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e-Table. Bedside scenarios for which treatment decisions should be based on a detailed evaluation of the benefit to harm balance

A. When there is a narrow margin between benefit and harm

A1. Treatment is of modest or uncertain benefit, with some possibility of harm.

  • Aspirin for primary prevention of cardiovascular events in a healthy patient, bearing in mind the increase in gastrointestinal haemorrhage
  • Antibiotics for sore throat and upper respiratory tract infections, given the possibility of antibiotic induced diarrhoea and rash, and the development of microbial resistance.
  • Alosteron for irritable bowel disease, bearing in mind the controversy surrounding the adverse effect of ischaemic colitis

A2. Treatment has considerable potential for benefit, but there are major safety concerns

  • Aspirin for a patient with a stroke, but who has a past history of gastrointestinal haemorrhage
  • An angiotensin converting enzyme inhibitor in a patient with severe heart failure who has moderate renal impairment, bearing in mind the possibility of drug- induced deterioration in renal function
  • Metformin in an obese patient with type II diabetes mellitus and renal insufficiency; risk of lactic acidosis

A3. Potentially beneficial in the long term or to the community, but no immediate direct benefit to the individual

  • Improving the uptake of a childhood vaccine to promote herd immunity, while trying to assuage parental fears about serious adverse effects

A4. Lifestyle treatments

  • Finasteride for the treatment of male pattern baldness; erectile dyfunction is a recognized adverse effect.

B. When there is more than one efficacious treatment with differing safety profiles

B1. Treatments are of equivalent efficacy, but one agent may have a better safety profile

  • Selective cyclo-oxygenase-2 (COX-2) inhibitors rather than conventional non- steroidal analgesics in reducing the risk of gastrointestinal ulcer complications
  • Antiepileptic drugs for a patient with epilepsy who plans to become pregnant
  • Warfarin or ximelagatran in an elderly patient with atrial fibrillation

B2. Relative benefits and harms differ substantially among the available treatments; e.g. the most efficacious drug may have serious adverse effects, while the least effective agent is safer

  • Warfarin or aspirin in a healthy middle aged man with lone atrial fibrillation
  • Dopamine receptor agonists or levodopa in patients with early stage Parkinson’s disease
  • Disease-modifying drugs in a patient with newly diagnosed erosive rheumatoid arthritis; e.g. deciding between hydroxychloroquine (relatively safe) and methotrexate (potentially more effective, but less safe)

C. When a patient has difficulty continuing the medication because of adverse effects

C1. Treatment is of considerable benefit but the patient is troubled by adverse effects

  • A patient with severe heart failure has responded well to an ACE inhibitor, but now complains of cough; which is the best option - trying a lower dose or changing to an angiotensin receptor blocker?


 



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