Table 6 Estimated incidence rates and relative risks for moderate or greater MR. The number of expected cases were based on estimated incidence rates utilizing the pooled control (unexposed) groups of these studies. Relative risks and z statistics were calculated within each study. No cases of MR were observed in unexposed groups of the Khan and Hensrud studies making relative risks inestimable. These studies did contribute to the summary estimates.
From: Risk of valvular heart disease associated with use of fenfluramine
Author, year | Duration (months) | "Incident" MR cases | Expected cases | p-value by Poisson | Relative Risk (RR) | Lower 95% CI of RR | Upper 95% CI of RR | z | p-value |
|---|---|---|---|---|---|---|---|---|---|
Khan, 1998 | 20.6 | 2.00 | 0.873 | 0.059 | - | - | - | 2.7 | 0.0033 |
Weissman, 1998 | 2.4 | 3.87 | 0.289 | 0.00023 | 14.9 | 5.2 | 42.5 | 5.0 | <0.00001 |
Shively, 1999 | 6.9 | 1.82 | 0.279 | 0.032 | 29.7 | 6.2 | 142.8 | 4.2 | 0.000012 |
Hensrud, 1999 | 9.6 | 0.00 | 0.033 | 0.97 | - | - | - | - | - |
Ryan, 1999 | 16.7 | 1.00 | 0.241 | 0.025 | - | - | - | - | - |
Gardin, 2000 | 11.9 | 8.69 | 0.950 | <0.00001 | 5.0 | 2.4 | 10.4 | 4.3 | <0.00001 |
6 | 8.06 | 0.500 | <0.00001 | 10.5 | 5.3 | 20.5 | 6.8 | <0.00001 | |
Jollis, 2000 | 2 | 0.00 | 0.009 | 0.99 | 0.0 | 0.0 | - | -0.1 | 0.54 |
4.5 | 2.31 | 0.253 | 0.0022 | 9.5 | 3.0 | 30.5 | 3.8 | 0.000079 | |
9 | 5.83 | 0.666 | 0.000069 | 9.1 | 3.9 | 21.1 | 5.1 | <0.00001 | |
18 | 3.28 | 1.018 | 0.020 | 3.3 | 1.0 | 10.8 | 2.0 | 0.022 | |
30 | 0.71 | 0.463 | 0.37 | 1.6 | 0.1 | 17.3 | 0.4 | 0.35 | |
Davidoff, 2001 | 2.5 | 0.96 | 0.120 | 0.11 | 3.6 | 0.5 | 25.3 | 1.3 | 0.096 |
Summary, 2002 | 8.89 | 38.5 | 5.7 | <0.00001 | 5.9 | 4.0 | 8.6 | 9.1 | <0.00001 |