Incidence of diabetes following ramipril or rosiglitazone withdrawal

Rury R. Holman, Bernie Zinman, Salim Yusuf, Patrick M. Sheridan, Sonia S. Anand, Jackie J. Bosch, Ignacio Conget, Melanie J. Davies, Valdis Pirags, Gilles R. Dagenais, Janice M. Pogue, Paul Z. Zimmet, Hertzel C. Gerstein

Research output: Contribution to journalArticle

19 Citations (Scopus)

Abstract

OBJECTIVE - To examine the impact of withdrawing rosiglitazone and ramipril medication on diabetes incidence after closeout of the Diabetes REduction Assessment with ramipril and rosiglitazone Medication (DREAM) trial. RESEARCH DESIGN AND METHODS - The 3,366 DREAM subjects at trial end who had not developed diabetes while taking double-blind study medication were transferred to single-blind placebo for 2 to 3months before undergoing an oral glucose tolerance test. Glycemic status was analyzed for the trial plus washout period and for the washout period alone. RESULTS - Following median (interquartile range) 71 (63-86) days drug withdrawal, overall glycemic status remained modestly improved in those allocated ramipril during the trial with an 11% increase in regression to normoglycemia, compared with placebo. In those previously allocated rosiglitazone, glycemic status remained substantially improved with a 49% reduction of new-onset diabetes or death and a 22% increase in regression to normoglycemia, compared with placebo. However, during the washout phase alone the incidence of diabetes or death was identical for those allocated previously to ramipril or placebo, or to rosiglitazone or placebo. CONCLUSIONS - In people allocated to ramipril comparedwith those not allocated ramipril during the trial, the postwashout normoglycemia incidence was higher. In people allocated to rosiglitazone compared with those not allocated rosiglitazone during the trial, the postwashout incidence of diabetes was significantly lower and the incidence of normoglycemia was higher. During the washout period, diabetes incidence was the same for ramipril versus placebo and for rosiglitazone versus placebo. Rosiglitazone delays disease progression during treatment but the process resumes at the placebo rate when the drug is stopped.

LanguageEnglish
Pages1265-1269
Number of pages5
JournalDiabetes Care
Volume34
Issue number6
DOIs
Publication statusPublished - 1 Jun 2011
Externally publishedYes

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Advanced and Specialised Nursing

Cite this

Holman, R. R., Zinman, B., Yusuf, S., Sheridan, P. M., Anand, S. S., Bosch, J. J., ... Gerstein, H. C. (2011). Incidence of diabetes following ramipril or rosiglitazone withdrawal. Diabetes Care, 34(6), 1265-1269. https://doi.org/10.2337/dc10-1567
Holman, Rury R. ; Zinman, Bernie ; Yusuf, Salim ; Sheridan, Patrick M. ; Anand, Sonia S. ; Bosch, Jackie J. ; Conget, Ignacio ; Davies, Melanie J. ; Pirags, Valdis ; Dagenais, Gilles R. ; Pogue, Janice M. ; Zimmet, Paul Z. ; Gerstein, Hertzel C. / Incidence of diabetes following ramipril or rosiglitazone withdrawal. In: Diabetes Care. 2011 ; Vol. 34, No. 6. pp. 1265-1269.
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abstract = "OBJECTIVE - To examine the impact of withdrawing rosiglitazone and ramipril medication on diabetes incidence after closeout of the Diabetes REduction Assessment with ramipril and rosiglitazone Medication (DREAM) trial. RESEARCH DESIGN AND METHODS - The 3,366 DREAM subjects at trial end who had not developed diabetes while taking double-blind study medication were transferred to single-blind placebo for 2 to 3months before undergoing an oral glucose tolerance test. Glycemic status was analyzed for the trial plus washout period and for the washout period alone. RESULTS - Following median (interquartile range) 71 (63-86) days drug withdrawal, overall glycemic status remained modestly improved in those allocated ramipril during the trial with an 11{\%} increase in regression to normoglycemia, compared with placebo. In those previously allocated rosiglitazone, glycemic status remained substantially improved with a 49{\%} reduction of new-onset diabetes or death and a 22{\%} increase in regression to normoglycemia, compared with placebo. However, during the washout phase alone the incidence of diabetes or death was identical for those allocated previously to ramipril or placebo, or to rosiglitazone or placebo. CONCLUSIONS - In people allocated to ramipril comparedwith those not allocated ramipril during the trial, the postwashout normoglycemia incidence was higher. In people allocated to rosiglitazone compared with those not allocated rosiglitazone during the trial, the postwashout incidence of diabetes was significantly lower and the incidence of normoglycemia was higher. During the washout period, diabetes incidence was the same for ramipril versus placebo and for rosiglitazone versus placebo. Rosiglitazone delays disease progression during treatment but the process resumes at the placebo rate when the drug is stopped.",
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Holman, RR, Zinman, B, Yusuf, S, Sheridan, PM, Anand, SS, Bosch, JJ, Conget, I, Davies, MJ, Pirags, V, Dagenais, GR, Pogue, JM, Zimmet, PZ & Gerstein, HC 2011, 'Incidence of diabetes following ramipril or rosiglitazone withdrawal', Diabetes Care, vol. 34, no. 6, pp. 1265-1269. https://doi.org/10.2337/dc10-1567

Incidence of diabetes following ramipril or rosiglitazone withdrawal. / Holman, Rury R.; Zinman, Bernie; Yusuf, Salim; Sheridan, Patrick M.; Anand, Sonia S.; Bosch, Jackie J.; Conget, Ignacio; Davies, Melanie J.; Pirags, Valdis; Dagenais, Gilles R.; Pogue, Janice M.; Zimmet, Paul Z.; Gerstein, Hertzel C.

In: Diabetes Care, Vol. 34, No. 6, 01.06.2011, p. 1265-1269.

Research output: Contribution to journalArticle

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T1 - Incidence of diabetes following ramipril or rosiglitazone withdrawal

AU - Holman, Rury R.

AU - Zinman, Bernie

AU - Yusuf, Salim

AU - Sheridan, Patrick M.

AU - Anand, Sonia S.

AU - Bosch, Jackie J.

AU - Conget, Ignacio

AU - Davies, Melanie J.

AU - Pirags, Valdis

AU - Dagenais, Gilles R.

AU - Pogue, Janice M.

AU - Zimmet, Paul Z.

AU - Gerstein, Hertzel C.

PY - 2011/6/1

Y1 - 2011/6/1

N2 - OBJECTIVE - To examine the impact of withdrawing rosiglitazone and ramipril medication on diabetes incidence after closeout of the Diabetes REduction Assessment with ramipril and rosiglitazone Medication (DREAM) trial. RESEARCH DESIGN AND METHODS - The 3,366 DREAM subjects at trial end who had not developed diabetes while taking double-blind study medication were transferred to single-blind placebo for 2 to 3months before undergoing an oral glucose tolerance test. Glycemic status was analyzed for the trial plus washout period and for the washout period alone. RESULTS - Following median (interquartile range) 71 (63-86) days drug withdrawal, overall glycemic status remained modestly improved in those allocated ramipril during the trial with an 11% increase in regression to normoglycemia, compared with placebo. In those previously allocated rosiglitazone, glycemic status remained substantially improved with a 49% reduction of new-onset diabetes or death and a 22% increase in regression to normoglycemia, compared with placebo. However, during the washout phase alone the incidence of diabetes or death was identical for those allocated previously to ramipril or placebo, or to rosiglitazone or placebo. CONCLUSIONS - In people allocated to ramipril comparedwith those not allocated ramipril during the trial, the postwashout normoglycemia incidence was higher. In people allocated to rosiglitazone compared with those not allocated rosiglitazone during the trial, the postwashout incidence of diabetes was significantly lower and the incidence of normoglycemia was higher. During the washout period, diabetes incidence was the same for ramipril versus placebo and for rosiglitazone versus placebo. Rosiglitazone delays disease progression during treatment but the process resumes at the placebo rate when the drug is stopped.

AB - OBJECTIVE - To examine the impact of withdrawing rosiglitazone and ramipril medication on diabetes incidence after closeout of the Diabetes REduction Assessment with ramipril and rosiglitazone Medication (DREAM) trial. RESEARCH DESIGN AND METHODS - The 3,366 DREAM subjects at trial end who had not developed diabetes while taking double-blind study medication were transferred to single-blind placebo for 2 to 3months before undergoing an oral glucose tolerance test. Glycemic status was analyzed for the trial plus washout period and for the washout period alone. RESULTS - Following median (interquartile range) 71 (63-86) days drug withdrawal, overall glycemic status remained modestly improved in those allocated ramipril during the trial with an 11% increase in regression to normoglycemia, compared with placebo. In those previously allocated rosiglitazone, glycemic status remained substantially improved with a 49% reduction of new-onset diabetes or death and a 22% increase in regression to normoglycemia, compared with placebo. However, during the washout phase alone the incidence of diabetes or death was identical for those allocated previously to ramipril or placebo, or to rosiglitazone or placebo. CONCLUSIONS - In people allocated to ramipril comparedwith those not allocated ramipril during the trial, the postwashout normoglycemia incidence was higher. In people allocated to rosiglitazone compared with those not allocated rosiglitazone during the trial, the postwashout incidence of diabetes was significantly lower and the incidence of normoglycemia was higher. During the washout period, diabetes incidence was the same for ramipril versus placebo and for rosiglitazone versus placebo. Rosiglitazone delays disease progression during treatment but the process resumes at the placebo rate when the drug is stopped.

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Holman RR, Zinman B, Yusuf S, Sheridan PM, Anand SS, Bosch JJ et al. Incidence of diabetes following ramipril or rosiglitazone withdrawal. Diabetes Care. 2011 Jun 1;34(6):1265-1269. https://doi.org/10.2337/dc10-1567