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Prevacid (Lansoprazole) - Summary

 
 



PREVACID SUMMARY

The active ingredient in PREVACID (lansoprazole) Delayed-Release Capsules, PREVACID (lansoprazole) for Delayed-Release Oral Suspension and PREVACID SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets is a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion.

PREVACID Delayed-Release Capsules, PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets and PREVACID For Delayed-Release Oral Suspension are indicated for:

SHORT-TERM TREATMENT OF ACTIVE DUODENAL ULCER

PREVACID is indicated for short-term treatment (for 4 weeks) for healing and symptom relief of active duodenal ulcer.

H. PYLORI ERADICATION TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE

Triple Therapy: PREVACID/amoxicillin/clarithromycin

PREVACID in combination with amoxicillin plus clarithromycin as triple therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION.)

Dual Therapy: PREVACID/amoxicillin

PREVACID in combination with amoxicillin as dual therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY section.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION.)

MAINTENANCE OF HEALED DUODENAL ULCERS

PREVACID is indicated to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months.

SHORT-TERM TREATMENT OF ACTIVE BENIGN GASTRIC ULCER

PREVACID is indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of active benign gastric ulcer.

HEALING OF NSAID-ASSOCIATED GASTRIC ULCER

PREVACID is indicated for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. Controlled studies did not extend beyond 8 weeks.

RISK REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER

PREVACID is indicated for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID. Controlled studies did not extend beyond 12 weeks.

GASTROESOPHAGEAL REFLUX DISEASE (GERD)

Short-Term Treatment of Symptomatic GERD

PREVACID is indicated for the treatment of heartburn and other symptoms associated with GERD.

Short-Term Treatment of Erosive Esophagitis

PREVACID is indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of all grades of erosive esophagitis.

For patients who do not heal with PREVACID for 8 weeks (5-10%), it may be helpful to give an additional 8 weeks of treatment.

If there is a recurrence of erosive esophagitis an additional 8-week course of PREVACID may be considered.

MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS

PREVACID is indicated to maintain healing of erosive esophagitis. Controlled studies did not extend beyond 12 months.

PATHOLOGICAL HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON SYNDROME

PREVACID is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.


See all Prevacid indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Prevacid (Lansoprazole)

A multicenter, randomized, comparative study to determine the appropriate dose of lansoprazole for use in the diagnostic test for gastroesophageal reflux disease. [2011.09]
BACKGROUND/AIMS: The diagnostic proton pump inhibitor test (PPI test) is a method used in diagnosing gastroesophageal reflux disease (GERD). This study aimed to determine the appropriate dose of lansoprazole for use in the diagnostic test for GERD... CONCLUSIONS: In this multicenter, randomized study of Korean patients, the standard dose of lansoprazole was as effective as a high dose of lansoprazole in relieving the symptoms of GERD, regardless of the presence of ERD, by day 14 of treatment.

Preventive effects of lansoprazole and famotidine on gastric mucosal injury induced by low-dose aspirin in Helicobacter pylori-negative healthy volunteers. [2011.07]
The preventive effects of lansoprazole and famotidine on low-dose aspirin-induced gastric mucosal injury in relation to gastric acidity were compared in healthy Japanese volunteers. Fifteen Helicobacter pylori-negative volunteers with different CYP2C19 genotypes were randomly administered aspirin 100 mg, aspirin plus famotidine 20 mg twice daily, or aspirin plus lansoprazole 15 mg once daily for 7 days each in a crossover fashion.

Lansoprazole for secondary prevention of gastric or duodenal ulcers associated with long-term low-dose aspirin therapy: results of a prospective, multicenter, double-blind, randomized, double-dummy, active-controlled trial. [2011.06]
BACKGROUND: The efficacy of low-dose lansoprazole has not been established for the prevention of recurrent gastric or duodenal ulcers in those receiving long-term low-dose aspirin (LDA) for cardiovascular and cerebrovascular protection. This study sought to examine the efficacy of low-dose lansoprazole (15 mg once daily) for the secondary prevention of LDA-associated gastric or duodenal ulcers... CONCLUSION: Lansoprazole was superior to gefarnate in reducing the risk of gastric or duodenal ulcer recurrence in patients with a definite history of gastric or duodenal ulcers who required long-term LDA therapy.

The effect of dexlansoprazole MR on nocturnal heartburn and GERD-related sleep disturbances in patients with symptomatic GERD. [2011.03]
OBJECTIVES: Nocturnal heartburn and related sleep disturbances are common among patients with gastroesophageal reflux disease (GERD). This study evaluated the efficacy of dexlansoprazole MR 30 mg in relieving nocturnal heartburn and GERD-related sleep disturbances, improving work productivity, and decreasing nocturnal symptom severity in patients with symptomatic GERD... CONCLUSIONS: In patients with symptomatic GERD, dexlansoprazole MR 30 mg is significantly more efficacious than placebo in providing relief from nocturnal heartburn, in reducing GERD-related sleep disturbances and the consequent impairments in work productivity, and in improving sleep quality/quality of life.

The 12-month safety profile of dexlansoprazole, a proton pump inhibitor with a dual delayed release formulation, in patients with gastro-oesophageal reflux disease. [2011.02]
BACKGROUND: Dexlansoprazole MR is a Dual Delayed Release formulation of dexlansoprazole, an enantiomer of lansoprazole, designed to extend the duration of acid suppression. AIM: To assess the 12-month safety of dexlansoprazole MR in patients with symptomatic gastro-oesophageal reflux disease (GERD)... CONCLUSIONS: Twelve-month treatment with dexlansoprazole MR 60 and 90 mg was well tolerated by GERD patients in this study (Clinicaltrials.gov identifier NCT00255190). (c) 2010 Blackwell Publishing Ltd.

more studies >>

Clinical Trials Related to Prevacid (Lansoprazole)

Intravenous vs Oral Lansoprazole on Gastric Acid Secretion in Subjects With Erosive Esophagitis [Completed]
The objective of this study was to compare the pharmacodynamics of intravenous (IV) lansoprazole 30 mg to oral lansoprazole 30 mg capsules in subjects with erosive esophagitis.

Study Comparing Esomeprazole Magnesium 40mg Once Daily Versus Lansoprazole 30 mg Twice Daily in Symptom Control of Subjects With Persistent GERD [Completed]
A double-blind study comparing Esomeprazole Magnesium 40 mg once daily and Lansoprazole 30 mg twice daily to control the symptoms in patients with gastroesophageal reflux disease (GERD) with continued heartburn symptoms with a course of therapy of 30 mg twice daily Lansoprazole.

Efficacy/Safety of Lansoprazole in Patients With Frequent Nighttime Heartburn [Completed]
Heartburn, a burning sensation in the chest or throat, occurs in many individuals when acidic stomach contents move upward into the esophagus from the stomach. This study will investigate the safety and efficacy of lansoprazole 15 mg or 30 mg administered once a day in preventing frequent nighttime heartburn.

The Insulin Independence Trial (IIT) Evaluating the Safety and Efficacy of Oral Cyclosporine and Oral Lansoprazole for Insulin Independence Among Patients With Existing Type 1 Diabetes [Not yet recruiting]
The purpose of this study is to determine if oral cyclosporine and oral lansoprazole are effective in rendering patients with existing type 1 diabetes, insulin independent. This four-arm study was designed to evaluate the safety and efficacy for insulin independence by utilizing the FDA-approved oral immune tolerance agent, cyclosporine, and the FDA-approved proton-pump inhibitor, lansoprazole. Lansoprazole and other proton-pump inhibitors increase gastrin levels. Gastrin was initially shown to have the potential to increase new beta cell formation in 1955 (Zollinger RM and Ellison EH. Ann Surg. 1955;142(4):709-23).

Studies with the immune tolerance agent, cyclosporine, previously demonstrated that among recently diagnosed type 1 diabetes patients, insulin independence was achieved in as many as 67. 5% of patients within 7 weeks of therapy (Bougneres PF et al. N Engl J Med. 1988: 17;318(11):663-70). Cyclosporine protected the remaining beta cells from further autoimmune attack, but over time, there was limited beta cell regeneration, and insulin was ultimately required by all patients. Therefore, this study proposes the usage of cyclosporine with a beta regeneration agent.

Follow-up studies for up to 13 years among 285 type 1 patients utilizing cyclosporine for 20 months, did not demonstrate renal or other side effects (Assan R. et al. Diabetes Metab Res Rev. 2002;18(6):464-72). Human clinical trials with gastrin and epidermal growth factor demonstrated reductions in daily insulin requirements by much as 75% within 3 months following four weeks of therapy among existing type 1 diabetes patients (Transition Therapeutics, March 5, 2007 http://www. transitiontherapeutics. com/media/archive. php Accessed January 1, 2013). Lack of the ability to sustain these results was likely due to the ongoing autoimmune attack on the new beta cells generated by therapy. Gastrin alone has been shown to induce beta cell neogenesis from human pancreatic ductal tissue without epidermal growth factor in in vitro studies (Suarez-Pinzon WL et al. JCEM. 2005;90(6):3401-3409).

Type 1 diabetes is an autoimmune disease. Despite evidence that many different immune tolerance agents have successfully reversed diabetes in rodent type 1 models, none have been successful in sustaining insulin independence in man (Ablamunits V et al. Ann NY Acad Sci. 2007;1103: 19-32). The distinctions and complexities of islets in man are far different than that of rodents (Levetan CS and Pierce SM. Endocr Pract. 2012 Nov 27: 1-36 Epub ahead of print). We hypothesize that in man, both an immune tolerance agent and a beta regeneration agent are required to sustain insulin independence.

Based upon proton-pump inhibitors having been shown to increase plasma gastrin levels up to 10-fold, this clinical trial utilizes the oral proton-pump inhibitor, lansoprazole. This study will determine the safety and efficacy of cyclosporine used with and without lansoprazole to determine the impact on insulin independence among patients with existing type 1 diabetes.

Cyclosporine is utilized to protect the new beta cells formed by lansoprazole. The combination of the two therapies may render reductions in insulin requirements and have a greater impact on sustained insulin independence than previously reported with cyclosporine or gastrin alone among type 1 patients.

This 12-week study consists of four treatment arms:

- Oral Cyclosporine/Placebo

- Oral Lansoprazole/Placebo

- Oral Lansoprazole/Oral Cyclosporine

- Oral Placebo/Oral Placebo

It is hypothesized that the combination of oral cyclosporine and oral lansoprazole will safely render significantly more patients with existing type 1 diabetes, insulin independent and may serve as a novel and innovative treatment approach for patients with type 1 diabetes utilizing two FDA-approved therapies.

The Insulin Independence Trial (IIT) Evaluating the Safety and Efficacy of Oral Cyclosporine and Oral Lansoprazole for Insulin Independence Among Recent Onset Type 1 Diabetes Patients [Not yet recruiting]
The purpose of this study is to determine if oral cyclosporine and oral lansoprazole are effective in rendering recent onset type 1 diabetes patients, insulin independent. This four-arm study was designed to evaluate the safety and efficacy for insulin independence by utilizing the FDA-approved oral immune tolerance agent, cyclosporine, and the FDA-approved proton-pump inhibitor, lansoprazole. Lansoprazole and other proton-pump inhibitors increase gastrin levels. Gastrin was initially shown to have the potential to increase new beta cell formation in 1955 (Zollinger RM and Ellison EH. Ann Surg. 1955;142(4):709-23).

Studies with the immune tolerance agent, cyclosporine, previously demonstrated that among recently diagnosed type 1 diabetes patients, insulin independence was achieved in as many as 67. 5% of patients within 7 weeks of therapy (Bougneres PF et al. N Engl J Med. 1988: 17;318(11):663-70). Cyclosporine protected the remaining beta cells from further autoimmune attack, but over time, there was limited beta cell regeneration, and insulin was ultimately required by all patients. Therefore, this study proposes the usage of cyclosporine with a beta regeneration agent.

Follow-up studies for up to 13 years among 285 type 1 patients utilizing cyclosporine for 20 months, did not demonstrate renal or other side effects (Assan R. et al. Diabetes Metab Res Rev. 2002;18(6):464-72). Human clinical trials with gastrin and epidermal growth factor demonstrated reductions in daily insulin requirements by much as 75% within 3 months following four weeks of therapy among existing type 1 diabetes patients (Transition Therapeutics, March 5, 2007 http://www. transitiontherapeutics. com/media/archive. php Accessed January 1, 2013). Lack of the ability to sustain these results was likely due to the ongoing autoimmune attack on the new beta cells generated by therapy. Gastrin alone has been shown to induce beta cell neogenesis from human pancreatic ductal tissue without epidermal growth factor in in-vitro studies (Suarez-Pinzon WL et al. JCEM. 2005;90(6):3401-3409).

Type 1 diabetes is an autoimmune disease. Despite evidence that many different immune tolerance agents have successfully reversed diabetes in rodent type 1 models, none have been successful in sustaining insulin independence in man (Ablamunits V et al. Ann NY Acad Sci. 2007;1103: 19-32). The distinctions and complexities of islets in man are far different than that of rodents (Levetan CS and Pierce SM. Endocr Pract. 2012 Nov 27: 1-36 Epub ahead of print). We hypothesize that in man, both an immune tolerance agent and a beta regeneration agent are required to sustain insulin independence.

Based upon proton-pump inhibitors having been shown to increase plasma gastrin levels up to 10-fold, this clinical trial utilizes the oral proton-pump inhibitor, lansoprazole. This study will determine the safety and efficacy of cyclosporine used with and without lansoprazole to determine the impact on insulin independence among recently diagnosed patients with type 1 diabetes.

Cyclosporine is utilized to protect the new beta cells formed by lansoprazole. The combination of the two therapies may render reductions in insulin requirements and have a greater impact on sustained insulin independence than previously reported with cyclosporine or gastrin alone among type 1 patients.

This 12-week study consists of four treatment arms:

- Oral Cyclosporine/Placebo

- Oral Lansoprazole/Placebo

- Oral Lansoprazole/Oral Cyclosporine

- Oral Placebo/Oral Placebo

It is hypothesized that the combination of oral cyclosporine and oral lansoprazole will safely render significantly more patients with existing type 1 diabetes, insulin independent and may serve as a novel and innovative treatment approach for recently diagnosed patients with type 1 diabetes utilizing two FDA-approved therapies.

more trials >>

Reports of Suspected Prevacid (Lansoprazole) Side Effects

Drug Ineffective (29)Drug Dose Omission (23)Malaise (20)Gastrooesophageal Reflux Disease (16)Dyspepsia (13)Diarrhoea (12)Vomiting (11)Weight Decreased (9)Fatigue (9)Chest Pain (9)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 22 ratings/reviews, Prevacid has an overall score of 7.77. The effectiveness score is 8 and the side effect score is 8.64. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Prevacid review by 54 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   acid reflux
Dosage & duration:   30 mg taken once daily for the period of 1 month
Other conditions:   asthma
Other drugs taken:   Advair
  
Reported Results
Benefits:   Taken each morning 30 minutes before eating, keep me from having any acid reflux. One daily dosage worked for the entire day. Even into the evening, if I ate spicy food or chocolate, I could go to bed without experiencing any heart burn.
Side effects:   None that I have encountered.
Comments:   I have been taking meds for my acid reflux for many years, originally Omeprazole (generic for Prilosec). However, becaus Omeprazole was not on my insurance drug formulary, I was taking Prilosec OTC. At my last check-up my doctor prescribed the Prevacid and I like it. It even tastes like strawberries!

 

Prevacid review by 57 year old male patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   pre-barrett (errosion of the esophagus)
Dosage & duration:   30 Mg. once a day taken once for the period of still taking it
Other conditions:   GIRD
Other drugs taken:   none
  
Reported Results
Benefits:   the prevacid allows me to eat and drink certain foods/fluids that I normally could not tolerate anymore without great discomfort i.e. spicy foods, coffee, chocolate, tomato products, and alcholic drinks, which I only drink occassionally such as red wine. If I skip the prevacid for any reason, I almost certainly will be very uncomfortable.
Side effects:   It seems to give me a tendency to gain weight in the abdomen. I did try some alternatives, including Nexium, which was not a good substitute at all!
Comments:   I have been on prevacid for approximately 6 years as a a prophylactic against the pre-barretts. I have tried to slowly come off the drug (it is the only one I use) but I would venture to guess that unless I changed my diet significantly, this is not going to happen.

 

Prevacid review by 82 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Extremely Severe Side Effects
  
Treatment Info
Condition / reason:   Indigestion
Dosage & duration:   one per day (dosage frequency: two days) for the period of Once for two days
Other conditions:   Nothing just indigestion through the night
Other drugs taken:   gaviscon
  
Reported Results
Benefits:   This was recommended to me instead of Gaviscon. Supposedly it was a better solution for my indigestion. Instead it was a disaster.
Side effects:   Terrible Terrible. I already suffer from constipation, but I took one of these tablets, as prescribed, for two consecutive days. After two days I knew they were a no-no for me. My innards came to a complete STOP. I shall throw the remainder of the tablets away. Four days on my innards are still at a standstill.
Comments:   Take one per day. I have stopped taking them. Don't forget I already take Dulcolax for my constipation, had I known these recommended tablets had a side effect of constipation I would have refused them. It is back to the Gaviscon for me, it is gentle, pleasant to take and liquid. Shell-like Capsules and me do not get along.

See all Prevacid reviews / ratings >>

Page last updated: 2011-12-09

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