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Background: The safety and pattern of use of a medicinal product cannot be fully studied prior to its marketing. In Denmark, the Danish Health and Medicines Authority (DHMA) monitors marketed drugs. An available source is the Register of Medicinal Product Statistics (RMPS), which can possibly be used for these purposes., Objective: To investigate utilisation and potential safety issues of relatively new antidepressants containing the active ingredient duloxetine (Cymbalta(®) and Xeristar(®)) by using dispensing data available in the RMPS., Methods: A retrospective study using dispensing data was designed to estimate the size and composition of the user population and patterns of use of the antidepressants Cymbalta(®) and Xeristar(®) (active ingredient: duloxetine) in the period from 1 January 2005 to 31 December 2010. Data were retrieved from Epikur, a register subset of the RMPS., Results: Both women and men in different age groups used duloxetine for depression. Some users switched to another antidepressant. Prescription of the drug for persons below the age of 18 years revealed a potential safety issue. Concomitant treatment with Cymbalta(®) or Xeristar(®) and fluvoxamine, isocarboxazid, Yentreve(®), or ciprofloxacin also revealed potential safety issues., Conclusions: The present study indicated that the RMPS is applicable in monitoring the pattern of use and potential safety issues related to duloxetine when it is prescribed for depression. Switching to other antidepressants could reflect some potential safety issues. Use of duloxetine for persons below the age of 18 years and its concomitant use with contraindicated drugs also indicated potential safety issues.

Objectives: The aim of this study was to assess the efficacy and safety in an "everyday clinical practice" population of anticoagulant-naïve patients with atrial fibrillation (AF) treated with dabigatran etexilate after its post-approval availability in Denmark, compared with warfarin., Background: Concerns have been raised about an excess of bleeding events or myocardial infarction (MI) among patients treated with the new oral direct thrombin inhibitor, dabigatran etexilate., Methods: From the Danish Registry of Medicinal Product Statistics, we identified a dabigatran-treated group and a 1:2 propensity-matched warfarin-treated group of 4,978 and 8,936, respectively. Comparisons on efficacy and safety outcomes were made on the basis of Cox-proportional hazards models stratified on propensity-matched groups., Results: Stroke and systemic embolism were not significantly different between warfarin- and dabigatran-treated patients. Adjusted mortality was significantly lower with both dabigatran doses (110 mg b.i.d., propensity-match group stratified hazard ratio [aHR]: 0.79, 95% confidence interval [CI]: 0.65 to 0.95; 150 mg b.i.d., aHR: 0.57, 95% CI: 0.40 to 0.80), when compared with warfarin. Pulmonary embolism was lower compared with warfarin for both doses of dabigatran. Less intracranial bleeding was seen with both dabigatran doses (110 mg b.i.d., aHR: 0.24, 95% CI: 0.08 to 0.56; 150 mg b.i.d., aHR: 0.08, 95% CI: 0.01 to 0.40). The incidence of MI was lower with both dabigatran doses (110 mg b.i.d., aHR: 0.30, 95% CI: 0.18 to 0.49; 150 mg b.i.d., aHR: 0.40, 95% CI: 0.21 to 0.70). Gastrointestinal bleeding was lower with dabigatran 110 mg b.i.d. (aHR: 0.60, 95% CI: 0.37 to 0.93) compared with warfarin but not dabigatran 150 mg b.i.d. The main findings were broadly consistent in a subgroup analysis of dabigatran users with ≥1-year follow-up (median follow-up 13.9 months [interquartile range: 12.6 to 15.3 months])., Conclusions: In this "everyday clinical practice" post-approval nationwide clinical cohort, there were similar stroke/systemic embolism and major bleeding rates with dabigatran (both doses) compared with warfarin. Mortality, intracranial bleeding, pulmonary embolism, and MI were lower with dabigatran, compared with warfarin. We found no evidence of an excess of bleeding events or MI among dabigatran-treated patients in this propensity-matched comparison against warfarin, even in the subgroup with ≥1-year follow-up., (Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Introduction: As from 2005, the Danish Medicines Agency has recommended prescription of topical calcineurin inhibitors (TCI) to patients aged two years and older after attempting treatment with topical corticosteroids., Material and Methods: Via the Danish Register of Medical Product Statistics every TCI-user was identified (encrypted ID) from July 2002-2007: 18,780 tacrolimus- and 40,895 pimecrolimus users. Changes over time in first-line users are studied by 2 test and in age distributions by Mann-Whitney U-test., Results: 1-year prevalence and incidence have decreased since 2005. In the period 2003-2007, 21% of all tacrolimus incident users and 36% of all pimecrolimus incident users were first-line users. In the period 2003-2007, 590 tacrolimus users and 4,913 pimecrolimus users were below the age of two years. These pimecrolimus users decreased in number from 1,440 in 2003 to 480 in 2007. In four out of five first-line pimecrolimus users below the age of two years, the first prescription was issued by a general practitioner., Conclusion: The decrease in the sale of TIM since 2005 coincided with the changed recommendations. On the basis of the available data, it is not possible to determine whether the percentage of first-line users are reasoned by the skin area is not suitable for corticosteroids. In 2007, the recommendation was not followed for a minor number of TIM users below the age of two years.

Introduction: The purpose of this survey was to map the sale of analgesics in the Danish primary care sector from 2000 to 2004., Materials and Methods: Data on analgesics and NSAIDs were drawn from the Register of Medicinal Products Statistics. Sales in 2004 and changes from 2000 to 2004 are treated with descriptive statistics. Our focus was on analgesics bought on prescription., Results: In 2004, approximately 580,000 persons bought an analgesic on prescription. Including NSAIDs it is a total of approximately 1.16 million people. Between 2000 and 2004, the number of users increased by 10%. STRONG OPIOIDS: The number of users was almost unchanged from 2000 to 2004. Most people bought ketobemidone and morphine, even though the number of these users decreased. In contrast, the number of oxycodone users increased greatly. Several-time users of oxycodone are often new users of strong opioids. Likewise, the number of users of transdermal fentanyl and buprenorphine patches increased. WEAK OPIOIDS: The number of users increased by approximately 31,000 (10%), due to a greater number of users of tramadol, while the number of users of other weak opioids decreased. Thirty percent of several-time users of tramadol had not previously bought other analgesics on prescription. NSAIDs: The number of users increased by approximately 95,000 (13%). After 2002, the number of coxib users decreased concurrently with an increased usage of other NSAIDs. After coxib treatment, 29% of several-time users did not shift to other analgesics bought on prescription. WEAK NON-OPIOIDS: The number of users increased by approximately 42,000 (15%). The majority were users of paracetamol., Conclusion: In 2004, every fifth Danish citizen bought analgesics on prescription. Between 2000 and 2004, the number increased. In particular, the number of users of NSAIDs was large. The number of users of strong opioids did not increase as did the number of users of the other groups of analgesics, but within that group there was a shift to more expensive drugs.