Tolerability of sibutramine during a 6-week treatment period in high-risk patients with cardiovascular disease and/or diabetes: a preliminary analysis of the Sibutramine Cardiovascular Outcomes (SCOUT) Trial.
Uncertainties about the cardiovascular safety of sibutramine led to the SCOUT trial that is investigating sibutramine plus weight management in high-risk, overweight/obese patients. A 6-week lead-in period during which all patients received sibutramine permitted an initial assessment of tolerability. A total of 10,742 patients received sibutramine and 3.1% of these discontinued due to an adverse event; issues affecting more than 10 patients were drug intolerance, headache, insomnia, nausea, dry mouth, and constipation-, tachycardia-, and hypertension-related events. Serious adverse events, most commonly associated with the System Organ Class, Cardiac disorders, were reported by 2.7% of patients; however, the majority was not considered sibutramine-related. Adverse events relating to high blood pressure and/or pulse rate, whether reported as adverse events leading to discontinuation, or serious adverse events were reported by less than 0.2% of patients. No serious or individual events leading to discontinuation occurred in more than 25 patients. There were 15 (0.1%) deaths; 10 were attributed to a cardiovascular cause. Discontinuations for adverse events were lower than anticipated. Serious adverse events generally reflected sibutramine's known pharmacology or were related to cardiac disorders already present in this high-risk population. When compared with epidemiological data, overall mortality rate was low and sibutramine was well tolerated in this mainly off-label population. No new safety issues were detected.
Maggioni
Aldo P
AP
ANMCO Research Center, Florence, Italy. maggioni@anmco.it
Caterson
Ian
I
Coutinho
Walmir
W
Finer
Nick
N
Gaal
Luc Van
LV
Sharma
Arya M
AM
Torp-Pedersen
Christian
C
Bacher
Peter
P
Shepherd
Gillian
G
Sun
Rui
R
James
Philip
P
D001067:Appetite Depressants / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D001794:Blood Pressure / Q000187:drug effects; D015992:Body Mass Index; D002318:Cardiovascular Diseases / Q000150:complications* / Q000175:diagnosis / Q000503:physiopathology; D003503:Cyclobutanes / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D003924:Diabetes Mellitus, Type 2 / Q000150:complications* / Q000503:physiopathology; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D016037:Single-Blind Method; D016896:Treatment Outcome
D001067:Appetite Depressants; D003503:Cyclobutanes; C058254:sibutramine