Treatment of Patients Over 64 Years of Age With Type 2 Diabetes
Experience from nateglinide pooled database retrospective analysis
- Stefano Del Prato, MD1,
- Robert J. Heine, MD, PHD2,
- Leonard Keilson, MD, MPH3,
- Christiane Guitard, MD4,
- Sharon G. Shen, PHD5 and
- Rebecca P. Emmons, PHD4
- 1Department of Endocrinology and Metabolism, Section of Diabetes, University of Pisa, Italy
- 2Diabetes Center, VU University Medical Center, Amsterdam, The Netherlands
- 3Department of Medicine, Division of Cardiology, Maine Medical Center, Portland, Maine
- 4Novartis Pharma, Basel, Switzerland
- 5Novartis Pharmaceutical, East Hannover, New Jersey
- Address correspondence and reprint requests to Dr. Rebecca Emmons, Novartis Pharma AG, WSJ 27.5.73, CH4002 Basel, Switzerland. E-mail: rebecca.emmons{at}pharma.novartis.com.
Abstract
OBJECTIVE—To evaluate the impact of renal impairment (RI) (estimated creatinine clearance [Clcr] <60 ml/min per 1.73 m2) and low baseline HbA1c (<7.5%) on comorbidity in patients with type 2 diabetes, and to assess the efficacy and safety of nateglinide monotherapy in these patients and in subgroups of patients over age 64 years (elderly) and elderly with RI.
RESEARCH DESIGN AND METHODS—Retrospective subgroup analyses were performed on pooled data from all completed nateglinide studies (12 randomized, double blind trials and 1 open trial) in patients with type 2 diabetes. A total of 3,702 patients with ≥1 postbaseline safety evaluation received monotherapy with nateglinide (n = 2,204), metformin (n = 436), glyburide (n = 293), or placebo (n = 769). Efficacy (HbA1c) was evaluated in pooled data from four studies with similar design using 120 mg nateglinide (n = 544) versus placebo (n = 521). Evaluations were performed in the overall population and subgroups of patients over age 64 years. Specific considerations were given to RI, comorbidity, and baseline HbA1c.
RESULTS—Patients over age 64 years (n = 1,170) represented 31.6% of the study population. Undiagnosed RI was common in the elderly with 83.4% of all patients being in this subgroup. Patients over 64 years with RI had a higher prevalence of cardio- and microvascular comorbidity compared with the overall population and all patients over age 64 years. Statistically significant HbA1c reductions versus placebo were observed with nateglinide in patients over age 64 years and elderly with RI patients at study end point (−0.9% and −1.1% in each subgroup, P < 0.01). Nateglinide was well tolerated with a low incidence of hypoglycemia in all subgroups, including those with RI and low baseline HbA1c.
CONCLUSIONS—RI and comorbidity are common in patients over age 64 years with type 2 diabetes. Nateglinide was effective and well tolerated in all treated patients. In subgroups in which metformin and long-acting sulfonylureas must be used with caution, nateglinide had a low risk of adverse events and hypoglycemia.
- AE, adverse event
- BL, baseline
- Clcr, creatinine clearance
- FPG, fasting plasma glucose
- ITT, intent-to-treat
- RI, renal impairment
- SAE, serious adverse event
- SU, sulfonylurea
Footnotes
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S.D.P. has received honoraria from Novartis. R.J.H. is a member of the Novartis Academy advisory board and has received honoraria for speaking engagements from Novartis. C.G. holds stock in Novartis.
A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.
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- Accepted March 20, 2003.
- Received June 20, 2002.
- DIABETES CARE
