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And Number Needed to Harm (NNH) in Randomized, Blinded Trials Original Contributions Number Needed to Treat (NNT) and Number Needed to Harm (NNH) in Randomized, Blinded Trials Comparing Olanzapine to Other Atypical Antipsychotics for Treatment of Schizophrenia Virginia Stauffer 1, Jamie Karagianis 2, Virginia Sutton 3, Haya Ascher-Svanum 1, Tamas Treuer 4, Mauricio Silva de Lima 5, Tamara Ball 6, Vicki Poole-Hoffmann 1, Mauricio Tohen 1, 7 Abstract Objective: All-cause discontinuation is considered a proxy for a medication’s effectiveness. We examined the number needed to treat (NNT) to avoid all-cause medication discontinuation in head-to-head clinical trials of olanzapine ver- sus other atypical antipsychotics. Methods: This was a post hoc analysis of five randomized trials of olanzapine versus risperidone (n=2), ziprasidone (n=2) and quetiapine (n=1) for treatment of patients with schizophrenia. All trials were of at least six months’ duration. The NNT or number needed to harm (NNH) was determined for all-cause discontinu- ation and other efficacy and safety parameters. NNT and NNH are calculated as the reciprocal of attributable risk. Desirable treatments are characterized as having low NNTs and relatively high NNHs. These measures are useful for ranking treatments when the same outcome measure is assessed over the same amount of time in similar patients. In this analysis, positive values indicated the superiority of olanzapine and negative values indicated the superiority of the comparator treatment. Results: Statistically significant NNTs (95% confidence intervals) to avoid all-cause medication discontinuation were 6 (4, 12) and 7 (5, 19) for olanzapine versus ziprasidone; and 7 (4, 22) for olanzapine versus que- tiapine. The NNHs indicated greater likelihood of weight gain with olanzapine versus all comparators except quetiap- ine. Statistically significant NNHs indicated greater likelihood of weight gain with olanzapine in one of the risperidone studies (-7 [-16, -4]) and both studies in which olanzapine was compared to ziprasidone (-4 [-5, -3] and -5 [-7, -4]). Conclusions: In this post hoc analysis of five studies in which olanzapine was compared to other atypical antipsychot- ics using the evidence-based medicine tools of NNT and NNH, olanzapine was superior to ziprasidone and quetiapine for prevention of treatment discontinuation for any cause. Ziprasidone was least associated with potentially clinically significant weight gain, followed by risperidone, with olanzapine and quetiapine ranked last. Key Words: All-Cause Discontinuation, Atypical Antipsychotics, Number Needed to Treat, Number Needed to Harm, NNT, NNH, Schizophrenia, Olanzapine 1 Lilly Research Laboratories, Indianapolis, IN, USA 2 Eli Lilly Canada Inc., Toronto, Ontario, Canada Introduction 3 i3 Research, Memphis, TN, USA Discontinuation of antipsychotic medication affects a 4 Eli Lilly and Company, Vienna, Austria sizeable proportion of patients with schizophrenia and is an 5 Eli Lilly and Company, United Kingdom 6 i3 Statprobe, Ann Arbor, MI, USA important factor in their clinical management. In a recent 7 McLean Hospital, Harvard Medical School, Cambridge, MA, USA integrated analysis of sixteen published, double-blind, ran- Address for correspondence: Virginia L. Stauffer, PharmD, domized trials of ≥12 weeks’ duration in which olanzapine Eli Lilly and Company, Lilly Corporate Center, Drop Code 4133, was compared to other antipsychotic drugs, discontinuation Indianapolis, IN 46285 Phone: 317-277-2904; Fax: 317-276-7100; rates ranged from 30 to 88% (1). Interruption or discon- E-mail: [email protected] tinuation of antipsychotic therapy due to poor adherence is Submitted: September 28, 2007; Revised: March 11, 2008; expected to be associated with increased rates of relapse and Accepted: April 9, 2008 psychiatric hospitalization, decreased functional outcome 136 • Clinical Schizophrenia & Related Psychoses July 2008 Virginia Stauffer et al. Olanzapine Treatment Discontinuation and NNT and quality of life, and increased treatment costs (2-6). point estimates has to include infinity, suggesting that, based The primary outcome of this study—time until dis- on our data sample, an infinite number of patients might continuation of treatment for any cause—is recognized as need to be treated with olanzapine rather than the compara- a valid measure of treatment effectiveness, an index that tor to expect one additional success or harm. The point esti- incorporates efficacy, safety and tolerability as evaluated by mate may still provide guidance in clinical decision making, both patient and physician (7). Time to all-cause medica- but should be used with caution until further data permit tion discontinuation and rates of discontinuation were key determination of a finite CI. outcome measures of treatment effectiveness in the Clinical The relative benefits and risks of treatment with differ- Antipsychotic Trials of Intervention Effectiveness (CATIE) ent antipsychotic medications has long been a topic of de- (8), a large, randomized, double-blind, eighteen-month, Na- bate within the psychiatric field. Phases 1 (8) and 2 (14, 15) tional Institute of Mental Health (NIMH)-sponsored trial. of the CATIE trial provided a vast amount of data regarding The number needed to treat (NNT) is a tool of evidence- the safety and efficacy of antipsychotic agents. In several -re based medicine designed to translate research findings into cent publications (16, 17), NNT and NNH have been used readily usable information for the practicing clinician. NNT to place data from the CATIE trial into a clinically meaning- is a measure of effect size: a number that indicates how many ful context. Citrome and Stroup reported that in Phase 1 of patients would need to be treated using intervention A in- CATIE, the NNTs (95% CIs) to avoid all-cause discontinua- stead of intervention B to see one additional success. When tion for olanzapine compared to quetiapine, risperidone and the comparison involves an adverse outcome, the measure is ziprasidone were 6 (4, 9), 11 (6, 35) and 7 (5, 13), respec- referred to as the number needed to harm (NNH). NNT (or tively. Compared to olanzapine, NNHs (95% CIs) for weight NNH) is calculated by taking the reciprocal of attributable gain ≥7% above baseline were -8 (-14, -5), -7 (-11, 5) and risk (AR): the difference in rates for the outcome of inter- -5 (-7, -4), respectively. est between two interventions. A low NNT indicates that Whether NNTs and NNHs derived from the indepen- the treatments being compared are substantially different, dently funded CATIE study are comparable to those derived whereas a high NNT suggests very little difference. Desir- from industry-sponsored, long-term, randomized clinical able treatments have small NNTs and relatively large NNHs trials is unknown. In this analysis, we use the clinically use- (9, 10). ful measure, NNT, to present data on all-cause discontinua- An example of the clinical application of NNT and tion from five randomized, double-blind, comparative clini- NNH is the use of influenza vaccine versus no treatment in cal trials of olanzapine versus other atypical antipsychotics healthy children between ages one and six. Vaccination re- from the Eli Lilly and Company Clinical Trial Database. The duces the risk of a culture-confirmed case of influenza with NNT and NNH for other secondary efficacy and safety mea- an NNT of 6, which means that one case of influenza can be sures are also presented, along with relative rankings based expected to be prevented for every six children vaccinated, on these data. regardless of their exposure status. The vaccine has an NNH of 72 for low-grade fever, meaning that one additional low- Methods grade fever can be expected to occur for every seventy-two children vaccinated (11). On balance, the vaccine offers a Study Selection and Patient high likelihood of protection from a potentially dangerous Characteristics infection and a low likelihood of occurrence of a relatively This was a post hoc analysis using data from five clini- minor adverse event (AE); therefore, most pediatricians ad- cal trials within the Eli Lilly and Company Clinical Trial vise vaccination for healthy children in this age group. Database. Each study met the following criteria: random- Both the NNT and NNH are expressed as single num- ized, double-blind clinical trial; head-to-head comparison of bers referred to as point estimates. As with any statistical re- olanzapine versus at least one other atypical antipsychotic; sult based on experimental data, the true value of the NNT study duration of at least six months; and, participants meet- or NNH can be higher or lower than the point estimate, and ing Diagnostic and Statistical Manual of Mental Disorders, the range of possibility for the true value is indicated by con- Fourth Edition, Text Revision (DSM-IV-TR) (18) criteria for fidence intervals (CIs). Whenever the NNT or NNH value is schizophrenia, schizophreniform disorder or schizoaffective not statistically significant, the endpoints of the 95% CIs are disorder. opposite in sign and the interval includes infinity (12, 13). Five studies met inclusion criteria, including two trials This occurs when the range of possible AR values includes comparing olanzapine to risperidone (RISP 1 [19], RISP 2 zero; that is, there may not be any difference in event rates [20]), two trials comparing olanzapine to ziprasidone (ZIP for patients treated with olanzapine versus the comparator. 1 [21], ZIP 2 [22]), and one trial comparing olanzapine to Since the inverse of zero is undefined,
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