Under the NICE guidance for the primary and secondary prevention of osteoporotic fragility fractures in postmenopausal women (TA 160 and 161)1,2 healthcare professionals are being presented with questions such as, should I take a patient centred or formulary led approach in managing my patients? Should I switch patients to generic alendronate, and if so do I undertake a blanket or targeted switching strategy?
It is important that clinical judgement is applied and used to build patient centred approaches to managing osteoporosis patients. Clinical experts and a PCT representative present their views at Procter & Gamble's sponsored satellite symposium - A Practical Approach to Managing Your Patients in a Changing Environment from the National Osteoporosis Society's 2009 annual conference.
- Despite the criticisms about the NICE TAs on the primary and secondary prevention of postmenopausal osteoporosis1,2 it is important that we apply clinical judgement and build patient centred approaches to managing our osteoporosis patients
- There are limited data available on switching patients between bisphosphonates, however, data available suggest that upper GI side effects are significantly more likely to emerge if a patient stabilised on risedronate is switched to alendronate, and this is particularly true if the patient has a history of upper GI symptoms, or PPI and H2 receptor antagonist use
- Ideally, patients who are established on risedronate, or another of NICE's previously-recommended osteoporosis treatments, should not be indiscriminately switched onto generic alendronate in ‘blanket switching schemes'. Instead, switching should be implemented in a targeted manner.
- Proactively engaging in evidence-based discussions with your local Pharmaceutical Advisor or Joint Drugs and Therapeutic Committee can help to ensure that osteoporosis management remains patient-focused rather than formulary-led
What does NICE recommend?
Almost 80% of new post menopausal osteoporotic patients are initiated on alendronate3 and in one study 30% of patients discontinued alendronate after their first prescription for unidentified reasons.4 NICE recognise that one third of users in post-marketing studies of alendronate reported the occurrence of adverse gastrointestinal events.1,2
Recommendations for treatment options within the NICE TAG 160 and 161 are not only based on the clinical efficacy of the therapies but also the acquisition cost of the available osteoporosis medicines and a summary of the stepwise process (as outlined in the table below)1,2
Table 1. Summarised Treatment Flow
Developed from NICE TAG 160 and 161 - see full guidance for details1,2
Each step is dependent on the following:
Patients being unable to comply with the special administration instructions, have a contraindication to, or intolerance (requiring discontinuation) of the preceding treatments, age, T score, independent clinical risk factors for fracture, indicators of low BMD & in some cases clinically apparent fragility fractures or an unsatisfactory response to previous therapies.
|Primary and Secondary Prevention of PMO|
|First treatment option||Alendronate|
|First alternatives||Risedronate or etidronate|
|Second alternatives||Strontium ranelate||raloxifene |
(secondary prevention only)
(secondary prevention only)
The benefits of patient-centred targeted bisphosphonate switching strategies
Dr Sanjeev Patel, Consultant Physician & Senior Lecturer in Rheumatology, St Helier University Hospital and St George's University of London, presents the benefits of patient centred, targeted bisphosphonate switching strategies.
In a local bisphosphonate switching scheme undertaken by Sutton & Merton PCT in 2007, switching from risedronate to generic alendronate was not performed if the patient had one or more of the following clinical characteristics:
- Patients with previous intolerance to weekly alendronate (e.g. dyspepsia, oesophagitis) who were now established on another osteoporosis therapy
- Patients who had experienced a lack of response to alendronate (e.g. those who suffered a fracture while the drug was being taken)
- Patients who had previously experienced administration problems with weekly alendronate and who were now established on another osteoporosis therapy
- Patients with a current/recent history of upper GI disorders (e.g. peptic ulcer disease)
- Male patients receiving weekly risedronate (weekly alendronate is not licensed for male osteoporosis - daily alendronate is)
- Patients with glucocorticoid-induced osteoporosis receiving daily risedronate (for patients on continuous steroids or those receiving intermittent courses in the last 12 months)
- Patients who had experienced administration problems with weekly alendronate
- Patients with alendronate hypersensitivity (extremely rare)
- Patients with documentation of an abnormal oesophageal condition (e.g. oesophageal stricture)
Dr Sanjeev Patel "There is sufficient clinical evidence to warrant the exclusion of these patients groups from any ‘blanket switching' of risedronate to generic alendronate. For example, NICE states that in post marketing studies approximately one-third of alendronate users experienced GI adverse events,1,2 and patients who are intolerant of alendronate could tolerate risedronate.5 In addition, elderly patients aged over 80 years were excluded from alendronate pivotal trials, whilst for risedronate, vertebral fracture efficacy data in these older patients exist."6
Clinical implications of bisphosphonate switching
Professor Stuart Ralston, ARC Professor of Rheumatology, University of Edinburgh, also presents some of the clinical implications of bisphosphonate switching.
Professor Stuart Ralston "When patients who have been stabilised on risedronate are switched to generic alendronate, the risk of suffering a GI event could increase by as much as 85%. According to the latest data, a patient with an upper GI history, or those on a PPI are particularly at risk of a GI event, but this high relative risk remains even if the patient has no GI history".7
Oral bisphosphonates have been associated with upper GI disorders - for specific cautions and dosing instructions, see the Actonel prescribing information.
Working with PCTs to ensure cost effective osteoporosis management
Mr Omar Ali, Formulary Development Pharmacist for Surrey and Sussex NHS Trust, provides an overview of how those working in primary and secondary care can work with their PCTs more effectively to ensure a patient centred approach to cost effective osteoporosis management.
Omar Ali "The cost of risedronate is higher than that of generic alendronate, but given that alendronate is associated with a higher incidence of GI events, any initial cost savings gained from switching may be negated if the patient requires additional GI-related healthcare, such as endoscopy or concomitant medications. There is also the question of whether ‘secondary' drugs, which are only prescribed to reduce the side effects of the ‘primary' medication, provide their own costly complications. For example, if a patient is prescribed a PPI".
Date of preparation: August 2009
1. National Institute for Health and Clinical Excellence. Alendronate, etidronate, risedronate, raloxifene and strontium ranelate for the primary prevention of osteoporotic fragility fractures in postmenopausal women: NICE Technology Guidance 160. Last updated 2008.
2. National Institute for Health and Clinical Excellence. Alendronate, etidronate, risedronate, raloxifene, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women: NICE Technology Appraisal Guidance 161. Last updated 2008
3. Data on file, IMS Monthly Share Report, September 2008
4. Lo JC, et al. Persistence with weekly alendronate therapy among postmenopausal women. Osteoporosis International 2006; 17: 922-928.
5. Adachi JD, et al. Tolerability of risedronate in postmenopausal women intolerant of alendronate. Aging (Milano) 2001;13(5):347-354
6. Boonen S, et al. Safety and efficacy of risedronate in reducing fracture risk in osteoporotic women aged 80 and older: implications for the use of antiresorptive agents in the old and oldest old. J Am Geriatr. Soc. 2004;52(11):1832-1839
7. Ralston SH, et al. The risk of upper gastrointestinal (GI) adverse events of patients switching from risedronate to alendronate after the introduction of generic alendronate products in the UK. Bone 2009;44(Suppl.):S114-S115.