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

Autor: Daisuke Inoue, Ryo Okazaki, Ryoichi Muraoka, Yoshiki Nishizawa, Toshitsugu Sugimoto
Jazyk: angličtina
Rok vydání: 2015
Předmět:
0301 basic medicine
Adult
Male
medicine.medical_specialty
Bone density
Endocrinology
Diabetes and Metabolism
medicine.medical_treatment
Osteoporosis
030209 endocrinology & metabolism
Comorbidity
Gastroenterology
Bone remodeling
03 medical and health sciences
0302 clinical medicine
Endocrinology
Double-Blind Method
Japan
Bone Density
Internal medicine
Post-hoc analysis
medicine
Bone mineral density
Diabetes Mellitus
Bisphosphonate
Humans
Orthopedics and Sports Medicine
Life style-related disease
Original Research
Aged
Dyslipidemias
Bone mineral
Metabolic Syndrome
Risedronate
Bone Density Conservation Agents
business.industry
Middle Aged
medicine.disease
Risedronate Sodium
030104 developmental biology
Metabolic syndrome
Bone turnover markers
Hypertension
Female
business
Risedronic Acid
Dyslipidemia
Zdroj: Calcified Tissue International
ISSN: 1432-0827
0171-967X
Popis: 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. Electronic supplementary material The online version of this article (doi:10.1007/s00223-015-0071-9) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
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