Crystalline Glucosamine Sulfate in the Treatment of Osteoarthritis: Evidence of Long-Term Cardiovascular Safety from Clinical Trials
Roberto Palma dos Reis 1, Giampaolo Giacovelli*, 2, Federica Girolami 2, Rui André 3, Albino Bonazzi 2, Lucio C Rovati 2
1 Cardiology Department, Hospital Pulido Valente, CHLN, Lisboa, Portugal
2 Department of Clinical Pharmacology, Rottapharm|Madaus, Monza, Italy
3 Rheumatology Service, Hospital Militar Principal, Lisboa, Portugal
Background and Objective:
Glucosamine is a safe and common treatment for osteoarthritis. Even so, literature data on the cardiovascular safety of glucosamine are limited. The objective of this paper is to investigate the long-term effects of crystalline glucosamine sulfate (CGS) on key measures of cardiovascular risk in patients with osteoarthritis.
We analyzed safety data from two long-term (6-month and 3-year, respectively) randomized controlled trials of CGS. Mean changes in blood pressure, lipids, and glucose were calculated for all patients randomized to CGS or placebo in either study and for subgroups with abnormally elevated baseline values. Shift tables were used to analyze transitions from normal to abnormal levels, or vice versa.
This analysis on 428 osteoarthritis patients includes data from subjects who had, on average, high normal blood pressure or high cholesterol at baseline. There were no significant changes in mean blood pressure after 6 months on CGS (systolic: -5±15 mmHg; diastolic: -5±10 mmHg) or placebo (systolic: -7±14 mmHg; diastolic: -4±10 mmHg). Subgroup analysis did not show significant effects in subjects with hypertension. Likewise, blood lipids (total/LDL cholesterol) and blood glucose did not change over 3 years and 6 months of treatment, respectively, even in hypercholesterolemic or hyperglycemic subjects. The proportions of patients whose blood pressure or cholesterol levels shifted from normal to abnormal, or vice versa, were comparable in the CGS and placebo groups.
Long-term use of CGS did not affect blood pressure, lipids, or glucose in patients with osteoarthritis. These findings further support the cardiovascular safety of CGS.
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* Address correspondence to this author at the Department of Clinical Pharmacology, Rottapharm|Madaus, via Valosa di Sopra 9, 20900 Monza, Italy; Tel: +39 0397390319; Fax: +39 0397390615; E-mail: email@example.com