title: Efficacy and Safety of Risedronate in Osteoporosis Subjects with Comorbid Diabetes, Hypertension, and/or Dyslipidemia: A Post Hoc Analysis of Phase III Trials Conducted in Japan.
abstract: Many osteoporotics have comorbid diabetes mellitus (DM), hypertension (HT), and dyslipidemia (DL). However, whether such comorbidities alter response to anti-osteoporotic treatment is unknown. We did post hoc analyses of combined data from three risedronate Japanese phase III trials to determine whether the presence of DM, HT, or DL affects its efficacy and safety. Data from 885 subjects who received 48-week treatment with risedronate were collected and combined from the three phase III trials. They were divided into two groups by the presence or absence of comorbidities: DM (n = 53) versus non-DM (n = 832); HT (n = 278) versus non-HT (n = 607); and DL (n = 292) versus non-DL (n = 593). Bone mineral density (BMD), urinary type 1 collagen N-telopeptide (uNTX), and serum bone-specific alkaline phosphatase (BAP) were measured at baseline and sequentially until 48 weeks. BMD or bone markers were not different between any of the two groups. Overall, BMD was increased by 5.52%, and uNTX and BAP were decreased by 35.4 and 33.8%, respectively. Some bone markers were slightly lower in DM and DL subjects, but the responses to risedronate were not significantly different. Statin users had lower uNTX and BAP, but showed no difference in the treatment response. All the other medications had no apparent effect. Adverse event incidence was marginally higher in DL compared with non-DL (Relative risk 1.06; 95% confidence interval 1.01-1.11), but was not related to increase in any specific events. Risedronate shows consistent safety and efficacy in suppressing bone turnover and increasing BMD in osteoporosis patients with comorbid DM, HT, and/or DL.
authors.affiliation: Third Department of Medicine, Teikyo University Chiba Medical Center, 3426-3, Anesaki, Ichihara-shi, Chiba, 299-0111, Japan. inoued@med.teikyo-u.ac.jp.
authors.forename: Daisuke
authors.initials: D
authors.lastname: Inoue
authors.affiliation: Data Science Group, Clinical Development Department, Ajinomoto Pharmaceuticals Co., Ltd., Tokyo, Japan.
authors.forename: Ryoichi
authors.initials: R
authors.lastname: Muraoka
authors.affiliation: Third Department of Medicine, Teikyo University Chiba Medical Center, 3426-3, Anesaki, Ichihara-shi, Chiba, 299-0111, Japan.
authors.forename: Ryo
authors.initials: R
authors.lastname: Okazaki
authors.affiliation: Department of Metabolism, Endocrinology, and Molecular Medicine, Graduate School of Medicine, Osaka City University, Osaka, Japan.
authors.forename: Yoshiki
authors.initials: Y
authors.lastname: Nishizawa
authors.affiliation: First Department of Internal Medicine, Faculty of Medicine, Shimane University, Matsue, Shimane, Japan.
authors.forename: Toshitsugu
authors.initials: T
authors.lastname: Sugimoto
mesh_terms: D000328:Adult; D000368:Aged; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D015897:Comorbidity; D003920:Diabetes Mellitus / Q000453:epidemiology; D004311:Double-Blind Method; D050171:Dyslipidemias / Q000453:epidemiology; D005260:Female; D006801:Humans; D006973:Hypertension / Q000453:epidemiology; D007564:Japan / Q000453:epidemiology; D008297:Male; D024821:Metabolic Syndrome / Q000453:epidemiology*; D008875:Middle Aged; D010024:Osteoporosis / Q000150:complications / Q000188:drug therapy* / Q000453:epidemiology*; D000068296:Risedronic Acid / Q000627:therapeutic use*
chemical_list: D050071:Bone Density Conservation Agents; D000068296:Risedronic Acid
keywords: Bisphosphonate; Bone mineral density; Bone turnover markers; Life style-related disease; Metabolic syndrome; Risedronate