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Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 50 – No. 3/2012 (195-201)

Antihypertensive treatment and risk of dementia: a retrospective database study

Gabriela Wagner², Andrea Icks¹, Heinz-Harald Abholz², Detlef Schröder-Bernhardi³, Wolfgang Rathmann¹ and Karel Kostev³

¹German Diabetes Center, Institute of Biometrics and Epidemiology, ²Department of General Practice, University Clinic, Heinrich Heine University, Düsseldorf, and ³IMS Health, Frankfurt/Main, Germany
Objective: Vascular risk factors play an important role in the pathogenesis of vascular dementia, as well as in Alzheimer disease. The effect of antihypertensive medication on risk of dementia is unclear. The aim was to investigate the association between antihypertensive prescriptions and incident dementia, using a primary care database. Methods: The analysis was based on 575 general and internal practices in Germany (10/2003 – 09/2008) (Disease analyzer database). Antihypertensive medication (ATC codes) during 3 years before newly diagnosed dementia (ICD codes or specific medication) in 1,297 patients was compared to 1,297 controls without dementia after matching for age (mean age: 80.6 ± 8.6 y), sex (females: 62%) and date of diagnosis. Conditional logistic regression was used to calculate crude and adjusted odds ratios (95% confidence intervals). Results: Betablocker prescriptions (≥ 1 per year over 3 y) showed a significant inverse association with newly diagnosed dementia (Odds ratio, OR: 0.79 95% CI 0.61 – 0.99) after adjusting for demographic covariates, health care use, and cardiovascular and neurological comorbidity. In the fully adjusted model, ACE inhibitors also tended to be inversely associated with incident dementia, but failed statistical significance (OR 0.84 95% CI 0.65 – 1.08). Calcium channel blockers were positively related to cognitive impairment only in the crude analysis. The other drug groups were not significantly related to dementia (diuretics OR: 0.89; 0.67 – 1.19; angiotensin- 1-inhibitors OR: 1.04; 0.66 – 1.64). Conclusions: This practice-based case-control study indicated a possible protective effect of some antihypertensive agents (betablockers, ACE-inhibitors) on the development of dementia. Randomized controlled trials are required to confirm this finding.Correspondence to:
Dr. med. Wolfgang Rathmann, MSPH (USA)
German Diabetes Center, Institute of Biometrics and Epidemiology
Auf´m Hennekamp 65, 40225 Düsseldorf, Germany
Email: rathmann@ddz. uni-duesseldorf.de

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 50 – No. 5/2012 (315-322)

Persistence and compliance of medications used in the treatment of osteoporosis – analysis using a large scale, representative, longitudinal German database

Volker Ziller¹*, Karel Kostev²*, Ioannis Kyvernitakis¹, Jelena Boeckhoff¹ and Peyman Hadji¹

¹Department of Endocrinology, Reproductive Medicine and Osteoporosis, Philipps-University, Marburg, and ²Health Economics and Outcomes Research, IMS Health GmbH & Co. OHG, Frankfurt, Germany

*Both authors contributed equally to this work.
Objective: Osteoporosis can be effectively treated with a number of medications. However, high persistence and compliance are required to assure efficacy. This study analyses persistence and compliance with a variety of medical interventions including p.o., i.v. and s.c. administrations in Germany. Methods: This retrospective cohort study used a representative longitudinal database (IMS^® LRx) comprising longitudinal prescription data for Germany from almost 80% of all German prescriptions of members of the German statutory health insurance system. Persistence is defined as the proportion of patients who remained on their initially prescribed therapy at 1 year. Compliance is measured indirectly based on the medication possession ratio (MPR). Results: A total of more than 1 million patients (1,107,482) for the period 07/2007 – 06/2009 was identified in the database who received a prescription for a bisphosphonate, strontium or PTH. Of these, 268,568 patients fulfilled further inclusion criteria and were included in the persistence and compliance analysis. At 12 months the proportion of patients that remained on treatment were 65.6% for zoledronate 5 mg; 56.6% for ibandronate i.v. 3 mg; 54.7% for PTH (teriparatide and 1-84 PTH), 51.0% for ibandronate 150 mg p.o.; 44.8% for alendronate 70 mg; 43.4% for etidronate. Other values were risedronate plus calcium 42.3%; alendronate plus vitamin D 37.8%; risedronate 35 mg 35.2%; risedronate 5 mg 30.6%; strontium ranelate 31.4% and alendronate 10 mg 17.3%. Conclusion: Persistence and compliance during the treatment of osteoporosis were found to be insufficient. Treatment using the intravenous route and PTH showed the highest persistence and compliance rates and daily oral bisphosphonates the lowest. More effort to improve treatment compliance and persistence is needed to assure clinical efficacy.Correspondence to:
Dr. med. Volker Ziller
Philipps-University of Marburg
Department of Endocrinology, Reproductive Medicine and Osteoporosis
Baldingerstraße, 35043 Marburg, Germany
Email: [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 50 – No. 4/2012 (257-264)

A retrospective database analysis on persistence with inhaled corticosteroid therapy: comparison of two dry powder inhalers during asthma treatment in Germany

Thomas Voshaar¹*, Karel Kostev²*, Juliana Rex², Detlef Schröder-Bernhardi², Joachim Maus³ and Ullrich Munzel³

¹Krankenhaus Bethanien, Moers, ²IMS Health, Frankfurt am Main, and ³Meda Pharma GmbH & Co KG, Bad Homburg, Germany
Background: Asthma is one of the most common chronic diseases worldwide. Patient persistence with treatment is essential to achieve sufficient outcomes, in particular to avoid exacerbations. Objective: To investigate inhaled corticosteroid (ICS) therapy with two different inhalers (Novolizer^® and Turbuhaler^®) by comparing persistence, concomitant use of additional asthma medication and occurrence of exacerbations in real life. Study design: A retrospective analysis of prescription data from outpatient treatment was performed using the IMS Disease Analyzer. It provides longitudinal anonymized patient data from ~ 3,000 office-based physicians in Germany. Treatment persistence of asthma patients (ICD 10 code: J45) using 200 μg budesonide either via Novopulmon^®/Budecort^® (Novolizer group = NOV) or Pulmicort^® (Turbuhaler group = TUR) was compared. Eligible patients hadthe first prescription of ICS medication (index day) between June 2001 and September 2007 and a data history available for at least twelve months before and after the index day. Results: Analysis of 1,780 NOV and 664 TUR patients revealed that 1 year after index day, 89% NOV patients remained on their ICS compared to 85% TUR patients. NOV patients changed significantly less often and later to another ICS (p = 0.0108; log-rank test). Significantly fewer NOV patients switched temporarily or permanently to another ICS during the observation time (NOV group: 14.7%; TUR group: 20.8%; p = 0.0002, log-rank test). On average, NOV and TUR patients received comparable prescriptions of short acting medication (NOV more SABA, TUR more formoterol). There was a trend towards fewer prescriptions of systemic corticosteroids in NOV patients. Conclusions: Our results suggest better therapy persistence with NOV compared to TUR during asthma treatment in Germany. This can be a marker of better compliance and may contribute to prevent exacerbations. However, the number of exacerbations per patient year in the NOV group (0.12) compared to the TUR group (0.18) was not statically significantly lower (p = 0.4096).Correspondence to:
Dr. rer. med. Karel Kostev
Senior Consultant CES LifeLink – Epidemiology
IMS HEALTH GmbH & Co. OHG
Darmstädter Landstraße 108
60598 Frankfurt am Main, Germany
Email: [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 50 – No. 4/2012 (281-289)

Cost comparison of outpatient treatment with granulocyte colony-stimulating factors (G-CSF) in Germany

Peyman Hadji¹*, Karel Kostev²*, Detlef Schröder-Bernhardi² and Volker Ziller¹

¹Philipps-University of Marburg, Marburg, and ²IMS Health, Frankfurt am Main, Germany

*Both authors contributed equally to the manuscript.
Background: Granulocyte colony-stimulating factors (G-CSF), are available for prevention of neutropenia and reduction of its complications in cytostatic chemotherapy. The purpose of this analysis was to determine the consumption rates for various G-CSF and to compare outpatient medication costs per patient and treatment cycle. Methods: Prescription data of statutory health insurance members in Germany (IMS^®LRx database) with G-CSF prescriptions between January 2008 and July 2010 were evaluated. A period of observation of at least 6 months prior to and after the G-CSF prescription was required. Results: Prescription data of 8,726 patients treated with original filgrastim, 4,240 with biosimilar filgrastim, 6,456 with lenograstim, and 9,939 with pegfilgrastim were analyzed. The regression model showed statistically significant costreducing effects per cycle for treatment with lenograstim compared with non-lenograstim (–0.47 vs. original filgrastim; –0.15 vs. biosimilar filgrastim; –1.04 vs. pegfilgrastim; each p < 0.0001). This result has been adjusted for patient age, gender, number of injections, and prescribing specialist group. Conclusions: Treatment with the original preparation lenograstim is significantly cheaper compared to the other two original drugs and biosimilar. The costs of G-CSF treatment with the original preparation lenograstim and the filgrastim biosimilars are in a similar range, but with a significantly lower cost for lenograstim. Compared to their reference product the biosimilars thus show a cost advantage.Correspondence to:
Prof. Dr. med. Peyman Hadji
Philipps-University of Marburg
Klinik für Gynäkologie, Gynäkologische, Endokrinologie und Onkologie
Baldinger Straße, 35033 Marburg, Germany
Email: [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 50 – No. 11/2012 (821-830)

Micro- and macrovascular outcomes in Type 2 diabetic patients treated with insulin glulisine or human regular insulin: a retrospective database analysis

Stephan Kress¹*, Karel Kostev²*, Franz W. Dippel³, Guido Giani⁴ and Wolfgang Rathmann⁴

¹Vinzentius-Krankenhaus, Landau, ²IMS HEALTH, Frankfurt, ³Sanofi-Aventis Deutschland GmbH, Berlin, and ⁴Institute of Biometrics and Epidemiology, German Diabetes Center, Düsseldorf, Germany

*S. Kress and K. Kostev share the first authorship.
Objective: Insulin glulisine has a higher efficacy in reducing postprandial glucose excursions and in restoring normal postprandial microcirculation than rapid human insulin. The aim was to compare the incidence of macro- and microvascular outcomes in Type 2 diabetic patients treated with insulin glulisine or regular human insulin. Materials: Computerized data from 952 glulisine (age: 61 ± 11 y) and 11,157 regular insulin (65 ± 11 y) users in general practices throughout Germany (Disease Analyzer, 11/2004 to 3/2010) were analyzed. Methods: Hazard ratios (HR; Cox regression) for 3.5-year-risk of macro- or microvascular outcomes were adjusted for age, sex, diabetes duration, diabetologist care, hypertension, hyperlipidemia, depression, and comedication (basal insulin, oral antidiabetics). Furthermore, adjustment was carried out for baseline microvascular complications when analyzing macrovascular outcomes and vice versa. Results: Overall, risk for macro- or microvascular outcomes was 20% lower for insulin glulisine users (p < 0.05). There was a decreased risk for coronary heart disease (HR; 95%CI: 0.78; 0.62 – 0.99), and an indication for a lower risk for incident myocardial infarction (HR: 0.66; 0.43 – 1.02). Also for microvascular complications, the adjusted hazard ratios for retinopathy, nephropathy and neuropathy were below 1.0, indicating a lower risk for the insulin glulisine group, however, which was significant for neuropathy only (HR: 0.74; 0.58 – 0.93). Conclusions: Prescription of the rapid-acting insulin analog glulisine was associated with a reduced incidence of macro- and microvascular outcomes in Type 2 diabetes under real-life conditions. Given that this was a retrospective database analysis, it is important to confirm this finding in a randomized controlled trial.Correspondence to:
Dr. Wolfgang Rathmann, MSPH
German Diabetes Center
Institute of Biometrics and Epidemiology
Auf´m Hennekamp 65, 40225 Düsseldorf
Email: [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 51 – No. 1/2013 (12-18)

Economic prescribing of corticosteroid nasal sprays in Germany. Comparison of mometasone and budesonide nasal sprays on the basis of the DDD, the PDD and reference prices

Beril Becker¹, Silvia Kruppert² and Karel Kostev²

¹MSD Sharp & Dohme GmbH, Haar, and ²IMS Health GmbH & Co. OHG, Frankfurt,
Germany
Aim: According to the German Social Security Code (SGB V), drugs should be prescribed on a cost-effective basis. An attempt is made to achieve this in Germany with the help of the DDD system and reference prices. Taking the example of the most frequently prescribed corticosteroid nasal sprays containing the active substances budesonide (BNS) or mometasone (MNS), we will show here that the DDD system is not necessarily suitable for tapping economic reserves. Despite the pharmacologic differences between the two substances, a uniformly defined daily dose (DDD) is assumed for both. Moreover, since 2006 they have formed a reference-price group of nasally administered medication with other active substances. Products were compared with regard to potential differences in patient populations and resulting treatment costs. The extent to which the two instruments are suitable for tapping economic reserves were estimated. Methods: We analyzed longitudinal diagnostic and prescription data in the IMS^® Disease Analyzer Database from the period 2006 to July 2010. Results: In total we analyzed data from 16,163 MNS and 4,218 BNS patients from GP practices plus 11,103 MNS and 2,521 BNS patients from ENT practices. The average quantity prescribed per patient differed in favor of MNS by –111.5 (for first prescriptions) to –260.1 puffs (after 730 days) in GP practices and by –137.3 to –488.3 puffs in ENT practices (p < 0.001). The mean calculated treatment cost per year from the point of view of the statutory health insurer was 20.40 € (GP practices) and 30.50 € (ENT practices) for MNS compared to 22.40 € (GP practices) and 32.10 € (ENT practices) for BNS. Based on the price level after the 2011 referenceprice adjustment, the treatment costs are 16.40 € (GP practices) and 24.20 € (ENT practices) for MNS versus 21.20 € (GP practices) and 32.30 € (ENT practices) for BNS. Conclusion: The volumes of MNS actually prescribed are significantly lower than those of BNS in the compared patient populations. Based on the actual consumption of the substances, there is no treatment-cost advantage for BNS in comparison to MNS from the statutory health insurer’s point of view. By contrast, the reference-price adjustment results in a greater reduction of treatment costs for mometasone, so that in this case the statutory health insurer is able to tap economic reserves. Both the comparative parameters used for calculating the reference price and the DDD system are only conditionally suitable for tapping economic reserves for drugs.Correspondence to:
Dr. Beril Becker
MSD Sharp & Dohme GmbH
Lindenplatz 1, 85540 Haar, Germany
Email: [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 51 – No. 5/2013 (416-422)

Frequency of hospitalizations prior to and after conversion to a rebate pharmaceutical in depression patients in Germany

Karel Kostev¹*, Uwe May²*, Christian Ott², Marc Paul², Klaus Schetschok², Malte Tingelhoff², Carolin Claus² and Lilia Waehlert²

¹IMS Health, Frankfurt am Main, and ²Hochschule Fresenius, FB Wirtschaft und Medien, FG Gesundheitsökonomie, Idstein, Germany

*both authors contributed equally to the manuscript
Background: The aim of this study was to investigate the frequency of hospitalization in depression patients with and without conversion to a rebate pharmaceutical and to show the negative consequences of rebate contracts on the health of patients with depression. Methods: This retrospective study was performed using two databases that included data on ~ 10 millions patients gathered between July 2009 and June 2012. This study included adults (> 18 years) on an antidepressive drug therapy who had statutory health insurance with rebate contracts on antidepressive pharmaceuticals. Results: In total, 47,968 patients on an antidepressive drug therapy were included in the persistence analysis using the IMS Disease Analyzer database. Of those, 26,651 patients were converted to a rebate product whereas 21,317 patients continued with the initial pharmaceutical product. After adjusting for the majority of demographic and clinical variables, the risk of hospitalization was 57% higher in patients who switched to a rebate pharmaceutical in comparison to patients who did not. When projected to the national level, this was found to equal an additional 34,157 patients hospitalized due to conversion to a rebate pharmaceutical resulting in direct inpatient costs amounting to 363.8 million EUR per year in Germany. Conclusions: Despite some limitations, this analysis presents a clear association between the initiation of rebate contracts and a negative impact on the health of patients on an antidepressive drug therapy.Correspondence to:
Dr. Karel Kostev
Senior Research Adviser
IMS HEALTH – Epidemiology
Darmstädter Landstraße 108
60598 Frankfurt am Main, Germany
Email: [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 51 – No. 12/2013 (969-975)

Adherence in tamoxifen therapy after conversion to a rebate pharmaceutical in breast cancer patients in Germany

Karel Kostev¹*, Uwe May²*, Daniela Hog², Janine Eisel², Tim Kremmers², Marjan Kosteic², Lilia Waehlert² and Peyman Hadji³

¹IMS Health, Frankfurt, ²Hochschule Fresenius, FB Wirtschaft und Medien, FG Gesundheitsökonomie, Idstein, and ³Department of Gynecology, Endocrinology and Oncology, Phillips-University of Marburg, Germany
Background: The aim of this study was to investigate the risk of therapy discontinuation in breast cancer patients treated with tamoxifen with and without conversion to a rebate pharmaceutical (tamoxifen) and to analyze the negative consequences of rebate contracts on the compliance of breast cancer patients among gynecologist and general practitioner practices in Germany. Methods: This retrospective analysis was performed using the IMS Disease Analyzer^® database. Women with a diagnosis of breast cancer and first time prescription of tamoxifen in the time from January 2008 until December 2011 were selected. Main outcome measure was the incident the hormone treatment discontinuation rates within 3 years after index date. Treatment discontinuation of tamoxifen was defined as 90 days without this or alternative hormonal therapy (aromatase inhibitors) during that time. Results: In total, 3,620 patients were included in the persistence analysis. 1,712 (47.3%) patients were converted to a rebate product. Within 3 years of follow-up, the discontinuation rates increased to 51.5% for switched patients and 46.3% for patients without switch (p < 0.01). Hazard ratios for 3-year risk of tamoxifen therapy discontinuation were adjusted for age, sex, gynecologist care, patient and physician’s residency, baseline co-morbidities (osteoporosis, diabetes, depression and thrombosis, side effects). These analyses comprised a significantly increased risk for treatment discontinuation for patients who were switched to a rebate pharmaceutical compared to patients without conversion to a rebate pharmaceutical (HR: 1.27, CI: 1.05 – 1.53, p = 0.014). Conclusions: This analysis underlines an association between the initiation of rebate contracts and a negative impact on the compliance of breast cancer patients on an adjuvant hormonal treatment The impact of rebate contracts on the health of patients and the health care costs should be evaluated in further therapeutic fields through additional research projects.

*both authors contributed equally to the manuscriptCorrespondence to:
Dr. Karel Kostev
Senior Research Advisor
IMS HEALTH – Epidemiology
Darmstädter Landstraße 108
60598 Frankfurt am Main, Germany
Email: [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 5/2014 (352-359)

Gender differences in persistency to bisphosphonates in patients with metastatic breast and prostate cancer

Peyman Hadji¹, Jannis Kyvernitakis¹, Ute Albert¹, Joachim Jockwig², and Karel Kostev¹,²,³

¹Philipps-University of Marburg, Department of Gynecology, Gynecological Endocrinology and Oncology, Marburg, ²Fresenius University of Applied Sciences, Health and Social faculty, Idstein, and ³IMS Health, Frankfurt, Germany
Background: Bisphosphonates (BIS) treatment is a standard of care in metastatic bone disease (MBD) and regular intake is of upmost importance to ensure the effectiveness. The aim of this study was to investigate gender specific differences in persistence with BIS in MBD for the first time in this regard. Patients and methods: Out of the original database of 16 million patients, we extracted first-time metastatic cancer related BIS prescriptions from January 2001 to December 2011 in patients diagnosed with MBD following breast cancer (BC) or prostate cancer (PC). Patients were matched (1 : 1) in accordance to age. For persistence analyses, 1,007 patients with metastatic BC and PC were available. Results: After 1 year of follow-up, 35.3% of BC and 26.6% of PC patients treated with BIS discontinued their treatment (p < 0.001). The differences were irrespective of increased refill gaps and route of BIS administration. The multivariate hazard ratios of the Cox regression models for 1-year risk of BIS discontinuation (adjusting for multiple variables) showed no increased risk for treatment discontinuation for BC vs. PC patients (HR: 0.87; 95% CI: 0.65 – 1.17). The use of co-medications decreased, regional and insurance aspects increased the risk of treatment discontinuation (HR of 0.88, 1.50, and 1.42). Conclusions: Although apparent in the primary analysis, we found no significant difference in the gender specific persistency after 12 months of first BIS treatment in MBD. Only co-medication, geographical and insurance aspects were associated with differences in discontinuation rates. Further studies are needed to investigate this clinically important relationship.Correspondence to:
Dr. Karel Kostev
IMS Health
Darmstädter Landstraße 108
60598 Frankfurt/Main, Germany
Email: [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 9/2014 (726-731)

Impact of comorbidities on the treatment of atopic dermatitis in clinical practice

Alexandra Werner-Busse¹, Karel Kostev², Guido Heine¹, and Margitta Worm¹

¹Department of Dermatology, Venereology and Allergology, Charité Universitätsmedizin Berlin, Berlin, and ²IMS Health Epidemiology and Pharmacovigilance, Frankfurt am Main, German
Background and aim: Atopic dermatitis is often associated with atopic comorbidities such as allergic rhinitis, allergic asthma and food allergy. The aim of the present study was to analyze treatment data pertaining to atopic dermatitis patients in Germany with regard to the presence of other atopic comorbidities in the primary care and to investigate whether the presence of atopic codiagnoses has an impact on the treatment of atopic dermatitis (AD) patients. Methods: We used data from the Disease Analyzer database (IMS HEALTH, Germany) including 1,631 physicians (general practitioners, dermatologists and pediatricians) and 3.3 million patients. 39,642 (7.5%) of these patients were treated by dermatologists, 17,124 (5.2%) by pediatricians and 15,774 (0.9%) by general practitioners and had a documented diagnosis of atopic dermatitis. Results: 46.4% of AD patients treated by general practitioners, 42.5% by dermatologists and 32.0% by pediatricians were codiagnosed with one defined atopic diseases (allergic asthma, urticaria, allergic rhinitis and food allergy). In patients without AD, the proportion of atopic diseases was significantly smaller (41.4% for those treated by general practitioners, 38.4% for those treated by dermatologists, 26.4% for those treated by pediatricians). AD patients with another atopic comorbidity received topical corticosteroids (CS) (42.5%) more frequently than those without comorbidity (46.4% vs. 41.4% for patients treated by general practitioners, 42.5% vs. 38.4% for patients treated by dermatologists, 32.0% vs. 26.4% for patients treated by pediatricians). The general practitioners and pediatricians prescribed systemic corticosteroids to 13.2% and 7.8% of AD patients with additional atopic diseases, while the rate was only 5.1% and 3.0% in patients without comorbidities. Conclusion: In AD patients, the share of patients diagnosed with atopic diseases is significantly higher than in patients without AD. AD outpatients with concomitant atopic comorbidities receive topical, but also systemic corticosteroid prescriptions more frequently.Correspondence to:
Dr. Karel Kostev
IMS Health – Epidemiologie and Pharmacovigilance
Darmstädter Straße 108
60598 Frankfurt am Main, Germany
Email: [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 11/2014 (933-939)

Treatment persistence evaluation of tamoxifen and aromatase inhibitors in breast cancer patients in early and late stage disease

Nina Schmidt¹, Karel Kostev¹,³, Achim Jockwig², Iannis Kyvernitakis³, Ute-Susann Albert³, and Peyman Hadji³

¹IMS Health, Frankfurt am Main, ²Fresenius University of Applied Sciences, Health and Social Faculty, Idstein, and ³Philipps-University of Marburg, Department of Gynecology, Gynecological Endocrinology and Oncology, Marburg, Germany
Background: The aim of our study was to analyze the persistence with tamoxifen (TAM) and aromatase inhibitors (AIs) in postmenopausal women with hormone-receptor-positive breast cancer (BC) in early and late stage disease. Methods: This study based on data from The IMS Oncology Analyzer (OA) including retrospective longitudinal patient treatment histories from diagnosis for all cancer types. 4,626 patients with a diagnosis of breast cancer with current or terminated treatment with TAM or AIs between January 2003 and March 2012 in Germany were included. Results: Our results indicate a significantly increased risk for treatment discontinuation for patients in the age groups of 41 – 50 and 51 – 60 years compared to older patients as well as in patients with a stage IV tumor compared to patients with lower stage tumors. If treatment was initiated by a gynecologist, patients are less likely to discontinue their therapy compared to treatment initiated by an oncologist. Furthermore, the risk of therapy break up was significantly lower in patients treated in an office-based setting compared to the reference group of patients treated in general hospitals. Conclusion: In conclusion, persistence with endocrine treatment in woman with hormone-receptor-positive breast cancer is low, especially in later stage disease, and needs to be significantly increased to improve outcome in clinical practice. Further research is required to understand this complex, but important aspect.Correspondence to:
Dr. Karel Kostev
Senior Research Advisor
CES LifeLink – Epidemiology and Pharmacovigilance
IMS HEALTH GmbH & Co. OHG
Darmstädter Landstraße 108
60598 Frankfurt am Main, Germany
Email: [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 53 – No. 2/2015 (107-114)

Association of time-to-levodopa with initial Parkinsonian medication: a retrospective cohort study

Jens Peter Reese¹,², Hajo Hamer², Wolfgang H. Oertel², Adam Strzelczyk², Ulrich O. Mueller¹, Christina Heilmaier³, and Karel Kostev⁴

¹Institute of Medical Sociology and Social Medicine, ²Department of Neurology, Philipps-University Marburg, Marburg, Germany, ³City Hospital Zuerich, Switzerland, and ⁴IMS Health, Epidemiology, Frankfurt, Germany
Objectives: To determine the initial distribution of medication in patients with de novo Parkinson’s disease (PD), to estimate the share of patients who not receive a recommended initial therapy according to current German guidelines, and to compare the time-to-levodopa. Methods: We used the Disease Analyzer database (IMS HEALTH), containing basic medical data from ~ 20 million patients in Germany. The primary outcome was the therapy change rate from initial treatment to levodopa estimated by Kaplan-Meier analyses. A Cox proportional hazards model was used to estimate the relationship between time-to-levodopa and confounders for a maximum follow-up of 10 years (between January 2002 and December 2011). Adjusted hazard ratios (HR) and 95% confidence intervals (CI) are presented for change-to-levodopa rate. Results: A representative sample of de-novo patients diagnosed with PD was drawn (n = 108,885). 71.8% of patients received levodopa as a first line treatment. 29,708 patients started with other anti-PD substances: 13.3% with dopamine agonists (DA), 3.6% with amantadine, 5.9% with anticholinergics, and 0.8% with monoamine oxidase B (MAO-B) inhibitors. Therefore, the proportion of patients who not receive a recommended initial therapy according to current German guidelines was ~ 10%. 29.0% of patients not starting with levodopa switched to levodopa within 5 years. After 5 years, more than 80% of PD patients using anticholinergics as their initial treatment remained levodopa-free. MAOB- inhibitors and DAs showed significantly lower proportions of levodopa-free patients after 5 years (35% and 55%, respectively). Compared to MAO-B inhibitors, the HR for switching to levodopa was 0.38 (CI 0.34 – 0.43; p < 0.001) for anticholinergics and 0.85 (CI 0.75 – 0.97; p = 0.017) for nonergot DA. Conclusions: Surprisingly, initial treatment with anticholinergics is correlated with the longest delay of levodopa treatment among all monotherapies. Our results suggest re-evaluating the comparative effectiveness of all initial PD treatments in head-tohead comparisons.Correspondence to:
Dr. Karel Kostev
IMS Health, Epidemiology
Darmstädter Str. 108, 60598 Frankfurt, Germany
Email: [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 54 – No. 5/2016 (323-329)

Persistence with antidepressant drugs in patients with dementia: a retrospective database analysis

Anke Booker¹, Jens Bohlken², Michael A. Rapp³, and Karel Kostev¹

¹Epidemiology and Evidence Based Medicine, Real World Evidence Solutions, IMS Health, Frankfurt, ²Praxis Bohlken, Berlin, and ³Social and Preventive Medicine, University of Potsdam, Potsdam, Germany
Background: The aims of the present study are to determine what proportion of patients with dementia receives antidepressants, how long the treatment is administered, and what factors increase the risk of discontinuation. Methods: The study was based on Disease Analyzer database and included 1,203 general practitioners (GP) and 209 neurologists/psychiatrists (NP). 12,281 patients with a diagnosis of dementia and an initial prescription of an antidepressant drug between January 2004 and December 2013 were included. The main outcome measure was antidepressant discontinuation rates within 6 months of the index date. Results: After 6 months of follow-up, 52.7% of dementia patients treated with antidepressants had stopped medication intake. There was a significantly decreased risk for treatment discontinuation for patients using selective serotonin reuptake inhibitors (SSRRIs) or serotonin and norepinephrine reuptake inhibitors (SSNRIs) compared to tricyclic antidepressants. There was a significantly increased risk of treatment discontinuation for older patients and patients treated in NP practice. Comorbidity of diabetes or history of stroke was associated with a decreased risk of treatment discontinuation. Conclusion: The study results show insufficient persistence in antidepressant treatment in dementia patients in a real world setting. The improvement must be achieved to ensure the treatment recommended in the guidelines.Correspondence to:
Prof. Dr. rer. med. Karel Kostev
Epidemiology and Evidence Based Medicine
Real World Evidence Solutions
IMS HEALTH GmbH & Co. OHG
Darmstädter Landstraße 108
60598 Frankfurt am Main, Germany
Email: [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 54 – No. 8/2016 (557-563)

Treatment of depression in patients with cardiovascular diseases by German psychiatrists

Marcel Konrad¹, Louis Jacob², Michael A. Rapp³, and Karel Kostev⁴

¹Fresenius University of Applied Sciences, Idstein, Germany, ²Department of Biology, École Normale Supérieure de Lyon, Lyon, France, ³Department of Social and Preventive Medicine, University of Potsdam, Potsdam, and ⁴IMS Health, Frankfurt am Main, Germany
Objective: To estimate the prevalence and the type of antidepressant medication prescribed by German psychiatrists to patients with depression and cardiovascular diseases (CVD). Methods: This study was a retrospective database analysis in Germany using the Disease Analyzer Database (IMS Health, Germany). The study population included 2,288 CVD patients between 40 and 90 years of age from 175 psychiatric practices. The observation period was between 2004 and 2013. Follow-up lasted up to 12 months and ended in April 2015. Also included were 2,288 non-CVD controls matched (1 : 1) to CVD cases on the basis of age, gender, health insurance coverage, depression severity, and diagnosing physician. Results: Mean age was 68.6 years. 46.2% of patients were men, and 5.9% had private health insurance coverage Mild, moderate, or severe depression was present in 18.7%, 60.7%, and 20.6% of patients, respectively. Most patients had treatment within a year, many of them immediately after depression diagnosis. Patients with moderate and severe depression were more likely to receive treatment than patients with mild depression. There was no difference between CVD and non-CVD in the proportion of patients treated. Nonetheless, CVD patients received selective serotonin reuptake inhibitors / serotonin-noradrenaline reuptake inhibitors (SSRIs/SNRIs) significantly more frequently. Conversely, patients without CVD were more often treated with TCA. Conclusion: There was no association between CVD and the initiation of depression treatment. Furthermore, CVD patients received SSRIs/SNRIs more frequently.Correspondence to:
Prof. Dr. rer. med. Karel Kostev
Epidemiology, Real World Evidence Solutions
IMS HEALTH GmbH & Co. OHG
Darmstädter Landstraße 108
60598 Frankfurt am Main, Germany
Email: [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 54 – No. 10/2016 (743-749)

Prevalence and type of antidepressant therapy used by German general practitioners to treat female patients with osteoporosis 

Julia Drosselmeyer¹, Michael Rapp², Karel Kostev³ 

¹Fresenius University of Applied Sciences, Idstein, ²Department of Social and Preventive Medicine, University of Potsdam, Potsdam, and ³IMS Health, Frankfurt am Main, Germany
Objective: To estimate the prevalence and type of antidepressant medication prescribed by German primary care physicians for patients with depression and osteoporosis. Methods: This study was a retrospective database analysis conducted in Germany utilizing the Disease Analyzer^® Database (IMS Health, Germany). The study population included 3,488 female osteoporosis patients aged between 40 and 90 years recruited from 1,179 general practitioner practices and who were initially diagnosed with depression during the index period (January 2004 to December 2013). Follow-up lasted up to 12 months and was completed in August 2015. Also included in this study were 3,488 nonosteoporosis controls who were matched (1 : 1) to osteoporosis cases on the basis of age, health insurance coverage, severity of depression, and physician carrying out the diagnosis. Results: After 12 months of follow-up, 30.1% of osteoporosis and 29.9% of nonosteoporosis patients with mild depression (p = 0.783), 52.4% of osteoporosis and 48.0% of non-osteoporosis patients with moderate depression (p = 0.003), and 39.4% of osteoporosis and 35.1% of nonosteoporosis patients with severe depression (p = 0.147) were being treated with antidepressants. Osteoporosis patients with moderate depression had a higher chance of being prescribed antidepressant therapy at the initial diagnosis (hazard ratio (HR): 1.12, p = 0.014). No differences were found between osteoporosis and nonosteoporosis patients regarding the proportion of patients receiving selective serotonin reuptake inhibitors (SSRI)/serotonin-noradrenaline reuptake inhibitors (SNRI), tricyclic antidepressant (TCA), or other antidepressants. Osteoporosis patients were more often referred to hospitals or psychiatrists for consultation. Conclusion: Osteoporosis patients are more often treated initially with antidepressants than non-osteoporosis patients, especially within the groups of patients with moderate or severe depression. TCA was the most frequently used antidepressant therapy class on initial diagnosis in both patient groups. Osteoporosis patients receive referrals to hospitals or psychiatrists more often than patients without osteoporosis. Correspondence to:
Prof. Dr. Karel Kostev
Senior Research Adviser
IMS Health – Epidemiology
Darmstäder Landstraße 108
60598 Frankfurt am Main, Germany
Email: [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 54 – No. 11/2016 (835-840)

Persistence with antipsychotics in dementia patients in Germany 

Anke Booker¹, Louis Jacob², Jens Bohlken³, Michael Rapp⁴, Karel Kostev¹ 

¹IMS Health, Epidemiology, Frankfurt, Germany, ²Department of Biology, Ecole Normale Supérieure de Lyon, Lyon, France, ³Psychiatric Practice Bohlken, Berlin, and ⁴Department of Social and Preventive Medicine, University of Potsdam, Potsdam, Germany
Background/Aims: To analyze the duration of treatment with antipsychotics in German dementia patients. Methods: This study included patients aged 60 years and over with dementia who received a first-time antipsychotic prescription by psychiatrists between 2009 and 2013. The main outcome measure was the treatment rate for more than 6 months following the index date. Results: A total of 12,979 patients with dementia (mean age 82 years, 52.1% living in nursing homes) were included. After 2 years of follow-up, 54.8%, 57.2%, 61.1%, and 65.4% of patients aged 60 – 69, 70 – 79, 80 – 89, and 90 – 99 years, respectively, received antipsychotic prescriptions. 63.9% of subjects living in nursing homes and 55.0% of subjects living at home also continued their treatment (p-value < 0.001). Conclusion: The percentage of dementia patients treated with antipsychotics is very high. Correspondence to:
Prof. Dr. rer. med. Karel Kostev
Epidemiology, Real World Evidence Solutions
IMS HEALTH GmbH & Co. OHG
Darmstädter Landstraße 108
60598 Frankfurt am Main, Germany 
Email: [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 55 – No. 1/2017 (9-15)

Prescription patterns and drug costs in German patients with dementia in nursing homes and home-care settings 

Louis Jacob¹, Jens Bohlken², Karel Kostev³ 

¹Department of Biology, École Normale Supérieure de Lyon, Lyon, France, ²Praxis Bohlken, Berlin, Germany, and ³IMS Health, Real World Evidence Solutions, Frankfurt, Germany
Aims: To analyze prescription patterns and drug costs in German patients with dementia who are in home-care settings and nursing homes. Methods: The present retrospective study based on the Disease Analyzer epidemiological database and included 41,064 patients treated by general practitioners (GPs) and 20,649 patients treated by psychiatric practitioners (PPs), who were diagnosed with dementia in 2014. Four different types of antidementia therapy were included in the analysis. The shares of prescriptions and the associated costs in dementia patients in home-care settings and nursing homes were estimated. Regression analyses were performed to study the impact of the type of residence on the likelihood of receiving a defined therapy and incurring its associated cost. Results: Antidementives were more frequently prescribed to patients in home-care settings, whereas antidepressants, antipsychotics, and benzodiazepines were more commonly administered to nursing-home patients in both the GP and the PP groups. Individuals residing in nursing homes had a lower likelihood of receiving antidementives but exhibited a higher likelihood of being prescribed antidepressants, antipsychotics, and benzodiazepines. The total cost of therapy was higher in nursing homes than in home-care settings (GPs: difference of € 27.20; PPs: difference of € 107.90). The cost of antidementives was significantly lower in GP patients residing in nursing homes than in GP patients living at home. There was no significant difference in the cost of antidementives in the PP groups. By contrast, the costs of the three other families of drugs were lower in individuals cared for at home than in individuals residing in nursing homes, in both practice types. Conclusion: Prescription patterns and the drug costs in dementia patients significantly differed between home-care settings and nursing-home settings. Correspondence to:
Prof. Dr. Karel Kostev
IMS Health, Epidemiology
Darmstädter Landstraße 1089
60598 Frankfurt am Main, Germany 
Email: kkostev@ de.imshealth.com

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 55 – No. 2/2017 (119-125)

Treatment persistence in the use of basal insulins in Poland and Germany 

Wolfgang Rathmann¹, Marcin Czech², Edward Franek³, Karel Kostev⁴ 

¹Institute of Biometrics and Epidemiology, German Diabetes Center, Leibniz Center for Diabetes Research at Heinrich Heine University, Duesseldorf, Germany,  ²Real World Evidence, IMS Health, Warsaw, ³Mossakowski Medical Research Center, Polish Academy of Sciences, Warsaw, Poland, and ⁴Epidemiology, IMS Health, Frankfurt am Main, Germany 
Aims: To compare short-term basal insulin therapy persistence and its predictors in Poland and Germany. Methods: Persistence was defined as proportions of patients remaining on the initial basal insulin (analogs: Poland: n = 6,889, Germany: n = 454,067; neutral protamine Hagedorn (NPH) insulins: Poland: n = 50,761, Germany: n = 226,064) over 2 years based on nationwide prescription databases (LRx; IMS Health) in Poland and Germany from 2013 to 2015. Persistence was evaluated by Kaplan-Meier curves (log-rank tests). Risk of discontinuation of initial basal insulin was investigated using Cox regression models adjusting for age, sex, comedication with other glucose-lowering agents and baseline or comedication with antihypertensives, lipid-lowering drugs, antidepressants, and antiepileptics. Results: In Poland, 2-year persistence was 83.0% in analog insulin and 73.3% in NPH users (p < 0.001). In Germany, persistence was also higher in patients with analog insulins (92.6% vs. 79.0%; p < 0.001). Analog insulin users were less likely to discontinue basal insulin compared with NPH users (adjusted hazard ratio (95%CI): Poland: 0.73 (0.67 – 0.79); Germany: 0.27 (0.27 – 0.28)). Higher age (> 75 vs. ≤ 60 years: Poland: 1.24 (1.16 – 1.33), Germany: 1.09 (1.07 – 1.11)) and GLP-1 receptor agonist use (Poland: 2.76 (1.38 – 5.53), Germany: 1.21 (1.16 – 1.26)) were related to higher risk of discontinuation. Male sex, metformin, sulfonylurea, thiazolidinedione, and short-acting insulin prescriptions as well as antihypertensive, antiepileptic, and lipid-lowering drug use were associated with lower risk of discontinuation in both countries (all p < 0.05). Conclusions: This real-world study shows that both in Poland and Germany treatment persistence of newly-prescribed basal insulin is influenced by type of insulin (analog vs. NPH) and by glucose-lowering and other comedications. Correspondence to:
Prof. Dr. rer. med.  Karel Kostev
Epidemiology IMS HEALTH GmbH & Co. OHG
Darmstädter Landstraße 108
60598 Frankfurt am Main 
Email: [email protected]

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 55 – No. 3/2017 (203-209)

Risk of dementia in German patients treated with antidepressants in general or psychiatric practices 

Louis Jacob¹, Jens Bohlken², and Karel Kostev³ 

¹Faculty of medicine, University of Paris ⁵, Paris, France, ²Psychiatric Practice Bohlken, Berlin, and ³IMS Health, Epidemiology, Frankfurt am Main, Germany
Aims: To study the impact of the use of antidepressants on dementia in German patients with depression treated in general (GPs) or psychiatric practices (PPs). Methods: Patients with a first-time documentation of depression with known severity level between 2010 and 2013 (index date) were identified by 1,126 general practitioners and 176 psychiatrists in the IMS Disease Analyzer database. We included patients between the ages of 60 and 80 years who had not previously received prescriptions for antidepressant drugs and had not been diagnosed with all-cause dementia prior to or on the index date. The main outcome of the study was the risk of dementia depending on antidepressant therapy. Cox proportional hazards models (dependent variable: incident dementia) were used to adjust for confounders and to estimate the effect of antidepressant therapy. Results: A total of 22,838 patients treated in GPs and 33,112 patients treated in PPs were included in this study. Of those, 9,570, 30,321, and 16,059 individuals suffered from mild, moderate, and severe depression, respectively. Antidepressant drug use was associated with a decreased risk of dementia in patients affected by moderate (HR = 0.86, 95% CI: 0.77 – 0.95) or severe depression (HR = 0.83, 95% CI: 0.73 – 0.94). Conclusion: The use of antidepressants decreased dementia risk in patients with moderate or severe depression. Correspondence to:
Prof. Dr. Karel Kostev
IMS Health, Epidemiology
Darmstädter Landstraße 108,
60598 Frankfurt am Main, Germany 
Email: kkostev@ de.imshealth.com

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 55 – No. 5/2017 (394-396)

Prevalence of bisphosphonate therapy in women with breast cancer treated with aromatase inhibitors in Germany 

Louis Jacob¹, Karel Kostev², Peyman Hadji³ 

¹Faculty of Medicine, University of Paris ⁵, Paris, France, ²Department of Epidemiology, IMS Health, Frankfurt, and ³Department of Bone Oncology, Endocrinology and Reproductive Medicine, Nordwest Hospital, Frankfurt, Germany 
Purpose: The aim of this study is to analyze the prevalence of bisphosphonate therapy in women with breast cancer (BC) treated with aromatase inhibitors (AI) in Germany. Methods: We included women with BC who started AI therapy between January 2005 and December 2014 (index date) and were followed for a maximum of 24 months. The number of women who received at least one prescription of bisphosphonate during AI therapy was calculated. Results: A total of 6,959 women with BC who received AI therapy between 2005 and 2014 were analyzed. Of these, only 202 (2.9%) received bisphosphonates. Conclusions: The prevalence of bisphosphonate use was low in women with BC treated with AI. Correspondence to:
Prof. Dr. rer. med.  Karel Kostev 
Epidemiology, IMS Health
Darmstädter Landstraße 108
60598 Frankfurt am Main, Germany 
Email: kkostev@ de.imshealth.com

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