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Lisinopril 10 mg brands of the day were also tested. overall results of the double-blind, randomized, placebo-controlled study are shown in Figure 1. The majority of patients felt that tesamorenlin was more effective than the 10 mg version of risedronate. Most patients (82%) felt they experienced better pain control with tesamorenlin (93%) and less headache with 10 mg risedronate (82%) than with placebo. DISCUSSION This is the first double-blind, randomized, placebo-controlled trial of tesamorenlin in migraine headaches. A key question in any trial involving the use of pharmacologic agents targeting inflammation is whether this approach can lead to sustained clinical benefits over time. This study has several important strengths that include a large sample size (N=1021), well-designed randomized, double-blind, placebo-controlled comparison of tesamorenlin and risedronate, the inclusion of two more active drugs in the tesamorenlin arm than risedronate arm. Despite these important differences, patients were able to reduce their migraine frequency by an average of 4 to 7 days during the study. This compares favorably to the mean reduction of 7 to 9 days reported in another randomized, double-blind, placebo-controlled trial of tesamorenlin in patients with migraine [15]. Tesamorenlin in our study was well tolerated and demonstrated adequate, sustained clinical efficacy in our patients. There was one significant side effect of headache during the double-blind period, which was associated with a 5% dropout rate. This rate could be expected as most of the subjects who stopped taking migraine medications started them again after a week or two. Also, there were no serious or severe cases of adverse drug reactions. The primary endpoint of this study was patients' headache frequency at 24 weeks. This was a valid outcome measure in trial examining the effects of tesamorenlin on migraine headache frequency. It will be critical to keep in mind that treating migraine patients, the primary endpoint of almost any trial is not necessarily the frequency of headache. Even when treatment frequency is measured as the mean number of days on therapy, it is important to analyze this by outcome measure to determine if efficacy is being maintained and if any other parameters may be contributing to the headache increase, such as pain, function, or duration of headache. This trial was designed to test the impact of tesamorenlin on headache severity (headache days per visit). For this outcome, the study found a decrease of 18.9 headache days in the tesamorenlin arm relative to risedronate over the 8-week study period. This is not a statistically significant improvement compared to the placebo arm. However, given its wide margin of safety, the study found increase in Esomeprazole 40 mg cost headache days to be clinically meaningful and in the right direction. While other trials have shown that the combination of tesamorenlin and risedronate can be helpful in treating migraine headaches, a critical question is whether this approach could be sustained with greater efficacy compared to tesamorenlin alone. However, this study, too, found a significant reduction in migraine headache frequency the tesamorenlin arm versus placebo arm, a result in line with previous results from some other studies, including the largest retrospective placebo-controlled study involving the use of tesamorenlin in patients with migraine [15]. A subsequent random-controlled study of tesamorenlin at 40 mg and 80 used in the same group evaluated whether tesamorenlin could maintain or even reverse a decrease from baseline in migraine headache severity [17]. The investigators found that combination of tesamorenlin and risedronate was equally effective at reducing headache frequency week 48 compared to tesamorenlin alone. This study used tesamorenlin in addition to another agent with a better mechanism of action in the treatment migraine. findings are not definitive in that other drugs could still be helpful. For example, the combination of risedronate, diclofenac, and natalizumab has shown some benefit in reducing headache frequency to some degree [18]. Additionally, in this study, the tesamorenlin arm used a higher dose Price of synthroid vs generic of tesamorenlin, which may have had an effect on the therapeutic benefit of drug. Therefore, any agent that has an anticonvulsant effect needs to be evaluated. A small study comparing tesamorenlin with lamotrigine in the treatment of migraine headaches has shown that tesamorenlin is more effective than lamotrigine in controlling pain and that tesamorenlin- lamotrigine has a better tolerability profile and has effects on clinical outcomes than lamotrigine [19].

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