Table 2.

Characteristics of uncontrolled echocardiographic studies included in analysis

Author	Year	Patient selection	Drugs used	Mean duration (days)	Blinding of outcome assessment	Total	FDA AR	FDA MR
Burger [4]	2001	343/591 participants of open-label study via postal invitation	Combination of fenfluramine-phentermine	370	Performed unblinded, reviewed on tape by two independent readers	343	19 (6%)	3 (1%)
FDA [2]	1997	Some convenience, some random. Prevalence survey across five clinics in USA where obese patients were treated	Fenfluramine, dexfenfluramine, and/or phentermine	Median 420	None	284	80 (28%)	18 (6%)
Fisher [5]	1998	Consecutive patients with history of appetite suppressants referrred for echocardiography	Combination of fenfluramine-phentermine	Not stated	None	156	29 (19%)	4 (3%)
Kancherla [6]	1999	Consecutive patients with history of appetite suppressant use referred for echo study	Fenfluramine, dexfenfluramine and/or phentermine	307	None	200	24 (12%)	10 (5%)
Lepor [7]	2000	Consecutive patients with history of appetite suppressant use referred for echocardiography	Combination of fenfluramine-phentermine	321	Blinded readers with 2nd independent assessment	85	24 (28%)	9 (11%)
Teramae [8]	2000	Retrospective review of patients referred for suspected valve disease	fenfluramine, dexfenfluramine and/or phentermine	245	None	191	55 (29%)	12 (6%)
Wadden [9]	1998	20 of 26 participants in open-label trial	Combination of fenfluramine-phentermine	730	Two independent readers, blinded to clinical status	20	5 (25%)	2 (10%)
					Total	1279	236 (18%)	58 (5%)