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P608. Mesalazine suppository use - ECCO guideline vs. real life

Background

The latest ECCO guideline on current management include statement 5A: A mesalazine 1 g suppository once daily is the preferred initial treatment for mild or moderately active proctitis [EL1b, RG A]. Mesalazine foam enemas are an alternative [EL1b, RG B]. Suppositories may deliver drug more effectively to the rectum and are better tolerated than enemas [EL3, RG C]. Combining topical mesalazine with oral mesalazine or topical steroid is more effective than either alone and should be considered for escalation of treatment [EL1b, RG B]. Oral mesalazine alone is less effective [EL1b, RG B]. This guideline represents the “state of the art” of medical treatment in UC. Independent of the prevalence and incidence of UC the relative number of prescriptions and the percentage of patients using suppositories should be identical in UC patients in various countries across Europe. Direct data sources to check this assumption are not available.

Methods

To get an indication of the level of suppository use in various countries (no differentiation between single treatment for proctitis or adjuvant to oral treatment, dose or the duration) sales data (in kg) for suppositories were received from IMS Health and correlated with the epidemiology of UC in various countries. Based on the number of residents (from Eurostatistics) and the prevalence of UC, the number of patients and the use of rectal mesalazine in suppositories were calculated.

Results

The aggregated sales data from Q2/2012 to Q1/2013 (12 months) show that 14618 kg Mesalzine in suppositories was sold in 14 EU countries with a total population of 275 millions. For the prevalence of UC three categories were used 80, 150 and 250 per 100000 people which reflect approximately the reported prevalence in the countries. The table shows that the theoretical number of 1 g doses per patient/year varies between 17 in Latvia and 55 in Portugal. Surprisingly the usage of suppositories in UK patients is almost 50% higher than in Germany.

Table: Countries with kg mesalazine sold, number of residents, prevalence of UC, number of UC patients and use of mesalazine suppositories per patients
CountryPopulation (millions) on 1/1/2010kg mesalazine in suppositorieskg/headRounded prevalence per 100,000No. of patientskg mesalazine per patientTheoretical no. of 1 g doses per patient/year
CZ10.5077090.0000715015,7600.0445
DK5.5355110.0000925013,8370.0437
DE81.80247240.00006250204,5060.0223
EE1.340370.00003801,0720.0335
IE4.4682070.0000525011,1700.0219
EL11.3058780.0000825028,2630.0331
FR62.79321740.000038050,2350.0443
LV2.248300.00001801,7990.0217
LT3.329570.00002802,6630.0221
PT10.6384680.00004808,5100.0555
FI5.3515450.0001025013,3790.0441
SE9.3416780.0000725023,3520.0329
UK62.00831040.0000515093,0120.0333
NO4.8584960.0001025012,1450.0441
All275.52414,618 479,7020.0330

Conclusion

Despite an uncertainty in the prevalence assumptions the results show clearly that the ECCO guideline is not followed to the same degree in all countries. Per patient use varies by factor 3 with Ireland, Latvia and Germany at the lower end and Portugal and Czech Republic at the “better” end. A definite pattern cannot be detected. If the differences are cultural or due to medical education needs further research.

  • Written by:

    R. Hofmann, L. MacKenzie, Tillotts Pharma, Medical Affairs, Rheinfelden, Switzerland