Table 2 Characteristics of uncontrolled echocardiographic studies included in analysis
From: Appetite suppressants and valvular heart disease – a systematic review
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%) |