Impact of angiotensin receptor blocker product recalls on antihypertensive prescribing in Germany

Rudolph, U.; Enners, Salka; Kieble, Marita; Mahfoud, Felix; Böhm, Michael; Laufs, Ulrich; Schulz, Martin

doi:10.1038/s41371-020-00425-z

Cited by 18 publications

(18 citation statements)

References 25 publications

(43 reference statements)

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“…Similarly, an analysis conducted in Germany by Rudolph et al found an increase in alternative ARBs after the valsartan recall, but no difference in utilization of other antihypertensive classes occurred. 23 The difference in medication changes seen between the present study and other studies could be attributed to the fact that a large proportion of the patients in the present study were on valsartan 320 mg tablets. Valsartan 320 mg tablets do not have equivalent dosing when converting to losartan, which is the other preferred formulary alternative by the VA PBM.…”

Section: Discussioncontrasting

confidence: 68%

Impact of national valsartan recalls on Veterans’ outcomes

Morizio

Britnell

Ottman

2021

Therapeutic Advances in Drug Safety

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Background and Aims: Chemical impurities discovered in angiotensin receptor blocker (ARB) products in late 2018–2019 resulted in recalls of various products and has likely had downstream effects for patients and prescribers. The purpose of this study is to determine how the valsartan recall impacted clinical endpoints and prescribing of antihypertensives. Methods: This was a retrospective, single-center, cohort study including patients receiving recalled valsartan with essential hypertension who were mailed a recall letter on 12 March 2019. Mean blood pressure endpoints were collected 6 months before (pre-recall) and after the recall letter was mailed (post-recall). Antihypertensive medication changes and titrations were also characterized post-recall. Results: A total of 300 patients meeting eligibility criteria were included. There was no statistically significant difference in mean systolic blood pressure (SBP) or diastolic blood pressure (DBP) when pre- and post-recall blood pressures were compared (SBP: 137.2 mmHg versus 135.8 mmHg, p = 0.125; DBP: 78.6 mmHg versus 78.5 mmHg, p = 0.900). In addition, the percentage of patients with controlled blood pressure readings was similar in the pre- and post-recall timeframes (28% versus 27%, p = 0.72). A total of 33 medication changes involving valsartan occurred, with approximately one-third being changed to another ARB ( n = 11) or drug class ( n = 12). In total, 11 valsartan medication changes were specifically documented to be related to the valsartan recall. Conclusion: The results of this study indicate the valsartan recalls that occurred in 2019 did not significantly impact the clinical outcomes of the studied population. Plain Language Summary Impact of a medication recall on Veterans’ outcomes Background: Chemical impurities discovered in a class of blood pressure medications known as angiotensin receptor blockers (ARBs) occurred in late 2018–2019. This resulted in recalls of various products and has likely had downstream effects for patients and prescribers. Objective: The purpose of this study is to determine how the recall of valsartan, which is a medication in the ARB class, impacted clinical endpoints and prescribing of medications for blood pressure. Methods: This was a retrospective, single-center, cohort study including patients receiving recalled valsartan with high blood pressure who were mailed a recall letter on 12 March 2019. Blood pressure endpoints were collected 6 months before (pre-recall) and after the recall letter was mailed (post-recall). Medication changes and titrations were also characterized post-recall. Results: Three hundred patients meeting eligibility criteria were included. There was no difference found in systolic blood pressure (SBP) or diastolic blood pressure (DBP) when pre- and post-recall blood pressures were compared (SBP: 137.2 mmHg versus 135.8 mmHg; DBP: 78.6 mmHg versus 78.5 mmHg). In addition, the percent of patients with controlled blood pressure readings was similar in the pre- and post-recall timeframes (28% versus 27%). A total of 33 medication changes involving valsartan occurred, with approximately one-third being changed to another ARB ( n = 11) or drug class ( n = 12). Eleven valsartan medication changes were specifically documented to be related to the valsartan recall. Conclusions: The results of this study indicate the valsartan recalls that occurred in 2019 did not significantly impact the clinical outcomes of the studied population.

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Section: Discussioncontrasting

confidence: 68%

Impact of national valsartan recalls on Veterans’ outcomes

Morizio

Britnell

Ottman

2021

Therapeutic Advances in Drug Safety

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“…Drug prescriptions were analyzed using the database of the German Institute for Drug Use Evaluation (DAPI), which contains anonymous dispensing data of community pharmacies claimed to the statutory health insurance (SHI) funds and thus covers 88% of Germany's population, that is, approximately 73.3 million people. 22 All claims data from a representative sample of more than 80% (until June 2019) and more than 95% (from July 2019 onwards) of community pharmacies were available. The data were extrapolated by regional factors to 100% of the SHI‐insured population.…”

Section: Methodsmentioning

confidence: 99%

Utilization of drugs with reports on potential efficacy or harm on COVID‐19 before, during, and after the first pandemic wave

Enners¹,

Gradl²,

Kieble³

et al. 2021

Pharmacoepidemiology and Drug

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Purpose Conflicting information on potential benefits of drugs as well as reports on hypothetical harm of commonly used drugs in COVID‐19 treatment have challenged clinicians and healthcare systems. We analyzed the change in ambulatory drug utilization before, during, and after the first wave of the pandemic in 2020. Methods We explored dispensing data of nearly 19 000 pharmacies at the expense of the statutory health insurance funds covering 88% of Germany's population. We analyzed utilization of publicly discussed drugs with conflicting information. Drug utilization as number of packages dispensed per week from January to June 2020, reflecting 314 million claims, was compared with 2019. Results Utilization of hydroxychloroquine increased +110% during March 2020 and then slightly decreased until week April 13–19. Renin–angiotensin–aldosterone system inhibitors and simvastatin/atorvastatin increased, +78% and +74%, respectively, and subsequently decreased below 2019 levels. Utilization of azithromycin and all systemic antibiotics decreased continuously from March 2–8 until June to levels considerably lower compared to 2019 (June 22–28: azithromycin: −55%, all systemic antibiotics: −27%). Pneumococcal vaccines utilization initially increased +373%, followed by supply shortages. Paracetamol utilization showed an initial increase of +111%, mainly caused by an increase of over‐the‐counter dispensings. Conclusions Apart from the pandemic itself, the data suggest that dissemination of misinformation and unsound speculations as well as supply shortages influenced drug prescribing, utilization, and purchasing behavior. The findings can inform post‐pandemic policy to prevent unfounded over‐ and underprescribing and off‐label use as well as drug shortages during a public health crisis.

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“…The database contains anonymized dispensing data on medications prescribed at the expense of the statutory health insurance (SHI) funds. The available data were extrapolated by regional factors to represent all SHI-insured persons (approximately 88% of the total German population—that is, 73.3 million people) ( 6 , 10 ). Prescriptions for privately insured patients are not covered, and no data on individual patients, treatment indication, duration, or dosages were available.…”

Section: Methodsmentioning

confidence: 99%

Trends in Ezetimibe Prescriptions as Monotherapy or Fixed-Dose Combination in Germany 2012–2021

Katzmann

Kieble²,

Enners³

et al. 2022

Front. Cardiovasc. Med.

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AimsAddition of ezetimibe to statin therapy is recommended by current guidelines when low-density lipoprotein cholesterol (LDL-C) targets are not achieved with statin monotherapy. Fixed-dose combinations (FDC) improve medication adherence and facilitate risk factor control. We assessed prescription trends of ezetimibe as monotherapy or FDC with statins.MethodsData from the German Institute for Drug Use Evaluation (DAPI) containing dispensing data of >80% of community pharmacies were analyzed. Prescriptions over time of lipid-lowering agents at the expense of the statutory health insurance (SHI) were extrapolated to all SHI-insured persons, representing approximately 88% of the total German population. Drug utilization was expressed as defined daily doses per 1,000 SHI-insured persons per day (DID).ResultsOf all lipid-lowering drug prescriptions in 2021, 91.2% were statin monotherapy. Ezetimibe was prescribed as monotherapy or FDC with statin in 4.4 and 2.9%, respectively. DID steadily increased for statin (69%) and ezetimibe (424%) monotherapies between 2012 and 2021. In contrast, statin-ezetimibe FDC prescriptions exhibited only a minor increase (29%). The proportion of statin-ezetimibe FDC among all statin prescriptions was stable over time at approximately 3%. FDC prescription rates by specialists were higher compared to general practitioners and varied considerably between geographic areas.ConclusionCombination lipid-lowering therapy is prescribed to a minority of patients. Prescriptions of ezetimibe as monotherapy increased to a much greater extent than statin-ezetimibe FDC. Considering the low proportion of patients achieving their LDL-C target and improved adherence to FDC compared to separate pills, statin-ezetimibe FDC may be utilized to improve the management of dyslipidemia.

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Impact of angiotensin receptor blocker product recalls on antihypertensive prescribing in Germany

Cited by 18 publications

References 25 publications

Impact of national valsartan recalls on Veterans’ outcomes

Impact of national valsartan recalls on Veterans’ outcomes

Utilization of drugs with reports on potential efficacy or harm on COVID‐19 before, during, and after the first pandemic wave

Trends in Ezetimibe Prescriptions as Monotherapy or Fixed-Dose Combination in Germany 2012–2021

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