Efficacy of Cevimeline Versus Pilocarpine in the Secretion of Saliva

Study Overview
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Brief Summary
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The main objectives were: 1) To determine the efficacy of both cevimeline and pilocarpine in the secretion of saliva in patients with xerostomia, and 2) To compare the side-effects between the treatment for xerostomia with cevimeline and with pilocarpine.

Detailed Description
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Pilocarpine is a cholinergic agonist with predominant muscarinic action.As such, it acts at muscarinic-cholinergic receptors found throughout the body and promotes fluid secretion. Due to this, one of the main side-effects of pilocarpine is an increased amount of sweating. Thus, not only are the salivary glands stimulated, but all of the body's exocrine glands' production is heightened. On the other hand, cevimeline is a drug with a high affinity for specific muscarinic receptors (M3) located on lachrymal and salivary gland epithelium. At least in theory, cevimeline will produce less side effects compared with pilocarpine because of the higher affinity for the muscarinic receptors located in the salivary glands. A limited number of human clinical trials in the efficacy of cevimeline and pilocarpine to increase the production of saliva and the side effects have been performed with no conclusive results. The main purposes of this study were to determine the efficacy of cevimeline and pilocarpine in the secretion of saliva in patients with xerostomia, and to compare the side-effects between these two medications.

Official Title
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Efficacy of Cevimeline vs. Pilocarpine in the Secretion of Saliva

Conditions
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Dry Mouth

Intervention / Treatment
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* Drug: Cevimeline
* Drug: Pilocarpine


Participation Criteria
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Eligibility Criteria
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Potential candidates with the diagnosis of moderate-severe xerostomia were identified from the Oral Medicine Clinic at the University Of Kentucky College Of Dentistry, or self referrals in response to IRB approved study announcements. Enrollment required no clinical evidence of oral lesions, subjective perception of dry mouth and less than 2 mL of saliva collected in 5 minutes without stimulation. Exclusion criteria included patients with non controlled chronic obstructive pulmonary disease (COPD), depression, asthma, cardiac arrhythmias, glaucoma, and the current use of any medication with interactions with cevimeline and pilocarpine.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cevimeline<br>Cevimeline vs Pilocarpine | Drug: Cevimeline<br>* Cevimlenine Vs Pilocarpine, cross over design. Two sequences were evaluated cevimeline first, then pilocarpine and pilocarpine first, then cevimeline. Each sequence was evaluated for 4 weeks with one week washout period in between both sequences. 15 patients were randomly assigned to a specific sequence by a research pharmacist independent from the study authors. The patients received 30mg of cevimeline three times a day and pilocarpine 5mg three times a day.<br>|
| Active Comparator: Pilocarpine<br>Pilocarpine vs. Cevimeline | Drug: Pilocarpine<br>* Cevimlenine Vs Pilocarpine, cross over design, 4 weeks, one week wash out<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Saliva Production in ml. | The primary outcome measure was the change of stimulated and non-stimulated saliva in ml from the baseline record. At each appointment (weekly), participants will provide 2 saliva samples to measure their current salivary output. The first measurement will be obtained by having the patient spit as much as he or she could into a cup for five minutes. The amount of saliva in ml will be recorded. The second measurement will be obtained in a similar manner with the addition of having the patient chew on a block of unflavored wax. Patients will complete weekly questionnaires to help determine which side-effects they experience as they take the medications. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dry mouth