New Research Reveals Need For Greater Awareness Of GI Tolerability Warning Signs In Post-Menopausal Osteoporosis Prescribing

New research has revealed a need for GPs to assess their patients' history more closely when prescribing for post-menopausal osteoporosis to reduce the risk of upper gastrointestinal (GI) side effects that could lead to treatment discontinuation.1



The research was commissioned by Procter & Gamble Pharmaceuticals and was co-developed by expert, Dr Jonathan Bayly, University of Derby. The 350 GPs questioned across the UK revealed:


-- Less than 1 in 3 GPs recognise key factors that might exacerbate upper GI tolerability such as:


- Prolonged NSAID use (30%)1

- Previous treatment with PPIs (27%)1


-- Less than half of GPs (49%) routinely assess for concomitant use of medications such as anticoagulants, aspirin, and corticosteroids before initiating a patient on to osteoporosis treatment1


-- In patients identified as being at increased risk of GI side effects severe enough to mean that they would be unable to persist with medication, only half of GPs (50%) would counsel the patient about the potential risk of side effects, and just 47% of GPs would reinforce messages about dosing instructions1



Almost 80% of new post menopausal osteoporosis patients are initiated on alendronate.2 In a separate study it was shown that 30% of patients discontinue alendronate after their first prescription for unidentified reasons.3 NICE recognise that one third of users in post-marketing studies of alendronate reported the occurrence of adverse gastrointestinal events.4,5



Dr Jonathan Bayly, Associate Lecturer, University of Derby commented, "This research suggests that GPs need to give greater consideration to a patient's risk of developing intolerable upper GI side effects and should prescribe accordingly. In addition, GPs need to tighten up on monitoring patients on therapy, to ensure that emergence of intolerable upper GI side effects does not compromise treatment adherence as this will negatively impact on the effectiveness of interventions. It's disappointing to see that nearly one in five GPs (19%) will only review their osteoporosis patients' medication for the emergence of upper GI tolerability issues if the patient raises concerns. 52% of GPs clearly state that remuneration through QOF would be likely to influence the regularity or consistency with which patients' medication was reviewed1. As with other long-term conditions, suitable inducements for primary care would be likely to improve health outcomes".



Dr Pam Brown, GP with a clinical interest in osteoporosis, added, "Current NICE guidance (TAG 160 and 161) recommend alternative treatment options, including risedronate and strontium ranelate for those who cannot tolerate alendronic acid. However, alendronic acid is contraindicated in some patients, such as those with previous upper GI problems, so it is important that GPs can identify these patients and use an alternative treatment first line".
















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)4,5




References



1 ICM Research. GPs GI Study. 2009


2. Data on file, IMS Monthly Share Report, September 2008


3. Lo, J. et al. Persistence with weekly alendronate therapy among postmenopausal women. Osteoporos International 2006; 17: 922-928


4. 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. Technology Appraisal Guidance 160, October 2008


5. National Institute for Health and Clinical Excellence, Alendronate, etidronate, risedronate, raloxifene, and strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women. Technology Appraisal Guidance 161, October 2008


6. Alendronate SmPC, Available online at Electronic Medicines Compendium, July 2009 emc.medicines.uk/emc/assets/c/html/displaydoc.asp?documentid=4115


7. Risedronate SmPC, Available online at Electronic Medicines Compendium, July 2008
emc.medicines.uk/medicine/11591/SPC/Actonel+Once+a+Week+35mg+film+coated+tablets


8. Etidronate (Didronel PMO) SmPC, Available online at Electronic Medicines Compendium, July 2006, emc.medicines.uk/medicine/1613/SPC/Didronel+PMO


9. NOGG National Osteoporosis Guideline Group. Guidelines for the diagnosis and management of osteoporosis in postmenopausal women and men from the age of 50 years in the UK. 2008



Source
Procter & Gamble Pharmaceuticals