF registers for Coronary Heart Disease (CHD), Peripheral Arterial Disease (PAD), or Stroke/Transient Ischemic Attack (TIA). It applies to patients who have a recorded value of non-HDL cholesterol lower than 2.5 mmol/L within this fiscal year. Alternatively, if non-HDL cholesterol is not recorded, the indicator applies to patients with a recorded value of LDL cholesterol lower than 1.8 mmol/L within this fiscal year.Personalised Care Adjustments applies in situations where the patient either declines a cholesterol blood test within this fiscal year or has registered within the last nine months of the fiscal year.Personalised Care Adjustments refers to specific circumstances or criteria under which adjustments or exceptions are made to the requirements or conditions of the QOF indicators related to cholesterol management. These personalized care adjustments take into consideration various factors that might impact a patient’s eligibility or treatment plan, allowing for a more tailored approach to their care. The purpose of PCA is to ensure that patients’ individual needs and situations are considered when assessing their compliance with the QOF indicators and when determining the appropriate treatment or interventions for them.

CHOL001 – This indicator assesses the percentage of patients registered in the QOF for conditions like Coronary Heart Disease (CHD), Peripheral Arterial Disease (PAD), Stroke/Transient Ischemic Attack (TIA), or Chronic Kidney Disease (CKD) who are currently prescribed a statin. In cases where a statin is declined or not clinically suitable, another lipid-lowering therapy is considered. The achievement of this indicator carries a total of 14 points, with the requirement that 95% of patients on the CHD, PAD, stroke, and CKD registers receive statin treatment. This indicator amalgamates what used to be separate assessments within each of these domains into one comprehensive measure.

However, patients aged 17 and above with diabetes have a distinct indicator for statin prescription and are excluded from this new combined indicator, even if they have concurrent CHD, PAD, or stroke conditions.

Exceptions to this indicator include patients on the palliative care register. Given the substantial overlap between cardiovascular disease and diabetes, the number of excluded patients might be considerable.

Personalised care adjustments (PCA) may apply to patients who have declined a statin treatment. Regarding adverse reactions, the majority of patients will be prescribed a statin. Additionally, patients receiving bempedoic acid, ezetimibe, icosapent ethyl, inclisiran, or a PCSK9 inhibitor will be included in the indicator only if they have a documented adverse reaction to a statin. Notably, recording an adverse reaction or allergy to a statin will not exempt a patient from the indicator. Exceptions may also be granted if patients have codes indicating informed dissent or an adverse reaction to lipid-lowering therapy in general.

The standard prescription timelines apply, necessitating issuance in the latter half of the QOF year. Prescriptions spanning six months or more may not be captured by this indicator.

While patients with cardiovascular disease typically receive statin prescriptions, the number of chronic kidney disease patients prescribed statins might be lower. It could be advantageous to focus efforts on this subgroup at the beginning of the year.

For patients intolerant to statins, there is now greater emphasis on alternative medications. Patients who were previously exception reported might benefit from assessing the suitability of alternative cholesterol-lowering medications.

CHOL002 – This indicator gauges the percentage of patients registered in the QOF for conditions like Coronary Heart Disease (CHD), Peripheral Arterial Disease (PAD), or Stroke/Transient Ischemic Attack (TIA) who have a recorded non-HDL cholesterol level below 2.5 mmol/L within the preceding 12 months. Alternatively, if non-HDL cholesterol is not recorded, the indicator applies to patients with a recorded LDL cholesterol level below 1.8 mmol/L within the same timeframe.

There are distinct differences in this indicator. First, it excludes patients with chronic kidney disease. Second, it includes patients with diabetes or on the palliative care register, provided they are also on the CHD, PAD, or stroke registers. Consequently, the patient population assessed by this indicator significantly differs from CHOL001.

Presently, there are limited exception reports available for this indicator. Patients are excepted only if they decline a cholesterol test or register with the practice after July in the QOF year, with a specific code indicating a declined test triggering this exception.

As of the current business rules for the 2023/2024 period, there are no exception reports for treatment allergies, informed dissent, or being on the maximum tolerated treatment dose.

The indicator’s criteria remain consistent, with non-HDL cholesterol being required to be below 2.5 mmol/L. If non-HDL data isn’t available, LDL cholesterol should be less than 1.8 mmol/L. Non-HDL takes precedence over LDL measurements, even if subsequent LDL data is available. This prioritization is particularly significant in cases of changes in local lab reporting or patient movement between practices.

This indicator carries a total of 16 points, with low thresholds for achievement, starting at 20% and reaching the full 16 points for 35% attainment.

Given that this indicator uses codes not previously featured in the QOF, it’s crucial to ensure their recognition. These codes can be derived from lab tests, point-of-care patient tests, or transcribed from hospital letters. Maintaining up-to-date templates for manual entry is essential.

Identifying patients with elevated values, adjusting medication, and retesting demands time. Initiating this process early on enhances the likelihood of achieving high scores in this indicator. The cholesterol indicators together offer a total of 30 points.

 

 

 

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