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SimvastatinAmlodipineInteraction ABHBfinalSept2012
SimvastatinAmlodipineInteraction ABHBfinalSept2012
The August 2012 edition of the MHRA’s Drug Safety Update (vol 6, issue 1)1 highlights updated contraindications
and dose recommendations for simvastatin when used with a number of other medicines. These changes have
been driven by concerns over the risks of myopathy and/or rhabdomyolysis at higher plasma concentrations of
simvastatin.
A full updated listing of all the interactions is provided in table 1 overleaf.
As amlodipine and simvastatin 40mg/day are widely co‐prescribed in Gwent the following advice has been issued by
ABHB Medicines Management for patients on this combination:
*Although NICE CG67 (2008) states that for both the primary and secondary prevention of CVD where there are potential
drug interactions a lower dose than simvastatin 40mg/day or alternative preparation such as pravastatin may be chosen,
CG67 also recommends that therapy should be initiated with a drug with a low acquisition cost (publication of CG67 pre‐
dated the availability of low‐cost generic atorvastatin).
Table 3 Absolute reductions (mmol/l) inc. 95% CIs and percentage reduction in serum LDL‐C according
to statin and daily dose:7
Statin 10mg/day 20mg/day 40mg/day 80mg/day
Atorvastatin 1.79 (1.62 to 1.97), 37% 2.07 (1.90 to 2.25), 43% 2.36 (2.12 to 2.59), 49% 2.64 (2.31 to 2.96), 55%
Pravastatin 0.95 (0.83 to 1.07), 20% 1.17 (1.10 to 1.23), 24% 1.38 (1.31 to 1.46), 29% 1.60 (1.46 to 1.74), 33%
Simvastatin 1.31 (1.22 to 1.40), 27% 1.54 (1.46 to 1.63), 32% 1.78 (1.66 to 1.90), 37% 2.01 (1.83 to 2.19), 42%
Note for secondary prevention of CVD NICE advice8 is to consider increasing statin dose if a total cholesterol of
< 4 mmol/litre or an LDL cholesterol of < 2 mmol/litre is not attained – the use of 4 and 2 is intended to guide
treatment rather than be a figure patients are expected to achieve.
1
http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON180637
2
SIMVASTATIN SmPC http://www.medicines.org.uk/emc/medicine/1201/SPC/
3
ATORVASTATIN SmPC http://www.medicines.org.uk/emc/medicine/1424/SPC/
4
PRAVASTATIN SmPC http://www.medicines.org.uk/emc/medicine/356/SPC/
5
GMC guidance on ‘off‐label’ prescribing http://www.gmc‐uk.org/guidance/ethical_guidance/prescriptions_faqs.asp#10
6
Park CG, Lee H, Choi JW et al. Int J Clin Pharmacol Ther. 2010 Aug;48(8):497‐503.
7
Law MR, Wald NJ, Rudnicka AR. BMJ 2003;326:1427‐31.
8
http://guidance.nice.org.uk/CG67