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Proton pump inhibitor attitudes and usage: a patient survey

Proton Pump Inhibitor Attitudes
and Usage: A Patient Survey
Malcolm Robinson, MD and Kimberly Shaw, BA
ABSTRACT Four hundred adults receiving proton pump
approximately once every three days. Despite the widely inhibitors (PPIs) were interviewed in the first quarter of held impression that PPI therapy renders all patients 2001 regarding their medication usage patterns, perceived asymptomatic, breakthrough symptoms are common. It acid-breakthrough symptoms, and their treatment. Despite seems likely that exploration of such symptoms with our high compliance with prescribed PPI regimens, 46% of daily patients might lead to further refinement of our thera- PPI users experienced breakthrough symptoms, which peutic interventions and enhanced quality of life as a occurred on 28% of treatment days. Of the total patient result. One approach to the management of patients with sample, 48% reported that their upper gastrointestinal breakthrough symptoms is the addition of H -receptor symptoms led to awakening from sleep. Almost half (45%) antagonists to PPI regimens that have failed to provide of these PPI users also took over-the-counter (OTC) acid adequate symptom relief. This article is intended to relievers, most commonly antacids, and these individuals explore these issues, including the pharmacologic basis tended to supplement PPI therapy with OTC remedies Proton pump inhibitors (PPIs) represent a landmark individuals prescribed these drugs for acid-related illnesses. A
development in gastroenterology. These drugs irre- specific focus of this study was to characterize apparent acid versibly inhibit the gastric H+, K+ ATPase pump and breakthrough symptoms among PPI users and to determine reduce both basal and stimulated gastric acid output.
Presently, five PPIs are marketed in the U.S.: omeprazole(Prilosec, AstraZeneca), lansoprazole (Prevacid, TAP Pharmaceu- ticals), rabeprazole (AcipHex, Eisai Inc.), pantoprazole (Protonix, Adults (>18 years of age) prescribed PPIs were targeted for Wyeth-Ayerst) and esomeprazole (Nexium, AstraZeneca); the lat- evaluation. A sample was randomly selected nationwide from ter two were approved most recently. PPIs are efficacious and postal zip codes of households returning health question- cost-effective for the treatment of severe gastroesophageal reflux naires (Polk Research) in which any family member reported and other acid-related illnesses.1,2 Prescriptions for PPIs have current use of omeprazole or lansoprazole (the then-available increased dramatically over the last decade,3 and available drug prescription PPIs). An attempt was made to obtain a represen- utilization data from Australia and the United Kingdom indicate tative sample of PPI users in terms of gender, age distribu- widespread use of PPIs for indications such as non-ulcer dyspep- tion, and prescribed medication based on 1999 PPI retail sales sia that are outside current prescribing guidelines.3-5 There are (January–October) and NDTI (National Disease and Thera- limited data, however, on how patients actually use PPIs, and on the frequency of breakthrough symptoms during therapy. The To be included in this study, individuals must have report- present study was undertaken to provide information on self- ed using a prescribed PPI at least once in the week preced- reported PPI medication-usage patterns and to evaluate the ing the study. Treated conditions included heartburn, acid occurrence and management of acid-breakthrough symptoms. indigestion, reflux, ulcer, and hiatus hernia. A total of 400persons qualified as PPI users for this study and were inter- OBJECTIVE
viewed by telephone between February 4 and 13, 2001, after The objective of this study was to gain a better understanding providing verbal consent. Key elements of the questionnaire of attitudes toward PPIs and usage patterns of these agents in are shown in Figure 1. The individuals were queried abouttheir PPI usage patterns, the occurrence of breakthroughacid-related symptoms, and the use of supplemental acid- Dr. Robinson is affiliated with the Oklahoma Foundation for Digestive relief remedies. Each survey took approximately 15 minutes Research at the University of Oklahoma Health Sciences Center in to complete, and respondents received no financial remuner- Oklahoma City, Oklahoma. Ms. Shaw works for Johnson & Johnson MerckConsumer Pharmaceuticals Co. in Fort Washington, Pennsylvania. 202 P&T® • April 2002 • Vol. 27 No. 4
Figure 1. Key Elements of Questionnaire*
(1a) About how often do you use (Prilosec/Prevacid) for stomach problems?
1. Every day2. 4 to 6 days per week3. 2 to 3 days per week4. Once a week/weekly 5. Less often than once a week (1b) Thinking about the days when you use it, about how many times a day do you take (Prilosec/Prevacid) for these problems?
1. Once a day2. Twice a day3. Three or more times a day (1c) And how often did your doctor tell you to take it?
1. Once a day2. Twice a day3. Three or more times a day4. Use as needed5. Other (2a) Do you usually use (Prilosec/Prevacid):
1. Only before your symptoms start,2. Only after your symptoms start, or3. Sometimes before and sometimes after? (2b) Do you typically take (Prilosec/Prevacid) at the same time of day? (Yes or No)
(2c) What time or times of day do you typically take (Prilosec/Prevacid)?
1. Morning2. Lunchtime3. Afternoon4. Dinnertime5. Evening (after dinner)6. At bedtime7. During the night (after bedtime) (3a) Thinking about the days when you take (Prilosec/Prevacid), are there ever any of those days when you still have some heartburn,
acid indigestion, reflux or other stomach problems? (Yes or No.) Let’s call these breakthrough symptoms.
(3b) Thinking about the last 10 days that you took (Prilosec/Prevacid), on about how many of those days did you experience breakthrough
symptoms after you took (Prilosec/Prevacid)?
(3c) What time or times of day do you typically experience breakthrough symptoms?
(3d) At which of those times do you experience breakthrough symptoms most often?
(4a) Please tell me what percent of the time you do each of these things when you have breakthrough symptoms.
1. Take a nonprescription stomach remedy2. Take another (Prilosec/Prevacid) pill3. Just do nothing - you deal with the symptoms4. Do something else (specify) (4b) Did someone recommend that you take a nonprescription stomach remedy when you experience breakthrough symptoms
(Yes or No)
(4c) Thinking about the times you suffer breakthrough symptoms, over the past month what brand or brands of nonprescription stomach
remedies have you used for breakthrough symptoms on days when you take (Prilosec/Prevacid)?
(5) For what condition or conditions did the doctor prescribe (Prilosec/Prevacid)?
1. Heartburn/burning feeling in chest2. Reflux/acid reflux3. Acid indigestion/acid in stomach4. Upset stomach5. Stomach or intestinal cramps or pain6. Hiatal hernia7. Ulcer8. GERD/Gastroesophageal Reflux Disease9. Acid feeling in throat10. Other Stomach ailments (Specify) (6) How satisfied are you with (Prilosec/Prevacid). Use a 0-10 scale where "10" means you are extremely satisfied and"0" means you are
not at all satisfied.
(7a) Since you started taking (Prilosec/Prevacid), have you ever taken any nonprescription stomach remedies such as antacids or acid
reducers? (Yes or No)
(7b) About how often do you, yourself, use a nonprescription stomach remedy for problems such as heartburn, acid indigestion, reflux,
or problems such as ulcers or hiatal hernias?
1. Everyday/daily2. 2 to 6 times per week3. Once a week/weekly4. 2 to 3 times a month5. Once a month6. Less often than once a month (8) Do you ever take a nonprescription stomach remedy and (Prilosec/Prevacid) during the same day? (Yes or No)
(9) How safe do you feel it is to take both (Prilosec/Prevacid) and a nonprescription stomach remedy in the same day.
Please use the same 0 to 10 scale where "10" means you feel that it is extremely safe and "0" means you feel it is not safe at all.
*These questions were extracted from the script used by the telephone interviewers. Demographic questions were excluded from this Appendix.
Vol. 27 No. 4 • April 2002 • P&T® 203
PPI Usage and Acid Breakthrough Symptoms
Table 1 Survey Participants Representative of
Table 2 Reported PPI Usage Patterns
General Population of PPI Users
Among Survey Respondents
Target Population
Survey Participants
Usage Pattern
Proportion of Respondents (n=400)
Characteristic
of PPI Users*
Reported Frequency of PPI:
Use per Week
Age Distribution
Daily Regimen of PPI Use:
Reported Actual*
Prescribed PPI
Omeprazole (Prilosec)
Daily Regimen of PPI Use:
Prescribed
Once-a-day
*Targets established based on 1999 PPI retail sales data through October and NDTIdata on Prilosec and Prevacid.
RESULTS
The individuals interviewed in this study were representative
Time of Day for Typical PPI Administration
of the target population of PPI users in terms of age (median, 56 years), gender (59% female) and prescribed PPI (67% omeprazole), as shown in Table 1. Our respondents described the most common reason for their PPI use as being either“reflux” (51%) or heartburn (28%). Use of PPI in Relationship to Symptoms
Take only before symptoms begin
Pattern of PPI Usage
Table 2 summarizes the PPI usage pattern reported by respon-dents. The average omeprazole user among our sample had *Reported use on days when a PPI was taken.
been taking this PPI for three years (mean, 35.2 months),whereas the average lansoprazole duration of use was two dents indicating that they had experienced such symptoms years (mean, 23 months). Fewer than 15% of survey respon- on days when they took their PPIs. Of 175 individuals report- dents (13.5%) had been taking PPIs for less than six months.
ing acid-breakthrough symptoms, such symptoms were All had used PPI therapy at least once per week. In fact, 84% of reported on 28% of the days that PPIs were taken. Among the study sample reported daily PPI use, with only 4% report- respondents taking a PPI daily, acid breakthrough symp- ing the use of a PPI only once per week. Of note, 97% of the toms were experienced by 46% and occurred on 28% of the respondents indicated that their doctors had instructed them to take their PPIs daily, indicating that a significant minority Acid-breakthrough symptoms tended to occur most com- (approximately 13%) had opted for ‘on-demand’ therapy rather monly in the evening after dinner and at night (Figure 2).
than complying with the prescribed PPI regimen. On days Nearly one-half (48%) of our total cohort reported that these when they used a PPI, most respondents reported taking the symptoms interrupted their sleep; among these individuals, drug once daily (89%), and the majority (71%) reported routine- the average frequency of waking up was once every 3.5 ly taking their PPIs before the onset of symptoms. Only 9% of our sample reported taking their PPIs only after symptoms Over-the-counter (OTC) stomach remedies were used for presented. Nine of ten (90%) respondents indicated that they these acid breakthrough symptoms about half of the time. In typically took their PPIs at the same time of day, with morning this setting, the use of an additional PPI capsule occurred only about 5% of the time (Figure 3). Antacids were the mostcommon OTC remedy taken to treat acid-breakthrough symp- Breakthrough Symptoms
toms (Figure 2). Two-thirds (65%) of respondents who report- Acid-breakthrough symptoms—defined as heartburn, acid ed using OTC stomach remedies for acid-breakthrough indigestion, reflux, or other stomach problems—were com- symptoms added these medications to their PPI therapy with- mon among our sample of PPI users, with 44% of respon- 204 P&T® • April 2002 • Vol. 27 No. 4
PPI Usage and Acid Breakthrough Symptoms
Figure 2. Time of day respondents experienced breakthrough symptoms most often (n=175 respondents who reported Figure 3. Mean percent of time respondents reported an action in response to acid-breakthrough symptoms.
For those respondents who did not use OTC stomach were reportedly taken most often in the evening after dinner remedies conjointly with their PPIs, their explanations (33%) or at night (26%). These times correspond closely to the focused on concerns over mixing medicines (23%). periods most often associated with acid-breakthrough symp-toms (see Figure 2). Satisfaction with PPIs
All respondents were asked to rate how safe they believed it Respondents were asked to rate their level of satisfaction with was to take both a PPI and an OTC stomach remedy on the their PPIs on a scale of 0 (not at all satisfied) to 10 (extremely same day, using an 11-point scale (0=not at all safe; 10= satisfied). Overall, 59% of the 400 respondents indicated that extremely safe). Not surprising, only 8% of dual PPI/OTC users they were extremely satisfied with their PPIs. The number of rated this type of concomitant therapy as unsafe (scores of 0 to respondents rating extreme satisfaction with their PPIs 4) and 72% assigned it a high rating (8–10). By comparison, 33% declined to 34% among the subset of individuals experiencing of respondents who reported using only a PPI rated the use of a PPI and an OTC stomach remedy on the same day as unsafe (0–4), and only one-quarter gave it a high rating (8–10). More Concomitant Medication Use
PPI/OTC dual users than PPI-only users (43% vs. 25%) had dis- Respondents were queried about their use of OTC stomach cussed with their doctor the concomitant use of both medica- remedies irrespective of whether they experienced acid- tions—which might explain the apparent difference in the breakthrough symptoms. Nearly one-half (n=179, 45%) of PPI perceived safety of this combination.
users in this study reported having taken an OTC stomachremedy since they began using a PPI and within the past year; DISCUSSION
of these, 82% reported ever taking a PPI and OTC remedy on Our survey of a representative national sample of PPI users the same day. The gender and age distributions of these dual indicates that the majority of individuals taking these drugs PPI/OTC users were nearly identical to those for the entire for gastric acid-related illnesses appear to be very satisfied sample (61% female; median age of 55 years).
with the therapeutic results. Nevertheless, acid-breakthrough The majority (57%) of dual PPI/OTC users indicated that symptoms appear to be common among PPI users. Even they took OTC products for their stomach ailments at least among compliant individuals taking PPIs daily as directed by once per week, with 11% reporting that they needed to supple- their physicians, nearly one-half (46%) experienced acid- ment their PPIs with OTC medications daily. Dual PPI/OTC breakthrough symptoms. These symptoms tended to occur users took OTC remedies for an average of 9.5 days per during 28% of their days of PPI use. Such symptom break- month, or once every three days. Although most (78%) dual through decreased satisfaction with the prescribed PPI thera- PPI/OTC users reported taking an OTC remedy one to two py. Although such symptoms could occur at any time during times per day (on the days of OTC remedy use), nearly one- the day, acid-breakthrough symptoms seemed most common quarter (22%) indicated that they needed to take their OTC after dinner and at bedtime or overnight. About one-half of medications three or more times daily.
PPI users reported waking up because of acid-breakthrough Nearly all respondents (94%) who indicated that they used symptoms; among these individuals, sleep was interrupted by a PPI and an OTC remedy on the same day did not take the these symptoms an average of twice per week. two acid-relief medications at the same time of day. Among The high rate of acid-breakthrough symptoms while on this subset of dual PPI/OTC users (n=146), OTC remedies PPI therapy—particularly the frequent occurrence of noctur- Vol. 27 No. 4 • April 2002 • P&T® 205
PPI Usage and Acid Breakthrough Symptoms
nal breakthroughs—might be explained by insufficient night- including weight loss). The proper application of individual- time acid control with PPIs, as demonstrated in several stud- ized therapy can dramatically improve symptoms in patients ies.6-8 For example, Katz and colleagues reported that who suffer from gastroesophageal reflux. nocturnal acid breakthrough, defined objectively as gastric It is surprising to have found such a high level of break- pH below 4 continuously for more than 60 minutes, occurred through symptoms in PPI users, a group viewed by physi- in one-third of healthy volunteers receiving a seven-day cians as exceptionally satisfied with their therapy. There is course of treatment with twice-daily omeprazole 20 mg, and in certainly ample justification for closely questioning patients half of the volunteers receiving a similar course of treatment on prescription therapy for heartburn and related symptoms; with twice-daily lansoprazole 30 mg.6 Nocturnal acid break- physicians can and should recommend supplementary mea- through has been documented in as many as 70% of patients sures to provide more complete symptom relief. Such sugges- with gastroesophageal reflux on twice-daily PPI therapy7 and tions should often include the addition of bedtime H RA in 100% of the participants in one study involving a single therapy to the regimens of those PPI-takers who are experi- encing significant breakthrough symptoms.
Almost half (44%) of the daily PPI users interviewed in our study took OTC stomach remedies to control their break- CONCLUSION
through symptoms, and most (65%) did so without consulting We conclude that breakthrough symptoms are surprisingly their physicians. Antacids were the most common type of common in patients taking prescription therapy for heartburn OTC remedy taken by PPI users to treat acid-breakthrough and other upper GI-related symptoms. With our present symptoms. Antacids provide only relatively short-term acid knowledge of PPI pharmacology, particularly the likelihood control, which likely contributes to the substantial proportion that nocturnal acid breakthrough can be extremely common in of dual PPI/OTC users (22%) who reported having to take PPI users, rational combination therapy, including concomi- their OTC medications three or more times daily on those tant H RA use, should be recommended to patients. Further days when they needed an OTC remedy. Longer-term sup- longitudinal studies might include a direct assessment of quali- pression of gastric acid secretion can be achieved by a his- ty of life in patients reporting breakthrough symptoms, as well tamine H -receptor antagonist (H RA) such as famotidine or as their responses to recommended adjunctive measures, ranitidine.10 Several clinical groups have reported that night- including antacids, H RAs, and reinforcement of lifestyle modi- time administration of an H RA is effective in controlling noc- fications that might further ameliorate symptoms and reduce turnal acid breakthrough, and the effectiveness of bedtime H RAs has been shown to be greater than that of even a third dose of a PPI.8,11,12 Only a small proportion (6%) of our cohort REFERENCES
of dual PPI/OTC users reported using an H RA to treat acid- Tolman KG, Chandramouli J, Fang JC. Proton pump inhibitors in the treatment of gastro-oesophageal reflux disease. Expert Opin Pharmacother breakthrough symptoms, so it is not possible to assess the usage patterns or the success of this form of OTC stomach Sonnenberg A. Cost effectiveness of competing strategies to prevent or treat GORD-related dysphagia. Pharmacoeconomics 2000;17:391–401.
Bashford JNR, Norwood J, Chapman SR. Why are patients prescribed proton The most common reason cited by our PPI users for not tak- pump inhibitors? Retrospective analysis of link between morbidity and prescrib- ing an OTC stomach remedy to treat breakthrough symptoms ing in the General Practice Research Database. BMJ 1998;317:452–456.
was the fear of an adverse drug interaction. Although PPIs and Hungin AP, Rubin GP, O’Flanagan H. Long-term prescribing of proton pumpinhibitors in general practice. Br J Gen Pract 1999;49:451–453.
H RAs can influence the metabolism and clearance of other Pillans PI, Kubler PA, Radford JM, Overland V. Concordance between use of medications by interacting with the cytochrome P- (CYP-) 450 proton pump inhibitors and prescribing guidelines. Med J Aust 2000;172:16–18.
enzyme system, famotidine, nizatidine, and ranitidine, and the Katz PO, Hatlebakk JG, Castell DO. Gastric acidity and acid breakthroughwith twice-daily omeprazole and lansoprazole. Aliment Pharmacol Ther newer PPIs pantoprazole and rabeprazole, they are less likely to induce or inhibit CYP and thereby result in clinically signifi- Katz PO, Anderson C, Khoury R, Castell DO. Gastro-oesophageal reflux associ- cant drug interactions.13 Presumably physicians who are aware ated with nocturnal gastric acid breakthrough on proton pump inhibitors. Aliment Pharmacol Ther 1999;12:1231–1234.
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206 P&T® • April 2002 • Vol. 27 No. 4

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